NUTRITION & PRODUCE L ABELING GUIDE
Updated 2009 PMA
Nutrition & Produce Labeling Guide
Revised September 2008 by Produce1 Marketing Association, 1500 Casho Mill Road, P.O. Box 6036, Newark, DE 19714-6036. Telephone: (302) 738-7100. Fax: (302) 731-2409. Reproduction of any part of this material must be requested in writing and directed to the Produce Marketing Association. Table of Contents
Introduction ...... 3 Legal Overview...... 5 Mandatory Wax Labeling...... 7 Nutrition Labeling Overview...... 10 Nutrition Labeling Exemptions ...... 12 Nutrition Panel...... 13 A. Content ...... 13 B. Format ...... 14 C. Typesetting Rules...... 16 Reference Amounts and Serving Sizes ...... 19 Daily Values—RDIs and DRVs ...... 21 Nutrient Content Descriptors...... 22 Other Claims...... 26 Health Claims ...... 28 Dietary Guidance Statements ...... 45 Structure / Function Claims...... 46 Foodservice...... 47
Appendix A: Formats......
Appendix B: Typesetting Rules......
Appendix C: Nutrition Labels, Descriptors, and Health Claims for Fruits and Vegetables
Appendix D: Fruits and Vegetables Categorized by Descriptors and Health Claims ...... 161
Appendix E: Background Information on Health Claims, General Requirements...... 188
Appendix F: PMA Food Labeling Q&A...... 193
A. Ingredient List...... 193 B. Company Name and Address ...... 196 C. Product Identity Statement...... 198 D. Nutrient Content Claims...... 200 E. General Labeling Matters...... 202 F. Wax Labeling ...... 205 G. Country–of-Origin Labeling...... 206 H. Foreign Language and/or Export Labeling ...... 208 I. Fresh, Natural, Organic, and Negative Ingredient Claims...... 210 J. Health Claims ...... 213
Updated 2009 1 K. Net Quantity of Contents Statement ...... 216 L. Nutrition Labeling...... 219 M. Pesticide Labeling...... 223
Updated 2009 2 Introduction
This guide is intended to provide an longstanding, FDA labeling requirements— overview of food labeling requirements and such as product identity statement, claims, including: ingredient list, company address line, country-of-origin marking, etc.—are • clarification of wax labeling addressed in the "Food Labeling Question requirements; and Answer" documents found in Appendix F of this Guide. • detailed rules for the nutrition labeling of foods. Nutrition labeling is mandatory Appendix C includes nutrition data for a for most processed foods, but remains variety of fresh fruit and vegetables. Where voluntary for many raw foods, including possible, data are used that have been produce and seafood; approved by FDA. Where FDA approved data does not yet exist, values have been • uniform rules for declaration of serving selected from databases developed by PMA size; and its members, or from other sources, such as USDA's Handbook 8. While PMA • uniform definitions for terms that believes use of non FDA-approved data describe a food's nutrient content, such should not result in FDA regulatory action, as "light," "low fat," "high fiber"; such a result can never be assured.
• requirements for health claims. FDA Information contained in this document currently permits several claims about concerning labeling requirements has been the relationship between a nutrient and a synopsized specifically for fruits and disease, which may be made for vegetables and represents our best produce; interpretation of the new rules. However, administrative and judicial interpretations, • the U.S. Department of Agriculture as well as the rules themselves, are subject (USDA) has promulgated regulations to change. Some states also have laws that regarding “organic” claims. impact on food labeling. The general This Guide provides information that is presentation of FDA's rules in this document intended to be especially helpful in is not intended as, and does not constitute, understanding the major changes to food legal advice for particularized facts. For labeling laws that occurred with the passage your specific labeling needs, contact your of the Nutrition Labeling and Education Act legal counsel. (NLEA) of 1990. The following chapters If you have any questions or would like cover, in detail, major food labeling areas more information regarding the material such as wax labeling, nutrition labeling, reported in this document, contact PMA at nutrient content claims, health claims, 302-738-7100. The law firm of Keller and dietary guidance statements, and Heckman, which represents PMA, can also structure/function claims. Other, more
Updated 2009 3 answer regulatory/technical questions. Direct your questions to Mel Drozen at (202) 434-4222. Possible fees associated with Keller and Heckman's work on behalf of your firm can be discussed when you contact Mr. Drozen.
Updated 2009 4 Legal Overview
on the label. These details are found in The Federal Food, FDA's regulation at 21 C.F.R. section 101.105, which provides specific Drug, and instructions for complying with the requirement (e.g., the regulation provides Cosmetic Act the units that must be used for expressing weight and volume, placement for the statement on the label, required type size, The Federal Food, Drug, and Cosmetic Act etc.). (the Act) contains nearly all of the labeling requirements that apply to fresh produce items. More specifically, Section 403 of the Act contains an extensive list of labeling Prohibition on requirements for food products that must be satisfied in order to avoid a charge that a False or product is "misbranded" (misbranding is a violation of the Act). Misleading Label Section 403 of the Act consists of a fairly Information basic list of "do's" and "don'ts" for providing information on the food label. For example, this list includes requirements for a product One requirement of Section 403(a) of the identity statement, net quantity of contents Act deserves special mention because it statement, ingredient list, company name applies to every item of information that is and address, and nutrition labeling. The placed on the food label. This is the Food and Drug Administration is the federal prohibition against information that is "false agency with primary responsibility for or misleading" in any particular. 21 U.S.C. § implementing and enforcing the Act. In 343(a)(1). In deciding whether labeling is discharging this responsibility, the Agency "false or misleading," FDA looks not only at has issued numerous regulations over the direct representations made or suggested by years that describe in detail how the words, designs, statements, etc., but also at requirements of Section 403 of the Act are the extent to which representations fail to to be complied with. As one example of the reveal material facts. For example, FDA relationship between section 403 of the Act might view the claim "No Preservatives" as and FDA's regulations, consider section misleading if the product involved never 403(e)(2) of the Act, which states that a food contains preservatives and this fact is not in package form must bear a label providing disclosed on the label. In this situation, FDA the net quantity of contents. The statute might argue that, even though the "No itself does not provide details on how to Preservatives" claim is factual, it execute a net quantity of contents statement nevertheless implies a "specialness" about the product that does not exist.
Updated 2009 5 NLEA Changes to Food Labeling Law
Food labeling law underwent a number of dramatic changes with the passage in 1990 of the Nutrition Labeling and Education Act (NLEA). NLEA amended the Act by adding, among other things, sections 403(q) and 403(r). Section 403(q) requires nutrition labeling for most food products (as we will see, fresh fruits and vegetables are one of the few exceptions). The other major NLEA addition, section 403(r), establishes very specific rules for making claims about the levels of nutrients in a food (e.g., "fat free," "good source of vitamin A") and for making claims about the potential health benefits of certain foods (e.g., "low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, or vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors").
FDA issued regulations to implement the NLEA changes in January, 1993. The NLEA changes are given special coverage in this Guide because the regulations governing them are detailed and complex.
Updated 2009 6 Mandatory Wax Labeling
FDA requires wax labeling for fresh fruits and vegetables that have been treated with post-harvest wax or resin coatings. The How to Label discussion below provides information on what wording to use when declaring waxes, For packers, repackers, and shippers, the the method(s) that must be used to provide information must appear on the packing this information to consumers, and how to cartons. The lettering should be at least handle allergen labeling. one-quarter inch in height. (The minimum size requirement of one-fourth of an inch refers to the height of the lower case letter What to Say "o" when both upper and lower case lettering is used.)
Packers, repackers, shippers, and retailers of Packaged fresh fruits and vegetables that fresh fruits and vegetables treated with have information on the label (such as the post-harvest wax or resin coatings are product name, weight or brand) must also be required to label for the coatings. Coatings labeled for wax or resin coatings by the shall be declared by: packer, repacker, or shipper. In this case, the lettering must be at least one-sixteenth of an the phrase: "Coated with food-grade inch. This requirement also applies to animal-based wax, to maintain packaged fruit baskets. freshness" (followed by a list of the commodity (-ies) coated with this wax) Each retailer can determine how to display signs in the produce department, but the or the phrase: "Coated with food-grade FDA regulation does require the following: vegetable-, petroleum-, beeswax-, and/or shellac-based wax or resin, to maintain 1. The labeling must be displayed freshness" (followed by a list of the prominently and in a conspicuous manner commodity (-ies) coated with these with lettering at least one-fourth of an inch waxes or resins) high. (The minimum size requirement of one-fourth of an inch refers to the height of The terms food-grade and to maintain the lower case letter "o" when both upper freshness are optional. The term lac-resin and lower case lettering is used.) may be substituted for the term shellac. Petroleum-based must be used instead of 2. The agency advises that enforcement mineral-based for such coatings. action may be taken against retail establishments where wax or resin labeling is not prominently and conspicuously displayed.
Updated 2009 7 3. The type size requirement does not ingredient list followed by the name preclude retailers from providing of the food source from which the information through brochures, plastic bags, major food allergen is derived (e.g., electronic signs, computer screen displays or “semolina (wheat),” “whey (milk)”). other means using any type size. But such information is not an appropriate form of The name of the food source from which the labeling and, therefore, can only be done in major food allergen is derived is not addition to the signage required. required in parentheses next to the common or usual name of the food allergen in the ingredient list when the common or usual Allergens name uses the name of the food source or the name of the food source appears elsewhere in the ingredient list. The Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Pub. Law The term "name of the food source from 108-282) (FALCPA) amends the FD&C Act which the major food allergen is derived" to require more complete labeling of foods refers to these eight major food allergen that contain the eight most common food groups. However, in the case of tree nuts, allergens or ingredients derived from them. fish or crustacean shellfish, the specific type The eight most common allergens, defined in must be included in the declaration (e.g., new section 201(qq)(1) of the FD&C Act, almond, salmon, shrimp). are: (1) milk; (2) eggs; (3) fish (e.g., bass, FDA issued guidance on allergen labeling flounder, or cod); (4) crustacean shellfish that elaborates on what it considers to be (e.g., crab, lobster, or shrimp); (5) tree nuts included in the term "tree nuts" (besides (e.g., almonds, pecans, or walnuts); (6) almonds, pecans, and walnuts, which are wheat; (7) peanuts; and (8) soybeans. The already enumerated in FALCPA). "Tree term “major food allergens” also includes nuts" include the following: food ingredients that contain protein derived Almond; Beech nut; Brazil nut; from one of the eight. So, if a wax coating Butternut; Cashew; Chestnut contains allergenic protein it must be labeled (Chinese, American, European, pursuant to FALCPA. The new labeling Seguin); Chinquapin; Coconut; provisions went into effect on January 1, Filbert/hazelnut; Ginko nut; Hickory 2006. nut; Lichee nut; Macadamia nut/Bush nut; Pecan; Pine nut/Pinon FALCPA adds labeling provisions in a new nut; Pili nut; Pistachio; Sheanut; section 403(w) of the FD&C Act. The label Walnut (English, Persian, Black, must either: Japanese, California) Heartnut, Butternut. (1) use the word "contains" followed by the name of the food source from Spices, flavoring, colorings, or incidental which the major food allergen is additives that are or that bear or contain a derived (e.g., “Contains peanuts”) or major food allergen must also adhere to the above outlined labeling requirements (e.g., (2) bear the common or usual name of “natural flavor (almond)”). Highly refined the major food allergen in the oils that are derived from any of the major
Updated 2009 8 allergen groups and ingredients from these These regulations pre-empt any state highly refined oils are exempt from the regulations on wax labeling. However, labeling requirements. In addition, FALCPA please keep PMA informed if there is any includes a petition and notification process activity regarding waxes in your state. For to exempt certain food ingredients that more about wax labeling or PMA's position contain protein from one or more of the paper on waxes, call PMA at 302-738-7100. eight major allergen groups.
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1. The agency did not grant industry's request to allow the term "may have been treated with ...." However, as noted above, FDA is allowing for the use of "and/or" labeling for coatings because it "adequately informs the consumer of the generic category of wax or resin coating as well as provides the flexibility needed by industry."
2. The FDA does not require a separate label for beeswax- and shellac- (or lac-) based waxes or resins. However, a packer, repacker, or retailer can use a more narrow term such as "vegetable-based" or "beeswax- and shellac-based" if they choose, as long as the label is factual.
3. FDA does not object to a "no wax or resin" claim for produce that hasn't been coated, but the agency doesn't require such labeling.
4. For packers, repackers, shippers only: a. Post-harvest pesticides must be declared on the shipping container. b. Any dairy-based ingredients in the waxes or resins should be included in an "animal-based wax" declaration.
5. For retailers only: a. Fungicides that are applied with or without wax coatings do not need to be labeled at the retail level.
Updated 2009 9 Nutrition Labeling Overview
The Nutrition Labeling and Education Act will result in a more rigid and, perhaps, specifically exempted raw agricultural more extensive mandatory program. commodities (including raw fruit and vegetables) from the mandatory nutrition FDA has established an approved nutrition labeling requirements that apply to most database for Top 40 produce items. This foods in the general food supply. In place of information may be found at Title 21 of the mandatory nutrition labeling, the forty most Code of Federal Regulations, Appendix C to frequently consumed varieties of raw fruit Part 101. If nutrition information is and vegetables (hereinafter, "Top 40") are provided, either on packages or in stores, for subject to a voluntary program whereby any top 40 produce item, the FDA-approved retailers must provide nutrition labeling at nutrition values must be used. FDA intends the point of purchase. Raw commodities not to update the top 40 database every 4 years. belonging to the Top 40 list are generally For produce items not in the Top 40, not part of either the mandatory or voluntary manufacturers may want to conduct their program. However, if a nutrient content own testing of the nutrient levels in their claim is made for any fresh fruit or products, or they may want to use a reliable vegetable, whether Top 40 or otherwise, the database for this information. The main exemption disappears and nutrition labeling difference between use of the FDA approved at point of purchase becomes mandatory. database and any other database is that, if an approved database is used, and FDA The voluntary program is subject to FDA conducts compliance checking and finds evaluation every two years to determine inaccuracies, the Agency would work with whether there is substantial compliance at the company to correct the problem before the retail level. All compliance checks initiating regulatory action. In contrast, conducted by FDA thus far have found where a non-approved database had been substantial compliance. If any subsequent relied on, FDA might initiate regulatory evaluation reveals that substantial action against the company. compliance no longer exists, FDA will propose rules for making nutrition labeling for fresh fruit and vegetables mandatory. In Presentation of the event that FDA should make the program mandatory, the Agency will not be limited to requiring nutrition labeling for Nutrition just Top 40 items of produce. The statute empowers FDA to establish a mandatory Information program for all "frequently consumed" items of produce, and provides FDA with FDA has requirements for the nutrition flexibility in terms of how to define labeling of both packaged fresh produce and "frequently consumed." PMA urges retailers bulk produce sold in retail stores. The to comply with the voluntary program to requirements, which are summarized below avoid having FDA initiate rulemaking that and on the following page, should be
Updated 2009 10 followed whenever nutrition labeling is provided for fresh produce, whether top 40 items or otherwise. Nutrition Labeling Rules for Packaged Fresh Produce
In general terms, when nutrition labeling is provided for packaged fresh produce, the same rules apply as for processed food products. That is, a NUTRITION FACTS box must be used, and the same formatting and typesetting rules should be observed as for any other food product. The rules for processed foods and fresh produce items diverge in that for fresh produce, FDA does not require a "servings per container" declaration, although, when it is possible to calculate one, manufacturers are encouraged to provide this information. Examples of NUTRITION FACTS boxes are provided in Appendix A.
Rules for bulk produce, which are very similar to those of packaged fresh produce, are discussed in detail starting on page 15.
Updated 2009 11 Nutrition Labeling Exemptions
Under the Nutrition Labeling and Education • medical foods, such as those used to Act (NLEA), some foods are exempt from address the nutritional needs of patients nutrition labeling. Included among the with certain diseases. exemptions are: • foods with no significant amounts of any • food produced by small businesses (that nutrients (e.g., some coffee, tea, and is, those with food sales of less than spice products). $50,000 a year or total sales of less than $500,000). • foods in small packages (having less than 12 square inches of total surface • a second "small business" exemption area available to bear labeling) provided was instituted by Congress in August that an address or phone number is given 1993 for persons employing fewer than where nutrition information can be an average of 100 full-time equivalent obtained. employees and where fewer than 100,000 units of product were sold the Although these food are generally exempt, 12 months preceding the time the nutrition information may be provided for exemption was claimed. Persons these products on a voluntary basis provided claiming this exemption must provide the information complies with FDA's yearly notice to FDA. regulations.
• restaurant food and other food sold for Importantly, many of the exemptions immediate consumption, such as foods above—except for the exemption for bulk served in hospital and school cafeterias foods and medical foods—are negated if a and airplanes. nutrient content claim or health claim is made for a product. • ready-to-eat food prepared primarily on-site; for example, bakery, deli, and candy store items.
• food sold by food service vendors, such as mall cookie counters, sidewalk vendors, and vending machines.
• foods shipped in bulk, as long as they are not for sale in that form to consumers.
Updated 2009 12 Nutrition Panel
• vitamin C* Nutrition • calcium* • iron* Panel-Content • other essential vitamins and minerals ' (vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, The standard NUTRITION FACTS box folate, vitamin B12, biotin, pantothenic includes a title (e.g., NUTRITION FACTS), acid, phosphorus, iodine, magnesium, several column headings and footnotes, and zinc, selenium, copper, manganese, listings for fourteen food chromium, molybdenum, and chloride). components/nutrients. Manufacturers are free to include listings for a limited number These mandatory and voluntary nutrients/ of additional food components/nutrients if components are the only ones allowed they wish. The list below includes the within the NUTRITION FACTS box. Note mandatory and voluntary that, when claims are made for the components/nutrients that must/may be part "voluntary" food components/nutrients of the NUTRITION FACTS box. listed above, or when these "voluntary" nutrients are added to food to provide *-- denotes mandatory food components/ fortification, the nutrients may become nutrients mandatory components of the NUTRITION FACTS box. • total calories* • calories from fat* Factual information about these and other
• calories from saturated fat nutrients may be provided outside the box • total fat* provided that the statement specifies only
• saturated fat* the amount of the nutrient per serving and • trans fat* does not imply that there is a lot or a little of • polyunsaturated fat that nutrient in the product. Examples of • monounsaturated fat statements that might be made outside the • cholesterol* NUTRITION FACTS box include "Contains • sodium* X grams of beta-carotene per serving" or • potassium "Provides X g of beta-carotene per serving." • total carbohydrate* In contrast, statements not providing • dietary fiber* quantitative information, e.g., "Contains • soluble fiber beta-carotene" or "Provides beta-carotene" • insoluble fiber would not be permitted since, in FDA's • sugars* view, they imply that the product is a "good • sugar alcohols source" (i.e., 10-19% of RDI) for the • other carbohydrate nutrient and FDA has not established an • protein* RDI for beta-carotene. • vitamin A*
Updated 2009 13 under the standard format. Alternative Nutrition Panel: format options include: Format (i) footnote-to-the-side arrangement (Exhibit 2, Appendix A),
An example of the standard NUTRITION (ii) tabular standard format (Exhibit 3, FACTS box is provided on Exhibit 1 in Appendix A), Appendix A. This example reflects all of FDA's requirements for the standard format (iii) simplified format (Exhibit 4, with respect to content; however, the type Appendix A), sizes used in the example are larger than the minimum that could be used. Note that the (iv) abbreviated columnar (Exhibit 5, NUTRITION FACTS box contains two Appendix A), columns, one for the quantitative amount of each nutrient, and the other for the (v) abbreviated tabular (Exhibit 6, percentage of the Daily Value, except that Appendix A), and quantitative amounts are not provided for vitamins and minerals, and percent Daily (vi) abbreviated linear (Exhibit 7, Values are not provided for sugars and Appendix A). protein. (vii) Dual format (Exhibit 8, Appendix One of FDA's objectives in requiring a A); percent Daily Value column was to facilitate (viii) Multi-lingual format (Exhibit 9, consumer misunderstanding that might arise Appendix A); from providing quantitative amounts alone. For example, a food with 140 milligrams (ix) Aggregate format (Exhibit 10, (mg) of sodium could be mistaken for a Appendix A). high-sodium food because 140 is a relatively large number. In reality, however, that (i) Footnote-to-side amount represents less than 6 percent of the Daily Value for sodium, which is 2,400 mg. This option is available only if the space beneath the Daily Values declarations for Conversely, a food with 5 grams of saturated the mandatory vitamins and minerals is not fat could be construed as being low in that sufficient to accommodate the Daily Value nutrient. But, 5 grams of saturated fat footnote(s). represents one-fourth the total Daily Value, which is 20 grams. (ii) Tabular Standard Format
While the "standard" format depicted on This option is available for packages with Exhibit 1 in Appendix A represents the insufficient continuous vertical labeling general rule, several other format options space to accommodate the standard format. exist if certain criteria are met. In general, FDA has estimated that 3 inches is the these options either provide for alternative approximate minimum amount of placement of the same information that must continuous vertical labeling space needed to appear in the standard format, or they permit execute the standard format. the omission of one or more items required
Updated 2009 14 (iii) Simplified Format standard format. These special case formats include: This option is available for raw fruits and vegetables containing insignificant amounts (vii) Dual Format of 8 or more of 14 mandatory nutrients (calories, total fat, saturated fat, trans fat, This format is voluntary in most situations. cholesterol, sodium, total carbohydrate, It is only mandatory when a product is dietary fiber, sugars, protein, vitamin A, promoted on the label or in advertising for a vitamin C, calcium, and iron). FDA's use that differs in quantity by two-fold or regulations define an "insignificant amount" greater from the use upon which the as the amount of a nutrient that may be Reference Amount Customarily Consumed declared as zero, or, in some cases, as less is based. The format may be used on a than 1 gram. Note that the format shortens voluntary format to provide nutrition the list of nutrients that must be declared in information for a product both on the the amount/ serving column and also permits required per serving/ as packaged basis and the deletion of the mandatory nutrition (1) as consumed (e.g., raw potato versus guidance footnote. cooked potato); (2) per standard quantity of product (e.g., "per 100 grams); (3) per unit; (iv)-(vi) Abbreviated Formats or (4) based on population groups other than adults and children over 4 years of age. (Columnar, Tabular, Linear) (viii) Multi-lingual Format To qualify for these options, the food's package must have total surface area One of FDA's pre-NLEA labeling available to bear labeling of less than 40 requirements is that, if a label contains any square inches. Each of these options is representation in a second language, all termed "abbreviated" for two reasons: (1) required information must be given in both certain specified abbreviations are permitted English and the second language. Now that in declaring items within the Nutrition Facts nutrition labeling is mandatory for most box (e.g., "total carbohydrate" = "total foods, nutrition labeling falls within the carb"); and (2) the nutrition guidance scope of this rule. If dual language information footnote required on the declaration is required, it may be provided standard format can be omitted. either by using two (or more) Nutrition Facts boxes or by use of the aggregate FDA rules require that the columnar format format depicted on Exhibit 10, Appendix A. be used if feasible. The tabular format can be used if a package cannot accommodate (ix) Aggregate Format the columnar format or if there is less than 12 square inches of labeling space. The Products that contain two or more separately linear format should be used only as a last packaged foods that are intended to be eaten resort (i.e., the package cannot individually (e.g., salads with separate accommodate even the tabular format). packages of dressing, croutons, or bacon bits) must provide nutrition information for In addition to these alterative formats, each individual food within the package. certain "special case" formats exist for One option for satisfying this requirement is situations where manufacturers provide to use different Nutrition Facts boxes for more information than is required in the each variety. Another option is to use the
Updated 2009 15 aggregate format depicted on Exhibit 10, At least one point leading is required Appendix A. between most lines on the nutrition panel. However, four points leading is (x) Potassium required between the declarations of all nutrients. See Exhibit 1 in Appendix B An example of how to place potassium for a summary of these spacing values on the new label is found on Exhibit requirements. 11, Appendix A. • Kerning Nutrition Panel: Letters should never touch. Typesetting Rules • Type Size Column headings (e.g., "Amount/ FDA's typesetting and other formatting Serving" and "% Daily Value"), the requirements are designed to make the required footnote, and the Nutrition nutrition information panel as simple and Guidance information (i.e. the Daily uncluttered as possible. The rules attempt to Values for the eight macronutrients customize the panel so that, to a large extent, based on 2,000 and 2,500 calorie diets) nutrition information panels will have the must be in type size no smaller than 6 same general appearance regardless of the points. If the calorie conversion product. information is provided, it also must be in type size no smaller than 6 points. The • General Rules remaining information (e.g., serving size information, nutrient declarations, etc.) The nutrition information panel must be must be in type size no smaller than 8 set off in a box. points. The one exception is for the title "NUTRITION FACTS" which must be a The printed information must be black, type size greater than any other or, at least all one color. information appearing on the panel. These requirements are summarized in The background must be white or some Exhibit 2 in Appendix B. Packages with other neutral color. less than 12 square inches of available surface area can use all 6 point type or The title Nutrition Facts must, unless all uppercase type with one-sixteenth impractical, span the full length of the minimum height. panel. • Highlighting Units must accompany all declarations of nutrients, even if the reported Certain information must be highlighted amount/serving is zero (e.g., "0 grams," by use of bold or extra bold lettering or not just "0"). by some other means. Reverse highlighting is not permitted. The Both upper and lower case letters must following information must be be used. highlighted, and are summarized in Exhibit 3, Appendix B: • Spaces Between Lines
Updated 2009 16 o The title "NUTRITION FACTS" approach whereby information for multiple produce items is provided using the same o Column Headings chart, table, etc.
o All nutrients that are not indented When nutrition labeling is provided using the "individual" approach, whether on signs, o Daily Values (the % posters, brochures, notebooks, or leaflets, declarations) the NUTRITION FACTS box should be used, and all rules relating to content and • Use of Hairlines and Bars formatting described earlier should be followed. Hairline rules (thin lines) or bars (thick lines) must be used to separate many of When nutrition information is provided the required items of information on the using an "aggregate" approach, the nutrition panel. The required hairlines following rules apply: and bars are depicted in Exhibit 4, Appendix B. • The title "Nutrition Facts" must be in a type size larger than all other print on the nutrition label. The required information Rules for (i.e., heading, serving sizes, list of nutrients, quantitative amounts by Presentation of weight, and percent of Daily Values) must be clearly presented and of Nutrition sufficient type size and color contrast to be plainly legible, with numeric values Information in for percent of Daily Values highlighted in contrast to quantitative amounts by weight and hairlines between all Retail Stores nutrients.
Retail stores that provide nutrition labeling • The listing for saturated fat and for the top 40 fresh produce items as part of cholesterol may be omitted from the the voluntary program should display the charts or individual nutrition labels so information at the point of purchase by an long as the fact that most fruits and appropriate means, such as by a label affixed vegetables contain negligible amounts of to the food or through labeling, including these nutrients, but that avocados contain shelf labels, signs, posters, brochures, 1 gram (g) of fat per ounce, is stated in a notebooks, or leaflets, that are readily footnote (e.g., "Most fruits and available and in close proximity to the vegetables provide negligible amounts of foods. This information may be saturated fat and cholesterol; avocados supplemented by a video, live provide 1 g of saturated fat per ounce"). demonstration, or other media. The footnote may also contain information about the polyunsaturated Retailers have the option of using an and monounsaturated fat content of "individual" approach whereby separate avocados. nutrition labels are provided for Top 40 produce items, or using an "aggregate"
Updated 2009 17 • The footnote "Percent Daily Values are based on a 2000 calorie diet" (a standard feature of the NUTRITION FACTS box) may be omitted; however, FDA encourages retailers to include it.
• The "servings per container" declaration is not required.
Updated 2009 18 Reference Amounts and Serving Sizes
Determination of serving size is an are broken down into 139 FDA-regulated important component of nutrition labeling food product categories. They list the since all nutrient values are expressed on a amounts of food customarily consumed per "per serving" basis. FDA has developed a eating occasion for each category, based detailed set of rules for determining serving primarily on national food consumption size. These rules have imposed uniformity in surveys. the marketplace in that similar products have (or should have) identical or nearly identical serving sizes. FDA has structured its rules so Reference that the declared serving size should reflect an amount of the product that a consumer Amounts might reasonably be expected to consume during a single eating occasion. FDA's reference amounts and serving The first step in determining serving size is suggestions for fruits and vegetables are as to find the appropriate reference amount for follows: the product in question. Common reference amounts for produce and related products • Dried fruits: 40 grams are provided below. The second step in the ___ piece(s) (___g) for large pieces (e.g., process is to convert the reference amount dates, figs, prunes); ___cup(s) (___g) for into an amount of product expressed in a small pieces (e.g., raisins) common household measure (e.g., "1 apple," "1 1/2 cup salad"). • Fruits used primarily as ingredients, avocado: 30 g Serving size is the amount of food customarily eaten at one time. The serving • Fruits used primarily as ingredients, sizes that appear on food labels should be others (cranberries, lemons, limes): 55 based on FDA-established lists of Reference g Amounts Customarily Consumed Per Eating ___ piece(s) (___ g) for large fruits; Occasion. ___cup(s) (___g) for small fruits measurable by cup According to the regulation, FDA requires serving size to be stated in household terms, • Watermelon: 280 g followed by the metric equivalent in 1/18 medium melon; 2 cups diced pieces; parentheses. The additional ounces per 280 g; 10 oz serving (in parentheses) is optional [e.g., 1 1/2 cup (138 g) (5 oz)]. These reference amounts, which are part of the regulations,
Updated 2009 19 • All other fruits (fresh, canned, or • Vegetable sauces or purees, e.g. frozen): 140 g tomato sauce, tomato puree: 60 g ___piece(s) (___g) for large pieces (e.g., ___cup (___g); strawberries, apricots, etc.); ___cup (___ml) ___ cups) (___g) for small pieces (e.g., blueberries, raspberries, etc.) • Olives: 15 g ___piece(s) (___g); • Juices, nectars, fruit drinks, vegetable ___tbsp(s) (___g) for sliced products juice: 8 fl oz (240 mL) • Beans, plain or in sauce: 130 g for • Juices as ingredients, e.g. lemon juice, beans in sauce or canned in liquid and lime juice: 1 tsp (5 mL) refried beans prepared; 90 g for others prepared; 35 grams dry • Vegetables primarily used for garnish ___ cup (___ g) or flavor, e.g., pimento, parsley: 4 g ___piece(s) (___g); ___ tbsp(s) (___g) for • Bean cake (tofu), tempeh: 85 g chopped products ___piece(s) (___g) for discrete pieces; 3 oz (84 g/visual unit of measure) for bulk • Chili pepper, green onion: 30 g products. ___ piece(s) (___g); ___ tbsp(s) (___g); ___ cup(s) (___g) for sliced or chopped products
• All other vegetables without sauce: fresh, canned, or frozen: 85 g for fresh or frozen; 95 g for vacuum canned; 130 g for canned in liquid, cream-style corn, canned or stewed tomatoes, pumpkin, or winter squash ___piece(s) (___g) for large pieces (e.g., Brussels sprouts); ___cup(s) (___g) for small pieces (e.g., cut corn, green peas); 3 oz (84 g/visual unit of measure) if not measurable by cup
• All other vegetables with sauce; fresh, canned, or frozen: 110 g ___ piece(s) (___g) for large pieces (e.g., Brussels sprouts); ___ cup(s) (___g) for small pieces (e.g., cut corn, green peas); 4 oz (112 g/visual unit of measure) if not measurable by cup
• Vegetable pastes, e.g. tomato paste: 30 g ___tbsp (___ g)
Updated 2009 20 Daily Values
Pantothenic acid 10 milligrams Introduction Phosphorus 1.0 gram Iodine 150 micrograms FDA has established recommended dietary Magnesium 400 milligrams intakes for a number of food nutrients. The Zinc 15 milligrams recommended intakes for vitamins and Selenium 70 micrograms minerals are referred to as "reference daily Copper 2.0 milligrams intakes" (RDIs) In contrast, the Manganese 2.0 milligram recommended daily intakes for Chromium 120 micrograms macronutrients are referred to as "daily Molybdenum 75 micrograms reference values" (DRVs) The collective Chloride 3,400 milligrams term for RDIs and DRVs is "Daily Value." The more general "Daily Value" is the term used in the Nutrition Facts box. DRVs
RDIs For the purpose of labeling the percent of DRV, the following DRVs are established The following RDIs and nomenclature are for the following food components based on established for the following vitamins and the reference caloric intake of 2,000 minerals which are essential in human calories: nutrition: Fat, gram (g) 65 Vitamin A 5,000 International Saturated fatty acids, gram (g) 20 Units Cholesterol, milligrams (mg) 300 Vitamin C 60 milligrams Total carbohydrate, grams (g) 300 Calcium 1.0 gram (1,000 mg) Fiber, gram (g) 25 Iron 18 milligrams Sodium, milligrams (mg) 2,400 Vitamin D 400 International Units Potassium, milligrams (mg) 3,500 Vitamin E 30 International Units Protein, grams (g) 50 Vitamin K 80 micrograms
Thiamin 1.5 milligrams Riboflavin 1.7 milligrams Niacin 20 milligrams Vitamin B6 2.0 milligrams Folic acid or 2.0 milligrams folacin Vitamin B12 6 micrograms Biotin 0.3 milligram
Updated 2009 21 Nutrient Content Descriptors
bear a “free” claim if this fact is disclosed in Synonyms & the claim. (e.g. “Artichokes are a naturally Definitions of fat free food.”) • Fat free Descriptors Synonyms: Free of fat, no fat, zero fat, without fat, nonfat, trivial source of fat, negligible source of fat, or dietarily Nutrient content claims are claims that insignificant source of fat expressly or implicitly characterize the level of a nutrient in a food. Examples include Definition: less than 0.5 grams total fat "fat free," "good source of vitamin A," and per reference amount. Reference "reduced calorie." FDA has established amounts are noted earlier in this detailed requirements for nutrient content document. claims in the following areas: (1) nutrient levels that must be satisfied when making a • Saturated fat free claim; (2) permitted terms to use when Synonyms: free of saturated fat, no referring to the level of a nutrient. A saturated fat, zero saturated fat, without disclosure statement is required if the level saturated fat, trivial source of saturated of fat, saturated fat, cholesterol, or sodium fat, negligible source of saturated fat, or exceeds 13g, 4g, 60 mg, and 480 mg, dietarily insignificant source of respectively, per reference amount and per saturated fat labeled serving size, or for foods with reference amounts of 30 grams or less, per Definition: less than 0.5 grams saturated 50 grams of food. If required, the disclosure fat and less than 0.5 grams trans fatty statement would, for example, simply state acids per reference amount. Reference “See nutrition information for sodium amounts are noted earlier in this content”. Other ancillary label statements document. may be required on a case-by-case basis. • Sodium free Synonyms: free of sodium, no sodium, Free zero sodium, without sodium, trivial source of sodium, negligible source of This term means that a product contains no sodium, or dietarily negligible source of amount of, or only trivial or "physiologically sodium inconsequential" amounts of, one or more of these components: fat, saturated fat, Definition: less than 5 mg sodium per cholesterol, sodium, sugars, and calories. reference amount. Reference amounts Foods that are naturally “free” may only are noted earlier in this document.
Updated 2009 22 • Cholesterol free naturally “low” in a nutrient may only bear a Synonyms: free of cholesterol, zero “low” claim if this fact is disclosed. (e.g. cholesterol, without cholesterol, no “Apples are a naturally low fat food.”) cholesterol, trivial source of cholesterol, negligible source of cholesterol, or • Low fat dietarily insignificant source of Synonyms: low in fat, contains a small cholesterol amount of fat, low source of fat, or little fat Definition: 2 g or less of saturated fatty acids and less than 2 mg of cholesterol Definition: 3 g fat or less per reference per reference amount. If the fat content amount (or per 50 grams if the exceeds 13 g fat per labeled serving, per appropriate reference amount is 30 reference amount—and per 50 g if the grams/2 Tbsp or less). reference amount is not greater than 30 grams/2 tablespoons—then the label • Low cholesterol must declare the level of total fat per Synonyms: low in cholesterol, contains serving. If the food is also not inherently a small amount of cholesterol, low free of cholesterol, then the food must source of cholesterol, or a little contain at least 25% less cholesterol than cholesterol the food for which it substitutes. This declaration must be in immediate Definition: < 20 mg per reference proximity to the most prominent amount descriptor claim preceding the referral • Low saturated fat statement and in type size no less than Synonyms: low in saturated fat, 1/2 that of the descriptor claim. contains a small amount of saturated. Reference amounts are noted earlier in fat, low source of saturated fat, or a little this document. saturated fat Calorie free • Definition: 1 g saturated fat or less per Synonyms: calorie free, free of calories, reference amount and not more than no calories, zero calories, without 15% of calories from saturated fatty calories, trivial source of calories, acids. negligible source of calories, or dietarily insignificant source of calories. • Very low sodium Synonym: very low in sodium Definition: less than 5 calories per reference amount. Reference amounts Definition: 35 mg or less sodium per are noted earlier in this document. reference amount (or per 50 grams if the appropriate reference amount is 30 Low grams/2 Tbsp or less).
This term could be used on foods that could • Low sodium be eaten frequently without exceeding Synonyms: low in sodium, little sodium, dietary guidelines for one or more of these contains a small amount of sodium, or components: fat, saturated fat, cholesterol, low source of sodium sodium, and calories. Foods that are
Updated 2009 23 Definition: 140 mg or less sodium per Synonyms: contains or provides reference amount (or per 50 grams if the appropriate reference amount is 30 Definition: one serving of a food grams/2 Tbsp or less). contains 10-19% of the Daily Value for a particular nutrient. • Low-calorie Synonyms: few calories, contains a Good source of fiber: 10-19% of DV (2.5 small amount of calories, low source of grams - < 5 grams) calories, or low-calorie Good source of potassium: 10-19% of DV (350 mg - < 700 mg) Definition: 40 calories or less per Good source of vitamin A: 10-19% of DV reference amount (or per 50 grams if the (500 IU - < 1000 IU) appropriate reference amount is 30 Good source of vitamin C: 10-19% of DV (6 grams/2 Tbsp or less). mg - < 12 mg) Good source of folate: 10-19% of DV (40 High μg - < 80 μg) Good source of iron: 10-19% of DV This term can be used if the food contains (1.8mg-<3.6mg) 20 percent or more of the Daily Value for a particular nutrient per reference amount. Healthy
Synonyms: rich in and excellent source The term "healthy" and related terms such as "healthful," "healthfulness," "healthier," etc. Definition: one serving of a food may constitute a nutrient content claim when contains 20% or more of the Daily Value these terms are used in a nutritional context. for a particular nutrient. When "healthy" is used in a nutritional context, the food must: High in fiber: 20% or more of DV (5 grams or more) meet the definition for "low" in fat and High in potassium: 20% or more of DV (700 saturated fat; mg or more) High in vitamin A: 20% or more of DV where the reference amount is greater (1000 IU or more) than 30 g or 2 tablespoons, must not High in vitamin C: 20% or more of DV (12 contain more than 480 milligrams of mg or more) sodium per reference amount and per High in folate: 20% or more of DV (80 μg labeled serving; where the reference or more) amount is equal to or less than 30 grams High in iron: 20% or more of DV (3.6 mg or or 2 tablespoons, must not contain more more) than 480 mg per 50g.
contain no more than 60 milligrams of Good source cholesterol. This term can be used if the food contains contain at least 10% of the Daily Value 10 to 19 percent of the Daily Value for a of either fiber, protein, vitamin A, particular nutrient per reference amount. vitamin C, calcium, or iron.
Updated 2009 24 Raw fruits and vegetables and frozen or canned single ingredient fruits and vegetables and mixtures of frozen or canned single ingredient fruits and vegetables are exempt from this requirement. Ingredients whose addition does not change the nutrient profile of the frozen or canned fruit/s or vegetable/s may be added to these products.
Updated 2009 25 Other Claims
USDA’s National Organic Program (NOP) Fresh requires that operations that intend to produce or handle organic products or The regulation defines the term fresh when it ingredients to obtain organic certification is used to suggest that a food is raw or through a USDA-accredited certifying unprocessed. In this context, fresh can be agent. Applicants seeking certification are used only on a food that is raw, has never required to submit an “Organic Plan” to been frozen or heated, and contains no demonstrate compliance with USDA’s preservatives. (Irradiation at low levels is production and/or handling standards. allowed.) Fresh frozen, frozen fresh, and Organic certification is available only for freshly frozen can be used for foods that are “agricultural products,” broadly defined to quickly frozen while still fresh. Blanching include crops, livestock, and certain (brief scalding before freezing to prevent processed products containing agricultural nutrient breakdown) is allowed. commodities. The addition of approved waxes or coatings; The percentage of organic ingredients in the post-harvest approved pesticides; mild product determines both the specific chlorine wash or mild acid wash; or marketing terms and the type of nonorganic treatment with 1 kiloGray of ionizing ingredients that may be used. The radiation does not preclude produce from regulations set forth four categories of use of the term fresh. Other uses of the term products that may, to varying degrees, be fresh, such as in fresh milk or freshly baked represented as organic or containing organic bread, are not affected. ingredients:
Natural • 100% organic products may be marketed as “100% organic” FDA has no specific regulations for "all • Products with no less than 95% organic natural" claims. FDA's informal policy is ingredients may be represented as that "natural" means that nothing artificial or “organic” synthetic (including all color additives • Products that contain at least 70% regardless of source) has been included in, organic ingredients may be marketed as or has been added to, a food that would not “made with organic” (specified normally be expected to be in the food. ingredients/food groups), naming up to three specific organic ingredients or food Organic groups • Products in package form that are less than 70% organic may identify specific FDA has no specific regulations for organic ingredients in the list of "organic" claims, although the USDA has ingredients promulgated regulations in this area.
Updated 2009 26 A product’s organic composition is determined by calculating the percentage of organic ingredients in the product (by weight or fluid volume) exclusive of water and salt.
USDA has carefully limited the circumstances under which non-organic ingredients are permitted in products represented as “organic” or “made with organic” (specified ingredients/food groups). For both types of products, non-organic ingredients may be used only if the ingredients are permitted under the National List of Allowed and Prohibited Substances set forth in the regulations. In addition, for organic products, non-organic ingredients that are agricultural products may be used only if the certified operation has documented that organic versions of the ingredients are not “commercially available.”
Updated 2009 27 Health Claims
• Health claims must not specify any Introduction degree of risk reduction when discussing the benefit of a particular nutrient/food in the diet. Health claims are claims that characterize the relationship between a nutrient/food and • Words such as "may" or "might' 'are a disease/health-related condition. Health required to be used when discussing the claims may take the form of statements, potential health benefits of a particular third-party endorsements, symbols (e.g., the nutrient/food. heart), etc. • Mandatory nutrition labeling is triggered Health claims are permitted on labels and in whenever a health claim is made. labeling only if the claims have been pre-approved by FDA and are made in • A food is not permitted to bear a health conformance with FDA's authorizing claim if it contains any nutrient which regulation for making the claim, or an FDA finds by regulation is present in an authoritative statement notification has been amount which exposed members of the filed with FDA and FDA has not objected to general population to an increased risk the proposed health claim based on the of disease or other adverse diet-related statement. FDA currently permits several condition. Toward this end, FDA has health claims, some of which are discussed established threshold limits for fat, in more detail in the following pages. saturated fat, cholesterol, and sodium. Raw produce items will almost always General Requirements be well below these limits. However, these limits may be applicable for FDA has established a number of "kit"-type products (such as salad kits) requirements when health claims are made where produce items are sold in on labels or in labeling. Some of these conjunction with processed items. requirements apply whenever any health claim is made; other requirements are • FDA requires most foods bearing a specific to the particular health claim that is health claim to contain, prior to being made. Among the general fortification, one of the following six requirements that apply whenever a health nutrients at a level of 10% or more of the claim is made are the following: reference daily intake (RDI) or daily reference value (DRV): vitamin A, • The health claim must be worded in such vitamin C, iron, calcium, protein, or a way as to enable the public to fiber. The Jelly Bean rule most likely comprehend the information provided does not apply to health claims based on and to understand the significance of an authoritative statement notification. such information in the context of a total daily diet.
Updated 2009 28 fortification, be a good source of dietary Health Claims on fiber. The fruits and vegetables listed in this publication that PMA believes Fiber-Containing qualify for this health claim are noted in Fruits, Appendix D. • Other Specific Requirements:
Vegetables, and (A) The claim states that diets low in fat and high in fiber-containing grain products, Grain Products fruits, and vegetables may or might reduce and Cancer (21 the risk of some cancers; (B) In specifying the disease, the claim C.F.R. § 101.76) must use the following terms: some types of cancer, or some cancers;
Specific requirements for making some of (C) The claim is limited to grain products, the health claims that are currently permitted fruits, and vegetables that contain dietary are detailed below (the other claims are not fiber; discussed because they are not relevant to produce). Consult Appendix E for other (D) The claim indicates that development important information on health claims for of cancer depends on many factors; produce. (E) The claim does not attribute any • Claim Examples: Low fat diets rich in degree of cancer risk reduction to diets low fiber-containing fruits, vegetables, and in fat and high in fiber-containing grain grain products may reduce the risk of products, fruits, and vegetables; some types of cancer, a disease affected by many factors. Bananas are low in fat (F) In specifying the dietary fiber and a good source of fiber. See the component of the labeled food, the claim poster in the produce department for uses the term fiber, dietary fiber, or total nutrition information on bananas; or dietary fiber; and Development of cancer depends on many factors. Eating a diet low in fat and high (G) The claim does not specify types of in grain products, fruits, and vegetables dietary fiber that may be related to risk of that contain dietary fiber may reduce cancer. your risk of some cancers. Bananas are low in fat and a good source of fiber. See • Optional Information. the poster in the produce department for nutrition information on bananas. If the (A) The claim may include information nutrition information is not immediately from sections (i) through (iv) below. next to the claim, you must reference where to find the nutrient information. (i) Cancer is a constellation of more than 100 different diseases, each • Criteria: A food must be/contain a grain characterized by the uncontrolled growth product, fruit, or vegetable and meet the and spread of abnormal cells. Cancer has requirements for low fat and, without many causes and stages in its development.
Updated 2009 29 Both genetic and environmental risk factors (B) The claim may identify one or more may affect the risk of cancer. Risk factors of the following risk factors for development include: A family history of a specific type of cancer: Family history of a specific type of cancer, cigarette smoking, overweight of cancer, cigarette smoking, overweight and obesity, alcohol consumption, and obesity, alcohol consumption, ultraviolet or ionizing radiation, exposure to ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary cancer causing chemicals, and dietary factors. factors.
(ii) The scientific evidence (C) The claim may indicate that it is establishes that diets low in fat and high in consistent with Nutrition and Your Health: fiber containing grain products, fruits, and Dietary Guidelines for Americans, U.S. vegetables are associated with a reduced risk Department of Agriculture (USDA) and of some types of cancer. Although the Department of Health and Human Services specific role of total dietary fiber, fiber (DHHS), Government Printing Office. components, and the multiple nutrients and other substances contained in these foods are (D) The claim may include information not yet fully understood, many studies have on the number of people in the United States shown that diets low in fat and high in who have cancer. The sources of this fiber-containing foods are associated with information must be identified, and it must reduced risk of some types of cancer. be current information from the National Center for Health Statistics, the National (iii) Cancer is ranked as a leading Institutes of Health, or Nutrition and Your cause of death in the United States. The Health: Dietary Guidelines for Americans, overall economic costs of cancer, including USDA and DHHS, Government Printing direct health care costs and losses due to Office. morbidity and mortality, are very high.
(iv) U.S. diets tend to be high in fat and low in grain products, fruits, and Health Claims on vegetables. Studies in various parts of the world indicate that populations who Fruits and habitually consume a diet high in plant foods have lower risks of some cancers. Vegetables and These diets generally are low in fat and rich in many nutrients, including, but not limited Cancer (21 C.F.R. to, dietary fiber. Current dietary guidelines from Federal government agencies and § 101.78) nationally recognized health professional organizations recommend decreased • Claim Examples: Low fat diets rich in consumption of fats (less than 30 percent of fruits and vegetables (foods that are low calories), maintenance of desirable body in fat and may contain dietary fiber, weight, and increased consumption of fruits vitamin A, or vitamin C) may reduce the and vegetables (five or more servings daily), risk of some types of cancer, a disease and grain products (six or more servings associated with many factors. Broccoli is daily). low in fat and high in vitamin C See the
Updated 2009 30 brochure in the produce department for (E) The claim does not attribute any nutrition information on broccoli; or degree of cancer risk reduction to diets low in fat and high in fruits and vegetables; Development of cancer depends on many factors. Eating a diet low in fat and high (F) In specifying the fat component of the in fruits and vegetables, foods that are labeled food, the claim uses the term total low in fat and may contain vitamin A, fat or fat; vitamin C and dietary fiber, may reduce your risk of some cancers. Broccoli, a (G) The claim does not specify types of food low in fat, is high in vitamin C. See fats or fatty acids that may be related to risk the brochure in the produce department of cancer; for nutrition information on broccoli. If the nutrition information is not (H) In specifying the dietary fiber immediately next to the claim, you must component of the labeled food, the claim reference where to find the nutrient uses the term fiber, dietary fiber, or total information. dietary fiber;
• Criteria: This claim may be made for (I) The claim does not specify types of fruits and vegetables that meet the dietary fiber that may be related to risk of requirements for low fat and, without cancer; and fortification, for good source of fiber or vitamins A or C. The fruits and (J) The claim indicates that development vegetables listed in this document that of cancer depends on many factors. PMA believes qualify for this health • Optional Information: claim are listed in Appendix D. (A) The claim may include information Other Requirements: • from sections (i) through (iv) below, which (A) The claim states that diets low in fat summarizes the relationship between diets and high in fruits and vegetables may or low in fat and high in fruits and vegetables might reduce the risk of some cancers; and some types of cancer and the relationship's significance. (B) In specifying the disease, the claim uses the following terms: some types of (i) Cancer is a constellation of more cancer, or some cancers; than 100 different diseases, each characterized by the uncontrolled growth (C) The claim characterizes fruits and and spread of abnormal cells. Cancer has vegetables as foods that are low in fat and many causes and stages in its development. may contain vitamin A, vitamin C, and Both genetic and environmental risk factors dietary fiber; may affect the risk of cancer. Risk factors include a family history of a specific type of (D) The claim characterizes the food cancer, cigarette smoking, alcohol bearing the claim as containing one or more consumption, overweight and obesity, of the following, for which the food is a ultraviolet or ionizing radiation, exposure to good source of dietary fiber, vitamin A, or cancer-causing chemicals, and dietary vitamin C; factors.
Updated 2009 31 (ii) Although the specific roles of the fruits and vegetables which contain dietary numerous potentially protective substances fiber, vitamin A, and vitamin C. in plant foods are not yet understood, many studies have shown that diets high in plant (B) The claim may identify one or more foods are associated with reduced risk of of the following risk factors for development some types of cancers. These studies of cancer: Family history of a specific type correlate diets rich in fruits and vegetables of cancer, cigarette smoking, alcohol and nutrients from these diets, such as consumption, overweight and obesity, vitamin C, vitamin A, and dietary fiber, with ultraviolet or ionizing radiation, exposure to reduced cancer risk. Persons consuming cancer-causing chemicals, and dietary these diets frequently have high intakes of factors. these nutrients. Currently, there is not scientific agreement as to whether the (C) The claim may use the word beta- observed protective effects of fruits and carotene in parentheses after the term vegetables against cancer are due to a vitamin A, provided that the vitamin A in combination of the nutrient components of the food bearing the claim is beta-carotene. diets rich in fruits and vegetables, including but not necessarily limited to dietary, fiber, (D) The claim may indicate that it is vitamin A (as beta-carotene) and vitamin C, consistent with Nutrition and Your Health: to displacement of fat from such diets, or to Dietary Guidelines for Americans, U.S. intakes of other substances in these foods Department of Agriculture (USDA) and the which are not nutrients but may be Department of Health and Human Services protective against cancer risk. (DHHS), Government Printing Office.
(iii) Cancer is ranked as a leading (E) The claim may include information on cause of death in the United States. The the number of people in the United States overall economic costs of cancer, including who have cancer. The sources of this direct health care costs and losses due to information must be identified, and it must morbidity and mortality, are very high. be current information from the National Center for Health Statistics, the National (iv) U.S. diets tend to be high in fat Institutes of Health, or Nutrition and Your and low in fruits and vegetables. Studies in Health: Dietary Guidelines for Americans, various parts of the world indicate that USDA and DHHS, Government Printing populations who habitually consume a diet Office. high in plant foods have lower risks of some cancers. These diets generally are low in fat and rich in many nutrients, including, but not limited to, dietary fiber, vitamin A (as beta-carotene), and vitamin C. Current dietary guidelines from Federal Government agencies and nationally recognized health professional organizations recommend decreased consumption of fats (less than 30 percent of calories), maintenance of desirable body weight, and increased consumption of fruits and vegetables (5 or more servings daily), particularly those
Updated 2009 32 panel. If the nutrition information is not Health Claims on immediately next to the claim, you must reference where to find the nutrient Fruits, information. Vegetables and • Criteria: A food must be/contain fruits, vegetables, or grain products and must Grain Products meet the requirements for low saturated fat, low-cholesterol, and low fat and contain, without fortification, at least 0.6 that Contain g soluble fiber per reference amount. (Industry data for soluble fiber is Fiber and Risk of limited. Until more data is available, this claim would be limited to a handful of Coronary Heart fruits and vegetables that have adequate data.) The fruits and vegetables listed in Disease (CHD) this document that PMA believes qualify for this health claim are listed in (21 C.F.R Appendix D.
§ 101.77) • Other Requirements: (A) The claim states that diets low in • Claim Examples: Diets low in saturated saturated fat and cholesterol and high in fat and cholesterol and rich in fruits, fruits, vegetables, and grain products that vegetables, and grain products that contain fiber may or might reduce the risk of contain certain types of dietary fiber heart disease; may reduce the risk of heart disease, a disease affected by many factors. (B) In specifying the disease, the claim Bananas are low fat and contain uses the following terms: heart disease or negligible saturated fat, have no coronary heart disease; cholesterol, and are a good source of fiber. See the banana nutrition (C) The claim is limited to those fruits, information on the reverse side of this vegetables, and grains that contain fiber; panel; or (D) In specifying the dietary fiber, the Development of heart disease depends claim uses the term fiber, dietary fiber, some on many factors. Eating a diet low in types of dietary fiber, some dietary fibers, or saturated fat and cholesterol and high in some fibers; the term soluble fiber may be fruits, vegetables, and grain products used in addition to these terms; that contain fiber may lower blood cholesterol levels and reduce your risk (E) In specifying the fat component, the of heart disease. Bananas are low fat, claim uses the terms saturated fat and contain negligible saturated fat, have no cholesterol; cholesterol, and are a good source of fiber. See the banana nutrition (F) The claim indicates that development information on the reverse side of this of heart disease depends on many factors; and
Updated 2009 33 (G) The claim does not attribute any levels of 160 mg/dL (4.13 mmol/L) or degree of risk reduction for coronary heart above. Borderline high risk blood disease to diets low in saturated fat and cholesterol levels range from 200 to 239 cholesterol and high in fruits, vegetables, mg/dL (5.17 to 6.18 mmol/L) and 130 to and grain products that contain fiber. 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) • Optional Information: include fatty acids and cholesterol. Total fat, commonly referred to as fat, is composed of (A) The claim may identify one or more saturated fat (fatty acids containing no of the following risk factors for heart disease double bonds), and monounsaturated and about which there is general scientific polyunsaturated fat (fatty acids containing agreement: A family history of coronary one or more double bonds). heart disease, elevated blood-, total- and LDL-cholesterol, excess body weight, high (ii) The scientific evidence blood pressure, cigarette smoking, diabetes, establishes that diets high in saturated fat and physical inactivity. and cholesterol are associated with increased levels of blood totaland LDL-cholesterol (B) The claim may indicate that the and, thus, with increased risk of coronary relationship of diets low in saturated fat and heart disease. Diets low in saturated fat and cholesterol, and high in fruits, vegetables, cholesterol are associated with decreased and grain products that contain fiber to heart levels of blood total- and LDL-cholesterol, disease is through the intermediate link of and thus, with decreased risk of developing blood cholesterol or blood total and coronary heart disease. LDL-cholesterol. (iii) Populations with relatively low (C) The claim may include information blood cholesterol levels tend to have dietary from sections (i) through (vii) below, which patterns that are not only low in total fat, summarize the relationship between diets especially saturated fat and cholesterol, but low in saturated fat and cholesterol and high are also relatively high in fruits, vegetables, in fruits, vegetables, and grain products that and grain products. Although the specific contain fiber and coronary heart disease, and roles of these plant foods are not yet fully the significance of the relationship. understood, many studies have shown that diets high in plant foods are associated with (i) Cardiovascular disease means reduced risk of coronary heart disease. diseases of the heart and circulatory system. These studies correlate diets rich in fruits, Coronary heart disease is the most common vegetables, and grain products and nutrients and serious form of cardiovascular disease from these diets, such as some types of fiber, and refers to diseases of the heart muscle with reduced coronary heart disease risk. and supporting blood vessels. High blood Persons consuming these diets frequently total- and low density lipoprotein have high intakes of dietary fiber, (LDL)-cholesterol levels are major particularly soluble fibers. Currently, there modifiable risk factors in the development is not scientific agreement as to whether a of coronary heart disease. High coronary particular type of soluble fiber is beneficial, heart disease rates occur among people with or whether the observed protective effects of high blood cholesterol levels of 240 fruits, vegetables, and grain products against milligrams per deciliter (mg/dL) (6.21 heart disease are due to other components, mmol/L) or above and LDL-cholesterol or a combination of components, in these
Updated 2009 34 diets, including, but not necessarily limited Intakes of fiber-containing fruits, vegetables, to, some types of soluble fiber, other fiber and grain products are about half of components, other characteristics of the recommended intake levels. One of the complex carbohydrate content of these major public health recommendations foods, other nutrients in these foods, or relative to coronary heart disease risk is to displacement of saturated fat and cholesterol consume less than 10 percent of calories from the diet. from saturated fat, and an average of 30 percent or less of total calories from all fat. (iv) Coronary heart disease is a Recommended daily cholesterol intakes are major public health concern in the United 300 mg or less per day. Recommended total States, primarily because it accounts for dietary fiber intakes are about 25 grams (g) more deaths than any other disease or group daily, of which about 25 percent (about 6 g) of diseases. Early management of risk should be soluble fiber. factors for coronary heart disease is a major public health goal that can assist in reducing (vii) Current dietary guidance risk of coronary heart disease. There is a recommendations encourage decreased continuum of mortality risk from coronary consumption of dietary fat, especially heart disease that increases with increasing saturated fat and cholesterol, and increased levels of blood LDL-cholesterol. Individuals consumption of fiber-rich foods to help with high blood LDL-cholesterol are at lower blood LDL-cholesterol levels. Results greatest risk. A larger number of individuals of numerous studies have shown that with more moderately elevated cholesterol fiber-containing fruits, vegetables, and grain also have increased risk of coronary events; products can help lower blood such individuals comprise a substantial LDL-cholesterol. proportion of the adult U.S. population. The scientific evidence indicates that reducing (D) In specifying the nutrients, the claim saturated fat and cholesterol intakes lowers may include the term total fat in addition to blood LDL-cholesterol and risk of heart the terms saturated fat and cholesterol. disease in most individuals, including persons with blood cholesterol levels in the (E) The claim may indicate that it is normal range. Additionally, consuming diets consistent with Nutrition and Your Health: high in fruits, vegetables, and grain Dietary Guidelines for Americans, U.S. products, foods that contain soluble fiber, Department of Agriculture (USDA) and may be a useful adjunct to a low saturated Department of Health and Human Services fat and low cholesterol diet. (DHHS), Government Printing Office (GPO). (v) Other risk factors for coronary heart disease include a family history of (F) The claim may state that individuals heart disease, high blood pressure, diabetes, with elevated blood total- and LDL- cigarette smoking, obesity (body weight 30 cholesterol should consult their physicians percent greater than ideal body weight), and for medical advice and treatment. If the lack of regular physical exercise. claim defines high or normal blood total- and LDL-cholesterol levels, then the claim (vi) Intakes of saturated fat exceed shall state that individuals with high blood recommended levels in many people in the cholesterol should consult their physicians United States. Intakes of cholesterol are, on for medical advice and treatment. average, at or above recommended levels.
Updated 2009 35 (G) The claim may include information (A) The claim states that diets low in fat on the number of people in the United States may or might reduce the risk of some who have heart disease. The sources of this cancers; information shall be identified, and it shall be current information from the National (B) In specifying the disease, the claim Center for Health Statistics, the National uses the following terms: some types of Institutes of Health, or Nutrition and Your cancer or some cancers; Health: Dietary Guidelines for Americans, USDA and DHHS, GPO. (C) In specifying the nutrient, the claim uses the term total fat or fat;
(D) The claim does not specify types of Health Claims on fat or fatty acid that may be related to the Fat and Cancer risk of cancer; (E) The claim does not attribute any (21 C.F.R. § degree of cancer risk reduction to diets low 101.73) in fat; and (F) The claim indicates that the development of cancer depends on many • Claim Examples: Development of factors. cancer depends on many factors. A diet low in total fat may reduce the risk of • Optional Information: some cancers. Broccoli is low in fat. (If the nutrition information is immediately (A) The claim may identify one or more next to the claim, a reference about of the following risk factors for development where to find it is not necessary,) or of cancer: Family history of a specific type of cancer, cigarette smoking, alcohol Eating a healthful diet low in fat may consumption, overweight and obesity, help reduce the risk of some types of ultraviolet or ionizing radiation, exposure to cancers. Development of cancer is cancer-causing chemicals, and dietary associated with many factors, including factors. a family history of the disease, cigarette smoking, and what you eat. Broccoli is (B) The claim may include information low in fat. from sections (i) through (vi) below, which summarize the relationship between dietary • Criteria: A food must meet the fat and cancer and the significance of the descriptor requirements of low fat. The relationship. fruits and vegetables listed in this document that PMA believes qualify for (i) Cancer is a constellation of more this health claim are found in Appendix than 100 different diseases, each D. characterized by the uncontrolled growth and spread of abnormal cells. Cancer has • Other Requirements: many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include a family history of a specific type of
Updated 2009 36 cancer, cigarette smoking, alcohol (vi) U.S. diets tend to be high in fat consumption, overweight and obesity, and high in calories. The average U.S. diet is ultraviolet or ionizing radiation, exposure to estimated to contain 36 to 37 percent of cancer-causing chemicals, and dietary calories from total fat. Current dietary factors. guidelines from the Federal Government and other national health professional (ii) Among dietary factors, the organizations recommend that dietary fat strongest positive association has been intake be reduced to a level of 30 percent or found between total fat intake and risk of less of energy (calories) from total fat. In some types of cancer. Based on the totality order to reduce intake of total fat, of the publicly available scientific evidence, individuals should choose diets which are there is significant scientific agreement high in vegetables, fruits, and grain products among experts, qualified by training and (particularly whole grain products), choose experience to evaluate such evidence, that lean cuts of meats, fish, and poultry, diets high in total fat are associated with an substitute low-fat dairy products for higher increased cancer risk. Research to date, fat products, and use fats and oils sparingly. although not conclusive, demonstrates that the total amount of fats, rather than any (C) The claim may indicate that it is specific type of fat, is positively associated consistent with Nutrition and Your Health: with cancer risk. The mechanism by which Dietary Guidelines for Americans, U.S. total fat affects cancer has not yet been Department of Agriculture (USDA) and established. Department of Health and Human Services (DHHS), Government Printing Office. (iii) A question that has been the subject of considerable research is whether (D) The claim may include information the effect of fat on cancer is site-specific. on the number of people in the United States Neither human nor animal studies are who have cancer. The sources of this consistent in the association of fat intake information must be identified, and it must with specific cancer sites. be current information from the National Center for Health Statistics, the National (iv) Another question that has been Institutes of Health, or Nutrition and Your raised is whether the association of total fat Health: Dietary Guidelines for Americans, intake to cancer risk is independently USDA and DHHS, Government Printing associated with energy intakes, or whether Office. the association of fat with cancer risk is the result of the higher energy (caloric) intake normally associated with high fat intake. FDA has concluded that evidence from both animal and human studies indicates that total fat intake alone, independent of energy intake, is associated with cancer risk.
(v) Cancer is ranked as a leading cause of death in the United States. The overall economic costs of cancer, including direct health care costs and losses due to morbidity and mortality, are very high.
Updated 2009 37 Many factors, such as a family history of Health Claims on the disease, increased blood- and LDL cholesterol levels, high blood pressure, Saturated Fat cigarette smoking, diabetes, and being overweight, contribute to developing and Cholesterol heart disease. A diet low in saturated fat, cholesterol, and total fat may help and Coronary reduce the risk of heart disease. Broccoli is a low fat vegetable; or
Heart Disease Diets low in saturated fat, cholesterol, and total fat may reduce the risk of heart (CHD) (21 C.F.R. disease. Heart disease is dependent upon many factors, including diet, a family 101.75) history of the disease, elevated blood LDL-cholesterol levels, and physical • Claim Examples: Although many inactivity. Broccoli is a low fat factors affect heart disease, diets low in vegetable. saturated fat and cholesterol may reduce the risk of this disease. Broccoli contains Remember, if the nutrition information is no cholesterol, a negligible amount of not immediately next to the claim, you must saturated fat, and is a low fat vegetable. reference where to find the nutrient See the poster in the produce department information. If the nutrition information is for nutrition information on broccoli; or immediately next to the claim, a reference is not needed. Development of heart disease depends upon many factors, but its risk may be • Criteria: The food must meet the reduced by diets low in saturated fat and definitions for the descriptors low cholesterol and healthy lifestyles. saturated fat, low-cholesterol, and low Broccoli contains no cholesterol, a fat. The fruits and vegetables listed in negligible amount of saturated fat, and this publication that PMA believes is a low fat vegetable; or qualify for this health claim are listed in Appendix D. Development of heart disease depends upon many factors, including a family • Other Requirements history of the disease, high blood LDL- (A) The claim states that diets low in cholesterol, diabetes, high blood saturated fat and cholesterol may or might pressure, being overweight, cigarette reduce the risk of heart disease; smoking, lack of exercise, and the type of dietary pattern. A healthful diet low in (B) In specifying the disease, the claim saturated fat, total fat, and cholesterol, uses the terms heart disease or coronary as part of a healthy lifestyle, may lower heart disease; blood cholesterol levels and may reduce the risk of heart disease. Broccoli is a (C) In specifying the nutrient, the claim low fat vegetable; or uses the terms saturated fat and cholesterol and lists both;
Updated 2009 38 (D) The claim does not attribute any [mmol/L]) or above and LDL-cholesterol degree of risk reduction for coronary heart levels of 160 mg/dL (4.13 mmol/L) or disease to diets low in dietary saturated fat above. Borderline high risk blood and cholesterol; and cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to (E) The claim states that coronary heart 159 mg/dL (3.36 to 4.11 mmol/L) of LDL- disease risk depends on many factors. cholesterol. Dietary lipids (fats) include fatty acids and cholesterol. Total fat, commonly • Optional Information: referred to as fat, is composed of saturated fat (fatty acids containing no double bonds), (A) The claim may identify one or more and monounsaturated and polyunsaturated of the following risk factors in addition to fat (fatty acids containing one or more saturated fat and cholesterol about which double bonds). there is general scientific agreement that they are major risk factors for this disease: A (ii) The scientific evidence family history of coronary heart disease, establishes that diets high in saturated fat elevated blood total and LDL-cholesterol, and cholesterol are associated with increased excess body weight, high blood pressure, levels of blood total and LDL-cholesterol cigarette smoking, diabetes, and physical and, thus, with increased risk of coronary inactivity. heart disease. Diets low in saturated fat and cholesterol are associated with decreased (B) The claim may indicate that the levels of blood total- and LDL-cholesterol, relationship of saturated fat and cholesterol and thus, with decreased risk of developing to heart disease is through the intermediate coronary heart disease. link of blood cholesterol or blood total- and LDL cholesterol. (iii) Coronary heart disease is a major public health concern in the United (C) The claim may include information States, primarily because it accounts for from sections (i) through (v) below, which more deaths than any other disease or group summarize the relationship between dietary of diseases. Early management of risk saturated fat and cholesterol and risk of factors for coronary heart disease is a major coronary heart disease, and the significance public health goal that can assist in reducing of the relationship. risk of coronary heart disease. There is a continuum of mortality risk from coronary (i) Cardiovascular disease means heart disease that increases with increasing diseases of the heart and circulatory system. levels of blood LDL-cholesterol. Individuals Coronary heart disease is the most common with high blood LDL-cholesterol are at and serious form of cardiovascular disease greatest risk. A larger number of individuals and refers to diseases of the heart muscle with more moderately elevated cholesterol and supporting blood vessels. High blood also have increased risk of coronary events; total- and low density lipoprotein (LDL)- such individuals comprise a substantial cholesterol levels are major modifiable risk proportion of the adult U.S. population. The factors in the development of coronary heart scientific evidence indicates that reducing disease. High coronary heart disease rates saturated fat and cholesterol intakes lowers occur among people with high blood blood LDL-cholesterol and risk of heart cholesterol levels of 240 milligrams/ disease in most individuals. There is also decaliter (mg/dL) (6.21 millimoles per liter evidence that reducing saturated fat and
Updated 2009 39 cholesterol intakes in persons with blood cholesterol should consult their physicians cholesterol levels in the normal range also for medical advice and treatment. reduces risk of heart disease. If the claim defines high or normal blood (iv) Other risk factors for coronary total- or LDL-cholesterol levels, then the heart disease include a family history of claim shall state that individuals with high heart disease, high blood pressure, diabetes, blood cholesterol should consult their cigarette smoking, obesity (body weight 30 physicians for medical advice and treatment. percent greater than ideal body weight), and lack of regular physical exercise.
(v) Intakes of saturated fat exceed Health Claims on recommended levels in many people in the United States. Intakes of cholesterol are, on Sodium and average, at or above recommended levels. One of the major public health Hypertension recommendations relative to coronary heart disease risk is to consume less than 10 (High Blood percent of calories from saturated fat, and an average of 30 percent or less of total calories Pressure) (21 from all fat. Recommended daily cholesterol intakes are 300 mg or less per day. C.F.R. § 101.74)
(D) In specifying the nutrients, the claim may include the term total fat in addition to • Claim Example: Diets low in sodium the terms saturated fat and cholesterol. may reduce the risk of high blood pressure, a disease affected by many (E) The claim may include information on factors. Broccoli is low in sodium. See the number of people in the United States the poster in the produce department for who have coronary heart disease. The nutrition information on broccoli; or sources of this information shall be identified, and it shall be current information Development of hypertension or high from the National Center for Health blood pressure depends on many factors. Statistics, the National Institutes of Health, Broccoli can be part of a low sodium, or Nutrition and Your Health: Dietary low salt diet that might reduce the risk of Guidelines for Americans, U.S. Department hypertension or high blood pressure. See of Health and Human Services (DHHS) and the poster in the produce department for U.S. Department of Agriculture (USDA), nutrition information on broccoli. Government Printing Office. • Criteria: A food must meet the descriptor (F) The claim may indicate that it is requirements for low-sodium. The fruits consistent with Nutrition and Your Health: and vegetables listed in this publication Dietary Guidelines for Americans, DHHS that PMA believes qualify for this health and USDA, Government Printing Office. claim are listed in Appendix D.
(G) The claim may state that individuals • Other Requirements: with elevated blood total- or LDL-
Updated 2009 40 (A) The claim states that diets low in associated with a high prevalence of sodium may or might reduce the risk of high hypertension or high blood pressure and blood pressure; with increases in blood pressure with age, and that diets low in sodium are associated (B) In specifying the disease, the claim with a low prevalence of hypertension or uses the term high blood pressure; high blood pressure and with a low or no increase of blood pressure with age. (C) In specifying the nutrient, the claim uses the term sodium; (iii) High blood pressure is a public health concern primarily because it is a (D) The claim does not attribute any major risk factor for mortality from coronary degree of reduction in risk of high blood heart disease and stroke. Early management pressure to diets low in sodium; and of high blood pressure is a major public health goal that can assist in reducing (E) The claim indicates that development mortality associated with coronary heart of high blood pressure depends on many disease and stroke. There is a continuum of factors. mortality risk that increases as blood pressures rise. • • Optional Information. Individuals with high blood pressure are at (A) The claim may identify one or more greatest risk, and individuals with of the following risk factors for development moderately high, high normal, and normal of high blood pressure in addition to dietary blood pressure are at steadily decreasing sodium consumption: Family history of high risk. The scientific evidence indicates that blood pressure, growing older, alcohol reducing sodium intake lowers blood consumption, and excess weight. pressure and associated risks in many but (B) The claim may include information not all hypertensive individuals. There is from sections (i) through (vi) below, which also evidence that reducing sodium intake summarizes the relationship between dietary lowers blood pressure and associated risks in sodium and high blood pressure and the many but not all normotensive individuals as significance of the relationship. well.
(i) Hypertension, or high blood (iv) The populations at greatest risk pressure, generally means a systolic blood for high blood pressure, and those most pressure of greater than 140 millimeters of likely to benefit from sodium reduction, mercury (mm Hg) or a diastolic blood include those with family histories of high pressure of greater than 90 mm Hg. blood pressure, the elderly, males because Normotension, or normal blood pressure, is they develop hypertension earlier in life than a systolic blood pressure below 140 mm Hg females, and black males and females. and diastolic blood pressure below 90 mm Although some population groups are at Hg. Sodium is specified here as the chemical greater risk than others, high blood-pressure entity or electrolyte sodium and is is a disease of public health concern for all distinguished from sodium chloride, or salt, population groups. Sodium intake, alcohol which is 39 percent sodium by weight. consumption, and obesity are identified risk factors for high blood pressure. (ii) The scientific evidence establishes that diets high in sodium are
Updated 2009 41 (v) Sodium intakes exceed recom- (G) The claim may state that individuals mended levels in almost every group in the with high blood pressure should consult United States. One of the major public their physicians for medical advice and health recommendations relative to high treatment. If the claim defines high or blood pressure is to decrease consumption of normal blood pressure, then the health claim salt. On a population-wide basis, reducing must state that individuals with high blood the average sodium intake would have a pressure should consult their physicians for small but significant effect on reducing the medical advice and treatment. average blood pressure, and, consequently, reducing mortality from cardiovascular disease and stroke. Health Claims on (vi) Sodium is an essential nutrient, and experts have recommended a safe Calcium and minimum level of 500 milligrams (mg) sodium per day and an upper level of 2,400 Osteoporosis (21 mg sodium per day, the FDA Daily Value for sodium. C.F.R. § 101.72)
(C) The claim may include information on • Calcium and osteoporosis: Fruits and the number of people in the United States vegetables could not use this claim. To who have high blood pressure. carry this claim, a food must contain 20 percent or more of the Daily Value for The sources of this information must be calcium (200 mg) per serving, have a identified, and it must be current calcium content that equals or exceeds information from the National Center for the food's content of phosphorus, and Health Statistics, the National Institutes of contain a form of calcium that can be Health, or Nutrition and Your Health: readily absorbed and used by the body. Dietary Guidelines for Americans, U.S. Department of Health and Human Services (DHHS) and U.S. Department of Agriculture (USDA), Government Printing Health Claim on Office. Folate and Neural (D) The claim may indicate that it is consistent with Nutrition and Your Health: Tube Defects (21 U.S. Dietary Guidelines for Americans, DHHS and USDA, Government Printing C.F.R. § 101.79) Office.
(E) In specifying the nutrient, the claim Claim examples: "Healthful diets with may include the term salt in addition to the adequate folate may reduce a woman's risk term sodium. of having a child with brain or spinal cord birth defects." (F) In specifying the disease, the claim may include the term hypertension in Women who consume healthful diets with addition to the term high blood pressure. adequate folate throughout their
Updated 2009 42 childbearing years may reduce their risk of risk of neural tube defects than a lower having a child with a birth defect of the amount per serving from another source. brain or spinal cord. Sources of folate include fruits, vegetables, whole grain (F) The claim must state that folate needs products, fortified cereals, and dietary to be consumed as part of a healthful diet. supplements. The claim may include the following Food Composition Criteria: A food making optional information in sections (A) to (E) this claim must be a "good source" (i.e. below: provide at least 10% of the Daily Value) of folate. The claim may not be made on foods (A) The claim may specifically identify that contain more than 100% of the RDI for risk factors for neural tube defects. Women vitamin A as retinol or preformed vitamin A at increased risk include those with a or vitamin D per serving or per unit. personal history of a neural tube defect affected pregnancy, those with a close Requirement for wording of the claim: relative (i.e., sibling, niece, nephew) with a neural tube defect; those with insulin (A) In specifying the nutrient, the claim dependent diabetes mellitus, those with should use the terms "folate," "folic acid," seizure disorders who are being treated with "folacin," "folate, a B vitamin," "folic acid, a valproic acid or carbomazepine. B vitamin, or "folacin, a B vitamin." (B) The claim may include a statement to (B) In specifying the health-related the effect that women with a history of a condition, the claim should identify the birth neural tube defect pregnancy should consult defects as "neural tube defects;" "birth their physicians or health care providers defects spina bifida or anencephaly;" "birth before becoming pregnant. If such a defects of the brain or spinal cord, statement is provided, the claim shall also anencephaly or spina bifida;" "spina bifida state that all women should consult a health and anencephaly, birth defects of the brain care provider when planning a pregnancy. or spinal cord;" "birth defects of the brain or spinal cord;" or "brain or spinal cord birth (C) The claim may identify 100% of the defects." DV (100% DV, 400 μg) for folate as the target intake goal. (C) The claim must not imply that folate intake is the only recognized risk factor for (D) The claim may provide estimates, neural tube defects. expressed on an annual basis, of the number of neural tube defect-affected births among (D) Claims on foods that contain more live births in the United States. Current than 100% of the Daily Value (400 μg) must estimates for these numbers are 6 of 10,000 identify the safe upper limit of daily intake live births annually (i.e., about 2,500 cases for folic acid. The safe upper limit is 1,000 among 4 million live births annually). μg (1 mg). (E) An estimate of the reduction in the (E) The claim may not state that a number of neural tube defect-affected births specified amount of folate per serving from that might occur in the United States if all one source is more effective in reducing the women consumed adequate folate throughout their childbearing years may be
Updated 2009 43 included in the claim. If such an estimate (i.e., 50%) is provided, the estimate shall be accompanied by additional information that states that the estimate is population based and that it does not reflect risk reduction that may be experienced by individual women. Potassium and Reduce Risk of High Blood Pressure and Stroke
The claim: Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke.
This claim was the subject of a health claim notification submitted to FDA. Unlike claims authorized by an FDA health claim regulation, claims authorized via notification are limited to the specific claim submitted to FDA. Thus, only the exact wording of the claim submitted to FDA, and not objected to by the Agency, may appear on product labels.
Requirements:
• GOOD SOURCE of Potassium • The food must contain 140 mg or less of sodium per reference amount. • The food must be LOW FAT, LOW SATURATED FAT, LOW CHOLESTEROL.
Updated 2009 44 Dietary Guidance Statements
FDA does not consider “dietary guidance statements” to be health claims subject to FDA review and authorization. Dietary guidance statements address the role of dietary patterns or of general categories of foods (e.g. fruits and vegetables) and remain guidance statements so long as the context of the statement does not suggest that a specific substance is the subject. Dietary guidance statements used on foods must be truthful and non-misleading.
In 2003, FDA published a dietary guidance statement for fruits and vegetables as part of the Consumer Health Information for Better Nutrition Initiative. The FDA, along with the National Cancer Institute (NCI), provided the message, “Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases.” FDA encourages the use of this message by the produce industry for all varieties of fruits and vegetables and by food manufacturers in association with those fruits, vegetables, and foods that meet the criteria established by the National Cancer Institute’s “5 A Day for Better Health Program.”
Updated 2009 45 Structure/Function Claims
Structure/function claims describe the context of health claims refers to a substance impact of a food on a structure of the body that has “value in sustaining human (e.g., the heart) or a bodily function (e.g., existence by such processes as promoting digestion). Structure/function claims may be growth, replacing loss of essential nutrients, used to describe all types of food, including or providing energy.” 21 C.F.R. § dietary supplements and conventional foods, 101.14(a)(3). although FDA has applied different standards to each. As opposed to a “health Historically, FDA has generally permitted claim” as discussed in Section 6, a structure/function claims for well-known structure/function claim does not require nutrients and the traditional role they play in FDA approval. There must, of course, be the body. A claim such as the “vitamin C in adequate substantiation for ___ helps maintain the body’s natural structure/function claims. defenses” also would be considered a permissible structure/function claim because A key to crafting a permissible it is based on the known nutritional role structure/function claim is to avoid vitamin C plays in the body. suggestions that the product is intended to cure, treat, mitigate, or prevent a disease or a health-related condition. If a claim suggests that a product is intended to serve one of these purposes, and the claim is not expressly authorized by FDA, FDA will consider the product misbranded and possibly an unapproved new drug. As a general rule, this problem may be avoided by placing claims in a context that presumes the body is healthy or functioning normally. The more closely a particular structure/function claim is connected to a particular disease condition, the less likely it is that FDA will consider the claim to be a permissible structure/function claim.
Structure/function claims for conventional foods must be based on the “nutritive value” of the food or nutrient (e.g., “cranberry products help maintain urinary tract health,” 62 Fed. Reg. 49859, 49860 (September 23, 1997)). Although FDA has not defined the meaning of “nutritive value” in the context of structure/function claims, the term in the
Updated 2009 46 may be made either by statements, Foodservice photographs, or vignettes. • Main dish products. A main dish product is defined as a food that makes a major contribution to a meal by (1) weighing at least 6 oz per labeled serving; Overview and (2) containing not less than 40 g of foods or food mixtures from two of the four FDA issued a final rule on August 2, 1996, food groups noted above; and is represented in which the Agency stated that its nutrient as, or is in a form commonly understood to content and health claim rules apply to be, a main dish (i.e., not a beverage or a restaurant menus and all other forms of dessert). Such representations may be made restaurant labeling, including signs, posters, either by statements, photographs, or and placards displayed in restaurants. This vignettes. rule represented a reversal to the position that FDA took in 1993 when the NLEA rules were first issued. At that time, FDA Nutrient Content had exempted restaurant foods from these rules, but that decision was soon attacked by Descriptors for consumer interest groups and the Agency decided to change its position. Meal or Main Dish Products Definitions Nutrient content claim definitions used on • Meal products. A meal product is meals or main dishes differ somewhat from defined as a food that makes a major those for individual foods. Synonyms are the contribution to the total diet by (1) weighing same as those for individual foods. Because at least 10 ounces per labeled serving; and they are somewhat more complex, criteria (2) containing not less than 40 grams for for making comparative claims (e.g. each of at least 3 different foods from 2 or "reduced in calories") are not provided in more of the following 4 food groups: a. this document. bread, cereal, rice, and pasta group; b. fruits and vegetables group; c. milk, yogurt, and cheese group; d. meat, poultry, fish, dry Free Claims beans, eggs, and nuts group; (these foods shall not be sauces [except for foods in the above four food groups that are in the • Sodium-free sauces], gravies, condiments, relishes, Synonyms: free of sodium, no sodium, pickles, olives, jams, jellies, syrups, zero sodium, without sodium, trivial breadings, or garnishes). The meal product source of sodium, negligible source of should also be represented as, or is in a form sodium, or dietarily negligible source of commonly understood to be, a breakfast, sodium lunch, dinner, or meal. Such representations
Updated 2009 47 Meal/main dish criteria: the meal or Meal/main dish criteria: the meal or main dish contains less than 5 mg of main dish contains less than 0.5 g of sodium per labeled serving size. saturated fat per labeled serving and the level of trans fatty acids does not exceed • Cholesterol free 0.5 g per reference amount and per Synonyms: free of cholesterol, zero serving. cholesterol, without cholesterol, no cholesterol, trivial source of cholesterol, negligible source of cholesterol, or dietarily insignificant source of Low Claims cholesterol • Low-calorie Meal/main dish criteria: meal products Synonyms: few calories, contains a and main dish products must contain less small amount of calories, low source of than 2 mg cholesterol and 2 g or less of calories, or low-calorie saturated fatty acids per labeled serving size. If the fat content exceeds 26 g fat Meal/main dish criteria: the meal or per serving for meal products or 19.5 g main dish contains 120 calories or less fat per serving for main dish products per 100 grams. and the food is not inherently free of cholesterol, then the food must contain • Very low sodium at least 25% less cholesterol than the Synonym: very low in sodium food for which it substitutes and the label must declare the level of total fat Meal/main dish criteria: the meal or per serving in immediate proximity to main dish contains 35 mg or less sodium the most prominent claim preceding the per 100 grams of product. referral statement. • Low-sodium • Fat free Synonyms: low in sodium, little sodium, Synonyms: Free of fat, no fat, zero fat, contains a small amount of sodium, or without fat, nonfat, trivial source of fat, low source of sodium negligible source of fat, or dietarily Meal/main dish criteria: the meal or insignificant source fat of main dish has 140 mg or less sodium per Meal/main dish criteria: the meal or 100 grams. main dish contains 3 grams or less of • Low fat total fat per labeled serving. Synonyms: Low in fat, contains a small amount of fat, low source of fat, or little • Saturated fat free fat Synonyms: free of saturated fat, no saturated fat, zero saturated fat, without Meal/main dish criteria: the meal or saturated fat, trivial source of saturated main dish must contain 3 g or less of fat, negligible source of saturated fat, or total fat per 100 g and not more than dietarily insignificant source of 30% of calories from total fat. saturated fat • Low-cholesterol Synonyms: low in cholesterol, low
Updated 2009 48 cholesterol, contains a small amount of High in vitamin A: 20% or more of DV cholesterol, low source of cholesterol, or (1000 IU or more) little cholesterol High in vitamin C: 20% or more of DV (12 mg or more) Meal/main dish criteria: the meal or High in folate: 20% or more of DV (80 μg main dish must contain 20 mg or more) cholesterol or less per 100 g and no more High in iron: 20% or more of DV (3.6 mg or than 2 g saturated fat per 100 g. If the fat more) content exceeds 26 g fat per serving for meal products or 19.5 g fat per serving for main dish products and the food is not inherently free of cholesterol, then Good Source the food must contain at least 25% less cholesterol than the food for which it Meal products or main dish products may substitutes and the label must declare the use this term provided that the product level of total fat per serving in contains a food that meets the definition of immediate proximity to the most good source and the label or labeling clearly prominent claim preceding the referral identifies the food that is the subject of the statement. claim (e.g., the serving of sweet potatoes in this product is a good source of fiber.) • Low saturated fat Synonyms: low in saturated fat, contains Good source of fiber: 10-19% of DV (2.5 a small amount of saturated fat, low grams - < 5 grams) source of saturated fat, or a little Good source of potassium: 10-19% of DV saturated fat (350 mg - < 700 mg) Good source of vitamin A: 10-19% of DV Meal/main dish criteria: the product (500 IU - < 1000 111J) contains 1 g or less of saturated fatty Good source of vitamin C: 10-19% of DV acids per 100 g and less than 10% of (6 mg - < 12 mg) calories from saturated fat. Good source of folate: 10-19% of DV (40 μg - < 80 μg) Good source of iron: 10-19% of DV High (1.8mg-<3.6mg)
Meal products or main dish products may use this term provided that the product Fresh contains a food that meets the definition of high and the label clearly identifies the food that is the subject of the claim (e.g., the The regulation defines the term fresh when it is used to suggest that a food is raw or serving of broccoli in this product is high in vitamin C). unprocessed. In this context, fresh can be used only on a food that is raw, has never High in fiber: 20% or more of DV (5 grams been frozen or heated, and contains no or more) preservatives. (Irradiation at low levels is High in potassium: 20% or more of DV (700 allowed.) Fresh frozen, frozen fresh, and mg or more) Fresh freshly frozen can be used for foods that are
Updated 2009 49 quickly frozen while still fresh. Blanching products may reduce the risk of some types (brief scalding before freezing to prevent of cancer, a disease affected by many nutrient breakdown) is allowed. factors.
The addition of approved waxes or coatings; Criteria: A meal/main dish product must post-harvest approved pesticides; mild be/contain a grain product, fruit, or chlorine wash or mild acid wash; or vegetable and meet the meal/main dish treatment with 1 kiloGray of ionizing requirements for low fat and, without radiation does not preclude produce from fortification, must be a good source of use of the term fresh. Other uses of the term dietary fiber. fresh, such as in fresh milk or freshly baked bread, are not affected. Specific requirements and optional information for written health claims can be found in the earlier Health Claims section of Health Claims for this document. • Health Claims on Fruits and Vegetables Meal or Main Dish and Cancer
Products Claim Examples: Place a cancer prevention symbol next to a label, poster, placard, etc. An example of a reference to the symbol In order for a meal product to make a health elsewhere on the label, poster, placard, etc. claim, the meal product must have no more would read: (symbol) These products than 26.0 g of fat, 8.0 g of saturated fat, 120 contain less than xx grams of fat, and more mg of cholesterol, or 960 mg of sodium per than 2.5 grams of fiber. An additional label serving size. statement must be added: Low fat diets rich For a main dish product to qualify for in fruits and vegetables (foods that are low making a health claim, the product must in fat and may contain dietary fiber and have no more than 19.5 g of fat, 6.0 g of vitamins A and C) may reduce the risk of saturated fat, 90 mg of cholesterol, or 720 some types of cancer, a disease affected by mg of sodium per label serving size. many factors.
• Health Claims on Fiber-Containing Criteria: This claim may be for meal Fruits, Vegetables, and Grain Products products or main dish products that are or and Cancer contain fruits and vegetables. The product must meet the meal/main dish product Claim Example: Place a cancer prevention requirements for low fat and, without symbol next to an item on a label, poster, fortification, for good source of fiber or placard, etc. An example of a reference to vitamins A or C. the symbol elsewhere on the label, poster, placard, etc. would read: (symbol) These Specific requirements and optional products contain less than xx grams of fat information for written health claims can be and contain more than 2.5 grams of fiber. found in the earlier Health Claims section of An additional statement must be added this document. similar to: Low fat diets rich in fiber-containing fruits, vegetables, and grain
Updated 2009 50 • Health Claims on Fruits, Vegetables and Criteria: A product must meet the main Grain Products that Contain Fiber and dish/meal product descriptor requirements Risk of Coronary Heart Disease (CHD) for low fat.
Claim Examples: Place a heart healthy Specific requirements and optional symbol next to a label, poster, placard, etc. information for written health claims can be An example of a reference to the symbol found in the earlier Health Claims section of elsewhere on the label, poster, placard, etc. this document. would read: (symbol) These products contain less than xx grams of fat, xx grams • Health Claims on Saturated Fat and of saturated fat, xx milligrams of Cholesterol and Coronary Heart Disease cholesterol, and more than xx grams of (CHD) soluble fiber. An additional statement must be added: Diets low in saturated fat and Claim Examples: Place a heart healthy cholesterol and rich in fruits, vegetables, symbol next to a label, poster, placard, etc. and grain products that contain certain An example of a reference to the symbol types of dietary fiber may reduce the risk of elsewhere on the label, poster, placard, etc. heart disease, a disease affected by many would read: (symbol) These products factors. contain less than xx grams of fat, xx grams of saturated fat, and xx milligrams of Criteria: A food must be/contain fruits, cholesterol. An additional statement must be vegetables, or grain products and must meet added: Although many factors affect heart the meal/main dish requirements for low disease, diets low in saturated fat and saturated fat, low-cholesterol, and low fat cholesterol may reduce the risk of this and contain, without fortification, at least disease. 0.6 g soluble fiber per serving. Criteria: The food must meet the definitions Specific requirements and optional for the meal/main dish product descriptors information for written health claims can be for low saturated fat, low cholesterol, and found in the earlier Health Claims section of low fat. this document. Specific requirements and optional • Health Claims on Fat and Cancer information for written health claims can be found in the earlier Health Claims section of Claim Examples: Place a cancer prevention this document. symbol next to a label, poster, placard, etc. An example of a reference to the symbol • Health Claims on Sodium and elsewhere on the label, poster, placard, etc. Hypertension (High Blood Pressure) would read: (symbol) These products contain less than xx grams of fat. An Claim Example: Place a high blood pressure additional statement must be added: prevention symbol or other symbol next to a Development of cancer depends on many label, poster, placard, etc. An example of a factors. A diet low in total fat may reduce reference to the symbol elsewhere on the the risk of some cancers. label, poster, placard, etc. would read; (symbol) These products contain less than xx milligrams of sodium. An additional statement must be added: Diets low in
Updated 2009 51 sodium may reduce the risk of high blood pressure, a disease affected by many factors.
Criteria: A food must meet the meal/main dish descriptor requirements for low sodium.
Specific requirements and optional information for written health claims can be found in the earlier Health Claims section of this document.
• Health Claims on Calcium and Osteoporosis
Claim Example: Place an osteoporosis prevention or other symbol next to a label, poster, placard, etc. An example of a reference to the symbol elsewhere on the label, poster, placard, etc. would read: (symbol) These products contain more than 200 milligrams of calcium. An additional statement must be added: Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their risk of osteoporosis later in life.
Criteria: To carry this claim, a food must contain 20 percent or more of the Daily Value for calcium (200 mg) per serving, have a calcium content that equals or exceeds the food's content of phosphorus, and contain a form of calcium that can be readily absorbed and used by the body.
Additional criteria about this claim can be obtained from PMA, (302) 738-7100.
Updated 2009 52
Appendix A
Nutrition Facts Serving Size 1 medium stalk (148g)
Amount Per Serving Calories 40 Calories from Fat 0
% Daily Value* Total Fat 0.5g 1% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Sodium 70mg 3% Total Carbohydrate 9g 3% Dietary Fiber 4g 16% Sugars 0g Protein 4g Vitamin A 10% * Vitamin C 200% Calcium 6% * Iron 4% * Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs: Calories: 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 * Carbohydrate 4 * Protein 4
Exhibit 1. Standard Format
This example complies with FDA’s requirements for the standard format.
Updated 2009 53 Appendix A
*Percent Daily Values (DV) are based on a 2,000 calorie Nutrition Facts diet. Your daily values may be higher or lower depending on Serving Size 1 medium stalk (148g your calorie needs: Calories: 2,000 2,500 Amount Per Serving Total Fat Less than 65g 80g Calories 40 Calories from Fat 0 Sat Fat Less than 20g 25g Cholesterol Less than 300 mg 300 mg % Daily Value* Sodium Less than 2,400 mg 2,400 mg Total Fat 0.5g 1% Total Carbohydrates 300 mg 375 mg Saturated Fat 0g 0% Dietary Fiber 25 g 30 g Trans Fat 0g Calories per gram: Fat 9 • Carbohydrates 4 • Protein 4 Cholesterol 0mg 0% Sodium 70mg 3% Total Carbohydrate 9g 3% Dietary Fiber 4g 16% Sugars 0g Protein 4g Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4%
Exhibit 2. Footnote-to-side
This option is available only if the space beneath the Daily Values declarations for the mandatory vitamins and minerals is not sufficient to accommodate the Daily Value footnote(s).
Updated 2009 54 Appendix A
Amount Per Serving Daily Value% Amount Per Serving Daily Value% Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher Nutrition or lower depending on your caloric needs: Total Fat 0.5g 1% Total Carbohydrate 9g 3% Saturated Fat 0g 0% Dietary Fiber 4g 16% Calories: 2,000 2,500 Facts Trans Fat 0g______Sugars 0g Total Fat Less than 65g 80g Sat. Fat Less than 20g 25g Serving Size 1 medium stalk Cholesterol 0mg 0% Protein 4g (148g) Cholesterol Less than 300mg 300mg Sodium 70mg 3% Sodium Less than 2,400mg 2,400mg Calories 40 Total Carbohydrate 300g 375g Calories from Fat 0 Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4% Dietary Fiber 25g 30g
Exhibit 3. Tabular Standard Format
This option is available for packages with insufficient continuous vertical labeling space to accommodate the standard format. FDA has estimated that 3 inches is the approximate minimum amount of continuous vertical labeling space needed to execute the standard format.
Updated 2009 55 Appendix A
Nutrition Facts Serving Size 1 medium stalk (148g)
Amount Per Serving Calories 40 % Daily Value* Total Fat 0.5g 1% Sodium 70mg 3% Total Carbohydrate 9mg 3% Sugars 1g Protein 4g
*Percent Daily Values are based on a 2,000 calorie diet
Exhibit 4. Simplified Format
This option is available for foods containing insignificant amounts of 8 or more of 14 mandatory nutrients (calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron). FDA’s regulations define an “insignifcant amount” as the amount of a nutrient that must be declared as zero, or, in some cases, as less than 1 gram. Note that the format shortens the list of nutrients that must be declared in the amount/serving column and also permits the deletion of the mandatory Daily Value footnote. If any nutrient content claim or health claim is made for a product when using this simplified format, the statement “not a significant source of ___” must be included as a footnote at the bottom of the box for nutrients not included.
Updated 2009 56 Appendix A
Nutrition Facts Serving Size 1 medium stalk (148g)
Amount Per Serving Calories 40 Fat Cal. 0
% Daily Value* Total Fat 0.5g 1% Sat. Fat 0g 0% Trans Fat 0g______Cholest. 0mg 0% Sodium 70mg 3% Total Carb. 9g 3% Fiber 4g 16% Sugars 0g Protein 4g
Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4% *Percent Daily Values are based on a 2,000 calorie diet.
Exhibit 5. Abbreviated Columnar
To qualify for this option, the food’s package must have total surface area available to bear labeling of less than or equal to 40 square inches.
Updated 2009 57 Appendix A
Nutrition Amount Per Serving % DV* Amount Per Serving % DV* Total Fat 0.5g 1% Total Carb. 9g 3% Sat. Fat 0g 0% Fiber 4g 16% Facts Trans Fat 0g______Sugars 0g Serving Size 1 medium stalk (148g) Cholest. 0 mg 0% Protein 4g Calories 40 Sodium 70 mg 3% Fat Cal. 0 *Percent Daily Values (DV) are based on a 2,000 Vitamin A 10 % Vitamin C 200% Calcium 6% Iron 4% calorie diet.
Exhibit 6. Abbreviated Tabular
To qualify for this option, the food’s package must have total surface area available to bear labeling of less than 40 square inches. FDA rules require that the abbreviated columnar format (Appendix A, Exhibit 5) be used if feasible. The tabular format can be used if a package cannot accommodate the columnar format or if there is less than 12 square inches of labeling space.
Updated 2009 58 Appendix A
Nutrition Facts Serv. Size: 1 medium stalk (148g), Amount Per Serving: Calories 40, Fat. Cal.0, Total Fat 0.5g (1% DV), Sat. Fat 0g (0% DV), Trans Fat 0g, Cholest. 0mg (0% DV), Sodium 70 mg (3% DV), Total Carb. 8g (3% DV), Fiber 4g (16% DV), Sugars 0g, Protein 4g, Vitamin A (10% DV), Vitamin C (200% DV), Calcium (6% DV), Iron (4% DV). Percent Daily Values (DV) are based on a 2,000 calorie diet.
Exhibit 7. Abbreviated Tabular
To qualify for this option, the food’s package must have total surface area available to bear labeling of less than 40 square inches. FDA rules require that the abbreviated columnar format (Appendix A, Exhibit 5) be used if feasible. The tabular format can be used if a package cannot accommodate the columnar format or if there is less than 12 square inches of labeling space. The linear format should be used only as a last resort (i.e., the package cannot accommodate even the tabular format). Bolding of nutrients is voluntary.
Updated 2009 59 Appendix A
Nutrition Facts Serving Size 1 medium potato (148)g
Amount Per Serving Raw Baked Calories 120 120 Calories from Fat 0 0 % Daily Value** Total Fat 0g* 0% 0% Saturated Fat 0g 0% 0% Trans Fat 0g Cholesterol 0mg 0% 0% Sodium 5mg 0% 0% Total Carbohydrate27g 9% 9% Dietary Fiber 2g 9% 9% Sugars 3g Protein 3g Vitamin A 0% 0% Vitamin C 40% 40% Calcium 2% 2% Iron 6% 6% *Amount in raw potato **Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories: 2,000 2,500 Total Fat Less than 65g 80g Sat.Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 Carbohydrate 4 Protein 4
Exhibit 8. Dual Format
This format is voluntary in most situations. It is only mandatory when a product is promoted on the label or in advertising for a use that differs in quantity by two-fold or greater from the use upon which the Reference Amount Customarily consumed is based. The format may be used on a voluntary format to provide nutrition information for a product both on the required per serving/as packaged basis and (1) as consumed (e.g., raw potato versus cooked potato); (2) per standard quantity of product (e.g., per 100 grams); (3) per unit; or (4) based on population groups other than adults and children over 4 years of age.
Updated 2009 60 Appendix A
Nutrition Facts/Datos de Nutricion Serving Size/Tamano por Racion 1 cup/1 taza (228g) Servings Per Container/Raciones por Envase 2 Amount Per Serving/Cantidad por Racion Calories/Calorias 260 Calories from Fat/Calorias de Grasa 120 % Daily Value*/% Diario Valor Total Fat/Grasa Total 13g 20% Saturated Fat/Grasa Saturada 5g 25% Trans Fat/Grasa del Transporte 2g Cholesterol/Colesterol 30mg 10% Sodium/Sodio 660mg 28% Total Carbohydrates/Carbohidrato Total 31g 11% Dietary Fiber/Fibra Dietetica 0g 0% Sugars/Azucares 5g Protein/Proteinas 5g Vitamin A/Vitamina A 4% • Vitamin C/Vitamina C 2% Calcium/Calcio 15% • Iron/Hierro 4%
*Percent Daily Values are based on a *Los porcentajes de Valores Diarios estan basados en 2,000 calorie diet. Your daily intake may una dieta de 2,000 calorias. Sus valores diarios be higher or lower depending on your pueden ser mayores o menores dependiendo de sus calorie needs: necesidades caloricas:
Calories 2,000 2,500 Total Fat/Grasa Total Less than 65g 80g Sat Fat/Frasa Saturada Less than 20g 25g Cholesterol/Colesterol Less than 300mg 300mg Sodium/Sodio Less than 2,400mg 2,400mg Total Carbohydrates/Carbohigrado Total 300mg 375mg Dietary Fiber/Fibra Dietetica 25g 30g
Exhibit 9. Multi-lingual Format
One of FDA’s pre-NLEA labeling requirements is that, if a label contains any representation in a second language, all required information must be given in both English and the second language. Now that nutrition labeling is mandatory for most foods, nutrition labeling falls within the scope of this rule. If dual language declaration is required, it may be provided either by using two (or more) Nutrition Facts boxes or by use of the above format.
Updated 2009 61 Appendix A
Nutrition Facts Lettuce Croutons Bacon Bits
Serving Size 1 package 1 cups (85g) 1 pkg. (31g) 1 pkg. (5g) Servings Per Container 1 1 1 1 Amount Per Serv ing Calories 120 70 100 Calories from Fat 0 0 0
% Daily Value* % Daily Value* % Daily Value* Total Fat 0g 0% 0g 0% 0g 0% Saturated Fat______0g 0% 0g 0% 0g 0% Trans Fat 0g______0g______0g______Cholesterol 0mg 0% 0mg 0% 0g 0% Sodium 5mg 0% 5mg 0% 0g 0% Total Carbohydrate 27g 9% 27g 0% 0g 0% Dietary Fiber 2g 9% 2g 9% 0g 0% Sugars 3g 3g 3g Protein 3g 3g 3g *Percent Daily Values are based on a 2,000 calorie diet. Your daily values may Vitamin A 0% 0% 0% be higher or lower depending on your calorie needs: Vitamin C 40% 40% 40% Calories: 2,000 2,500 Calcium 2% 2% 2% Total Fat Less than 65g 80g Iron 6% 6% 6% Sat.Fat Less than 20 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 Carbohydrate 4 Protein 4
Exhibit 10. Aggregate Format
Products that contain two or more separately packaged ingredients intended to be eaten together (e.g., salads with separate packages of salads, croutons, or bacon bits) may provide nutrition information on a composite basis (e.g., one label with everything) or on a per serving basis for each ingredient. If nutrition information is provided for each ingredient either 1) separate Nutrition Facts boxes could be used for each ingredient, or 2) the format above could be used.
[Note: if the product contains only raw fruits and vegetables (e.g., carrots, cabbage, and onions) the package is exempt from labeling requirements.]
Updated 2009 62 Appendix A
Nutrition Facts Serving Size 1 medium stalk (148g)
Amount Per Serving Calories 40 Calories from Fat 0
% Daily Value* Total Fat 0.5g 1% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Sodium 70mg 3% Potassium 480mg 14% Total Carbohydrate 9g 3% Dietary Fiber 4g 16% Sugars 0g Protein 4g Vitamin A 10% * Vitamin C 200% Calcium 6% * Iron 4% * Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs: Calories: 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 * Carbohydrate 4 * Protein 4
Exhibit 11. Label Format Containing Potassium Values
When adding potassium to the label, it must be added both in the top panel and in the Daily Values footnote.
Updated 2009 63 Appendix B
Nutrition Facts Serving Size 1 medium stalk (148)g
Amount Per Serving Calories 40 Calories from Fat 0 % Daily Value* Total Fat 0.5g 1% ] 4 pts. leading Saturated Fat 0g 0% ] 4 Trans Fat 0g Cholesterol 0mg 0% ]] 4 4 Sodium 70mg 3% ] 4 Total Carbohydrate 9g 3% ] 4 Dietary Fiber 4g 16% ] 4 Sugars 0g ] 4 Protein 4g Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4% *Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Potassium 3,500mg 3,500mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Voluntary Fat 9 Carbohydrate 4 Protein 4
Exhibit 1. Line Spacing Requirements
At least one point leading is required between lines of text, except that 4 points leading is required between the lines indicated above.
Updated 2009 57 Appendix B
Nutrition Facts ] larger type than everything else on panel Serving Size 1 medium stalk (148)g ] ≥ 8 pts.
Amount Per Serving ] ≥ 6 pts. Calories 40 Calories from Fat 0 ] ≥ 8 pts. % Daily Value* Total Fat 0.5g 1% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Sodium 70mg 3% Total Carbohydrate 9g 3% ≥ 8 pts. Dietary Fiber 4g 16% Sugars 0g Protein 4g Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4% *Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg ≥ 6 pts. Sodium Less than 2,400mg 2,400mg Potassium 3,500mg 3,500mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Voluntary Fat 9 Carbohydrate 4 Protein 4
Exhibit 2. Type size Requirements
Updated 2009 58 Appendix B
Nutrition Facts ] * Serving Size 1 medium stalk (148)g
Amount Per Serving Calories 40 Calories from Fat 0 % Daily Value* ] * Total Fat 0.5g 1% Names (but not numbers) Saturated Fat 0g 0% of all nutrients that are * Trans Fat 0g not indented Cholesterol 0mg 0% Sodium 70mg 3% Total Carbohydrate 9g 3% * % Daily Values Dietary Fiber 4g 16% Sugars 0g Protein 4g Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4% *Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Potassium 3,500mg 3,500mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Voluntary Fat 9 Carbohydrate 4 Protein 4
Exhibit 3. Highlighting Requirements
An asterisk [*] indicates that the item must be highlighted.
Updated 2009 59 Appendix B
Nutrition Facts Serving Size 1 medium stalk (148)g ] Required Bar Amount Per Serving ] Required Hairline * Calories 40 Calories from Fat 0 ] Required Bar % Daily Value* Total Fat 0.5g 1% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Required Hairlines * Sodium 70mg 3% Total Carbohydrate 9g 3% Dietary Fiber 4g 16% Sugars 0g Protein 4g ] Required Bar Vitamin A 10% Vitamin C 200% Calcium 6% Iron 4% ] Required Hairline *Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Potassium 3,500mg 3,500mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g ] Required Hairline Calories per gram: Voluntary Fat 9 Carbohydrate 4 Protein 4
Exhibit 4. Required Hairlines and Bars
An asterisk [*] indicates that the hairlines must be centered between the two lines.
Updated 2009 60 APPENDIX C
Apple
Voluntary Data: Nutrition Facts Potassium 260 mg; 7% DV Serving Size 1 large apple (242g) Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 3 g Calories 130 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 260mg 7% sodium free Total Carbohydrate 34g 11% cholesterol free Dietary Fiber 5g 20% high source of fiber Sugars 25g Protein 1g
Vitamin A 2% • Vitamin C 8% Health Claims Allowed: Calcium 2% • Iron 2% Fiber-containing fruits, vegetables, and grain products * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or and cancer lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Total Fat Less than 65g 80g Fruits, vegetables and grain products that contain fiber Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg and the risk of coronary heart disease Sodium Less than 2,400mg 2,400mg Fat and Cancer Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Saturated fat and cholesterol and coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Apples are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program. Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 61 APPENDIX C Apricots
Nutrition Facts Serving Size 4 apricots (140g) Nutrient Content Descriptors
Amount Per Serving Allowed: Calories 70 Calories from Fat 0 low fat % Daily Value* saturated fat free Total Fat 0.5g 1% sodium free Saturated Fat 0g 0% cholesterol free Trans Fat 0g high in vitamin A Cholesterol 0mg 0% high in vitamin C Sodium 0mg 0% Potassium 360mg 10% Total Carbohydrate 16g 5% Dietary Fiber 3g 12% Health Claims Allowed: Sugars 13g Fruits and vegetables and cancer Protein 2g Fat and cancer Sodium and hypertension Vitamin A 50% • Vitamin C 25% Calcium 0% • Iron 4%
* Percent Daily Values are based on a 2,000 References: calorie diet. Your daily values may be higher or lower depending on your calorie needs: • USDA Nutrient Data Base for Standard Reference, Full Version, Calories 2,000 2,500 Release 9 IBM PC 360K for microcomputers, National Technical Total Fat Less than 65g 80g Information Service, Order Number PB90-50241, May, 1990. Prediction Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg interval compliance calculations were used to develop label data. Sodium Less than 2,400mg 2,400mg • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farbat-Sabet, Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 USDA HNIS, Home Economics Research Report Number 48, September l987. Note: Pursuant to the final rule on the • Fat calories were calculated based on the fat prediction interval values, voluntary nutrition labeling regulations for fruits and vegetables published on July 25, multiplied by 9 kcal/g and rounded to 5 <= 50 calories. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel..
Updated 2009 62 APPENDIX C Dried Apricots
Nutrition Facts Serving Size 4 apricots (140g) Nutrient Content Descriptors
Amount Per Serving Allowed: Calories 70 Calories from Fat 0 fat free % Daily Value* saturated fat free Total Fat 0.5g 1% very low sodium Saturated Fat 0g 0% cholesterol free Trans Fat 0g high in vitamin Cholesterol 0mg 0% A good source of potassium (add 500 mg potassium; Sodium 0mg 0% 14% DV to label) Potassium 360mg 10% Total Carbohydrate 16g 5% Dietary Fiber 3g 12% Sugars 13g Health Claims Allowed: Protein 2g Fruits and vegetables and cancer Fat and cancer Vitamin A 50% • Vitamin C 25% Saturated fat and cholesterol and coronary heart disease Calcium 0% • Iron 4% Sodium and hypertension * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 References: Total Fat Less than 65g 80g Sat Fat Less than 20g 25g • USDA Nutrient Data Base for Standard Reference, Full Version, Cholesterol Less than 300mg 300mg Release 9 IBM PC 360K for microcomputers, National Technical Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Information Service, Order Number PB90-50241, May, 1990. Prediction Dietary Fiber 25g 30g interval compliance calculations were used to develop label data. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for USDA HNlS, Home Economics Research Report Number 48, fruits and vegetables published on July 25, September 1987. 2006, trans fat labeling for fruits and Dietary fiber data is based on fresh apricot data. vegetables becomes mandatory on January • 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 63 APPENDIX C Artichoke
Nutrition Facts Voluntary Data: Serving Size 1 artichoke (56g edible portion) Potassium 180 mg; 5% DV; 3500 mg per 2000 calorie Amount Per Serving diet Calories 25 Calories from Fat 0 Folate 10% % Daily Value* Magnesium 10% DV Phosphorus 6% DV Total Fat 0g 0% Saturated Fat 0g 0% Manganese 8% DV Vitamin E 2% DV Trans Fat 0g Cholesterol 0mg 0% Sodium 70mg 3% Total Carbohydrate 6g 2% Nutrient Content Descriptors Dietary Fiber 3g 12% Sugars 1g Allowed: Protein 2g healthy cholesterol free Vitamin A 2% * Vitamin C 10% good source of fiber low calorie Calcium 2% * Iron 2% * Percent Daily Values are based on a 2,000 calorie diet. good source of vitamin C fat free Your Daily Values may be higher or lower depending on your calorie needs: good source of folate saturated fat free Calories: 2,000 2,500 good source of magnesium low sodium Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Health Claims Allowed: Fat 9 * Carbohydrate 4 * Protein 4 Fruits and vegetables and cancer Note: Pursuant to the final rule on the Fat and cancer voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, Saturated fat and cholesterol and coronary heart disease trans fat labeling for fruits and vegetables Fiber-containing fruits, vegetables, and grain products becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently and cancer accepted by FDA. Sodium and hypertension Fruits, vegetables, and grain products that contain fiber and risk of coronary heart disease
References: • PMA 1985 Artichoke Study. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sahet, USDA HNlS, Home Economics Research Report Number 48, September 1987. • Vitamin A: USDA, HNIS, Agriculture Handbook Number 8-11 (1989). NDB No. 11007.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 64 APPENDIX C Asparagus
Nutrition Facts Serving Size 5 spears (93g) Voluntary Data: Potassium 230 mg; 7% DV Amount Per Serving 100% of vitamin A is Beta Carotene Calories 20 Calories from Fat 0 Soluble Fiber 1 g % Daily Value* Insoluble Fiber 1 g Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Nutrient Content Descriptors Sodium 0mg 0% Allowed: Potassium 230mg 7% Total Carbohydrate 4g 1% fat free Dietary Fiber 2g 8% saturated fat free Sugars 2g sodium free Protein 2g cholesterol free low calorie Vitamin A 10% • Vitamin C 15% good source of vitamin C Calcium 2% • Iron 2% high in folate (add 30% folate to label) Folate 30% • Vitamin K 45% good source of vitamin A * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Health Claims Allowed: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Fruits and vegetables and cancer Total Carbohydrate 300g 375g Fat and cancer Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Saturated fat and cholesterol and coronary heart disease Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is References: currently accepted by FDA. • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Asparagus is one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 65 APPENDIX C Avocado, California
Nutrition Facts Voluntary Data: Serving Size 1/5 medium (30g) Potassium 140 mg; 4% DV
Amount Per Serving Calories 50 Calories from Fat 35
% Daily Value* Nutrient Content Descriptors Total Fat 4.5g 7% Allowed: Saturated Fat 0.5g 3% sodium free Trans Fat 0g cholesterol free Cholesterol 0mg 0% low in saturated fat Sodium 0mg 0% Potassium 140mg 4% Total Carbohydrate 3g 1% References: Dietary Fiber 1g 4% • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Sugars 0g Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Protein 1g Register, Vol. 71, No. 159, Rules and Regulations • Avocados are one of the top 40 produce items that are labeled as part of Vitamin A 0% • Vitamin C 4% the voluntary fruit and vegetable labeling program. Calcium 0% • Iron 2%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 66 APPENDIX C Banana
Nutrition Facts Voluntary Data: Serving Size 1 medium banana (126g) Soluble Fiber 1 g Insoluble Fiber 2 g Amount Per Serving Vitamin B6 20% Calories 110 Calories from Fat 0 Folate 6% % Daily Value* Potassium 450 mg, 13% DV Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Nutrient Content Descriptors Sodium 0mg 0% Potassium 450mg 13% Allowed: Total Carbohydrate 30g 10% fat free Dietary Fiber 3g 12% saturated fat free Sugars 19g sodium free Protein 1g cholesterol free good source of fiber Vitamin A 2% • Vitamin C 15% good source of vitamin C Calcium 0% • Iron 2% good source of potassium (add 450 mg potassium; Vitamin B6 20% • Maganese 15% 13% DV to label) * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Health Claims Allowed: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Fiber-containing fruits, vegetables, and grain products Total Carbohydrate 300g 375g and cancer Dietary Fiber 25g 30g Fruits and vegetables and cancer Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the Fruits, vegetables and grain products that contain fiber voluntary nutrition labeling regulations for and the risk of coronary heart disease fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and Fat and cancer vegetables becomes mandatory on January Saturated fat and cholesterol and coronary heart disease 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Sodium and hypertension
References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Bananas are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured.
Updated 2009 67 Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 68 APPENDIX C Green Snap Beans
Nutrition Facts Voluntary Data: Serving Size 3/4 cup cut beans (85g) Potassium 200 mg; 6% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 2 g Calories 20 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 0mg 0% sodium free Potassium 200mg 6% cholesterol free Total Carbohydrate 5g 2% low calorie Dietary Fiber 3g 12% good source of fiber Sugars 2g good source of vitamin C Protein 1g
Vitamin A 4% • Vitamin C 10% Calcium 4% • Iron 2% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fiber-containing fruits, vegetables, and grain products and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Total Fat Less than 65g 80g Fruits, vegetables and grain products that contain fiber and the risk Sat Fat Less than 20g 25g of coronary heart disease Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Fat and cancer Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Saturated fat and cholesterol and coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, References: 2006, trans fat labeling for fruits and vegetables becomes mandatory on January • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, 1, 2008. Voluntary trans fat disclosure is Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, currently accepted by FDA. No. 159, Rules and Regulations • Green beans are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 69 APPENDIX C Yellow Snap Beans
Voluntary Data: Nutrition Facts Potassium 135 mg; 4% DV Serving Size 3/4 cup cut beans (85g) Folate 6% Amount Per Serving Calories 25 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrition Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 0mg 0% very low sodium Potassium 175mg 4% cholesterol free Total Carbohydrate 6g 1% low-calorie Dietary Fiber 3g 12% high in vitamin C Sugars 2g Protein 2g Vitamin A 2% • Vitamin C 25% Health Claims Allowed: Calcium 4% • Iron 4% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for microcomputers, National Technical Note: Pursuant to the final rule on the Information Service, Order Number PB90-50241, May, 1990. Prediction voluntary nutrition labeling regulations for fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and • •Sugar (raw snap beans): "Sugar Content of Selected Foods: Individual vegetables becomes mandatory on January and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987
.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 70 APPENDIX C Beets
Nutrition Facts Voluntary Data: Serving Size 1 medium beet (100g) Potassium 290 mg; 8% DV
Amount Per Serving Calories 50 Calories from Fat 5 % Daily Value* Nutrient Content Descriptors Total Fat 0.5g 1% Saturated Fat 0g 0% Allowed: Trans Fat 0g low fat Cholesterol 0mg 0% Sodium 150mg 0% saturated fat free Total Carbohydrate 11g 4% cholesterol free Dietary Fiber 2g 9% good source of folate (add 15% folate to label) Sugars 6g Protein 1g Vitamin A 0% * Vitamin C 4% Calcium 0% * Iron 0% Health Claims Allowed: Fruits, vegetables and grain products that contain fiber * Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on and the risk of coronary heart disease your calorie needs: Calories: 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Saturated fat and cholesterol and coronary heart disease Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 * Carbohydrate 4 * Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
References: • PMA 1990 Beet Study. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farbat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 71 APPENDIX C Bell Pepper
Nutrition Facts Serving Size 1 medium pepper (148g) Voluntary Data: Potassium 220 mg; 6% DV Amount Per Serving Soluble Fiber 1 g Calories 25 Calories from Fat 0 Insoluble Fiber 1 g % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Allowed: Sodium 40mg 2% fat free Potassium 220mg 6% Total Carbohydrate 6g 2% saturated fat free Dietary Fiber 2g 8% low sodium Sugars 4g cholesterol free Protein 1g low calorie high in vitamin C Vitamin A 4% • Vitamin C 190% Calcium 2% • Iron 4%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Fat and cancer Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the References: voluntary nutrition labeling regulations for • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw fruits and vegetables published on July 25, Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal 2006, trans fat labeling for fruits and vegetables becomes mandatory on January Register, Vol. 71, No. 159, Rules and Regulations 1, 2008. Voluntary trans fat disclosure is • Bell peppers are one of the top 40 produce items that are labeled as part currently accepted by FDA. of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 72 APPENDIX C Blackberries
Nutrition Facts Voluntary Data: Serving Size 1 cup (140g) Potassium 280 mg; 8% DV
Amount Per Serving Calories 60 Calories from Fat 5 Nutrient Content Descriptors % Daily Value* Total Fat 0.5g 1% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 15mg 0% cholesterol free Potassium 230mg 8% high in fiber Total Carbohydrate 14g 6% Dietary Fiber 7g 28% high in vitamin C Sugars 7g good source of folate (add 10% folate to label) Protein 2g Vitamin A 6% • Vitamin C 50% Health Claims Allowed: Calcium 4% • Iron 6% Fiber-containing fruits, vegetables, and grain products and Folate 10% • Vitamin K 35% * Percent Daily Values are based on a 2,000 cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Saturated fat and cholesterol and coronary heart disease Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Sodium and hypertension Total Carbohydrate 300g 375g Fruits, vegetables, and grain products that contain fiber and Dietary Fiber 25g 30g risk of coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4
Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July References: 25, 2006, trans fat labeling for fruits and • USDA Nutrient Data Base for Standard Reference, Full Version, Release vegetables becomes mandatory on 9 IBM PC 360K for microcomputers, National Technical Information January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Service, Order Number PB90-50241, May, 1990. Prediction interval compliance calculations were used to develop label data. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, USDA HNIS, Home Economics Research Report Number 48, September 1987. • Fat calories were calculated based on the fat prediction interval values, multiplied by 9 kcal/g and rounded to 5 <= 50 calories.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general
Updated 2009 73 presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 74 APPENDIX C Blueberries
Nutrition Facts Voluntary Data: Serving Size 1 cup (140g) Potassium 105 mg; 3% DV
Amount Per Serving Calories 80 Calories from Fat 0 % Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Saturated Fat 0g 0% Allowed: Trans Fat 0g low fat Cholesterol 0mg 0% saturated fat free Sodium 0mg 0% sodium free Potassium 105mg 3% Total Carbohydrate 20g 7% cholesterol free Dietary Fiber 3g 12% good source of fiber Sugars 14g good source of vitamin C Protein 1g
Vitamin A 2% • Vitamin C 20% Calcium 0% • Iron 2% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fiber-containing fruits, vegetables, and grain products and lower depending on your calorie needs: cancer Calories 2,000 2,500 Total Fat Less than 0g 0g Fruits and vegetables and cancer Sat Fat Less than 0g 0g Cholesterol Less than 300mg 300mg Fruits, vegetables and grain products that contain fiber and the Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g risk of coronary heart disease Dietary Fiber 25g 30g Calories per gram: Fat 0 • Carbohydrate 4 • Protein 4 Fat and cancer Saturated fat and cholesterol and coronary heart disease Note: Pursuant to the final rule on the voluntary nutrition labeling Sodium and hypertension regulations for fruits and vegetables . published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 75 APPENDIX C Broccoli
Nutrition Facts Voluntary Data: Serving Size 1 medium stalk (148g) Potassium 460 mg; 13% DV 100% of vitamin A is Beta Carotene Amount Per Serving Soluble Fiber 2 g Calories 45 Calories from Fat 0 Insoluble Fiber 3 g % Daily Value* Total Fat 0.5g 1% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Allowed: Sodium 80mg 3% low fat Potassium 460mg 13% Total Carbohydrate 8g 3% saturated fat free Dietary Fiber 3g 12% low sodium Sugars 2g cholesterol free Protein 4g high in vitamin C high in folate (add 25% folate to label) Vitamin A 6% • Vitamin C 220% good source of fiber Calcium 6% • Iron 6% good source of potassium Folate 25% • Vitamin K 190% good source of vitamin A * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Health Claims Allowed: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Fruits and vegetables and cancer Total Carbohydrate 300g 375g Fat and cancer Dietary Fiber 25g 30g Saturated fat and cholesterol and coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for Fruits, vegetables, and grain products that contain fiber and fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and risk of coronary heart disease vegetables becomes mandatory on Fiber-containing fruits, vegetables, and grain products and January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. cancer
References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Broccoli is one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However,
Updated 2009 76 administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 77 APPENDIX C Brussels Sprouts
Nutrition Facts Voluntary Data: Serving Size 4 sprouts (85g) Potassium 290 mg; 8% DV
Amount Per Serving Calories 40 Calories from Fat 5
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 20mg 1% cholesterol free Potassium 340mg 10% Total Carbohydrate 8g 3% low-calorie Dietary Fiber 3g 12% good source of fiber Sugars 2g high in vitamin C Protein 2g good source of folate (add 10% folate to label)
Vitamin A 15% • Vitamin C 120% Calcium 4% • Iron 6% Folate 10% • Vitamin K 200% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fiber-containing fruits, vegetables, and grain products and calorie diet. Your daily values may be higher or lower depending on your calorie needs: cancer Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Fat and cancer Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Saturated fat and cholesterol and coronary heart disease Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Fruits, vegetables, and grain products that contain fiber and risk of coronary heart disease Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
References: • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for microcomputers, National Technical Information Service; Order Number PB90-50241, May, 1990. Prediction interval compliance calculations were used to develop label data. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987. • Fiber: "Provisional Table on the Dietary Fiber Content of Selected Foods," USDA, HNIS, HNIS/PT- 106, 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other
Updated 2009 78 sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 79 APPENDIX C Green Cabbage
Nutrition Facts Voluntary Data: Serving Size 1/12 medium head (84g) Potassium 190 mg; 5% of DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 25 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 20mg 1% saturated fat free Potassium 190mg 5% very low sodium Total Carbohydrate 5g 2% Dietary Fiber 2g 8% cholesterol free Sugars 3g low-calorie Protein 1g high in vitamin C
Vitamin A 0% • Vitamin C 70% Calcium 4% • Iron 2% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Note: Pursuant to the final rule on the • voluntary nutrition labeling regulations for Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. fruits and vegetables published on July 25, 71, No. 159, Rules and Regulations 2006, trans fat labeling for fruits and Cabbage is one of the top 40 produce items that are labeled as part of the vegetables becomes mandatory on January • 1, 2008. Voluntary trans fat disclosure is voluntary fruit and vegetable labeling program. currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 80 APPENDIX C Red Cabbage
Nutrition Facts Voluntary Data: Serving Size 1 1/4 cups shredded (85g) Potassium 85 mg; 2% DV Folate 4% Amount Per Serving Calories 25 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 20mg 1% very low sodium Potassium 200mg 6% cholesterol free Total Carbohydrate 5g 2% Dietary Fiber 2g 8% low-calorie Sugars 3g high in vitamin C Protein 1g Vitamin A 4% • Vitamin C 70% Health Claims Allowed: Calcium 4% • Iron 6% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for microcomputers, National Technical Note: Pursuant to the final rule on the Information Service, Order Number PB90-50241, May, 1990. Prediction voluntary nutrition labeling regulations for fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," vegetables becomes mandatory on January Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 81 APPENDIX C Cabbage, Pe-Tsai
Nutrition Facts Voluntary Data: Serving Size 1 cup shredded (76g) Potassium 135 mg; 4% DV
Amount Per Serving Calories 15 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 5mg 0% cholesterol free Potassium 180mg 5% Total Carbohydrate 5g 2% low-calorie Dietary Fiber 3g 12% high in vitamin A Sugars 1g high in vitamin C Protein 1g good source of folate (add 15% folate to label)
Vitamin A 6% • Vitamin C 35% Calcium 6% • Iron 2% Vitamin B6 10% • Folate 15% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fruits and vegetables and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fat and cancer Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release Note: Pursuant to the final rule on the 9 IBM PC 360K for microcomputers, National Technical Information voluntary nutrition labeling regulations for Service, Order Number PB90-50241, May, 1990. Prediction interval fruits and vegetables published on July compliance calculations were used to develop label data. 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," January 1, 2008. Voluntary trans fat Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA disclosure is currently accepted by FDA. HNIS, Home Economics Research Report Number 48, September 1987. • Fiber: "Provisional Table on the Dietary Fiber Content of Selected Foods," USDA, HNIS, HNIS/PT-I06, 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 82 APPENDIX C Cantaloupe
Nutrition Facts Voluntary Data: Serving Size 1/4 medium melon (134g) Potassium 240 mg; 7% DV 100% of vitamin A is Beta Carotene Amount Per Serving Calories 50 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 20mg 1% very low sodium Potassium 240mg 7% cholesterol free Total Carbohydrate 12g 4% Dietary Fiber 1g 4% high in vitamin A Sugars 11g high in vitamin C Protein 1g good source of folate (add 10% folate to label)
Vitamin A 120% • Vitamin C 80% Calcium 2% • Iron 2% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Note: Pursuant to the final rule on the • voluntary nutrition labeling regulations for Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal fruits and vegetables published on July Register, Vol. 71, No. 159, Rules and Regulations 25, 2006, trans fat labeling for fruits and Cantaloupe is one of the top 40 produce items that are labeled as part of vegetables becomes mandatory on • January 1, 2008. Voluntary trans fat the voluntary fruit and vegetable labeling program. disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 83 APPENDIX C Carambola
Nutrition Facts Voluntary Data: Serving Size 3/4 cup (140g) Potassium 140 mg; 4% DV
Amount Per Serving Calories 45 Calories from Fat 10
% Daily Value* Nutrient Content Descriptors Total Fat 1g 2% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 185mg 5% Total Carbohydrate 9g 3% high in vitamin C Dietary Fiber 4g 16% low-calorie Sugars 7g Protein 1g Health Claims Allowed: Vitamin A 2% • Vitamin C 80% Fruits and vegetables and cancer Calcium 0% • Iron 0% Fat and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Saturated fat and cholesterol and coronary heart disease lower depending on your calorie needs: Calories 2,000 2,500 Sodium and hypertension Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg References: Total Carbohydrate 300g 375g Dietary Fiber 25g 30g • USDA Nutrient Data Base for Standard Reference, Full Version, Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Release 9 IBM PC 360K for microcomputers, National Technical Information Service, Order Number PB90-50241, May, 1990. Note: Pursuant to the final rule on the Prediction interval compliance calculations were used to develop voluntary nutrition labeling regulations for fruits and vegetables published on July 25, label data. 2006, trans fat labeling for fruits and • Sugar: "Sugar Content of Selected Foods: Individual and Total vegetables becomes mandatory on January Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat- 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Sabet, USDA HNlS, Home Economics Research Report Number 48, September 1987. • Fat calories were calculated based on the fat prediction interval values, multiplied by 9 kcal/g and rounded to 5 <= 50 calories. • Saturated fat presumed to be zero.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 84 APPENDIX C Carrot
Nutrition Facts Voluntary Data: Serving Size 7” long, 1 1/4” diam. (78g) Potassium 250 mg; 7% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 30 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 60mg 3% saturated fat free Potassium 250mg 7% Total Carbohydrate 7g 2% low sodium Dietary Fiber 2g 8% cholesterol free Sugars 5g high in vitamin A Protein 1g good source of vitamin C low-calorie Vitamin A 110% • Vitamin C 10% Calcium 2% • Iron 2%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Fat and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Fruits, vegetables, and grain products that contain fiber and Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 risk of coronary heart disease Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and References: vegetables becomes mandatory on January • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Carrots are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 85 APPENDIX C Cauliflower
Nutrition Facts Voluntary Data: Serving Size 1/6 medium head (99g) Potassium 270 mg; 8% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 25 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 30mg 1% saturated fat free Potassium 270mg 8% Total Carbohydrate 5g 2% very low sodium Dietary Fiber 2g 8% cholesterol free Sugars 2g low-calorie Protein 2g high in vitamin C good source of folate (add 10% folate to label) Vitamin A 0% • Vitamin C 100% Calcium 2% • Iron 2% Vitamin K 20% • Folate 10% * Percent Daily Values are based on a 2,000 Health Claims Allowed: calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Saturated fat and cholesterol and coronary heart disease Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Sodium and hypertension Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Note: Pursuant to the final rule on the • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw voluntary nutrition labeling regulations for fruits Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables Register, Vol. 71, No. 159, Rules and Regulations becomes mandatory on January 1, 2008. • Cauliflower is one of the top 40 produce items that are labeled as part of Voluntary trans fat disclosure is currently the voluntary fruit and vegetable labeling program. accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 86 APPENDIX C Green Cauliflower
Nutrition Facts Voluntary Data: Serving Size 1 1/2 cups (85g) Potassium 280 mg; 8% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 30 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 20mg 1% saturated fat free Potassium 275mg 8% very low sodium Total Carbohydrate 5g 2% Dietary Fiber 3g 12% cholesterol free Sugars 3g low-calorie Protein 3g high in vitamin C good source of folate (add 10% folate to label) Vitamin A 4% • Vitamin C 120% Calcium 2% • Iron 4% Vitamin K 15% • Folate 10% * Percent Daily Values are based on a 2,000 Health Claims Allowed: calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Fruits, vegetables and grain products that contain fiber Total Fat Less than 65g 80g Sat Fat Less than 20g 25g and the risk of coronary heart disease Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Fat and cancer Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July References: 25, 2006, trans fat labeling for fruits and • PMA 1991-92 Green Cauliflower Study. vegetables becomes mandatory on Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars, January 1, 2008. Voluntary trans fat • disclosure is currently accepted by FDA. “Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 87 APPENDIX C Celery
Nutrition Facts Voluntary Data: Serving Size 2 medium stalks (110g) Potassium 260 mg; 7% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 15 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% Fat free Sodium 115mg 5% saturated fat free Potassium 260mg 7% low sodium Total Carbohydrate 4g 1% Dietary Fiber 2g 8% cholesterol free Sugars 2g low-calorie Protein 0g good source of vitamin C
Vitamin A 10% • Vitamin C 15% Calcium 4% • Iron 2% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Note: Pursuant to the final rule on the Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal voluntary nutrition labeling regulations for fruits and vegetables published on July Register, Vol. 71, No. 159, Rules and Regulations 25, 2006, trans fat labeling for fruits and • Celery is one of the top 40 produce items that are labeled as part of the vegetables becomes mandatory on voluntary fruit and vegetable labeling program. January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 88 APPENDIX C Sweet Cherries
Nutrition Facts Serving Size 1 cup (21 cherries) (140g) Voluntary Data: Potassium 350 mg; 10% DV Amount Per Serving Soluble Fiber 1 g Calories 100 Calories from Fat 0 Insoluble Fiber 2 g % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Allowed: Sodium 0mg 0% fat free Potassium 350mg 10% Total Carbohydrate 26g 9% saturated fat free Dietary Fiber 1g 4% sodium free Sugars 16g cholesterol free Protein 1g good source of vitamin C good source of potassium Vitamin A 2% • Vitamin C 15% Calcium 2% • Iron 2%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Fat and cancer Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the References: voluntary nutrition labeling regulations for • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw fruits and vegetables published on July 25, Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal 2006, trans fat labeling for fruits and vegetables becomes mandatory on January Register, Vol. 71, No. 159, Rules and Regulations 1, 2008. Voluntary trans fat disclosure is • Cherries are one of the top 40 produce items that are labeled as part of currently accepted by FDA. the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 89 APPENDIX C Collards
Nutrition Facts Voluntary Data: Serving Size 1 cup (85g) Potassium 25 mg; 1% DV
Amount Per Serving Calories 25 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 15mg 1% cholesterol free Potassium 25mg 1% low-calorie Total Carbohydrate 5g 2% Dietary Fiber 3g 12% high in vitamin A Sugars 2g high in vitamin C Protein 2g Vitamin A 110% • Vitamin C 50% Health Claims Allowed: Calcium 10% • Iron 0% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for microcomputers, National Technical Note: Pursuant to the final rule on the Information Service, Order Number PB90-50241, May, 1990. Prediction voluntary nutrition labeling regulations for fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and • Sugar, kale: "Sugar Content of Selected Foods: Individual and Total vegetables becomes mandatory on January Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat- 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Sabel, USDA HNlS, Home Economics Research Report Number 48, September 1987. • Fiber, turnip greens: USDA, HNlS, "Provisional Table on the Dietary Fiber Content of Selected Foods," 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 90 APPENDIX C Sweet Corn
Voluntary Data: Nutrition Facts Potassium 250 mg: 7% DV Serving Size kernals of 1 medium ear (90g)
Amount Per Serving Calories 90 Calories from Fat 20 Nutrient Content Descriptors % Daily Value* Total Fat 2.5g 4% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 250mg 7% good source of vitamin C Total Carbohydrate 18g 6% Dietary Fiber 2g 8% Sugars 5g Protein 4g Health Claims Allowed: Fruits and vegetables and cancer Vitamin A 2% • Vitamin C 10% Fat and cancer Calcium 0% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Total Carbohydrate 300g 375g Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Dietary Fiber 25g 30g Register, Vol. 71, No. 159, Rules and Regulations Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Sweet corn is one of the top 40 produce items that are labeled as part of Note: Pursuant to the final rule on the the voluntary fruit and vegetable labeling program. voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 91 APPENDIX C Cucumber
Nutrition Facts Voluntary Data: Serving Size 1/3 medium (99g) Potassium 140 mg; 4% DV
Amount Per Serving Calories 10 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 140mg 4% low-calorie Total Carbohydrate 2g 1% Dietary Fiber 1g 4% good source of vitamin C Sugars 1g Protein 1g Health Claims Allowed: Vitamin A 4% • Vitamin C 10% Fat and cancer Calcium 2% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg References: Total Carbohydrate 300g 375g Dietary Fiber 25g 30g • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations Note: Pursuant to the final rule on the • Cucumbers are one of the top 40 produce items that are labeled as part voluntary nutrition labeling regulations for fruits and vegetables published on July 25, of the voluntary fruit and vegetable labeling program. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 92 APPENDIX C Dried Currants
Voluntary Data: Nutrition Facts Potassium 280 mg; 8% DV Serving Size 1/4 cup (36g)
Amount Per Serving Calories 100 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 320mg 9% Total Carbohydrate 26g 9% Dietary Fiber 2g 8% Sugars 22g Health Claims Allowed: Protein 1g Fat and cancer Saturated fat and cholesterol and coronary heart disease Vitamin A 0% • Vitamin C 2% Sodium and hypertension Calcium 4% • Iron 6%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: References: Calories 2,000 2,500 • USDA Nutrient Data Base for Standard Reference, Full Version, Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Release 9 IBM PC 360K for microcomputers, National Technical Cholesterol Less than 300mg 300mg Information Service, Order Number PB90-50241, May, 1990. Prediction Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g interval compliance calculations were used to develop label data. Dietary Fiber 25g 30g • Sugar, raw currants (water content was accounted for): "Sugar Content Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farbat-Sabet, USDA' HNIS, Home Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for Economics Research Report Number 48, September 1987. fruits and vegetables published on July 25, • Fiber: USDA, HNIS, "Provisional Table on the Dietary Fiber Content of 2006, trans fat labeling for fruits and Selected Foods," 1988. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 93 APPENDIX C Dates
Nutrition Facts Voluntary Data: Serving Size 5-6 dates (40g) Potassium 240 mg; 7% DV
Amount Per Serving Calories 120 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 270mg 7% good source of fiber Total Carbohydrate 31g 10% Dietary Fiber 3g 12% Sugars 29g Protein 1g Health Claims Allowed: Fiber-containing fruits, vegetables, and grain products and Vitamin A 0% • Vitamin C 0% cancer Calcium 2% • Iron 2% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • PMA 1985-1987 Date Survey. California Date Administrative Committee. Note: Pursuant to the final rule on the Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," voluntary nutrition labeling regulations for • fruits and vegetables published on July 25, Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, 2006, trans fat labeling for fruits and USDA HNIS, Home Economics Research Report Number 48, vegetables becomes mandatory on January September 1987. 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 94 APPENDIX C Eggplant
Voluntary Data: Nutrition Facts Potassium 150 mg; 4% DV Serving Size 1/5 average eggplant (85g)
Amount Per Serving Calories 25 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 195mg 5% low-calorie Total Carbohydrate 5g 2% Dietary Fiber 3g 12% Sugars 3g Protein 1g Health Claims Allowed: Fruits, vegetables and grain products that contain fiber and Vitamin A 0% • Vitamin C 4% the risk of coronary heart disease Calcium 0% • Iron 2% Fat and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Saturated fat and cholesterol and coronary heart disease lower depending on your calorie needs: Calories 2,000 2,500 Sodium and hypertension Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg References: Total Carbohydrate 300g 375g PMA 1990 Eggplant Survey. Dietary Fiber 25g 30g • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, USDA Note: Pursuant to the final rule on the HNIS, Home Economics Research Report Number 48, September 1987. voluntary nutrition labeling regulations for Fiber: "Provisional Table on the Dietary Fiber Content of Selected fruits and vegetables published on July • 25, 2006, trans fat labeling for fruits and Foods," USDA, HNIS, HNIS/PT-106, 1988. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 95 APPENDIX C Endive
Nutrition Facts Voluntary Data: Serving Size 1 cup chopped (85g) Potassium 170 mg; 5% DV
Amount Per Serving Calories 20 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 20mg 1% cholesterol free Potassium 275mg 8% Total Carbohydrate 3g 2% low-calorie Dietary Fiber 3g 12% high in folate (add 20% folate to label) Sugars 1g Protein 1g Health Claims Allowed: Vitamin A 30% • Vitamin C 10% Fat and cancer Calcium 4% • Iron 4% Vitamin K 250% • Folate 10% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 Sodium and hypertension calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g References: Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg • USDA Nutrient Data Base for Standard Reference, Full Version, Sodium Less than 2,400mg 2,400mg Release 9 IBM PC 360K for microcomputers, National Technical Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Information Service, Order Number PB90-50241, May, 1990. Prediction Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 interval compliance calculations were used to develop label data. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Note: Pursuant to the final rule on the Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat- voluntary nutrition labeling regulations for fruits and vegetables published on July 25, Sabet,USDA HNlS, Home Economics Research Report Number 48, 2006, trans fat labeling for fruits and September 1987. vegetables becomes mandatory on January • Fiber, chinese cabbage: USDA, HNlS, Provisional Table on the Dietary 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Fiber Content of Selected Foods," 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 96 APPENDIX C Belgian Endive
Nutrition Facts Serving Size 1 endive (85g) Voluntary Data: Potassium 140 mg; 4% DV Amount Per Serving Soluble Fiber 0 g Calories 15 Calories from Fat 0 Insoluble Fiber 1 g % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Allowed: Sodium 0mg 0% fat free Potassium 190mg 5% Total Carbohydrate 4g 1% saturated fat free Dietary Fiber 3g 12% sodium free Sugars 1g cholesterol free Protein 0g low-calorie
Vitamin A 0% • Vitamin C 4% Calcium 2% • Iron 0% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • PMA 1989 Belgian Endive Study. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, fruits and vegetables published on July 25, USDA HNIS, Home Economics Research Report Number 48, 2006, trans fat labeling for fruits and September 1987. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 97 APPENDIX C Figs
Nutrition Facts Voluntary Data: Serving Size 3 medium figs (153g) Potassium 310 mg; 9% DV
Amount Per Serving Calories 120 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0.5g 1% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 350mg 10%
Total Carbohydrate 28g 9% good source of fiber Dietary Fiber 4g 16% Sugars 22g Protein 1g Health Claims Allowed: Fiber-containing fruits, vegetables, and grain products and Vitamin A 4% • Vitamin C 6% cancer Calcium 6% • Iron 2% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat-and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release IBM PC 360K for microcomputers, National Technical Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for Information Service, Order Number PB90-50241, May, 1990. Prediction fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, currently accepted by FDA. USDA HNIS, Home Economics Research Report Number 48, September 1987. • Fiber, dried figs: "Provisional Table on the Dietary Fiber Content of Selected Foods," USDA, HNIS, HNIS/PT-106, 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 98 APPENDIX C Dried Figs
Nutrition Facts Voluntary Data: Serving Size 2-3 figs (40g) Potassium 230 mg; 6% DV
Amount Per Serving Calories 100 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 5mg 0% cholesterol free Potassium 270mg 8% good source of fiber Total Carbohydrate 23g 8% Dietary Fiber 4g 16% Sugars 20g Protein 1g Health Claims Allowed: Fiber-containing fruits, vegetables, and grain products and Vitamin A 0% • Vitamin C 0% cancer Calcium 6% • Iron 2% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for microcomputers, National Technical Note: Pursuant to the final rule on the Information Service, Order Number PB90-50241, May, 1990. Prediction voluntary nutrition labeling regulations for fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," vegetables becomes mandatory on January Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. USDA HNIS, Home Economics Research Report Number 48, September 1987. • Fiber: USDA, HNIS, Provisional Table on the Dietary Fiber Content of Selected Foods," 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 99 APPENDIX C Garlic
Nutrition Facts Voluntary Data: Serving Size 1 clove (4g) Potassium 15 mg; 0% DV
Amount Per Serving Calories 5 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 15mg 0% low-calorie Total Carbohydrate 1g 0% Dietary Fiber 0g 0% Sugars 0g Protein 0g Health Claims Allowed: Fat and cancer Vitamin A 0% • Vitamin C 2% Sodium and hypertension Calcium 0% • Iron 0%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: References: Calories 2,000 2,500 USDA Nutrient Data Base for Standard Reference, Full Version, Total Fat Less than 65g 80g • Sat Fat Less than 20g 25g Release 9 IBM PC 360K for microcomputers, National Technical Cholesterol Less than 300mg 300mg Information Service, Order Number PB90-50241, May, 1990. Prediction Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g interval compliance calculations were used to develop label data. Dietary Fiber 25g 30g • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farbat-Sabet, USDA HNlS, Home Economics Research Report Number 48, Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for September 1987. fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 100 APPENDIX C Gooseberries
Nutrition Facts Voluntary Data: Serving Size 1 cup (150g) Potassium 250 mg; 7% DV
Amount Per Serving Calories 70 Calories from Fat 10
% Daily Value* Nutrient Content Descriptors Total Fat 1g 2% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 295mg 8% Total Carbohydrate 15g 5% high in vitamin C Dietary Fiber 6g 24% Sugars 12g Protein 0g Health Claims Allowed: Fruits and vegetables and cancer Vitamin A 10% • Vitamin C 70% Fat and cancer Calcium 4% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg References: Total Carbohydrate 300g 375g • USDA Nutrient Data Base for Standard Reference, Full Version, Dietary Fiber 25g 30g Release 9 IBM PC 360K for microcomputers, National Technical Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Information Service, Order Number PB90-50241, May, 1990. Prediction Note: Pursuant to the final rule on the interval compliance calculations were used to develop label data. voluntary nutrition labeling regulations for • Sugar, currants: "Sugar Content of Selected Foods: Individual and Total fruits and vegetables published on July 25, Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat- 2006, trans fat labeling for fruits and vegetables becomes mandatory on January Sabet, USDA HNlS, Home Economics Research Report Number 48, 1, 2008. Voluntary trans fat disclosure is September 1987. currently accepted by FDA. • Dietary Fiber: USDA, HNlS, Agriculture Handbook Number 8-9 (1981), NDB No. 09107.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 101 APPENDIX C Grapefruit
Voluntary Data: Nutrition Facts Potassium 160 mg; 5% DV Serving Size 1/2 medium grapefruit (154g) Soluble Fiber 4 g Amount Per Serving Insoluble Fiber 1 g Calories 60 Calories from Fat 0 100% of vitamin A is Beta Carotene % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Cholesterol 0mg 0% Allowed: Sodium 0mg 0% fat free Potassium 160mg 5% saturated fat free Total Carbohydrate 15g 5% sodium free Dietary Fiber 2g 8% cholesterol free Sugars 11g high in vitamin A Protein 1g high in vitamin C Vitamin A 35% • Vitamin C 100% Calcium 4% • Iron 0%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Total Fat Less than 65g 80g Fat and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Sodium and hypertension Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw fruits and vegetables published on July Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal 25, 2006, trans fat labeling for fruits and Register, Vol. 71, No. 159, Rules and Regulations vegetables becomes mandatory on January 1, 2008. Voluntary trans fat • Grapefruit is one of the top 40 produce items that are labeled as part of disclosure is currently accepted by FDA. the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 102 APPENDIX C Grapes
Nutrition Facts Voluntary Data: Serving Size 3/4 cup grapes (126g) Potassium 240 mg; 7% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 90 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 15mg 1% saturated fat free Potassium 240mg 7% very low sodium Total Carbohydrate 23g 8% Dietary Fiber 1g 4% cholesterol free Sugars 20g Protein 0g Health Claims Allowed: Vitamin A 0% • Vitamin C 2% Fat and cancer Calcium 2% • Iron 0% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg References: Total Carbohydrate 300g 375g Dietary Fiber 25g 30g • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations Note: Pursuant to the final rule on the • Grapes are one of the top 40 produce items that are labeled as part of the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, voluntary fruit and vegetable labeling program. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 103 APPENDIX C Green Onion
Voluntary Data: Nutrition Facts Potassium 70 mg; 2% DV Serving Size 1/4 cup chopped (25g)
Amount Per Serving Calories 10 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 10mg 0% cholesterol free Potassium 70mg 2% low-calorie Total Carbohydrate 2g 1% Dietary Fiber 1g 4% Sugars 1g Protein 0g Health Claims Allowed: Fat and cancer Vitamin A 2% • Vitamin C 8% Saturated fat and cholesterol and coronary heart disease Calcium 2% • Iron 2% Sodium and hypertension * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g References: Sat Fat Less than 20g 25g • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Cholesterol Less than 300mg 300mg Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Register, Vol. 71, No. 159, Rules and Regulations Dietary Fiber 25g 30g • Green onions are one of the top 40 produce items that are labeled as part Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 of the voluntary fruit and vegetable labeling program. Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 104 APPENDIX C Guavas
Voluntary Data: Nutrition Facts Potassium 200 mg; 6% DV Serving Size 1 guava (90g)
Amount Per Serving Calories 60 Calories from Fat 5 Nutrient Content Descriptors % Daily Value* Total Fat 0.5g 1% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 375mg 10% good source of fiber Total Carbohydrate 13g 4% high in vitamin C Dietary Fiber 4g 16% low-calorie Sugars 8g Protein 2g Vitamin A 10% • Vitamin C 300% Health Claims Allowed: Calcium 2% • Iron 2% Fiber-containing fruits, vegetables, and grain products and * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or cancer. lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Fat and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the References: voluntary nutrition labeling regulations for • USDA Nutrient Data Base for Standard Reference, Full Version, fruits and vegetables published on July 25, Release 9 IBM PC 360K for microcomputers, National Technical 2006, trans fat labeling for fruits and vegetables becomes mandatory on January Information Service, Order Number PB90-50241, May, 1990. Prediction 1, 2008. Voluntary trans fat disclosure is interval compliance calculations were used to develop label data. currently accepted by FDA. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, USDA HNIS, Home Economics Research Report Number. 48, September 1987. • Fat calories were calculated based on the fat prediction interval values, multiplied by 9 kcal/g and rounded to 5 <= 50 calories. • Fiber: USDA, HNIS, Agriculture Handbook Number 8-9 (1981), NDB No. 09139.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. Updated 2009 105 The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 106 APPENDIX C Honeydew Melon
Nutrition Facts Voluntary Data: Serving Size 1/10 medium melon (134g) Potassium 210 mg; 6% DV
Amount Per Serving Calories 50 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 30mg 1% cholesterol free Potassium 210mg 6% high in vitamin C Total Carbohydrate 12g 4% Dietary Fiber 1g 4% Sugars 11g Protein 1g Health Claims Allowed: Fruits and vegetables and cancer Vitamin A 2% • Vitamin C 45% Fat and cancer Calcium 2% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Total Carbohydrate 300g 375g Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Dietary Fiber 25g 30g Register, Vol. 71, No. 159, Rules and Regulations Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Honeydew melon is one of the top 40 produce items that are labeled as Note: Pursuant to the final rule on the part of the voluntary fruit and vegetable labeling program. voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 107 APPENDIX C
Kiwifruit
Nutrition Facts Voluntary Data: Serving Size 2 medium kiwifruit (148g) Potassium 450 mg; 13% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 3 g Calories 90 Calories from Fat 10
% Daily Value* Total Fat 1g 2% Saturated Fat 0g 0% Nutrient Content Descriptors Allowed: Trans Fat 0g low fat Cholesterol 0mg 0% saturated fat free Sodium 0mg 0% sodium free Potassium 450mg 13% cholesterol free Total Carbohydrate 20g 7% good source of fiber Dietary Fiber 4g 16% high in vitamin C Sugars 13g good source of potassium (add 450 mg, 13% potassium to the Protein 1g label) Vitamin A 2% • Vitamin C 240% good source of vitamin E (add 10% vitamin E to the label) Calcium 4% • Iron 2% Vitamin K E 10% • Vitamin K 50% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Fiber-containing fruits, vegetables, and grain products and cancer Calories 2,000 2,500 Total Fat Less than 65g 80g Fruits and vegetables and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Fat and cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Fruits, vegetables and grain products that contain fiber and the risk Note: Pursuant to the final rule on the of coronary heart disease voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. References: Voluntary trans fat disclosure is currently • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, accepted by FDA. Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Kiwifruit is one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 108 APPENDIX C Iceberg Lettuce
Voluntary Data: Nutrition Facts Potassium 125 mg; 4% DV Serving Size 1/6 medium head (89g)
Amount Per Serving Calories 10 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 10mg 0% cholesterol tree Potassium 125mg 4% low-calorie Total Carbohydrate 2g 1% Dietary Fiber 1g 4% Sugars 2g Protein 1g Health Claims Allowed: Fat and cancer Vitamin A 6% • Vitamin C 6% Saturated fat and cholesterol and coronary heart disease Calcium 2% • Iron 2% Sodium and hypertension * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g References: Sat Fat Less than 20g 25g • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Cholesterol Less than 300mg 300mg Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Register, Vol. 71, No. 159, Rules and Regulations Dietary Fiber 25g 30g • Iceberg lettuce is one of the top 40 produce items that are labeled as part Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 of the voluntary fruit and vegetable labeling program. Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 109 APPENDIX C Lemon
Nutrition Facts Voluntary Data: Serving Size 1 medium lemon (58g) Potassium 75 mg; 2% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 0 g Calories 15 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 75mg 2% sodium free Total Carbohydrate 5g 2% Dietary Fiber 2g 8% cholesterol free Sugars 2g low-calorie Protein 0g high in vitamin C
Vitamin A 0% • Vitamin C 40% Calcium 2% • Iron 0% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fruits vegetables and grain products that contain fiber and the Total Fat Less than 65g 80g risk of coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Fat and cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for References: fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw vegetables becomes mandatory on Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal January 1, 2008. Voluntary trans fat Register, Vol. 71, No. 159, Rules and Regulations disclosure is currently accepted by FDA. • Lemons are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 110 APPENDIX C Leaf Lettuce
Nutrition Facts Voluntary Data: Serving Size 1 1/2 cups shredded (85g) Potassium 170 mg; 5% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 0 g Calories 15 Calories from Fat 0 100% of vitamin A is Beta Carotene. % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Allowed: Sodium 35mg 1% fat free Potassium 170mg 5% Total Carbohydrate 2g 1% saturated fat free Dietary Fiber 1g 4% very low in sodium (35mg or less) Sugars 1g cholesterol free Protein 1g low-calorie high in vitamin A Vitamin A 130% • Vitamin C 6% good source of folate (add 15% folate to label) Calcium 2% • Iron 4% Vitamin K 120% • Folate 15% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Health Claims Allowed: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Fruits, vegetables and grain products that contain fiber and Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg the risk of coronary heart disease Total Carbohydrate 300g 375g Fat and cancer Dietary Fiber 25g 30g Saturated fat and cholesterol and coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on References: January 1, 2008. Voluntary trans fat • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw disclosure is currently accepted by FDA. Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Leaf lettuce is one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 111 APPENDIX C Romaine Lettuce
Nutrition Facts Voluntary Data: Serving Size 6 leaves (85g) Potassium 140 mg; 4% DV
Amount Per Serving Calories 15 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 5mg 0% Potassium 205mg 6% cholesterol free Total Carbohydrate 3g 1% low-calorie Dietary Fiber 1g 4% high in vitamin A Sugars 2g good source of folate (add 10% folate to label) Protein 1g
Vitamin A 90% • Vitamin C 30% Calcium 2% • Iron 2% Health Claims Allowed: Vitamin K 100% • Folate 10% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 Fat and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Saturated fat and cholesterol and coronary heart disease Calories 2,000 2,500 Sodium and hypertension Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g References: Dietary Fiber 25g 30g • 1990 PMA Romaine Lettuce Study. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Note: Pursuant to the final rule on the Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, voluntary nutrition labeling regulations for USDA HNIS, Home Economics Research Report Number 48, fruits and vegetables published on July 25, September 1987. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 112 APPENDIX C Lime
Nutrition Facts Voluntary Data: Serving Size 1 medium lime (67g) Potassium 75 mg; 2% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 20 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 75mg 2% sodium free Total Carbohydrate 7g 2% Dietary Fiber 2g 8% cholesterol free Sugars 0g low calorie Protein 0g high in vitamin C
Vitamin A 0% • Vitamin C 35% Calcium 0% • Iron 0% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Note: Pursuant to the final rule on the • voluntary nutrition labeling regulations for Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal fruits and vegetables published on July Register, Vol. 71, No. 159, Rules and Regulations 25, 2006, trans fat labeling for fruits and Limes are one of the top 40 produce items that are labeled as part of the vegetables becomes mandatory on • January 1, 2008. Voluntary trans fat voluntary fruit and vegetable labeling program. disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 113 APPENDIX C Mango
Voluntary Data: Nutrition Facts Potassium 125 mg; 4% DV Serving Size 1/2 mango (104g)
Amount Per Serving Calories 70 Calories from Fat 5 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 160mg 4% high in vitamin A Total Carbohydrate 17g 6% good source of vitamin C Dietary Fiber 2g 8% Sugars 15g Protein 0g Health Claims Allowed: Vitamin A 15% • Vitamin C 50% Fruits and vegetables and cancer Calcium 2% • Iron 0% Fat and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Saturated fat and cholesterol and coronary heart disease lower depending on your calorie needs: Sodium and hypertension. Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg References: Total Carbohydrate 300g 375g • USDA Nutrient Data Base for Standard Reference, Fun Version, Dietary Fiber 25g 30g Release 9 IBM PC 360K for microcomputers, National Technical Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Information Service, Order Number PB90-50241, May, 1990. Prediction Note: Pursuant to the final rule on the interval compliance calculations were used to develop label data. voluntary nutrition labeling regulations for • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars:' fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, vegetables becomes mandatory on January USDA HNIS, Home Economics Research Report Number 48, 1, 2008. Voluntary trans fat disclosure is September 1987. currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 114 APPENDIX C Mushrooms
Voluntary Data: Nutrition Facts Potassium 300 mg; 9% DV Serving Size 5 medium mushrooms (85g) Riboflavin 20% Amount Per Serving Niacin 15% Calories 20 Calories from Fat 0 Copper 15% % Daily Value* Pantothenate 10% Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Sodium 15mg 1% Allowed: Potassium 300mg 9% fat free Total Carbohydrate 3g 1% saturated fat free Dietary Fiber 1g 4% very low in sodium Sugars 0g cholesterol free Protein 3g low-calorie Vitamin A 0% • Vitamin C 2% high in riboflavin (add 20% riboflavin to the label) Calcium 0% • Iron 2% good source of niacin (add 15% niacin to the label) Riboflavin 25% • Niacin 15% good source of copper (add 15% copper to the label) Pantothenate 10% • Copper 20% good source of pantothenate (add 10% pantothenate to the * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or label) lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Health Claims Allowed: Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Fat and cancer Dietary Fiber 25g 30g Saturated fat and cholesterol and coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and References: vegetables becomes mandatory on Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw January 1, 2008. Voluntary trans fat • disclosure is currently accepted by FDA. Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Mushrooms are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 115 APPENDIX C Mustard Greens
Nutrition Facts Voluntary Data: Serving Size 1 1/2 cups shredded (85g) Potassium 230 mg; 7% DV
Amount Per Serving Calories 25 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% low sodium Sodium 20mg 1% cholesterol free Potassium 295mg 8% Total Carbohydrate 5g 2% low-calorie Dietary Fiber 2g 8% high in vitamin A Sugars 1g high in vitamin C Protein 2g high in folate (add 40% folate to label)
Vitamin A 130% • Vitamin C 90% Calcium 8% • Iron 8% Vitamin K 500% • Folate 40% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fruits and vegetables and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fat and cancer Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Fun Version, Note: Pursuant to the final rule on the Release 9 IBM PC 360K for microcomputers, National Technical voluntary nutrition labeling regulations for Information Service, Order Number PB90-50241, May, 1990. Prediction fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," 1, 2008. Voluntary trans fat disclosure is Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, currently accepted by FDA. USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 116 APPENDIX C Nectarine
Nutrition Facts Voluntary Data: Serving Size 1 medium (140g) Potassium 250 mg; 7% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 60 Calories from Fat 5
% Daily Value* Total Fat 0.5g 1% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% low fat Sodium 0mg 0% saturated fat free Potassium 250mg 7% sodium free Total Carbohydrate 15g 5% Dietary Fiber 2g 8% cholesterol free Sugars 11g good source of vitamin C Protein 1g Vitamin A 8% • Vitamin C 15% Health Claims Allowed: Calcium 0% • Iron 2% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Note: Pursuant to the final rule on the Register, Vol. 71, No. 159, Rules and Regulations voluntary nutrition labeling regulations for fruits and vegetables published on July 25, • Nectarines are one of the top 40 produce items that are labeled as part 2006, trans fat labeling for fruits and of the voluntary fruit and vegetable labeling program. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 117 APPENDIX C Okra
Nutrition Facts Voluntary Data: Serving Size 6 pods (83g) Potassium 150 mg; 4% DV Amount Per Serving Calories 30 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 15mg 1% saturated fat free Total Carbohydrate 6g 2% Dietary Fiber 1g 4% very low sodium Sugars 2g cholesterol free Protein 2g low-calorie Vitamin A 10% * Vitamin C 20% good source of vitamin A Calcium 6% * Iron 4% * Percent Daily Values are based on a 2,000 calorie diet. high in vitamin C Your Daily Values may be higher or lower depending on your calorie needs: good source of folate (add 10% folate to label) Calories: 2,000 2,500 good source of thiamin (add 10% thiamin to the label) Total Fat Less than 65g 80g Sat Fat Less than 20g 25g good source of magnesium (add 10% magnesium to the Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg label) Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 * Carbohydrate 4 * Protein 4 Note: Pursuant to the final rule on the Health Claims Allowed: voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, Fruits and vegetables and cancer trans fat labeling for fruits and vegetables Fat and cancer becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently Saturated fat and cholesterol and coronary heart disease accepted by FDA. Sodium and hypertension
References: • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for microcomputers, National Technical Information Service, Order Number PB90-50241, May, 1990. Prediction interval compliance calculations were used to develop label data. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars:' Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS. Home Economics Research Report Number 48, September 1987. • Fiber: USDA, HNIS, Agriculture Handbook Number 8-11 (1982). NDB No. 11278.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 118 APPENDIX C Onion
Voluntary Data: Nutrition Facts Potassium 190 mg; 5% DV Serving Size 1 medium onion (148g) Soluble Fiber 2 g
Amount Per Serving Insoluble Fiber 1 g Calories 45 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 5mg 0% saturated fat free Potassium 190mg 5% very low sodium Total Carbohydrate 11g 4% cholesterol free Dietary Fiber 3g 12% high in vitamin C Sugars 9g good source of fiber Protein 1g
Vitamin A 0% • Vitamin C 20% Calcium 4% • Iron 4% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fruits and vegetables and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fat and cancer Calories 2,000 2,500 Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Note: Pursuant to the final rule on the Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal voluntary nutrition labeling regulations for Register, Vol. 71, No. 159, Rules and Regulations fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and • Onions are one of the top 40 produce items that are labeled as part of the vegetables becomes mandatory on voluntary fruit and vegetable labeling program. January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 119 APPENDIX C Orange
Nutrition Facts Voluntary Data: Serving Size 1 medium orange (154g) Potassium 250 mg; 7% DV Soluble Fiber 2 g Amount Per Serving Insoluble Fiber 2 g Calories 80 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 250mg 7% sodium free Total Carbohydrate 19g 6% Dietary Fiber 3g 12% cholesterol free Sugars 14g good source of fiber Protein 1g high in vitamin C
Vitamin A 2% • Vitamin C 130% Calcium 6% • Iron 0% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fiber-containing fruits, vegetables, and grain products and lower depending on your calorie needs: Calories 2,000 2,500 cancer Total Fat Less than 65g 80g Fruits and vegetables and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Fruits, vegetables and grain products that contain fiber and Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g the risk of coronary heart disease Dietary Fiber 25g 30g Fat and cancer Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Saturated fat and cholesterol and coronary heart disease Note: Pursuant to the final rule on the Sodium and hypertension voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January References: 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Oranges are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 120 APPENDIX C Papaya
Nutrition Facts Voluntary Data: Serving Size 1/2 papaya (140g) Potassium 220 mg; 6% DV
Amount Per Serving Calories 70 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 5mg 0% cholesterol free Potassium 360mg 10% Total Carbohydrate 14g 5% good source of fiber Dietary Fiber 2g 8% high in vitamin C Sugars 9g good source of folate (add 10% folate to label) Protein 1g Vitamin A 30% • Vitamin C 140% Health Claims Allowed: Calcium 4% • Iron 0% Vitamin E 8% • Folate 10% Fiber-containing fruits, vegetables, and grain products and * Percent Daily Values are based on a 2,000 cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fruits and vegetables and cancer Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Saturated fat and cholesterol and coronary heart disease Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Sodium and hypertension Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Note: Pursuant to the final rule on the • PMA 1984 Papaya Study. voluntary nutrition labeling regulations for Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," fruits and vegetables published on July • 25, 2006, trans fat labeling for fruits and Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, USDA vegetables becomes mandatory on HNIS, Home Economics Research Report Number 48, September 1987. January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 121 APPENDIX C Parsley
Nutrition Facts Voluntary Data: Serving Size 1 Tbsp chopped (4 g) Potassium 10 mg; 0% DV Amount Per Serving Folate 2% Calories 0 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Cholesterol 0mg 0% Allowed: Sodium 5mg 0% fat free Total Carbohydrate 0g 0% Dietary Fiber 0g 0% saturated fat free Sugars 0g very low sodium Protein 0g cholesterol free Vitamin A 4% * Vitamin C 6% calorie free Calcium 0% * Iron 2% * Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs: Calories: 2,000 2,500 Total Fat Less than 65g 80g Health Claims Allowed: Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Fat and cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 * Carbohydrate 4 * Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits References: and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables • USDA Nutrient Data Base for Standard Reference, Full Version, becomes mandatory on January 1, 2008. Release 9 IBM PC 360K for microcomputers, National Technical Voluntary trans fat disclosure is currently Information Service, Order Number PB90-50241, May, 1990. accepted by FDA. Prediction interval compliance calculations were used to develop label data. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987. • Fiber: "Provisional Table on the Dietary Fiber Content of Selected Foods," USDA, HNIS, HNIS/PT-106, 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 122 APPENDIX C Peaches
Nutrition Facts Voluntary Data: Serving Size 1 medium peach (147g) Potassium 230 mg; 7% DV
Amount Per Serving Calories 60 Calories from Fat 5 Nutrient Content Descriptors % Daily Value* Total Fat 0.5g 1% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 230mg 7% good source of vitamin C Total Carbohydrate 15g 5% Dietary Fiber 2g 8% Sugars 13g Protein 1g Health Claims Allowed: Fruits and vegetables and cancer Vitamin A 6% • Vitamin C 15% Fat and cancer Calcium 0% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Total Carbohydrate 300g 375g Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Dietary Fiber 25g 30g Register, Vol. 71, No. 159, Rules and Regulations Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Peaches are one of the top 40 produce items that are labeled as part of Note: Pursuant to the final rule on the the voluntary fruit and vegetable labeling program. voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 123 APPENDIX C Pear
Nutrition Facts Voluntary Data: Serving Size 1 medium (166g) Potassium 190 mg; 5% DV Soluble Fiber 2 g Amount Per Serving Insoluble Fiber 2 g Calories 100 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 190mg 5% sodium free Total Carbohydrate 26g 9% Dietary Fiber 6g 24% cholesterol free Sugars 16g high in fiber Protein 1g good source of vitamin C
Vitamin A 0% • Vitamin C 10% Calcium 2% • Iron 0% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fiber-containing fruits, vegetables, and grain products and lower depending on your calorie needs: Calories 2,000 2,500 cancer Total Fat Less than 65g 80g Fruits and vegetables and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Fat and cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Fruits, vegetables and grain products that contain fiber and Note: Pursuant to the final rule on the the risk of coronary heart disease voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January References: 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Pears are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 124 APPENDIX C Hot Chili Pepper
Voluntary Data: Nutrition Facts Potassium 0 mg; 0% DV Serving Size one pepper (45g) Folate 2% Amount Per Serving Calories 20 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 10mg 0% very low sodium Potassium 145mg 4% cholesterol free Total Carbohydrate 4g 1% low-calorie Dietary Fiber <1g 2% high in vitamin A Sugars 2g Protein 1g high in vitamin C
Vitamin A 10% • Vitamin C 170% Calcium 0% • Iron 2% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: • USDA Nutrient Data Base for Standard Reference, Full Version, Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for Release 9 IBM PC 360K for microcomputers, National Technical fruits and vegetables published on July 25, Information Service, Order Number PB90-50241, May, 1990. Prediction 2006, trans fat labeling for fruits and interval compliance calculations were used to develop label data. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," currently accepted by FDA. Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number. 48, September 1987. • Fiber. USDA, HNIS, Agriculture Handbook Number 8.11 (1982), NDB No. 11670.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 125 APPENDIX C Le Rouge Royale Pepper
Nutrition Facts Voluntary Data: Serving Size 1/3 medium pepper (68g) Potassium 140 mg; 4% DV
Amount Per Serving Calories 20 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 140mg 4% Total Carbohydrate 5g 2% low calorie Dietary Fiber 1g 5% high in vitamin A Sugars 2g high in vitamin C Protein 1g good source of folate (add 10% folate to label)
Vitamin A 20% • Vitamin C 100% Calcium 0% • Iron 0% Vitamin B6 8% • Folate 10% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fruits and vegetables and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fat and cancer Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • PMA 1988 Le Rouge Royale Pepper. Note: Pursuant to the final rule on the • Sugar (sweet green): "Sugar Content of Selected Foods: Individual and voluntary nutrition labeling regulations for Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan fruits and vegetables published on July 25, Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 48, September 1987. 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 126 APPENDIX C Pineapple
Voluntary Data: Nutrition Facts Potassium 120 mg; 3% DV Serving Size 2 slices, 3” diameter, 3/4” thick (112g)
Amount Per Serving Calories 50 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 10mg 0% cholesterol free Potassium 120mg 3% high in vitamin C Total Carbohydrate 13g 4% Dietary Fiber 1g 4% Sugars 10g Protein 1g Health Claims Allowed: Fruits and vegetables and cancer Vitamin A 2% • Vitamin C 50% Fat and cancer Calcium 2% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Total Carbohydrate 300g 375g Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Dietary Fiber 25g 30g Register, Vol. 71, No. 159, Rules and Regulations Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Pineapples are one of the top 40 produce items that are labeled as Note: Pursuant to the final rule on the part of the voluntary fruit and vegetable labeling program. voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 127 APPENDIX C Plums
Nutrition Facts Voluntary Data: Serving Size 2 medium (151g) Potassium 230 mg; 7% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 70 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 230mg 7% sodium free Total Carbohydrate 19g 6% Dietary Fiber 2g 8% cholesterol free Sugars 16g good source of vitamin C Protein 1g Vitamin A 8% • Vitamin C 10% Health Claims Allowed: Calcium 0% • Iron 2% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Note: Pursuant to the final rule on the Register, Vol. 71, No. 159, Rules and Regulations voluntary nutrition labeling regulations for fruits and vegetables published on July • Plums are one of the top 40 produce items that are labeled as part 25, 2006, trans fat labeling for fruits and of the voluntary fruit and vegetable labeling program. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 128 APPENDIX C Potato
Nutrition Facts Voluntary Data: Serving Size 1 medium (148g) Potassium 620 mg; 18% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 2g Calories 110 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 620mg 18% sodium free Total Carbohydrate 26g 9% Dietary Fiber 2g 8% cholesterol free Sugars 1g high in vitamin C Protein 3g good source of potassium
Vitamin A 0% • Vitamin C 45% Calcium 2% • Iron 6% Health Claims Allowed: * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Note: Pursuant to the final rule on the • voluntary nutrition labeling regulations for Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal fruits and vegetables published on July 25, Register, Vol. 71, No. 159, Rules and Regulations 2006, trans fat labeling for fruits and Potatoes are one of the top 40 produce items that are labeled as vegetables becomes mandatory on January • 1, 2008. Voluntary trans fat disclosure is part of the voluntary fruit and vegetable labeling program. currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 129 APPENDIX C Pricklypear
Nutrition Facts Nutrient Content Descriptors Serving Size 1 pricklypear (103g) Allowed:
Amount Per Serving low fat Calories 40 Calories from Fat 5 saturated fat free % Daily Value* very low sodium Total Fat 0.5g 1% cholesterol free Saturated Fat 0g 0% high in vitamin C Trans Fat 0g Cholesterol 0mg 0% Sodium 5mg 0% Potassium 226mg 6% Health Claims Allowed: Total Carbohydrate 8g 3% Fruits and vegetables and cancer Dietary Fiber 3g 12% Fat and cancer Sugars 7g Saturated fat and cholesterol and coronary heart disease Protein 1g Sodium and hypertension
Vitamin A 0% • Vitamin C 25% Calcium 6% • Iron 2% References: * Percent Daily Values are based on a 2,000 • USDA Nutrient Data Base for Standard Reference, Full Version, calorie diet. Your daily values may be higher or lower depending on your calorie needs: Release 9 IBM PC 360K for microcomputers, National Technical Calories 2,000 2,500 Information Service, Order Number PB90-50241, May, 1990. Prediction Total Fat Less than 65g 80g interval compliance calculations were used to develop label data. Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg • Sugar (passion fruit): "Sugar Content of Selected Foods: Individual and Sodium Less than 2,400mg 2,400mg Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Total Carbohydrate 300g 375g Farhat-Sabet, USDA HNIS, Home Economics Research Report Number Dietary Fiber 25g 30g 48, September 1987. Data adjusted downward. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Fiber: USDA, HNIS, Agriculture Handbook Number 8-9 (1981), NDB Note: Pursuant to the final rule on the No. 09287. voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 130 APPENDIX C Dried Prunes
Nutrition Facts Voluntary Data: Serving Size 5 prunes (42g) Potassium 280 mg; 8% DV
Amount Per Serving Calories 100 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 280mg 8% good source of fiber Total Carbohydrate 25g 8% Dietary Fiber 3g 12% good source of vitamin A Sugars 18g Protein 1g Health Claims Allowed: Vitamin A 8% • Vitamin C 2% Fiber-containing fruits, vegetables. and grain products Calcium 2% • Iron 4% and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Saturated fat and cholesterol and coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: USDA Nutrient Data Base for Standard Reference, Full Version, Note: Pursuant to the final rule on the • voluntary nutrition labeling regulations for Release 9 IBM PC 360K for microcomputers, National Technical fruits and vegetables published on July 25, Information Service, Order Number PB90-50241, May, 1990. Prediction 2006, trans fat labeling for fruits and interval compliance calculations were used to develop label data. vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," currently accepted by FDA. Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987. • Fiber: "Provisional Table on the Dietary Fiber Content of Selected Foods," USDA, HNIS, HNIS/PT-106, 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 131 APPENDIX C Pummelo
Nutrition Facts Voluntary Data: Serving Size 1/4 pummelo (52g) Potassium 260 mg; 7% DV
Amount Per Serving Calories 60 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 300mg 9% high in vitamin C Total Carbohydrate 14g 5% Dietary Fiber 1g 4% Sugars 10g Protein 1g Health Claims Allowed: Fruits and vegetables and cancer Vitamin A 0% • Vitamin C 130% Fat and cancer Calcium 0% • Iron 0% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • USDA Nutrient Data Base for Standard Reference, Full Version, Total Carbohydrate 300g 375g Release 9 IBM pc. 360K for microcomputers, National Technical Dietary Fiber 25g 30g Information Service, Order Number PB90-50241, May, 1990. Prediction Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 interval compliance calculations .were us~ to develop label data. Note: Pursuant to the final rule on the • Sugar (grapefruit): "Sugar Content of Selected Foods: Individual and voluntary nutrition labeling regulations for Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and Farhat-Sabet, USDA HNIS, Home Economics Research Report Number vegetables becomes mandatory on January 48, September 1987. 1, 2008. Voluntary trans fat disclosure is • Vitamin A and fiber: USDA, HNlS, Agriculture Handbook Number 8-9 currently accepted by FDA. (1981), NDB No. 09295.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 132 APPENDIX C Radishes
Voluntary Data: Nutrition Facts Potassium 190 mg; 5% DV Serving Size 7 radishes (85g)
Amount Per Serving Calories 20 Calories from Fat 0 Nutrient Content Descriptors Allowed:
% Daily Value* fat free Total Fat 0g 0% saturated fat tree Saturated Fat 0g 0% low sodium Trans Fat 0g cholesterol free Cholesterol 0mg 0% low-calorie Sodium 20mg 1% high in vitamin C Potassium 150mg 4% Total Carbohydrate 6g 2% Dietary Fiber 1g 4% Sugars 2g Health Claims Allowed: Protein 1g Fruits and vegetables and cancer Fat and cancer Vitamin A 0% • Vitamin C 15% Saturated fat and cholesterol and coronary heart disease Calcium 2% • Iron 0% Sodium and hypertension * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 References: Total Fat Less than 65g 80g Sat Fat Less than 20g 25g • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Cholesterol Less than 300mg 300mg Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Register, Vol. 71, No. 159, Rules and Regulations Dietary Fiber 25g 30g • Radishes are one of the top 40 produce items that are labeled as part Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 of the voluntary fruit and vegetable labeling program. Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 133 APPENDIX C Raisins
Nutrition Facts Voluntary Data : Serving Size 1/4 cup (40g) Potassium 310 mg; 9% DV
Amount Per Serving Calories 130 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 10mg 0% cholesterol free Potassium 300mg 8% Total Carbohydrate 31g 10% Dietary Fiber 2g 9 % Sugars 24g Health Claims Allowed: Protein 1g Fat and cancer Saturated fat and cholesterol and coronary heart disease Vitamin A 0% • Vitamin C 2% Sodium and hypertension Calcium 2% • Iron 6%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: References: Calories 2,000 2,500 USDA Nutrient Data Base for Standard Reference, Full Version, Release Total Fat Less than 65g 80g • Sat Fat Less than 20g 25g 9 IBM PC 360K for microcomputers, National Technical Information Cholesterol Less than 300mg 300mg Service, Order Number PB90-50241, May, 1990. Prediction interval Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g compliance calculations were used to develop label data. Dietary Fiber 25g 30g • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sahet, USDA HNIS, Home Economics Research Report Number 48, September 1987. Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for • Fiber: "Provisional Table on the Dietary Fiber Content of Selected fruits and vegetables published on July Foods," USDA, HNIS, HNIS/PT-106, 1988. 25, 2006, trans fat labeling for fruits and California Raisin Advisory Board. vegetables becomes mandatory on • January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 134 APPENDIX C Raspberries
Voluntary Data: Nutrition Facts Potassium 160 mg; 5% DV Serving Size 1 cup (125g) Soluble Fiber 3 g Amount Per Serving Insoluble Fiber 5 g Calories 60 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Allowed: Saturated Fat 0g 0% Fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% sodium free Sodium 0mg 0% cholesterol free Potassium 185mg 5% high in fiber Total Carbohydrate 17g 6% high in vitamin C Dietary Fiber 8g 32% Sugars 8g Protein 1g Health Claims Allowed: Vitamin A 0% • Vitamin C 50% Fiber-containing fruits, vegetables, and grain products and Calcium 2% • Iron 4% cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fruits and vegetables and cancer lower depending on your calorie needs: Fruits, vegetables and grain products that contain fiber and Calories 2,000 2,500 Total Fat Less than 65g 80g the risk of coronary heart disease Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Fat and cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for References: fruits and vegetables published on July 25, • 1990 PMA Raspberry Study. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," 1, 2008. Voluntary trans fat disclosure is Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, currently accepted by FDA. USDA FINIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 135 APPENDIX C Rhubarb
Nutrition Facts Voluntary Data: Serving Size 2/3 cup diced (85g) Potassium 130 mg; 4% DV
Amount Per Serving Calories 15 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 5mg 0% cholesterol free Potassium 230mg 7% low-calorie Total Carbohydrate 4g 1% Dietary Fiber 1g 4% Sugars 1g Protein 1g Health Claims Allowed: Fat and cancer Vitamin A 2% • Vitamin C 10% Saturated fat and cholesterol and coronary heart disease Calcium 8% • Iron 0% Sodium and hypertension * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g References: Sat Fat Less than 20g 25g • USDA Nutrient Data Base for Standard Reference, Full Version, Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Release 9 IBM PC 360K for microcomputers, National Technical Total Carbohydrate 300g 375g Information Service, Order Number PB90-50241, May, 1990. Prediction Dietary Fiber 25g 30g interval compliance calculations were used to develop label data. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Note: Pursuant to the final rule on the Ruth H. Matthews. Pamela R. Pehrsson, and Mojgan Farhat-Sabet, voluntary nutrition labeling regulations for USDA HNIS, Home Economics Research Report Number 48, fruits and vegetables published on July 25, September 1987. 2006, trans fat labeling for fruits and vegetables becomes mandatory on January • Fiber: USDA, HNIS, Agriculture Handbook Number 8-9 (1981), NDB 1, 2008. Voluntary trans fat disclosure is No. 09307. currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 136 APPENDIX C Rutabagas
Voluntary Data: Nutrition Facts Potassium 230 mg; 6% DV Serving Size 1/2 cup (85g) Folate 2% Amount Per Serving Calories 30 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 15mg 1% very low sodium Potassium 290mg 7% cholesterol free Total Carbohydrate 7g 2% low-calorie Dietary Fiber 2g 8% high in vitamin C Sugars 4g Protein 1g Vitamin A 0% • Vitamin C 30% Health Claims Allowed: Calcium 4% • Iron 2% Fruits and vegetables and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Fat and cancer lower depending on your calorie needs: Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference, Full Version, Release IBM PC 360K for microcomputers, National Technical Information Note: Pursuant to the final rule on the Service, Order Number PB90-50241, May, 1990. Prediction interval voluntary nutrition labeling regulations for fruits and vegetables published on July compliance calculations were used to develop label data. 25, 2006, trans fat labeling for fruits and • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," vegetables becomes mandatory on Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet. USDA January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. HNIS, Home Economics Research Report Number 48, September 1987. • Fiber, vitamin A, and potassium: USDA, HNIS, Agriculture Handbook Number 8-11 (1991), NDB No. 11435.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 137 APPENDIX C Spinach
Nutrition Facts Voluntary Data: Serving Size 1 1/2 cups shredded (85g) Potassium 130 mg; 4% DV
Amount Per Serving Calories 20 Calories from Fat 0
% Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Allowed: Saturated Fat 0g 0% fat free Trans Fat 0g saturated fat free Cholesterol 0mg 0% cholesterol free Sodium 65mg 3% low-calorie Potassium 470mg 13% Total Carbohydrate 4g 1% good source of fiber Dietary Fiber 2g 8% high in vitamin A Sugars 0g high in vitamin C Protein 2g high in iron high in folate (add 20% folate to label) Vitamin A 110% • Vitamin C 40% good source of magnesium (add 15% magnesium to the Calcium 8% • Iron 15% label) Magnesium 15% • Folate 20% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Health Claims Allowed: Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Fiber-containing fruits, vegetables, and grain products Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg and cancer Total Carbohydrate 300g 375g Fruits and vegetables and cancer Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Fruits, vegetables and grain products that contain fiber and the risk of coronary heart disease Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for Fat and cancer fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and Saturated fat and cholesterol and coronary heart disease vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. References: • 1989 PMA Spinach Study. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 138 APPENDIX C Crookneck Squash
Nutrition Facts Voluntary Data: Serving Size 1/2 cup (85g) Potassium 120 mg; 3% DV Folate 4% Amount Per Serving Calories 15 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 0mg 0% sodium free Potassium 120mg 3% cholesterol free Total Carbohydrate 3g 1% Dietary Fiber 2g 8% low-calorie Sugars 1g Protein 0g Health Claims Allowed: Vitamin A 2% • Vitamin C 10% Fat and cancer Calcium 2% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Reference: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • USDA Nutrient Database for Standard Reference, Fun Version, Release Total Carbohydrate 300g 375g 9 IBM PC 360K for microcomputers, National Technical Information Dietary Fiber 25g 30g Service, Order Number PB90-50241, May, 1990. Prediction interval Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 compliance calculations were used to develop label data. Note: Pursuant to the final rule on the • Sugar (for raw squash): "Sugar Content of Selected Foods; Individual voluntary nutrition labeling regulations for and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and Farhat-Sabet, USDA HNIS, Home Economics Research Report Number vegetables becomes mandatory on January 48, September 1987. 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 139 APPENDIX C Spaghetti Squash
Voluntary Data: Nutrition Facts Potassium 75 mg; 2% DV Serving Size 1/2 cup (85g) Folate 2% Amount Per Serving Calories 25 Calories from Fat 0 % Daily Value* Nutrient Content Descriptors Total Fat 0g 0% Saturated Fat 0g 0% Allowed: Trans Fat 0g no fat Cholesterol 0mg 0% saturated fat free Sodium 15mg 1% very low sodium Potassium 75mg 2% cholesterol free Total Carbohydrate 6g 2% low-calorie Dietary Fiber <1g 2% Sugars 2g Protein 1g Health Claims Allowed: Vitamin A 0% • Vitamin C 2% Fat and cancer Calcium 2% • Iron 2% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg References: Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g • USDA Nutrient Data Base for Standard Reference, Full Version, Release Dietary Fiber 25g 30g 9 IBM PC 360K for microcomputers, National Technical Information Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Service, Order Number PB90-50241, May, 1990. Prediction interval compliance calculations were used to develop label data. Note: Pursuant to the final rule on the • Sugar (for raw squash): "Sugar Content of Selected Foods: Individual and voluntary nutrition labeling regulations for fruits and vegetables published on July Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan 25, 2006, trans fat labeling for fruits and Farhat-Sabet, USDA HNIS, Home Economics Research Report Number vegetables becomes mandatory on 48, September 1987. January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. • Fiber (for winter squash): "Provisional Table on the Dietary Fiber Content of Selected Foods," USDA, HNIS, HNIS/PT-106, 1988.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 140 APPENDIX C Summer Squash
Nutrition Facts Voluntary Data: Serving Size medium squash (98g) Potassium 260 mg; 7% DV Amount Per Serving 100% of vitamin A is Beta Carotene Calories 20 Calories from Fat 0 Soluble Fiber <1 g % Daily Value* Insoluble Fiber 1 g Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Cholesterol 0mg 0% Sodium 0mg 0% Nutrient Content Descriptors Total Carbohydrate 4g 1% Dietary Fiber 2g 8% Allowed: Sugars 2g fat free Protein 1g saturated fat free Vitamin A 6% * Vitamin C 30% sodium free Calcium 2% * Iron 2% * Percent Daily Values are based on a 2,000 calorie diet. cholesterol free Your Daily Values may be higher or lower depending on your calorie needs: low-calorie Calories: 2,000 2,500 high in vitamin C Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Health Claims Allowed: Fat 9 * Carbohydrate 4 * Protein 4 Fruits and vegetables and cancer Note: Pursuant to the final rule on the Fat and cancer voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, Saturated fat and cholesterol and coronary heart disease trans fat labeling for fruits and vegetables Sodium and hypertension becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Summer squash is one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 141 APPENDIX C Strawberries
Nutrition Facts Voluntary Data: Serving Size 8 medium berries (147g) Potassium 170 mg; 5% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 3 g Calories 50 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 0mg 0% saturated fat free Potassium 170mg 5% Total Carbohydrate 11g 4% sodium free Dietary Fiber 2g 8% cholesterol free Sugars 8g high in vitamin C Protein 1g high in folate (add 20% folate to label)
Vitamin A 0% • Vitamin C 160% Calcium 2% • Iron 2% Manganese 25% • Folate 20% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fruits and vegetables and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fat and cancer Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Note: Pursuant to the final rule on the Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal voluntary nutrition labeling regulations for fruits and vegetables published on July 25, Register, Vol. 71, No. 159, Rules and Regulations 2006, trans fat labeling for fruits and • Strawberries are one of the top 40 produce items that are labeled as part vegetables becomes mandatory on January of the voluntary fruit and vegetable labeling program. 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 142 APPENDIX C Sweet Potato
Voluntary Data: Nutrition Facts Potassium 440 mg; 13% DV Serving Size 1/2 medium, 5” long, 2” diam.(130g) Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 3 g Calories 100 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Nutrient Content Descriptors Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 70mg 3% saturated fat free Potassium 440mg 13% low sodium Total Carbohydrate 23g 8% cholesterol free Dietary Fiber 4g 16% good source of fiber Sugars 7g Protein 2g high in vitamin A high in vitamin C Vitamin A 120% • Vitamin C 30% good source of potassium Calcium 4% • Iron 4%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Health Claims Allowed: Total Fat Less than 65g 80g Fiber-containing fruits, vegetables and grain products and Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Fruits and vegetables and cancer Dietary Fiber 25g 30g Fat and cancer Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Saturated fat and cholesterol and coronary heart disease Note: Pursuant to the final rule on the Sodium and hypertension voluntary nutrition labeling regulations for fruits and vegetables published on July 25, Fruits, vegetables and grain products that contain fiber and 2006, trans fat labeling for fruits and the risk of coronary heart disease vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Sweet potatoes are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 143 APPENDIX C Tangerines
Nutrition Facts Voluntary Data: Serving Size 1 medium (109 g) Potassium 160 mg; 5% DV Amount Per Serving Soluble Fiber 1 g Calories 50 Calories from Fat 0 Insoluble Fiber 2 g % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Sodium 0mg 0% Allowed: Total Carbohydrate 13g 4% Dietary Fiber 2g 8% fat free Sugars 9g saturated fat free Protein 1g sodium free Vitamin A 6% * Vitamin C 45% cholesterol free Calcium 4% * Iron 0% * Percent Daily Values are based on a 2,000 calorie diet. high in vitamin C Your Daily Values may be higher or lower depending on your calorie needs: Calories: 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Health Claims Allowed: Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Fruits and vegetables and cancer Dietary Fiber 25g 30g Fat and cancer Calories per gram: Fat 9 * Carbohydrate 4 * Protein 4 Saturated fat and cholesterol and coronary heart disease Note: Pursuant to the final rule on the Sodium and hypertension voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
References: • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal Register, Vol. 71, No. 159, Rules and Regulations • Tangerines are one of the top 40 produce items that are labeled as part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 144 APPENDIX C Tofu
Nutrition Facts Voluntary Data: Serving Size 3 oz (85g) Potassium 75 mg; 2% DV
Amount Per Serving Calories 70 Calories from Fat 20
% Daily Value* Nutrient Content Descriptors Total Fat 2g 3% Allowed: Saturated Fat 0g 0% very low sodium Trans Fat 0g cholesterol free Cholesterol 0mg 0% high in magnesium (add 30% magnesium to the label) Sodium 10mg 1% Potassium 185mg 5% Total Carbohydrate 11g 4% Dietary Fiber <1g 2% Health Claims Allowed: Sugars 1g Sodium and hypertension Protein 4g
Vitamin A 2% • Vitamin C 0% References: Calcium 8% • Iron 6% • USDA Nutrient Data Base for Standard Reference, Full Version, Manganese 30% • Magnesium 10% Release 9 IBM PC 360K for microcomputers, National Technical * Percent Daily Values are based on a 2,000 Information Service, Order Number PB90-50241 , May, 1990. calorie diet. Your daily values may be higher or lower depending on your calorie needs: Prediction interval compliance calculations were used to develop Calories 2,000 2,500 label data. Total Fat Less than 65g 80g • Sugar: "Sugar Content of Selected Foods; Individual and Total Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Sodium Less than 2,400mg 2,400mg Farhat-Sabel, USDA HNIS, Home Economics Research Report Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Number 48, September 1987. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Fat calories were calculated based on the fat prediction interval values, multiplied by 9 kcal/g and rounded to 5 <= 50 calories. Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 145 APPENDIX C Tomato
Voluntary Data: Nutrition Facts Potassium 340 mg; 10% DV Serving Size 1 medium tomato (148g) 100% of vitamin A is. Beta Carotene Amount Per Serving Calories 25 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g fat free Cholesterol 0mg 0% saturated fat free Sodium 20mg 1% very low sodium Potassium 340mg 10% cholesterol free Total Carbohydrate 5g 2% low-calorie Dietary Fiber 1g 4% high in vitamin A Sugars 3g Protein 1g high in vitamin C good source of potassium Vitamin A 20% • Vitamin C 40% Calcium 2% • Iron 4%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Fat and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the References: voluntary nutrition labeling regulations for fruits • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw and vegetables published on July 25, 2006, Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Register, Vol. 71, No. 159, Rules and Regulations Voluntary trans fat disclosure is currently • Tomatoes are one of the top 40 produce items that are labeled as part accepted by FDA. of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 146 APPENDIX C Watermelon
Nutrition Facts Voluntary Data: Serving Size 2 cups diced, 1/18 medium melon (280g) Potassium 270 mg; 8% DV Soluble Fiber 1 g Amount Per Serving Insoluble Fiber 1 g Calories 80 Calories from Fat 0 100% of vitamin A is Beta Carotene % Daily Value* Total Fat 0g 0% Saturated Fat 0g 0% Trans Fat 0g Nutrient Content Descriptors Cholesterol 0mg 0% Allowed: Sodium 0mg 0% fat free Potassium 270mg 8% saturated fat free Total Carbohydrate 21g 7% Dietary Fiber 1g 4% sodium free Sugars 20g cholesterol free Protein 1g high in vitamin A high in vitamin C Vitamin A 30% • Vitamin C 25% Calcium 2% • Iron 4%
* Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Calories 2,000 2,500 Fruits and vegetables and cancer Total Fat Less than 65g 80g Fat and cancer Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Saturated fat and cholesterol and coronary heart disease Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Sodium and hypertension Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the References: voluntary nutrition labeling regulations for fruits • Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw and vegetables published on July 25, 2006, Fruits, Vegetables, and Fish; Correction; August 17, 2006 Federal trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Register, Vol. 71, No. 159, Rules and Regulations Voluntary trans fat disclosure is currently • Watermelon is one of the top 40 produce items that are labeled as accepted by FDA. part of the voluntary fruit and vegetable labeling program.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 147 APPENDIX C Baby Lima Bean
Voluntary Data: Nutrition Facts Potassium 600 mg; 17% DV Serving Size 1/2 cup dry (85g)
Amount Per Serving Calories 110 Calories from Fat 0 Nutrient Content Descriptors % Daily Value* Total Fat 0g 0% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 15mg 1% cholesterol free Potassium 360mg 10% good source of fiber Total Carbohydrate 21g 7% good source of potassium Dietary Fiber 7g 28% good source of iron Sugars 4g high in folate (add 40% folate to label) Protein 10g good source of thiamin (add 15% to label) Vitamin A 0% • Vitamin C 0% good source of phosphorus (add 15% to label) Calcium 2% • Iron 10% good source of magnesium (add 20% to label) Thiamin 15% • Magnesium 20% good source of copper (add 15% to label) Manganese 40% • Folate 40% high in fiber Copper 15% • Phosphorus 15% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Health Claims Allowed: Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Fruits and vegetables and cancer Cholesterol Less than 300mg 300mg Fat and cancer Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Sodium and hypertension. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits References: and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables • USDA Nutrient Data Base for Standard Reference, Full Version, becomes mandatory on January 1, 2008. Release 9 IBM PC 360K for microcomputers, National Technical Voluntary trans fat disclosure is currently Information Service, Order Number PB90-50241, May, 1990. accepted by FDA. Prediction interval compliance calculations were used to develop label data. • Sugar (lima beans, raw): "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNlS, Home Economics Research Report Number 48, September 1987. • Vitamin C: USDA, HNIS, Agriculture Handbook Number 8-16 (1986), NDB No. 16074.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other
Updated 2009 148 sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 149 APPENDIX C Large Lima Bean
Nutrition Facts Serving Size 1/2 cup dry (85g) Voluntary Data:
Amount Per Serving Potassium 780 mg; 22% DV Calories 120 Calories from Fat 0
% Daily Value* Total Fat 0g 0% Nutrient Content Descriptors Saturated Fat 0g 0% Trans Fat 0g Allowed: Cholesterol 0mg 0% fat free Sodium 10mg 0% saturated fat free Potassium 400mg 10% very low sodium Total Carbohydrate 24g 8% cholesterol free Dietary Fiber 7g 28% high in fiber Sugars 4g high in potassium Protein 8g good source of iron
Vitamin A 0% • Vitamin C 0% high in folate (add 40% folate to label) Calcium 2% • Iron 10% good source of phosphorus (add 15% phosphorus to Copper 15% • Magnesium 25% label) Phosphorus 15% • Folate 40% good source of copper (add 15% copper to label) * Percent Daily Values are based on a 2,000 high in magnesium (add 25% magnesium to label) calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Health Claims Allowed: Sodium Less than 2,400mg 2,400mg Fat and cancer Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Saturated fat and cholesterol and coronary heart disease Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Sodium and hypertension Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
References: • USDA Nutrient Data Base for Standard Reference, Full Version, Release 9 IBM PC 360K for. microcomputers, National Technical Information Service, Order Number PB90-50241, May, 1990. Prediction interval compliance calculations were used to develop label data. • Sugar (lima bean, raw): "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987. • Vitamins A and C: USDA, HNIS, Agriculture Handbook Number 8-16 (1986), NDB No. 16071.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other
Updated 2009 150 sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 151 APPENDIX C Pinto Bean
Nutrition Facts Voluntary Data: Serving Size 1/4 cup dry (35g) Potassium 580 mg; 17% DV
Amount Per Serving Calories 120 Calories from Fat 5 % Daily Value* Nutrient Content Descriptors Total Fat 0.5g 1% Saturated Fat 0g 0% Allowed: Trans Fat 0g low fat Cholesterol 0mg 0% saturated fat free Sodium 10mg 0% very low sodium. Potassium 360mg 10% cholesterol free Total Carbohydrate 22g 7% high in fiber good source of potassium (add 580 mg Dietary Fiber 7g 28% Sugars 0g potassium to label) high in folate (add 50% folate to label) Protein 7g good source of phosphorus (add 15% phosphorus to label) good source of magnesium (add 15% magnesium to label) Vitamin A 0% • Vitamin C 2% good source of copper (add 15% coppertone label) Calcium 4% • Iron 10% good source of iron Phosphorus 15% • Magnesium 15% Copper 15% • Folate 50% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Health Claims Allowed: Calories 2,000 2,500 Total Fat Less than 65g 80g Fruits and vegetables and cancer Sat Fat Less than 20g 25g Fat and cancer Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Saturated fat and cholesterol and coronary heart disease Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Sodium and hypertension Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for References: fruits and vegetables published on July USDA Nutrient Data Base for Standard Reference, Full Version, Release 25, 2006, trans fat labeling for fruits and • vegetables becomes mandatory on 9 IBM PC 360K for microcomputers, National Technical Information January 1, 2008. Voluntary trans fat Service, Order Number PB90-50241, May, 1990. Prediction interval disclosure is currently accepted by FDA. compliance calculations were used to develop label data. • Sugar (common bean): "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 152 APPENDIX C Chickpea
Nutrition Facts Voluntary Data: Serving Size 1/4 cup dry (50g) Potassium 360 mg; 10% DV
Amount Per Serving Calories 170 Calories from Fat 30
% Daily Value* Nutrient Content Descriptors Total Fat 3g 6% Allowed: Saturated Fat 0g 0% Trans Fat 0g low fat Cholesterol 0mg 0% very low sodium Sodium 20mg 1% saturated fat free Potassium 430mg 12% cholesterol free Total Carbohydrate 27g 9% good source of iron Dietary Fiber 9g 36% high in folate (add 60% folate to label) Sugars 5g good source of phosphorus (add 15% phosphorus to label) Protein 10g good source of copper (add 15% copper to label) good source of fiber Vitamin A 0% • Vitamin C 2% good source of potassium (add 360 mg of potassium to Calcium 4% • Iron 15% Phosphorus 15% • Manganese 50% label) Copper 15% • Folate 60% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Health Claims Allowed: Calories 2,000 2,500 Total Fat Less than 65g 80g Sodium and hypertension Sat Fat Less than 20g 25g Fat and cancer Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Saturated fat and cholesterol and coronary heart disease Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Note: Pursuant to the final rule on the voluntary nutrition labeling regulations for • USDA Nutrient Data Base for Standard Reference, Full Version, fruits and vegetables published on July 25, Release 9 IBM PC 360K for microcomputers, National Technical 2006, trans fat labeling for fruits and Information Service, Order Number PB90-50241, May, 1990. Prediction vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is interval compliance calculations were used to develop label data. currently accepted by FDA. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 153 APPENDIX C Lentils
Nutrition Facts Voluntary Data: Serving Size 1/4 cup dry (35g) Potassium 380 mg; 11% DV
Amount Per Serving Calories 120 Calories from Fat 5
% Daily Value* Nutrient Content Descriptors Total Fat 0.5g 1% Allowed: Saturated Fat 0g 0% low fat Trans Fat 0g saturated fat free Cholesterol 0mg 0% very low sodium Sodium 5mg 0% cholesterol free Potassium 200mg 6% high in fiber Total Carbohydrate 22g 7% Dietary Fiber 7g 28% good source of iron Sugars 2g high in folate (add 40% folate to label) Protein 8g high in phosphorus (add 20% phosphorus. to label) good source of copper (add 15% copper to label) Vitamin A 0% • Vitamin C 4% good source of potassium Calcium 2% • Iron 15% Thiamin 15% • Phosphorus 20% Vitamin B6 15% • Folate 40% Manganese 35% • Copper 15% Health Claims Allowed: * Percent Daily Values are based on a 2,000 Fruits and vegetables and cancer calorie diet. Your daily values may be higher or lower depending on your calorie needs: Fat and cancer Calories 2,000 2,500 Saturated fat and cholesterol and coronary heart disease Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • USDA Nutrient Data Base for Standard Reference. Full Version, Note: Pursuant to the final rule on the Release 9 IBM PC 360K for microcomputers. National Technical voluntary nutrition labeling regulations for Information Service, Order Number PB90-50241, May, 1990. Prediction fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and interval compliance calculations were used to develop label data. vegetables becomes mandatory on January • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," 1, 2008. Voluntary trans fat disclosure is Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabet, currently accepted by FDA. USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 154 APPENDIX C Winged Bean
Nutrition Facts Voluntary Data: Serving Size 2/3 cup sliced, raw (85g) Potassium 350 mg; 10% DV Folate 6% Amount Per Serving Calories 65 Calories from Fat 10
% Daily Value* Total Fat 1g 2% Nutrient Content Descriptors Saturated Fat 0g 0% Allowed: Trans Fat 0g very low sodium Cholesterol 0mg 0% cholesterol free Sodium 10mg 0% Potassium 150mg 4% high in fiber Total Carbohydrate 12g 4% good source of calcium Dietary Fiber 3g 12% good source of iron Sugars <1g high in thiamin (add 30% thiamin to label) Protein 5g high in copper (add 60% copper to label) good source of magnesium (add 15% magnesium to label) Vitamin A 140% • Vitamin C 60% good source of phosphorus (add 15% phosphorus to label) Calcium 20% • Iron 20% good source of potassium Thiamin 60% • Copper 20% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 Health Claims Allowed: Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Sodium and hypertension Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Fat and cancer Total Carbohydrate 300g 375g Saturated fat and cholesterol and coronary heart disease Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 Note: Pursuant to the final rule on the References: voluntary nutrition labeling regulations for fruits and vegetables published on July 25, • USDA Nutrient Data Base for Standard Reference, Full Version, 2006, trans fat labeling for fruits and Release 9 IBM PC 360K for microcomputers, National Technical vegetables becomes mandatory on January Information Service, Order Number PB90-50241, May, 1990. Prediction 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. interval compliance calculations were used to develop label data. • Sugar: "Sugar Content of Selected Foods: Individual and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson. and Mojgan Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 155 APPENDIX C White Bean
Nutrient Content Descriptors Nutrition Facts Serving Size 1/4 cup dry (35g) Allowed: low fat Amount Per Serving saturated fat free Calories 120 Calories from Fat 0 very low sodium % Daily Value* Total Fat 0g 0% cholesterol free Saturated Fat 0g 0% high in iron Trans Fat 0g good source of potassium (add 620 mg potassium; 18% DV Cholesterol 0mg 0% to label) Sodium 0mg 0% high folate (add 50% folate to label) Potassium 620mg 18% good source of phosphorus (add 15% phosphorus to label) Total Carbohydrate 21g 7% high in magnesium (add 25% magnesium to label) Dietary Fiber 5g 20% high in copper (add 25% copper to label) Sugars 1g good source of fiber Protein 8g
Vitamin A 0% • Vitamin C 4% Calcium 6% • Iron 25% Health Claims Allowed: Folate 35% • Magnesium 20% Fat and cancer Phosphorus 10% • Copper 20% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg USDA Nutrient Data Base for Standard Reference, Full Version, Sodium Less than 2,400mg 2,400mg • Total Carbohydrate 300g 375g Release 9 IBM PC 360K for microcomputers, National Technical Dietary Fiber 25g 30g Information Service, Order Number PB90-50241, May, 1990. Prediction Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 interval compliance calculations were used to develop label data. Note: Pursuant to the final rule on the • Sugar (common bean): "Sugar Content of Selected Foods: Individual voluntary nutrition labeling regulations for and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan fruits and vegetables published on July 25, Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 48, September 1987. 1, 2008. Voluntary trans fat disclosure is • Fiber (crude), Vitamins A and C: USDA, HNIS, Agriculture Handbook currently accepted by FDA. Number 8-16 (1986), NDB No. 16049.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 156 APPENDIX C Small White Bean
Nutrient Content Descriptors Nutrition Facts Serving Size 1/4 cup dry (35g) Allowed: low fat Amount Per Serving saturated fat free Calories 120 Calories from Fat 5 very low sodium % Daily Value* Total Fat 0.5g 1% cholesterol free Saturated Fat 0g 0% high in fiber Trans Fat 0g good source of iron Cholesterol 0mg 0% high in potassium (add 750 mg potassium; 21% DV to label) Sodium 5mg 0% high in folate (add 45% folate to label) Potassium 540mg 18% high in thiamin (add 20% thiamin to label) Total Carbohydrate 22g 7% high in phosphorus (add 20% phosphorus to label) Dietary Fiber 9g 36% high in magnesium (add 20% magnesium to label) Sugars 2g Protein 7g
Vitamin A 0% • Vitamin C 4% Health Claims Allowed: Calcium 6% • Iron 25% Fat and cancer Folate 35% • Magnesium 15% Saturated fat and cholesterol and coronary heart disease Phosphorus 15% • Thiamin 20% Sodium and hypertension * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs: Calories 2,000 2,500 References: Total Fat Less than 65g 80g Sat Fat Less than 20g 25g • USDA Nutrient Data Base for Standard Reference, Full Version, Release Cholesterol Less than 300mg 300mg 9 IBM PC 360K for microcomputers, National Technical Information Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Service, Order Number PB90-50241, May, 1990. Prediction interval Dietary Fiber 25g 30g compliance calculations were used to develop label data. Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Sugar (common bean): "Sugar Content of Selected Foods: Individual and Note: Pursuant to the final rule on the Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan voluntary nutrition labeling regulations for Farhat-Sabel, USDA HNIS, Home Economics Research Report Number fruits and vegetables published on July 48, September 1987. 25, 2006, trans fat labeling for fruits and vegetables becomes mandatory on January 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 157 APPENDIX C Pink Bean
Nutrition Facts Nutrient Content Descriptors Serving Size 1/4 cup dry (40g) Allowed:
Amount Per Serving low fat Calories 140 Calories from Fat 5 saturated fat free % Daily Value* very low sodium Total Fat 0.5g 1% cholesterol free Saturated Fat 0g 0% good source of fiber Trans Fat 0g good source of iron Cholesterol 0mg 0% high in potassium (add 730 mg potassium; 21% DV to Sodium 5mg 0% label) Potassium 590mg 17% high in folate (add 50% folate to label) Total Carbohydrate 26g 9% high in thiamin (add 25% thiamin to label) Dietary Fiber 9g 36% high in of phosphorus (add 20% phosphorus to label) Sugars 2g high in of magnesium (add 20% magnesium to label) Protein 8g good source of copper (add 15% copper to label) Vitamin A 0% • Vitamin C 4% Calcium 6% • Iron 15% Folate 45% • Magnesium 20% Health Claims Allowed: Phosphorus 15% • Thiamin 20% Fat and cancer * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Saturated fat and cholesterol and coronary heart disease lower depending on your calorie needs: Calories 2,000 2,500 Sodium and hypertension Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g References: USDA Nutrient Data Base for Standard Reference, Full Version, Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 • Release 9 IBM PC 360K for microcomputers, National Technical Note: Pursuant to the final rule on the Information Service, Order Number PB90-50241, May, 1990. Prediction voluntary nutrition labeling regulations for fruits and vegetables published on July 25, interval compliance calculations were used to develop label data. 2006, trans fat labeling for fruits and • Sugar (common bean): "Sugar Content of Selected Foods:. Individual vegetables becomes mandatory on January and Total Sugars," Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA. Farhat-Sabet, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 158 APPENDIX C Pigeon Peas
Nutrient Content Descriptors Nutrition Facts Serving Size 1/4 cup dry (40g) Allowed: low fat Amount Per Serving Calories 140 Calories from Fat 5 saturated fat free
% Daily Value* very low sodium Total Fat 0.5g 1% cholesterol free Saturated Fat 0g 0% high in fiber Trans Fat 0g good source of potassium (add 680 mg potassium; 19% DV Cholesterol 0mg 0% to label) Sodium 5mg 0% high in folate (add 50% folate to label) Potassium 560mg 16% good source of thiamin (add 15% thiamin to label) Total Carbohydrate 25g 8% good source of magnesium (add 15% magnesium to label) Dietary Fiber 6g 24% good source of copper (add 25% copper to label) Sugars 1g good source of iron Protein 9g
Vitamin A 0% • Vitamin C 0% Calcium 6% • Iron 12% Health Claims Allowed: Thiamin 20% • Magnesium 20% Fat and cancer Copper 20% • Folate 45% Saturated fat and cholesterol and coronary heart disease * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Sodium and hypertension lower depending on your calorie needs: Calories 2,000 2,500 Total Fat Less than 65g 80g Sat Fat Less than 20g 25g References: Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg • USDA Nutrient Data Base for Standard Reference, Full Version. Total Carbohydrate 300g 375g Release 9 IBM PC 360K for microcomputers, National Technical Dietary Fiber 25g 30g Information Service, Order Number PB90-50241, May, 1990. Prediction Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 interval compliance calculations were used to develop label data. Note: Pursuant to the final rule on the • Sugar (common bean): "Sugar Content of Selected Foods: Individual voluntary nutrition labeling regulations for and Total Sugars," Ruth H. Matthews. Pamela R. Pehrsson, and Mojgan fruits and vegetables published on July 25, 2006, trans fat labeling for fruits and Farhat-Sabet, USDA HNlS, Home Economics Research Report Number vegetables becomes mandatory on January 48, September 1987. 1, 2008. Voluntary trans fat disclosure is currently accepted by FDA.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 159 APPENDIX C Split Pea
Nutrition Facts Voluntary Data: Serving Size 1/4 cup dry (35g) Potassium 390 mg; 11% DV Amount Per Serving Calories 120 Calories from Fat 5 % Daily Value* Nutrient Content Descriptors Total Fat 0.5g 1% Saturated Fat 0g 0% Allowed: Trans Fat 0g low fat Cholesterol 0mg 0% saturated fat free Sodium 5mg 0% very low sodium Potassium 390mg 11% cholesterol free Total Carbohydrate 22g 7% high in folate (add 20% folate to label) Dietary Fiber 9g 36% high in thiamin (add 25% thiamin to label) Sugars 3g good source of phosphorus (add 15% phosphorus to label) Protein 9g high in copper (add 20% copper to label) Vitamin A 2% • Vitamin C 2% good source of fiber Calcium 2% • Iron 10% good source of potassium Folate 20% • Thiamin 20% Phosphorus 15% • Copper 20% * Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or Health Claims Allowed: lower depending on your calorie needs: Calories 2,000 2,500 Fat and cancer Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Saturated fat and cholesterol and coronary heart disease Cholesterol Less than 300mg 300mg Sodium and hypertension Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 375g Dietary Fiber 25g 30g Calories per gram: Fat 9 • Carbohydrate 4 • Protein 4 References: Note: Pursuant to the final rule on the • USDA Nutrient Data Base for Standard Reference, Fun Version, voluntary nutrition labeling regulations for Release 9 IBM PC 360K for microcomputers, National Technical fruits and vegetables published on July 25, Information Service, Order Number PB90-50241, May, 1990. Prediction 2006, trans fat labeling for fruits and vegetables becomes mandatory on January interval compliance calculations were used to develop label data. 1, 2008. Voluntary trans fat disclosure is • Sugar: "Sugar Content of Selected Foods; Individual and Total Sugars," currently accepted by FDA. Ruth H. Matthews, Pamela R. Pehrsson, and Mojgan Farhat-Sabel, USDA HNIS, Home Economics Research Report Number 48, September 1987.
Please Note: Where possible, data are used that have been approved by FDA. Where FDA-approved data do not yet exist, values have been selected from databases developed by PMA and its members, or from other sources, such as USDA’s Handbook 8. While PMA believes use of non FDA-approved data should not result in FDA regulatory action, such a result can never be assured. Information contained in this document concerning labeling requirements has been synopsized specifically for fruits and vegetables and represents our best interpretation of the new rules. However, administrative and judicial interpretations, as well as the rules themselves, are subject to change. The general presentation of FDA’s new rules in this document is not intended as, and does not constitute, legal advice for particularized facts. For your specific labeling needs, contact your legal counsel.
Updated 2009 160 Appendix D
Fat Free
This descriptor may be made for fruits and vegetables that contain less than 0.5 g total fat per reference amount. If the fruit or vegetable is naturally fat free, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: apple leaf lettuce dried apricots lime artichoke mushrooms asparagus mustard greens banana okra green beans onion yellow snap beans oranges bell pepper papaya cabbage parsley red cabbage peaches Pe-tsai cabbage hot chili pepper cantaloupe Le Rouge Royale pepper carrot pineapple cauliflower potato dried figs dried prunes green cauliflower pummelo celery radishes collards seedless raisins cucumber raspberries dried currants rhubarb dates rutabagas eggplant spinach endive crookneck squash Belgian endive spaghetti squash figs summer squash garlic strawberries grapefruit sweet potato green onion watermelon honeydew melon large lima beans Iceberg lettuce lemons
Updated 2009 161 Low Fat
This descriptor may be made for fruits and vegetables that contain 3 grams fat or less per reference amount of fruit or vegetable. If the fruit or vegetable is naturally low in fat, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: apricots beets blackberries blueberries broccoli Brussels sprouts carambola cherries sweet corn gooseberries grapes guavas kiwifruit Romaine lettuce mango nectarines pear plums prickly pears tangerines tomatoes baby lima beans pinto bean chickpeas lentils white bean small white beans pink beans pigeon pea (bean) split pea
Updated 2009 162 Saturated Fat Free
This descriptor may be made for fruits and vegetables that contain less than 0.5 grams saturated fat and less than 0.5 grams trans fatty acids per reference amount or per 50 grams if the reference amount is 30 g/2 tbsp or less. If the fruit or vegetable is naturally free of saturated fats, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: apples grapefruit crookneck quash apricots grapes spaghetti squash dried apricots green onion summer squash artichoke asparagus guavas strawberries banana honeydew melon sweet potato green beans kiwifruit tangerines yellow snap beans Iceberg lettuce tomatoes beets lemons watermelon bell pepper leaf lettuce baby lima beans blackberries Romaine lettuce large lima beans blueberries lime pinto bean broccoli mango chickpea Brussels sprouts mushrooms lentils cabbage mustard greens white bean red cabbage nectarines small white beans Pe-tsai cabbage okra pink bean cantaloupe onion pigeon pea (bean) carambola oranges split pea carrot papaya cauliflower parsley green cauliflower peaches celery pears cherries hot chili pepper collards Le Rouge Royale pepper sweet corn pineapple cucumbers plums dried Zante potato currants pricklypears dates dried prunes eggplant pummelo endive radishes Belgian endive seedless raisins figs raspberries dried figs rhubarb garlic rutabagas gooseberries spinach
Updated 2009 163 Sodium Free
This descriptor may be made for fruits and vegetables that contain less than 5 mg sodium per reference amount. If the fruit or vegetable is naturally free of sodium, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: apples raspberries apricots crookneck squash asparagus summer squash avocado strawberries banana tangerines green bean bell pepper blackberries blueberries carambola cherries corn cucumber currants dried dates eggplant Belgian endive figs garlic gooseberries grapefruit grapes guava kiwifruit Romaine lettuce lime mango mushrooms nectarines oranges peaches pear Le Rouge Royale pepper plums potato prunes pummelo
Updated 2009 164 Very Low Sodium
This descriptor may be made for fruits and vegetables that contain 35 mg or less sodium per reference amount (or per 50 grams if the reference amount is 30 grams/2 tbsp or less). If the fruit or vegetable is naturally very low in sodium, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: dried apricots lentils yellow snap beans winged bean Brussels sprouts white bean green cabbage small white bean red cabbage pink bean Pe-tsai cabbage pigeon pea (bean) cantaloupe split pea cauliflower green cauliflower collards endive dried figs green onion honeydew melon Iceberg lettuce leaf lettuce lemons okra onion papaya parsley hot chili pepper pineapple pricklypears radishes seedless raisins rhubarb rutabagas spaghetti squash tofu tomatoes watermelon baby lima bean large lima bean pinto bean chickpea
Updated 2009 165 Low Sodium
This descriptor may be made for fruits and vegetables that contain 140 mg or less sodium per reference amount (or per 50 grams if the appropriate reference amount is 30 grams/2 tbsp or less). If the fruit or vegetable is naturally low in sodium, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: artichoke broccoli carrot celery mustard greens sweet potato
Updated 2009 166 Cholesterol Free
This descriptor may be made for fruits and vegetables that contain 2 g or less of saturated fatty acids and less than 2 mg of cholesterol per reference amount. If the fruit or vegetable is naturally cholesterol free, the claim must communicate this fact. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: apple grapefruit spaghetti squash apricots grapes summer squash dried apricots green onion strawberries artichoke guavas sweet potato asparagus honeydew melon tangerines avocado kiwifruit tofu banana Iceberg lettuce tomato green beans lemon watermelon yellow snap beans leaf lettuce baby lima bean beets Romaine lettuce large lima bean bell pepper lime pinto bean blackberries mango chickpea blueberries mushrooms lentils broccoli mustard greens winged bean Brussels sprouts nectarines white bean green cabbage okra small white bean red cabbage onion pink bean Pe-tsai cabbage orange pigeon peas (bean) cantaloupe papaya split pea carambola parsley carrot peaches cauliflower pear green cauliflower hot chili pepper celery Le Rouge Royale pepper cherries pineapple collards plums sweet corn potato cucumber pricklypears dried currants dried prunes dates pummelo eggplant radishes endive raisins Belgian endive raspberries figs rhubarb dried figs rutabagas garlic spinach gooseberries crookneck squash
Updated 2009 167 Low Calorie
This descriptor may be made for fruits and vegetables that contain 40 calories or less per reference amount (or per 50 grams if the reference amount is 30 grams/2 tbsp or less). Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: artichoke squash asparagus crookneck squash green beans spaghetti yellow snap beans summer squash bell pepper tomatoes Brussels sprouts green cabbage red cabbage Pe-tsai cabbage carambola carrot cauliflower green cauliflower celery collards cucumber eggplant endive Belgian endive garlic green onion guava Iceberg lettuce lemons leaf lettuce Romaine lettuce lime mushrooms mustard greens okra onion hot chili pepper Le Rouge Royale pepper radishes rhubarb rutabagas spinach
Updated 2009 168 Calorie Free
This descriptor may be made for fruits and vegetables that contain less than 5 calories per reference amount. Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: parsley
Updated 2009 169 High in Fiber
This description may be made for fruits and vegetables that contain 5 grams or more fiber per reference amount (20% or more of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: apple blackberries broccoli grapefruit oranges raspberries baby lima bean large lima bean pinto bean lentils small white bean winged bean pigeon pea
Updated 2009 170 Good Source of Fiber
This descriptor may be made for fruits and vegetables that contain 2.5 grams but less than 5 grams fiber per reference amount (10-19% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: artichoke banana green beans blueberries Brussels sprouts sweet corn cherries dates figs dried figs guavas kiwifruit nectarines onion papaya pear potato dried prunes spinach strawberries sweet potato tangerines pink bean chickpea white bean split pea
Updated 2009 171 Good Source of Potassium
This descriptor may be made for fruits and vegetables that contain 350 mg to less than 700 mg potassium per reference amount (10-19% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: dried apricots broccoli banana celery kiwifruit potato sweet potato tomato baby lima bean chickpea lentils winged bean split pea pinto bean white bean pigeon peas (bean)
Updated 2009 172 High in Potassium
This description may be made for fruits and vegetables that contain 700 milligrams or more potassium per reference amount (20% or more of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes to qualify for this descriptor are: large lima bean small white bean pink bean
Updated 2009 173 High in Vitamin A
This descriptor may be made for fruits and vegetables that contain 1000 IU or more of vitamin A per reference amount (20% or more of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: apricots dried apricots Pe-tsai cabbage cantaloupe carrot collards leaf lettuce Romaine lettuce mango mustard greens hot chili pepper Le Rouge Royale pepper spinach sweet potato tomato watermelon
Updated 2009 174 Good Source of Vitamin A
This descriptor may be made for fruits and vegetables that contain 500 IU to less than 1000 IU of vitamin A per reference amount (10-19% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: asparagus broccoli grapefruit okra dried prunes
Updated 2009 175 High in Vitamin C
This descriptor may be made for fruits and vegetables that contain 12 mg or more vitamin C per reference amount (20% or more of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: apricots spinach yellow snap beans summer squash bell pepper strawberries blackberries sweet potato broccoli tangerines Brussels sprouts tomato cabbage watermelon red cabbage Pe-tsai cabbage cantaloupe carambola cauliflower green cauliflower collards gooseberries grapefruit grapes green onion guavas honeydew melon kiwifruit lemon lime mustard greens okra onion orange papaya hot chili pepper Le Rouge Royale pepper pineapple plums potato prickly pears pummelo radishes raspberries rutabagas
Updated 2009 176 Good Source of Vitamin C
This descriptor may be made for fruits and vegetables that contain 6 mg to less than 12 mg vitamin C per reference amount (10-19°l0 of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: artichoke asparagus banana blueberries carrot celery sweet cherries sweet corn cucumber mango nectarines peaches pear green snap beans
Updated 2009 177 High in Folate
This descriptor may be made for fruits and vegetables that contain 80 μg or more folate per reference amount (20% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: asparagus broccoli endive mustard greens spinach strawberries baby lima bean large lima bean pinto bean chickpea lentils white bean small white bean pink bean pigeon peas (bean) split pea
Updated 2009 178 Good Source of Folate
This descriptor may be made for fruits and vegetables that contain 40 μg to less than 80 μg folate per reference amount (10-19% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: artichoke beets blackberries Brussels sprouts Pe-tsai cabbage cantaloupe cauliflower green cauliflower leaf lettuce Romaine lettuce okra papaya Le Rouge Royale pepper
Updated 2009 179 High in Iron
This descriptor may be made for fruits and vegetables that contain 3.6 mg or more iron per reference amount (20% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are: spinach white bean lentils winged beans
Updated 2009 180 Good Source of Iron
This descriptor may be made for fruits and vegetables that contain 1.8 mg to less than 3.6 mg iron per reference amount (10-19% of the Daily Value per reference amount). Fruits and vegetables in this document that PMA believes qualify for this descriptor are:
dried apricots baby lima bean large lima bean pinto bean chickpea lentils small white bean pink bean pigeon peas
Updated 2009 181 Health Claims on Fiber-Containing Fruits, Vegetables, and Grain Products and Cancer
In order to make this claim, a food must be or contain a grain product, fruit, or vegetable and meet the requirements for low fat and, without fortification, be a good source of dietary fiber. Fruits and vegetables in this document that PMA believes to qualify for this health claim are: apple artichoke banana green beans blackberries blueberries broccoli Brussels sprouts cherries sweet corn dates figs dried figs grapefruit guavas kiwifruit onion orange papaya pear potato dried prunes raspberries spinach strawberries sweet potato tangerines
Updated 2009 182 Health Claims on Fruits and Vegetables and Cancer
This claim may be made for fruits and vegetables that meet the requirements for low fat and, without fortification, for good source of fiber or vitamins A or C. Fruits and vegetables in this document that PMA believes to qualify for this health claim are: apple lemon apricots leaf lettuce dried apricots Romaine lettuce artichoke lime asparagus mango banana mustard greens green beans nectarines yellow snap beans okra bell pepper onion blackberries orange blueberries papaya broccoli peaches Brussels sprouts pear cabbage hot chili pepper red cabbage Le Rouge Royale pepper Pe-tsai cabbage pineapple cantaloupe plums carambola potato carrot prickly pears cauliflower dried prunes green cauliflower pummelos celery radishes cherries raspberries collards rutabagas sweet corn spinach cucumber summer squash dates strawberries figs sweet potato dried figs tangerines gooseberries tomato grapefruit watermelon grapes green onion guavas honeydew melon kiwifruit
Updated 2009 183 Health Claims on Fruits, Vegetables, and Grain Products that Contain Fiber and Risk of Coronary Heart Disease (CHD)
In order to make this claim, a food must be/contain fruits, vegetables, or grain products and must meet the requirements for low saturated fat, low-cholesterol, and low fat and contain, without fortification, at least 0.6 g soluble fiber per reference amount. Fruits and vegetables in this document that PMA believes to qualify for this health claim are: apple sweet potato artichoke tangerines banana watermelon green beans baby lima bean beets large lima bean blackberries pinto bean blueberries lentils Brussels sprouts small white bean carrot pink bean green cauliflower pigeon peas (bean) cherries dates figs dried figs grapefruit guavas kiwifruit lemon leaf lettuce Romaine lettuce lime nectarines orange papaya pear dried prunes raspberries spinach summer squash strawberries
Updated 2009 184 Health Claims on Fat and Cancer
In order to make this health claim, a food must meet the descriptor requirements of lowfat. Fruits and vegetables in this document that PMA believes to qualify for this health claim are: apple Romaine lettuce apricots lime dried apricots mango artichoke mustard greens asparagus nectarines banana okra green beans onion yellow snap beans orange bell pepper papaya blackberries peaches blueberries pear broccoli hot chili pepper Brussels sprouts Le Rouge Royale pepper cabbage pineapple red cabbage plums Pe-tsai cabbage potato cantaloupe pricklypears carambola dried prunes carrot pummelos cauliflower radishes green cauliflower raspberries celery rutabagas cherries spinach collards summer squash sweet corn strawberries cucumber sweet potato tangerines dates tomato Belgian endive watermelon figs baby lima bean dried figs large lima bean gooseberries pinto bean grapefruit lentils grapes white bean guavas small white bean honeydew melon pink bean kiwifruit pigeon peas (bean) lemon split pea leaf lettuce
Updated 2009 185 Health Claims on Saturated Fat and Cholesterol and Coronary Heart Disease (CHD)
In order to make this health claim, a food must meet the definitions for the descriptors low saturated fat, low-cholesterol, and low fat. Fruits and vegetables in this document that PMA believes to qualify for this health claim are: apple honeydew melon baby lima bean apricots kiwifruit large lima bean dried apricots lemon pinto bean artichoke leaf lettuce lentils asparagus Romaine lettuce white bean banana lime small white bean green beans mango pink bean yellow snap beans mustard greens pigeon peas (bean) bell pepper nectarines split pea blackberries okra blueberries onion broccoli orange Brussels sprouts papaya cabbage peaches red cabbage pear Pe-tsai cabbage hot chili pepper cantaloupe Le Rouge Royale pepper carambola pineapple carrot plums cauliflower potato green cauliflower pricklypears celery dried prunes cherries pummelos collards radishes sweet corn raspberries cucumber rhubarb dates rutabagas figs spinach dried figs summer squash gooseberries strawberries grapefruit sweet potato grapes tangerines guavas tomato watermelon
Updated 2009 186 Health Claims on Sodium and Hypertension (High Blood Pressure)
In order to make this health claim, a food must meet the descriptor requirements for low sodium. Fruits and vegetables in this document that PMA believes to qualify for this health claim are: apple honeydew melon large lima bean apricots kiwifruit pinto bean dried apricots lemon chickpea artichoke leaf lettuce lentils asparagus avocado Romaine lettuce winged bean banana lime white bean green beans mango small white bean yellow snap beans mustard greens pink bean bell pepper nectarines pigeon peas (bean) blackberries okra split pea blueberries onion broccoli orange Brussels sprouts papaya cabbage peaches red cabbage pear Pe-tsai cabbage hot chili pepper cantaloupe Le Rouge Royale pepper carambola pineapple carrot plums cauliflower potato green cauliflower pricklypears celery dried prunes cherries pummelos collards radishes sweet corn raspberries cucumber rhubarb dates rutabagas endive summer squash figs strawberries dried figs sweet potato gooseberries tangerines grapefruit tomato grapes watermelon guavas baby lima bean
Updated 2009 187 Appendix E
Background Information on Health Claims
(3) Nutritive value means a value in Health Claims: sustaining human existence by such General processes as promoting growth, replacing loss of essential nutrients, Requirements. (21 or providing energy.
C.F.R. § 101.14). (4) Disqualifying nutrient levels means the levels of total fat, (a) Definitions. For purposes of this saturated fat, cholesterol, or sodium section, the following definitions apply: in a food above which the food will be disqualified from making a health (1) Health claim means any claim claim. These levels are 13.0 grams made on the label or in labeling of a (g) of fat, 4.0 g of saturated fat, 60 food, including a dietary supplement, milligrams (mg) of cholesterol, or that expressly or by implication, 480 mg of sodium, per reference including “third-party” references, amount customarily consumed, per written statements (e.g., a brand label serving size, and, only for name including a term such as foods with reference amounts “heart”), symbols (e.g., a heart customarily consumed of 30 g or less symbol), or vignettes, characterizes or 2 tablespoons or less, per 50 g. the relationship of any substance to a For dehydrated foods that must have disease or health-related condition. water added to them prior to typical Implied health claims include those consumption, the per 50 g criterion statements, symbols, vignettes, or refers to the as prepared form. Any other forms of communication that one of the levels, on a per reference suggest, within the context in which amount customarily consumed, a per they are presented, that a relationship label serving size or, when exists between the presence or level applicable, a per 50 g basis, will of a substance in the food and a disqualify a food from making a disease or health-related condition. health claim unless an exception is provided in subpart E of this part, (2) Substance means a specific food except that: or component of food. (i) The levels for a meal product as defined in 101.13(1) are 26.0 g
Updated 2009 188 of fat, 8.0 g of saturated fat, 120 conventional food at decreased mg of cholesterol, or 960 mg of dietary levels, the substance must be sodium per label serving size, a nutrient listed in 21 U.S.C. and 343(q)(1)(C) or (q)(1)(D), or one that the Food and Drug Administration (ii) The levels for a main dish (FDA) has required to be included in product as defined in 101.13 (m) the label or labeling under 21 U.S.C. are 19.5 g of fat, 6.0 g of 343 (q)(2)(A); or saturated fat, 90 mg of cholesterol, or 720 mg of sodium (3) If the substance is to be per label serving size. consumed at other than decreased dietary levels: (5) Disease or health-related condition means damage to an (i) The substance must contribute organ, part, structure, or system of taste, aroma, or nutritive value, the body such that it does not or any technical effect listed in function properly (e.g., 170.3(o) of this chapter, to the cardiovascular disease), or a state of food and must retain that health leading to such dysfunctioning attribute when consumed at (e.g., hypertension); except that levels that are necessary to diseases resulting from essential justify a claim; and nutrient deficiencies (e.g., scurvy, pellagra) are not included in this (ii) The substance must be a food definition (claims pertaining to such or a food ingredient or a diseases are thereby not subject to component of a food ingredient 101.14 or 101.70). whose use at the levels necessary to justify a claim has been (b) Eligibility. For a substance to be demonstrated by the proponent of eligible for a health claim: the claim, to FDA’s satisfaction, to be safe and lawful under the (1) The substance must be associated applicable food safety provisions with a disease or health-related of the Federal Food, Drug, and condition for which the general U.S. Cosmetic Act. population, or an identified U.S. population subgroup (e.g., the (c) Validity requirement. FDA will elderly) is at risk, or, alternatively, promulgate regulations authorizing a the petition submitted by the health claim only when it determines, proponent of the claim otherwise based on the totality of publicly explains the prevalence of the available scientific evidence (including disease or health-related condition in evidence from well-designed studies the U.S. population and the conducted in a manner which is relevance of the claim in the context consistent with generally recognized of the total daily diet and satisfies the scientific procedures and principles), other requirements of this section. that there is significant scientific agreement, among experts qualified by (2) If the substance is to be scientific training and experience to consumed as a component of a
Updated 2009 189 evaluate such claims, that the claim is health-related condition, such supported by such evidence. factors may be required to be addressed in the claim by a (d) General health claim labeling specific regulation in subpart E requirements. of this part;
(1) When FDA determines that a (iv) All information required to health claim meets the validity be included in the claim appears requirements of paragraph (c) of this in one place without other section, FDA will propose a intervening material, except that regulation in subpart E of this part to the principal display panel of the authorize the use of that claim. If the label or labeling may bear the claim pertains to a substance not reference statement, “See provided for in 101.9, FDA will _____for information about the propose amending that regulation to relationship include declaration of the substance. between_____and_____,” with the blanks filled in with the (2) When FDA has adopted a location of the labeling regulation in subpart E of this part containing the health claim, the providing for a health claim, firms name of the substance, and the may make claims based on the disease or health related regulation in subpart E of this part, condition (e.g., “See attached provided that: pamphlet for information about calcium and osteoporosis”), with (i) All label or labeling the entire claim appearing statements about the elsewhere on the other labeling, substance-disease relationship Provided that, where any graphic that is the subject of the claim are material (e.g., a heart symbol) based on, and consistent with, the constituting an explicit or conclusions set forth in the implied health claim appears on regulations in subpart E of this the label or labeling, the part; reference statement or the complete claim shall appear in (ii) The claim is limited to immediate proximity to such describing the value that graphic material; ingestion (or reduced ingestion) of the substance, as part of a total (v) The claim enables the public dietary pattern, may have on a to comprehend the information particular disease or provided and to understand the health-related condition; relative significance of such information in the context of a (iii) The claim is complete, total daily diet; and truthful, and not misleading. Where factors other than dietary (vi) If the claim is about the intake of the substance affect the effects of consuming the relationship between the substance at decreased dietary substance and the disease or levels, the level of the substance
Updated 2009 190 in the food is sufficiently low to (A) Where the food that bears the justify the claim. To meet this claim meets the requirements of requirement, if a definition for paragraphs (d)(2)(vi) or (d)(2)(vii) of use of the term “low” has been this section based on its reference established for that substance amount customarily consumed, and under this part, the substance the labeled serving size differs from must be present at a level that that amount, the claim shall be meets the requirements for use of followed by a statement explaining that term, unless a specific that the claim is based on the alternative level has been reference amount rather than the established for the substance in labeled serving size (e.g., “Diets low subpart E of this part. If no in salt and sodium may help lower definition for “low” has been blood pressure in many people. A established, the level of the serving of_____ounces of this substance must meet the level product conforms to such a diet.”). established in the regulation authorizing the claim; or (B) Where the food that bears the claim is sold in a restaurant (except (vii) If the claim is about the if the claim is made on a menu) or in effects of consuming the other establishments in which food substance at other than decreased that is ready for human consumption dietary levels, the level of the is sold, the food can meet the substance is sufficiently high and requirements of paragraphs (d)(2)(vi) in an appropriate form to justify or (d)(2)(vii) of this section if the the claim. To meet this firm that sells the food has a requirement, if a definition for reasonable basis on which to believe use of the term “high” for that that the food that bears the claim substance has been established meets the requirements of paragraphs under this part, the substance (d)(2)(vi) and (d)(2)(vii) of this must be present at a level that section and providing that basis upon meets the requirements for use of request. that term, unless a specific alternative level has been (3) Nutrition labeling shall be established for the substance in provided in the label or labeling of subpart E of this part. If no any food for which a health claim is definition for “high” has been made in accordance with 101.9 or, established (i.e., where the claim for restaurant foods, in accordance pertains to a food either as a with 101.10. whole food or as an ingredient in another food), the claim must (e) Prohibited health claims. No specify the daily dietary intake expressed or implied health claim may necessary to achieve the claimed be made on the label or in labeling for a effect, as established in the food unless: regulation authorizing the claim, provided that: (1) The claim is specifically provided for in subpart E of this part;
Updated 2009 191 (2) The claim conforms to all general fiber per reference amount provisions of this section as well as customarily consumed prior to any to all specific provisions in the nutrient addition. appropriate section of subpart E of this part; (f) The requirements of this section do not apply to: (3) None of the disqualifying levels identified in paragraph (a)(5) of this (1) Infant formulas subject to section section is exceeded in the food, 412(h) of the Federal Food, Drug, unless specific alternative levels and Cosmetic Act, and have been established for the substance in subpart E of this part; or (2) Medical foods defined by section unless FDA has permitted a claim 5(b) of the Orphan Drug Act. despite the fact that a disqualifying level of a nutrient is present in the (g) Applicability. The requirements of food based on a finding that such a this section apply to foods intended for claim will assist consumers in human consumption that are offered for maintaining healthy dietary sale. practices, and, in accordance with
the regulation in subpart E of this part that makes such a finding, the label bears a referral statement that complies with 101.13(h), highlighting the nutrient that exceeds the disqualifying level;
(4) Except as provided in paragraph (e)(3) of this section, no substance is present at an inappropriate level as determined in the specific provision authorizing the claim in subpart E of this part;
(5) The label does not represent or purport that the food is for infants and toddlers less than 2 years of age except if the claim is specifically provided for in subpart E of this part; and
(6) Except for dietary supplements not in conventional food form, or unless otherwise specified, the food contains 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or
Updated 2009 192 Appendix F PMA Food Labeling Q&A Where should the ingredient list be INGREDIENT placed on the label? The ingredient list may be placed on the LIST principal display panel, which is that portion of the package label that is most likely to be seen by consumers at the This Q & A presents information time of purchase. relating to the requirements of the Food and Drug Administration on declaration 21 C.F.R. § 101.1. of ingredients. Some of the answers below include citations that the reader A second (and more commonly used) may refer to for additional information option is to place the ingredient list on about a particular requirement. The the “information panel.” The “C.F.R.” refers to the Code of Federal information panel is the label panel Regulations. All other references are immediately to the right of the principal presented in nonabbreviated form. display panel, as the package is displayed to consumers. If this panel is One of the Food and Drug not usable due to package design or Administration’s (FDA) primary construction, then the information panel requirements for a food label is to is the first available label panel to the identify all ingredients present in a food. right of the principal display panel. An exemption to this rule exists for foods consisting of a single ingredient 21 C.F.R. § 101.2(a). (e.g., fresh produce with no coatings of any kind). However, other types of What type size is required for the produce items, as well as the majority of ingredient list? processed foods, are subject to the requirement. The ingredient list must have a minimum type size of 1/16th inch (expressed as the What rules apply with respect to the height for small case letters used in the order in which ingredients are declared statement). on the label? 21 C.F.R. § 101.2(c). All ingredients in a product must be declared in descending order of How do I decide what names to use predominance. when declaring ingredients?
21 C.F.R. § 101.4(a)(1). Ingredients should be identified by their common or usual name. FDA generally requires each ingredient to be identified
Updated 2009 193 by a specific name, but collective long as the substances are used in (generic) names (e.g., “natural flavors,” accordance with food additive “spices”) are permitted for some regulations. substances. FDA’s lists of permitted collective names are found at 21 C.F.R. NOTE: Sulfites cannot qualify for § § 101.4 and 101.22. incidental additive status unless present at levels below 10 parts per billion. How do I declare an ingredient that is Please see the last question in this itself made up of more than one section for a discussion on allergen ingredient? labeling.
One option would be to include a 21 C.F.R. § 101.100(a)(3). parenthetical after the name of the ingredient and list each component Must I declare pesticide residues on the within the parenthetical in descending ingredient list? order of predominance. Residues of pesticide chemicals that are A second option would be to incorporate applied either pre-harvest or post-harvest the individual components into a to fresh produce are exempt from “master” ingredient list as if each were a ingredient labeling requirements. Section distinct ingredient. 4030) of the Federal Food, Drug, and Cosmetic Act. However, when 21 C.F.R. § 101.4(b). postharvest pesticides are used, the shipping container of the produce must Is it necessary to declare trace bear the name of the pesticide as well as ingredients? a description of its function.
Ingredients need not be declared if they When individual bags, berry boxes, or are “incidental additives” that meet the similar containers of raw agricultural following two conditions: (1) they have commodities that are products of the soil no technical or functional effect in the are packed into master cartons for finished food, and (2) they are present at shipment, only the master carton is insignificant levels in the finished food. considered the shipping carton that must bear the required labeling. If the bags, Examples of incidental additives boxes, or other packages are not packed include: into other containers, but are shipped individually, each individual bag or • substances that are present in a food other container is the “shipping by reason of having been container” and must bear the required incorporated into the food as an labeling. ingredient of another food where the substance did have a technical or FDA Compliance Policy Guide 7120.27. functional effect; Must I declare chlorine residues for • processing aids; products that have been washed with chlorine? • substances migrating to food from equipment or packaging materials, so
Updated 2009 194 Whether or not chlorine washes should coatings. Coatings should be declared by be declared on the ingredient list using either the phrase: depends on whether the chlorine residue qualifies for incidental additive status • Coated with food-grade (see above). animal-based wax, to maintain freshness (followed by a list of What special ingredient list labeling commodity (-ies) coated with this requirements apply if chemical wax) preservatives are used in or on my product? or the phrase:
Chemical preservatives used in or on • Coated with food-grade vegetable-, produce items must be declared in the petroleum-, beeswax-, and/or ingredient list (assuming that the shellac-based wax or resin, to substances are serving a preservative maintain freshness (followed by a function in the finished product). FDA list of the commodity (-ies) coated requires that the ingredient listing for with these waxes or resins) preservatives be followed by a parenthetical description of the purpose 21 C.F.R. § 101.4(b)(22). of the preservative, e.g., “potassium sorbate (to preserve freshness).” Are there specific rules that apply to labeling of allergens, including those in 21 C.F.R. § 101.220). wax coatings?
If I have a multi-component product Yes. The Food Allergen Labeling and consisting of distinct foods, e.g., a salad Consumer Protection Act of 2004 kit containing a produce mix, salad (FALCPA) amends the FD&C Act to dressing, and croutons, should I require more complete labeling of foods provide one big ingredient list, or have that contain the eight most common food separate ingredient lists for each allergens or ingredients derived from component? them. The eight most common allergens, FDA’s rules do not specify whether a defined in new section 201(qq)(1) of the single “master” ingredient list should be FD&C Act, are: (1) milk; (2) eggs; (3) used in such situations, or whether fish (e.g., bass, flounder, or cod); (4) separate ingredient lists for each crustacean shellfish (e.g., crab, lobster, or component should be provided. We are shrimp); (5) tree nuts (e.g., almonds, not aware of any situations where FDA pecans, or walnuts); (6) wheat; (7) has challenged either approach. peanuts; and (8) soybeans. The term “major food allergens” also includes food Do I have to list waxes as ingredients? ingredients that contain protein derived Packers, repackers, shippers, and from one of the eight. So, if a wax coating retailers of fresh fruits and vegetables contains allergenic protein it must be treated with post-harvest wax or resin labeled pursuant to FALCPA. The new coatings are required to declare the labeling provisions went into effect on January 1, 2006.
Updated 2009 195 notification process to exempt certain To adhere to FALCPA’s labeling food ingredients that contain protein provisions the label must either: from one or more of the eight major allergen groups. (1) use the word “contains” followed by the name of the food source All citations are to the Code of Federal from which the major food Regulations (C.F.R.). allergen is derived (e.g., “Contains peanuts”) or Information contained in this document concerning labeling requirements has (2) bear the common or usual name been synopsized specifically for fruits of the major food allergen in the and vegetables and represents our best ingredient list followed by the interpretation of the rules in this area. name of the food source from However, administrative and judicial which the major food allergen is interpretations, as well as the rules derived (e.g., “semolina themselves, are subject to change. Some (wheat),” “whey (milk)”). states have laws that also impact on food labeling. The general presentation of The name of the food source from which FDA’s rules in this document does not the major food allergen is derived is not constitute legal advice for particularized required in parentheses next to the facts. For your specific labeling needs, common or usual name of the food contact your legal counsel. allergen in the ingredient list when the The law firm of Keller and Heckman, common or usual name uses the name of which represents PMA and assisted in the food source or the name of the food the preparation of this document, is source appears elsewhere in the available to answer your particular ingredient list. regulatory/ technical questions. Direct your questions to Melvin S. Drozen The term “name of the food source from 202-434-4222. Fees associated with which the major food allergen is Keller and Heckman’s assistance with derived” refers to these eight major food your questions will be discussed when allergen groups. However, in the case of you contact the firm. tree nuts, fish, or crustacean shellfish, the specific type must be included in the declaration (e.g., almond, salmon, shrimp). Spices, flavoring, colorings, or COMPANY incidental additives that are or that bear or contain a major food allergen must NAME AND also adhere to the above outlined labeling requirements (e.g., “natural ADDRESS flavor (almond)”). Highly refined oils that are derived from any of the major This Q & A presents information allergen groups and ingredients from relating to the requirements of the Food these highly refined oils are exempt from and Drug Administration on the labeling requirements. In addition, identification of manufacturer, FALCPA includes a petition and distributor, or packer. Some of the
Updated 2009 196 answers below include citations that the What is the required type size for the reader may refer to for additional company signature line? information about a particular requirement. The “C.F.R.” refers to the The company signature line must have a Code of Federal Regulations. All other minimum type size of 1/16th inch references are presented in non- (expressed as the minimum height for abbreviated form. small case letters used in the statement).
One of the Food and Drug 21 C.F.R. § 101.2(c). Administration’s (FDA) primary labeling requirements is that the name What name should be used, the name and place of business of the of the producer or the distributor? manufacturer, packer, or distributor of a particular food product must be stated on FDA permits use of the name of either the label. This requirement is sometimes the manufacturer, packer, or distributor. referred to as the “company signature If the food product is not manufactured line.” (produced) by the company whose name Where must the company signature line appears on the label, the name should be be placed on the label? qualified by a phrase that reveals the connection such company has with the The company signature line may be food, such as “Distributed placed on the “principal display panel” by______” or “Produced (PDP), which is that portion of the for______” or any other package label that is most likely to be words that express the facts. seen by consumers at the time of purchase. 21 C.F.R. § 101.5(a).
A second (and more commonly used) Must I include the entire street address, option is to place the company signature including the zip code? line on the “information panel.” The The company signature line must information panel is the label panel include the actual corporate name immediately to the right of the PDP, as (which may be preceded or followed by the package is displayed to consumers. If division names), the street address, city, this panel is not usable due to package state, and zip code. design or construction, then the information panel is the first available The street address may be omitted if it is label panel to the right of the PDP. published in a current city directory or telephone directory. For example, for a bag of potatoes with no significant side panels, the 21 C.F.R. § 101.5(b) and (d). information panel would be the back panel of the bag. All citations are to the Code of Federal Regulations (C.F.R.). 21 C.F.R. §§ 101.1 and 101.2. Information contained in this document concerning labeling requirements has
Updated 2009 197 been synopsized specifically for fruits The product name must appear on the and vegetables and represents our best front panel of a food label, and should interpretation of the rules in this area. generally be in a type size no smaller However, administrative and judicial than half that of the largest type interpretations, as well as the rules appearing on the front panel. themselves, are subject to change. Some states have laws that also impact on food How do I pick an appropriate name for labeling. The general presentation of my product? FDA’s rules in this document does not constitute legal advice for particularized FDA has established a three-step facts. For your specific labeling needs, hierarchy in choosing an appropriate contact your legal counsel. name for a product. The first option is to use the name picked by FDA if the The law firm of Keller and Heckman, product has a “standard of identity.” which represents PMA and assisted in FDA’s standards of identity are found at the preparation of this document, is 21 C.F.R. Parts 130-169. FDA has no available to answer your particular standards of identity for fresh produce, regulatory/ technical questions. Direct but there are standards for related your questions to Melvin S. Drozen products, such as canned fruits (Part 202-434-4222. Fees associated with 145), canned vegetables (Part 155), Keller and Heckman’s assistance with frozen vegetables (Part 158), and your questions will be discussed when condiment-type products that are you contact the firm. sometimes sold in conjunction with fresh products, e.g., cheeses (Part 133), sour cream (Part 131), and food dressings and PRODUCT flavorings (Part 169). If no standard of identity exists, the IDENTITY second option is to use a “common or usual name.” For nearly all fresh STATEMENT produce, the common or usual name will be obvious (“Celery,” “Brussels This Q & A presents information Sprouts,” “Raspberries”). relating to the requirements of the Food If there is no common or usual name, and Drug Administration on identifying because the product is unique or novel, food products. Some of the answers the third and last option is to use an below include citations that the reader appropriately descriptive term, or, when may refer to for additional information the nature of the food is obvious, a about a particular requirement. The fanciful name commonly used by the “C.F.R.” refers to the Code of Federal public for the food, e.g., “Party Platter: Regulations. All other references are Fresh Vegetables with Sour Cream Dip.” presented in nonabbreviated form. 21 C.F.R. § 101.3. One of the Food and Drug Administration’s (FDA) primary May I identify my fruit or vegetable requirements for a food label is to product by a general name (e.g., identify or name the product being sold.
Updated 2009 198 “Apples”) or must also include a appearing on the principal display panel. reference to the variety (“Golden The absolute minimum type size ever Delicious Apples”)? permitted for the product name is 1/16 inch type (for the height of any small FDA has no hard or fast rules for the case letters that are used), but for many degree of specificity that must be used in packages this minimum type size may identifying most produce items. In the not satisfy the “reasonably related” absence of a specific requirement, requirement. manufacturers and distributors should include a varietal name if such 21 C.F.R. § 101.2(c). information would be of potential importance or materiality to consumers When is it necessary to include terms (e.g., are there significant differences like “cut,” “sliced,” “diced,” etc., as among the varieties of a particular part of the statement of identity? produce item that make it important to identify a particular product as FDA generally requires that information belonging to a certain variety?) Look to about the form in which a food is sold current industry practice as a useful (whole, sliced, diced, etc.) should be part guide for what to do with your product. of the product name when that food is normally marketed in a variety of forms. Where must the product name be Such information must be in a type size placed on the label? reasonably related to the type size used for the rest of the product name. Id. The FDA requires the product name However, if the physical form of the (also called the “product identity food is visible through the package or is statement”) to appear on the “principal depicted by an appropriate vignette on display panel.” The principal display the label, the particular form need not be panel is that portion of the package label specified in the product name. that is most likely to be seen by consumers at the time of purchase. The 21 C.F.R. § 1013(c). product name must be generally parallel to the base of the package. All citations are to the Code of Federal Regulations (C.F.R.) unless otherwise 21 C.F.R. § 101.3(a) and (d). noted.
What size type should I use for the Information contained in this document product name? concerning labeling requirements has been synopsized specifically for fruits The product name should be in a type and vegetables and represents our best size reasonably related to the most interpretation of the rules in this area. prominently printed material on the However, administrative and judicial PDP. interpretations, as well as the rules themselves, are subject to change. Some FDA’s informal rule is that to meet the states have laws that also impact on food “reasonably related” requirement, the labeling. The general presentation of product name should be no less than FDA’s rules in this document does not one-half the size of the largest type constitute legal advice for particularized
Updated 2009 199 facts. For your specific labeling needs, mind that nutrient content claims trigger contact your legal counsel. the need for nutrition labeling. That is, the exemption from nutrition labeling The law firm of Keller and Heckman, that normally exists for raw agricultural which represents PMA and assisted in commodities is lost when a nutrient the preparation of this document, is content claim is made either on the label, available to answer your particular or in labeling or advertising. regulatory/ technical questions. Direct your questions to Melvin S. Drozen Second, companies making nutrient 202-434-4222. Fees associated with content claims should also keep in mind Keller and Heckman’s assistance with that certain threshold levels for the your questions will be discussed when nutrient must be satisfied when making a you contact the firm. claim. For example, to make a “high” claim for a vitamin, the product must contain at least 20% of the Daily Value NUTRIENT for that vitamin. If I make a nutrient content claim on CONTENT my label, is nutrition labeling required?
CLAIMS This question raises a very important point. If a nutrient content claim is made This Q & A addresses requirements of on the label, or in labeling or the Food and Drug Administration’s advertising, nutrition labeling becomes (FDA) relating to nutrient content mandatory. The normal exemption from claims. Many of the answers below nutrition labeling for raw agricultural include citations that the reader may commodities is lost. refer to for additional information about May I make nutrient content claims a particular requirement. The “C.F.R.” other than those listed in FDA’s refers to the Code of Federal regulations? Regulations. All other references are presented in non-abbreviated form. FDA’s current rules provide for the use Another excellent source for information of a limited number of “defined” claims. about nutrient content claims is the PMA Undefined terms may not be used. Nutrition and Produce Labeling Guide. What proof must I have that my Nutrient content claims are claims that products qualify for a nutrient content characterize, either expressly or by claim? implication, the level of a nutrient in a product. Examples include: “High in FDA’s regulations do not specify how a Vitamin C,” “Fat Free,” and “Low- manufacturer must document the validity calorie.” of a claim. In the event that FDA questions a claim, the Agency would The Food and Drug Administration conduct analytical testing to determine (FDA) has a number of requirements the level of the nutrient in the product. that must be satisfied when a nutrient The manufacturer should be comfortable content claim is made. First, keep in
Updated 2009 200 that, in the event its product were tested, FDA did note, however, that companies the claim would be justified. For those should only use these terms in a truthful nutrients and products where there is an and non-misleading manner. Further, approved database, a company can be when these claims are directly or relatively comfortable that the approved indirectly tied to the level of a particular data may be used as the basis for the nutrient(s) (“The fiber and vitamin A in claim. In other cases, it may be this product assure that it is nutritious”), necessary to conduct analytical testing to they may become nutrient content assure that the qualifying levels for the claims. nutrients are met. May I report on my label how many What is the status of “healthy” and grams of beta-carotene or some other similar claims? nutrient is in a serving of my product?
When the term “healthy” (and variations Yes. FDA permits simple quantitative such as “healthier,” “healthiest”) is used statements on the label about the level of in a nutritional context, the term is a nutrient for which there is no established nutrient content claim because it Daily Value. However, FDA views these characterizes — indirectly — the level statements as nutrient content claims. of nutrients that the food contains. FDA Thus, their presence on the label would has determined that “healthy” represents require full nutrition. that a product does not exceed threshold levels of fat, saturated fat, cholesterol, Care must also be taken when making and sodium, and that the product these statements to assure that they only contains at least 10% of the Daily Value specify the amount of a nutrient per of either fiber, protein, vitamin A, serving, and do not imply that there is a vitamin C, calcium, or iron. Raw fruits lot or a little of that nutrient in the and vegetables are exempt from the product. A statement such as “x mg of latter requirement, as well as frozen or beta carotene” would be permitted since canned single ingredient fruit and it is a straightforward quantitative vegetables and mixtures thereof – statement. However, statements such as ingredients whose addition does not “contains beta carotene” or “provides change the nutrient profile of the fruit or beta carotene” would not be permitted vegetable added. since they imply the product is a “good source” of beta carotene. In FDA’s view, 21 C.F.R. § 101.65(d). it is not possible to make a “good source” claim for a nutrient with no Do general claims such as “nutritious” established Daily Value since there is no or “wholesome” fall within the nutrient basis for making this determination. content claim category? Are there any limits on the placement FDA considered whether it should or size of nutrient content claims on the establish requirements for use of the label? terms “nutritious” and “wholesome” when it finalized its rule for “healthy.” Nutrient content claims must never be The Agency decided against establishing more than twice the size of the product special rules for the use of these terms. identity statement and must not be
Updated 2009 201 unduly prominent in type-style that the reader may refer to for compared to the product identity additional information about a particular statement. requirement. The “C.F.R.” refers to the Code of Federal Regulations. All other All citations are to the Code of Federal references are presented in non- Regulations (C.F.R.) unless otherwise abbreviated form. noted. The Federal Food, Drug, and Cosmetic Information contained in this document Act (the “Act”) contains two major concerning labeling requirements has commandments with respect to the been synopsized specifically for fruits preparation and marketing of food and vegetables and represents our best products: (1) thou shall not adulterate; interpretation of the rules in this area. and (2) thou shall not misbrand. However, administrative and judicial Commandment 1 relates to food safety interpretations, as well as the rules issues. Commandment 2, which is the themselves, are subject to change. Some subject of this Q & A, and a series of states have laws that also impact on food related Q & A’s, is concerned with labeling. The general presentation of assuring that food labels contain all FDA’s rules in this document does not necessary information, and that all label constitute legal advice for particularized information is presented in a truthful and facts. For your specific labeling needs, non-misleading manner. contact your legal counsel. Where must label information required The law firm of Keller and Heckman, by FDA appear on a food package? which represents PMA and assisted in the preparation of this document, is With a few exceptions, discussed below, available to answer your particular required label information must appear regulatory/ technical questions. Direct either on the principal display panel or your questions to Melvin S. Drozen the information panel. 202-434-4222. What is the principal display panel? Fees associated with Keller and Heckman’s assistance with your The principal display panel (PDP) is that questions will be discussed when you portion of the package label most likely contact the firm. to be seen by the consumer at the time of purchase. Depending on how the package is designed to be displayed to the consumer, this is normally the front GENERAL or the top of a bag or box or can. Many containers are designed with two or LABELING more different surfaces that are suitable for display as the PDP. These are MATTERS referred to as alternative PDP panels.
This Q & A addresses issues of general 21 C.F.R. § 101. interest relating to food labeling. Many of the answers below include citations
Updated 2009 202 What label statements must appear on • net quantity of contents statement the PDP? • ingredient list • company name and address The statement of identity or name of the • nutrition information (packaged food, and the net quantity of contents produce is exempt from nutrition statement must be placed on the labeling and falls under the voluntary principal display panel. Other required program unless a nutrient or health label information (e.g., ingredient list, claim is made for the product) company name and address, nutrition labeling) may be placed on the PDP. Other elements may be mandatory in particular cases, e.g., wax labeling, 21 C.F.R. § 101.3(a) and 101.105(a). country-of-origin labeling.
What is the information panel? What type size and placement requirements apply to each required The information panel is the label panel label item? immediately to the right of the PDP, as displayed to the consumer. If this panel The product name should be in is not usable, due to package design or prominent print and type, parallel to the construction (e.g., folded flaps), then the base of the package. To be sufficiently information panel is the next label panel “prominent,” the Food and Drug immediately to the right. Administration (FDA) advises that the product name be at least 1/2 the size of 21 C.F.R. § 101.2(a). the largest print on the label.
What label statements must appear on The net quantity of contents should be in the information panel? a minimum type size that is related to the size of the PDP on which it appears. The The ingredient list, company signature relationship between the area of the PDP line, and the Nutrition Facts box (if and the minimum type size is shown required) must be placed together, below. without intervening material, on the information panel. If the information panel will not accommodate all three Min. Height of items, nutrition information may be Area of PDP Any Letter or Number placed on any alternative panel likely to < 5 sq. in. 1/16th inch be seen by consumers during ordinary 5-25 sq. in. 1/8th inch conditions of purchase. 25-100 sq. in. 3/16th inch over 100 sq. in. 1/4 inch 21 C.F.R. § 101.2(a) and (b). The ingredient list and company name What label information must appear on and address should appear in at least food packages? 1/16 inch type (this height applies to all letters and numbers, whether capital or The five “core” mandatory labeling small-case). requirements are:
• product name
Updated 2009 203 The typesetting requirements for (February 9, 1989) (pesticide labeling); nutrition information are very complex. and 19 C.F.R. Part 134 For details, consult the PMA Nutrition (country-of-origin labeling) and Produce Labeling Guide or FDA’s regulation at 21 C.F.R. § 101.9(d). If I have a multi-component product (e.g., a salad kit), must required label What are FDA rules with respect to information be placed on the outer using stickers, adhesives, or inks for retail package if it already appears on label information (e.g., little stickers for smaller packages contained within the apples, inks for oranges)? larger package? For example, if a small package of salad dressing already Label information may be provided in contains labeling information, must this manner. However, companies this same information be repeated on should carefully consider the extent to the outer package of the salad kit? which some label information might trigger the need for other information. Yes. FDA rules state that all mandatory Companies wishing to provide labeling label information must appear on the information by using stickers on outermost container. This rule is individual pieces of fruit or vegetable intended to assure that all information is must assure that all adhesives, papers, available to be read by the consumer at inks, etc., that contact food, or can the time of purchase. reasonably be expected to become a component of the food, have appropriate All citations are to the Code of Federal safety clearances from FDA. Regulations (C.F.R.) unless otherwise noted. See, generally, 21 C.F.R. Parts 172, 182, 184. Information contained in this document concerning labeling requirements has What label information must appear on been synopsized specifically for fruits shipping cartons? and vegetables and represents our best interpretation of the rules in this area. Much of the information required on the However, administrative and judicial label of retail packages is not required interpretations, as well as the rules on shipping cartons. However, there are themselves, are subject to change. Some situations where FDA’s rules require states have laws that also impact on food information on the labels of shipping labeling. The general presentation of cartons. Examples of information that is FDA’s rules in this document does not sometimes required to appear on the constitute legal advice for particularized shipping carton include: (1) wax facts. For your specific labeling needs, labeling; (2) postharvest pesticide contact your legal counsel. labeling; and (3) country-of-origin marking (consult the relevant Q&As on The law firm of Keller and Heckman, each of the subjects for more which represents PMA and assisted in information). the preparation of this document, is available to answer your particular 21 C.F.R. § 101.4 (wax labeling); FDA regulatory/ technical questions. Direct Compliance Policy Guide No. 7120.27
Updated 2009 204 your questions to Melvin S. Drozen In addition, the Food Allergen Labeling (202-434-4222). and Consumer Protection Act (FALCPA) creates labeling requirements Fees associated with Keller and for foods that are a major food allergen Heckman’s assistance with your or that contain protein from one of the questions will be discussed when you eight major food allergens. Please see contact the firm. the section in the “Mandatory Wax Labeling” section for more information. WAX LABELING 21 C.F.R. § 101.4(b)(22). What wax labeling requirements apply This Q & A presents information to packers, repackers, and shippers? relating to the requirements of the Food and Drug Administration on wax Packers, repackers, and shippers must labeling. Some of the answers below provide coating information on the include citations that the reader may packing cartons. The lettering should be refer to for additional information about at least 1/4 inch in height for all a particular requirement. The “C.F.R.” characters. refers to the Code of Federal Regulations. All other references are 21 C.F.R. § 101.100(a)(2)(i). presented in non-abbreviated form. What requirements apply to packaged Packers, repackers, shippers, and products sold at retail? retailers of fresh fruits and vegetables treated with post-harvest wax or resin When packaged products have written or coating are required to label to indicate graphic material on their labels, wax and the presence of the wax or coating. coating information must also appear in lettering at least 1/16th inch in height. Waxes and coatings should be declared The information may be placed on either by one of the following two phrases: the front panel or the panel immediately to the right of the front panel. “Coated with food-grade animal-based wax, to maintain freshness.” 21 C.F.R. § 101.2(c).
or What requirements apply to retailers?
“Coated with food-grade vegetable-, Retailers must provide information on petroleum-, beeswax-, and/or shellac- coatings for non-packaged produce items based wax or resin, to maintain via point-of-purchase signs. The freshness.” information relating to coating must appear in a minimum type size of 1/4th Use of the terms “food-grade” and “to inch. maintain freshness” are optional. The term “lac-resin” may be substituted for 21 C.F.R. § 101.100(a)(2)(ii). the term “shellac.” “Petroleum-based” must be used instead of “mineral-based” for such coatings.
Updated 2009 205 As a retailer, how do I know what commodities are waxed so I know what COUNTRY-OF- to put on my signs? ORIGIN This information will often appear on the shipping cartons. In cases of doubt, LABELING retailers should check with their suppliers. This Q & A presents information What should be done with respect to relating to the requirements of the U.S. labeling dairy waxes? Customs and Border Protection (U.S. Customs) and the USDA Agricultural Any dairy-based ingredients in the Marketing Service (AMS) on country- waxes or resins are covered by the of-origin marking. Some of the answers “animal-based wax” designation below include citations that the reader described in the beginning paragraphs of may refer to for additional information this document. about a particular requirement. The “C.F.R.” refers to the Code of Federal All citations are to the Code of Federal Regulations. All other regulations are Regulations (C.F.R.) unless otherwise presented in non-abbreviated form. noted. One of the requirements of the U.S. Information contained in this document Customs Service is that all articles of concerning labeling requirements has foreign origin that are imported into the been synopsized specifically for fruits United States be marked in such a and vegetables and represents our best manner that its ultimate purchaser will interpretation of the rules in this area. be aware of its country of origin. However, administrative and judicial interpretations, as well as the rules In addition, the USDA-AMS has issued themselves, are subject to change. Some regulations at part 65 to Title 7 of the states have laws that also impact on food C.F.R. regarding country-of-origin labeling. The general presentation of labeling (COOL) for covered FDA’s rules in this document does not commodities including perishable constitute legal advice for particularized agricultural commodities—fresh and facts. For your specific labeling needs, frozen fruits and vegetables. These contact your legal counsel. regulations went into effect on September 30, 2008. The regulations The law firm of Keller and Heckman, also set forth recordkeeping which represents PMA and assisted in requirements for suppliers and retailers. the preparation of this document, is available to answer your particular For produce items, the country of origin regulatory/ technical questions. Direct is generally considered to be the country your questions to Melvin S. Drozen where the article was produced or 202-434-4222. Fees associated with grown. Keller and Heckman’s assistance with your questions will be discussed when you contact the firm.
Updated 2009 206 What if I import produce and then component (such as water, salt, or sugar) further process it? Is country-of-origin that enhances or represents a further step marking necessary? in the preparation of the product for consumption, would not in itself result in When imported from a non-NAFTA a processed food item. Examples of country (i.e., not Mexico or Canada), processed food items exempt from U.S. Customs does not require country- USDA-AMS COOL requirements are: of-origin marking if the product has been fruit medley, salad mix that contains substantially transformed in the U.S. lettuce and a dressing packet, salad mix that contains lettuce and carrots, a bag of Whether or not substantial mixed vegetables that contains peas and transformation has occurred is a carrots. complicated determination that must be made after considering the facts in each Foodservice establishments are exempt particular case. In general, slight from USA-AMS COOL requirements. processing will not result in substantial transformation. More substantial USDA-AMS regulations provide that processing will result in substantial imported covered commodities for transformation. which origin has already been established and for which no production For products imported from a NAFTA has taken place in the U.S. will retain country (Canada or Mexico), country-of- their origin as declared to Customs at the origin marking is not required if further time of import. processing results in a change of tariff classification. Special provisions have been made for “commingled covered commodities.” For most fresh-cut product items—e.g., Commingled covered commodities are fruit and salads—there will likely not be defined as the same type of covered a tariff shift or substantial transformation commodity that is prepared from raw by processing in the U.S. materials that have different origins. For these products, all countries of origin Under USDA-AMS COOL regulations, must be represented. For example, for a “processed food items” are excluded bag of red and green leaf lettuce where from country-of-origin notification the red and green leaf lettuces come requirements. A “processed food item” from different countries, the product is defined as either: (1) a retail item must bear all possible countries of derived from a covered commodity that origin. USDA will use U.S. Grade has undergone specific processing Standards to help determine whether a resulting in a change in the character of product is a combination of different the covered commodity (includes covered commodities. cooking, curing, smoking, and restructuring); or (2) a covered Describe the placement and type size commodity that has been combined with requirements for the country-of-origin at least one other covered commodity statement. (e.g., lettuce and tomatoes) or other substantive food component (e.g., U.S. Customs requires that the country- croutons), except that the addition of a of-origin statement be legibly,
Updated 2009 207 permanently, and conspicuously marked will bear the country-of-origin marking. in a manner that will notify the product’s 19 C.F.R. § 134.25. If the fruit is “ultimate purchaser” of its country of shipped in bulk to a subsequent party for origin. Generally, the marking may repacking, the importing party must appear anywhere on the label and in any certify to Customs that notice has been type size with one exception. If a provided to the subsequent party of the domestic firm’s name and address is need to mark the new containers with the declared as the firm responsible for the country of origin. manufacturing, distributing, or packing of a product, then the country-of-origin USDA-AMS regulations require retailers statement must appear in close proximity to inform consumers, at the final point of to the company name and address and purchase of the commodity’s country of must be at least comparable in size and origin. This can be done either by lettering to the name and address. product marking or posting at point of purchase via the label placard, sign, USDA-AMS COOL regulations do not sticker, band, twist tie, pin tag, or other specify exact placement or type size of clear and visible sign on the product or the country-of-origin notifications. The on the package, display, holding unit, or regulations state that the marking may be bin at final point of sale. In addition, the typed, printed, or handwritten as long as USDA regulations permit the use of it is legible and conspicuous. checkboxes to deliver country-of-origin information. 19 C.F.R. § 134.11 As a retailer, do I need to worry about Should the country-of-origin statement country-of-origin markings for be placed on individual fruit or unpackaged fruits and vegetables sold vegetables, the shipping container, or from bulk containers? on the consumer package? Under Customs jurisdiction, when fruits U.S. Customs does not require and vegetables are transferred from bulk individual pieces of fresh fruits and containers and displayed in an open bin vegetables to be directly stickered with a on a grocery store shelf there is no need country-of-origin marking. However, the to place any designation of country of outermost container in which they are origin at the point of purchase. Customs imported must be marked. Thus, for does not consider an open bin a example, the crate or other shipping “container.” However, if fruits are container in which apples or pears are repackaged in bags, boxes, baskets, or shipped into the U.S. would have to bear other such containers and wrappings, the required marking. Repacked they must be labeled with the country of containers of imported apples and pears origin. must also be marked with the country of origin. However, under USDA-AMS requirements retailers will have to If the fruit is to be repacked by the party deliver country-of-origin information for that imports it, the importing party must unpackaged fruits and vegetables to the provide a certificate to Customs stating consumers at the final point of purchase. that the new containers for the product Where there are multiple countries of
Updated 2009 208 origin on retail bulk containers (e.g., your questions will be discussed when display case, shipper, bin, carton, barrel) you contact the firm. all possible origins may be listed instead of labeling each commodity individually. When stickers are used on FOREIGN individual items, USDA encourages retailers to also use point-of-sale signage given that the adherence level of stickers LANGUAGE is not 100%. AND/OR Certain states, such as Florida, have had required point-of-purchase country–of- EXPORT origin labeling. Any state country-of- origin requirements that conflict with LABELING USDA-AMS COOL requirements would be preempted. This Q & A presents information relating to the requirements of the Food
and Drug Administration on foreign All citations are to the Code of Federal language labeling and the labeling for Regulations (C.F.R.) unless otherwise exported products. Some of the answers noted. below include citations that the reader may refer to for additional information Information contained in this document about a particular requirement. The concerning labeling requirements has “C.F.R.” refers to the Code of Federal been synopsized specifically for fruits Regulations. All other references are and vegetables and represents our best presented in non-abbreviated form. interpretation of the rules in this area. However, administrative and judicial What is the “all-or-nothing” rule with interpretations, as well as the rules respect to providing labeling themselves, are subject to change. Some information in more than one states may also have laws that also language? impact on food labeling. The general Food and Drug Administration (FDA) presentation of FDA’s rules in this regulations state that, if any document does not constitute legal representation appears on the label in a advice for particularized facts. For your foreign language, all required label specific labeling needs, contact your elements must appear in both English legal counsel. and in the foreign language. The law firm of Keller and Heckman, For instance, on a salad kit product, if which represents PMA and assisted in instructions for use are given in English the preparation of this document, is and Spanish, all required label available to answer your particular information (e.g., product name, regulatory/ technical questions. Direct ingredient list, company name and your questions to Melvin S. Drozen address, nutrition labeling, net weight 202-434-4222. Fees associated with statement) must appear in both Keller and Heckman’s assistance with languages.
Updated 2009 209 21 C.F.R. § 101.15(c)(2). USDA’s Agricultural Market Service, the embassy of the country of interest, or May I provide label information in your legal counsel are all good places to Spanish only for product being sold in start in trying to obtain this information. Puerto Rico? All citations are to the Code of Federal Yes. For articles distributed solely in Regulations (C.F.R.) unless otherwise Puerto Rico or in a U.S. Territory where noted. the predominant language is one other than English, the predominant language Information contained in this document may be substituted for English. concerning labeling requirements has been synopsized specifically for fruits Can I sell my products in Canada if and vegetables and represents our best they have a U.S. label? interpretation of the rules in this area. However, administrative and judicial Whether a label in compliance with U.S. interpretations, as well as the rules law will comply with Canadian law is a themselves, are subject to change. Some question that must be answered on a case states have laws that also impact on food by-case basis by taking into labeling. The general presentation of consideration the nature of the product FDA’s rules in this document does not involved. constitute legal advice for particularized facts. For your specific labeling needs, Any suggestions on what I should do if contact your legal counsel. I am not sure whether my product will be sold in the U.S. or Canada? The law firm of Keller and Heckman, which represents PMA and assisted in Depending on the nature of the product the preparation of this document, is involved, it may be possible to develop a available to answer your particular “universal” label that would be regulatory/ technical questions. Direct acceptable in both the U.S. and in your questions to Melvin S. Drozen Canada. If this is not possible, a 202-434-4222. company would have no choice but to maintain separate label inventories for Fees associated with Keller and products intended for sale in the U.S. Heckman’s assistance with your and those intended for sale in Canada. questions will be discussed when you contact the firm. I export my product. What label information do I need?
Exported products must comply with the label requirements of the country to which they are being exported.
How can I find out about labeling regulations for other markets: Japan, Canada, Mexico, South America, European Union, etc.?
Updated 2009 210 What are FDA’s requirements for FRESH, making a “fresh” claim? NATURAL, FDA requires that, when “fresh” is used in a manner that implies a product is ORGANIC, AND unprocessed, the claim should only be used for products in the raw state, i.e., NEGATIVE products that have not been frozen or subjected to any form of thermal INGREDIENT processing or preservation. The following minimal “processing” CLAIMS steps do not preclude use of the term “fresh”: This Q & A addresses the requirements of the Food and Drug Administration • waxing raw fruits or vegetables (FDA) relating to certain food claims. • use of pesticides before or after Many of the answers below include harvest citations that the reader may refer to for • pasteurization of milk additional information about a particular • treatment of produce with mild requirement. The “C.F.R.” refers to the chorine wash or mild acid wash Code of Federal Regulations. All other • refrigeration references are presented in non- • treatment with ionizing radiation in abbreviated form. compliance with FDA regulations
Each item of information found on a 21 C.F.R. § 101.95(a) and (c). food label or in labeling is subject to the Am I disqualified from making a statutory mandate that it must not be “fresh” claim if my product contains “false or misleading in any particular.” processed ingredients? In deciding on whether a particular representation is false or misleading, the This answer will depend in part on Food and Drug Administration (FDA) whether the “fresh” claim can looks at not only direct representations reasonably be expected to be understood made or suggested by statements, by consumers to suggest that the entire designs, vignettes, etc., but also at the product is made of fresh ingredients. extent to which representations fail to reveal material facts important to fully This determination needs to be made on understanding a claim. a case-by-case basis by considering the way the “fresh” claim is presented and Each of the claims discussed in this the nature of the product involved. document is subject to this “false or misleading” prohibition. “Fresh” claims What are FDA’s requirements for are also subject to a specific regulation making “all natural” claims? issued by FDA which sets forth conditions as to when a product may be FDA has no specific regulations for “all referred to by that term. natural” claims. FDA’s informal policy is that “natural” means that nothing
Updated 2009 211 artificial or synthetic (including all color rule follows a ten-year rulemaking additives regardless of source) has been period in which USDA issued two major included in, or has been added to, a food proposals to implement the OFPA, one that would not normally be expected to of which was withdrawn in response to a be in the food. hailstorm of criticism voiced in over 275,000 comments. The National Are there any requirements for making Organic Program (NOP) established by “organic” claims? the final rule was fully implemented on October 21, 2002. FDA has no specific regulations for “organic” claims, although the United The NOP regulations require (with States Department of Agriculture has limited exceptions) operations that promulgated regulations in this area. intend to produce or handle organic products or ingredients to obtain organic The Organic Foods Production Act of certification through a USDA-accredited 1990 (OFPA), codified as amended at 7 certifying agent. Applicants seeking U.S.C. § 6501 et seq., was enacted to certification are required to submit an provide uniform standards for the “Organic Plan” to demonstrate marketing of raw and processed organic compliance with USDA’s production agricultural products in the United States and/or handling standards. Organic for human or livestock consumption. certification is available only for The OFPA, administered by the USDA, “agricultural products,” broadly defined provides for the establishment of a to include crops, livestock, and certain national program to implement organic processed products containing standards, including production, agricultural commodities. handling, certification, accreditation of certifying agents, and testing of Central to the NOP is the notion that a products. The National Organic product’s organic composition—that is, Standards Board, appointed by USDA the percentage of organic ingredients in pursuant to the OFPA, develops the the product—determines both the National List of Allowed and Prohibited specific marketing terms and the type of Substances, which governs organic nonorganic ingredients that may be used. production and processing. Violators are The regulations set forth four categories subject to civil penalties of up to of products that may, to varying degrees, $10,000 per violation. be represented as organic or containing organic ingredients: As mentioned, USDA is responsible for regulating the use of “organic” claims on • 100% organic products may be food labels, pursuant to OFPA. On marketed as “100% organic” December 21, 2000, USDA’s • Products with no less than 95% Agricultural Marketing Service (AMS) organic ingredients may be issued long-awaited regulations to represented as “organic” implement the OFPA and establish • Products that contain at least 70% uniform national standards to govern the organic ingredients may be marketed production, handling, and marketing of as “made with organic” (specified foods bearing “organic” claims. 65 Fed. ingredients/food groups), naming up Reg. 80548 (Dec. 21, 2000). The final
Updated 2009 212 to three specific organic ingredients MADE WITH ORGANIC). In taking or food groups this approach, USDA has declined to • Products in package form that are exercise independent judgment, and has less than 70% organic may identify positioned the NOP as simply a specific organic ingredients in the marketing standard that is intended to list of ingredients conform to consumers’ expectations. The Agency’s approach is problematic A product’s organic composition is from a compliance standpoint, as organic determined by calculating the percentage food processors will undoubtedly of organic ingredients in the product (by struggle to find and document sources of weight or fluid volume) exclusive of non-biotech materials. water and salt. How do I know whether I qualify for a USDA has carefully limited the “negative ingredient” claim? circumstances under which non-organic ingredients are permitted in products Negative ingredient claims include represented as “organic” or “made with statements such as “No Artificial organic” (specified ingredients/food Flavors,” “No Preservatives,” “No groups). For both types of products, non- Added MSG.” These claims are organic ingredients may be used only if governed only by FDA’s general the ingredients are permitted under the prohibition against “false and National List of Allowed and Prohibited misleading” information. Companies Substances set forth in the regulations. making these claims should assure that In addition, for organic products, non- the claims are substantiated based on the organic ingredients that are agricultural formulation of their products. products may be used only if the Multi-component ingredients in a certified operation has documented that product should be checked to assure that organic versions of the ingredients are they have no components that would not “commercially available.” The final invalidate a claim. rule provides little guidance on the meaning of this term. Although USDA Companies should also carefully had announced its intention to issue consider the extent to which a negative standards for determining “commercial ingredient statement might be truthful on availability” before the rule went into its face, but misleading because of effect in October 2002, it failed to do so. failure to reveal a material fact. For instance, a “No Added MSG” claim As expected, USDA has bowed to public might be viewed by FDA as false and pressure and has prohibited the use of misleading for a product containing technologies such as biotechnology (i.e., hydrolyzed vegetable protein (HVP) the use of food that contains or that is products, even if the product contains no produced using genetically modified added MSG. HVPs are known to be high organisms (GMOs) and irradiation in in free glutamic acid, which, in the organic foods). USDA has even gone so presence of salt or other sources of far as to prohibit the use of these sodium, would result in the formation of technologies in connection with non- MSG. organic ingredients in organically produced products (ORGANIC or
Updated 2009 213 All citations are to the Code of Federal PMA’s Nutrition and Produce Labeling Regulations (C.F.R.) unless otherwise Guide. noted. Claims made on the label or in labeling Information contained in this document that characterize the relationship of any concerning labeling requirements has substance to a disease or health-related been synopsized specifically for fruits condition are known as “health claims.” and vegetables and represents our best Health claims may take several different interpretation of the rules in this area. forms. The substance/disease However, administrative and judicial relationship might be characterized interpretations, as well as the rules either expressly or implicitly, by means themselves, are subject to change. The of statements, third party endorsements, general presentation of FDA’s rules in symbols, or vignettes. this document does not constitute legal advice for particularized facts. Some Health claims may not be made unless states have laws that also impact on food the substance/disease relationship has labeling. For your specific labeling been approved by FDA and authorized needs, contact your legal counsel. by means of a regulation. Currently approved relationships include: The law firm of Keller and Heckman, which represents PMA and assisted in • calcium/osteoporosis (21 C.F.R. § the preparation of this document, is 101.72) available to answer your particular • dietary lipids/cancer (§ 101.73) regulatory/ technical questions. Direct • sodium/hypertension (§ 101.74) your questions to Melvin S. Drozen • saturated fat, cholesterol/coronary 202-434-4222. Fees associated with heart disease ( § 101.75) Keller and Heckman’s assistance with • fiber-containing produce, your questions will be discussed when grain/cancer (§ 101.76) you contact the firm. • fiber-containing produce, grain/ coronary heart disease (§ 101.77) • fruits and vegetables/cancer (§ HEALTH CLAIMS 101.78) • folates/neural tube defects (§ 101.79) • sugarfree/dental caries (§ 101.80) This Q & A addresses issues relating to • soluble fiber from whole oats and the Food and Drug Administration’s psyllium husk/reduced risk of heart (FDA) health claim regulations. Many of disease (§ 101.81) the answers below include citations that • soybean protein/reduced risk CHD (§ the reader may refer to for additional 101.82) information about a particular • plant sterol and stanol esters and requirement. The “C.F.R.” refers to the CHD (adding § 101.83) (Interim Code of Federal Regulations. All other Final Rule) references are presented in • whole grain foods/certain cancers non-abbreviated form. An excellent and CHD (per authorization source for additional information on statement) FDA’s health claim regulations is
Updated 2009 214 • whole grain foods with moderate fat product(s) qualify for any of the eight content/reduced risk of CHD, certain currently approved health claims. First, cancers (per authorization statement) general requirements for making health • potassium/high blood pressure, claims are found at 21 C.F.R. § 101.14. stroke (per authorization statement) These requirements include saturated fat, • dietary supplements containing cholesterol, and sodium) and omega-3 fatty acids/CHD (qualified “qualifying” levels for other nutrients health claim) (10% of the Daily Value for at least one • dietary supplements containing folic of six of the following nutrients: fiber, acid, vitamin B6, and vitamin protein, vitamin A, vitamin C, calcium, B12/vascular disease (qualified health iron). claim) • dietary supplements containing folic The second source of important acid/neural tube defects (qualified information is the individual health health claim) claim regulation that authorizes the • antioxidant vitamins/cancer claim. These regulations contain (qualified health claim) compositional requirements for making • dietary supplements containing the specific claim of interest (for selenium/cancer (qualified health example, the calcium/ osteoporosis claim) authorizing regulation sets threshold • dietary supplements containing levels for the amount of calcium needed phosphatidylserine /cognitive to qualify for the claim). dysfunction, dementia (qualified health claim) If I make a health claim on my label, • nuts and heart disease (qualified am I required to report any other health claim) information on the label? • walnuts and heart disease (qualified health claim) Mandatory nutrition labeling is triggered when a health claim is made on the label • omega-3 fatty acids (ALA and DHA) and heart disease (qualified health or in labeling. claim) Also, keep in mind that FDA closely monounsaturated fatty acid from • regulates the wording of health claims. olive oil and heart disease (qualified For many health claims, FDA requires health claim) that the claim use the words “might” or How can I find out whether my “may” reduce the risk of disease. Many products qualify for any health claims? claims must also indicate that the disease in question depends on many factors, The PMA Nutrition and Produce and the claim must not attribute any Labeling Guide provides information on degree of risk reduction to consumption the eligibility of many popular produce of the food substance that is the subject items for the some of the currently of the claim. authorized health claims. 21 C.F.R. § 101.14(d)(3). For products not listed in the Labeling Guide, companies should look at two sources to determine whether their
Updated 2009 215 May I make a health claim other than As one example, an endorsement of a those listed in the PMA Nutrition and product by the American College of Produce Labeling Guide? Nutrition would not, standing alone, be a health claim since there would be no Only FDA-approved health claims may reference to either a substance (nutrient) be made. The approved substance/ or a disease. disease relationships are listed in the beginning paragraphs of this document. In contrast, an endorsement by the American Heart Association of a I want to use the PMA “5-A-Day” vegetable product where there is a slogan on my label. Is it a health claim? specific reference to the fiber content of the vegetable would be a health claim Whether the “5-A-Day” slogan is a since a relationship is established health claim or not depends on how it is between the two basic elements of a used. Label statements such as “5-A-Day health claim, i.e., the substance and the for better health” or “The National disease/ health-related condition. Cancer Institute recommends that you eat five servings daily of fruits and Are there any limits on the placement vegetables” would not be health claims or size of health claims on the label? as long as the information cannot reasonably be understood to be about a FDA has no type size requirements for specific food or food substance. health claims. The Agency does have a However, the statement: “The National requirement that all required elements of Cancer Institute recommends that you a health claim appear in a single eat five servings daily of fruits and location, without intervening material. vegetables to increase your intake of FDA is currently considering a proposal fiber” would be a health claim because that would permit an abbreviated form of of the reference to a specific nutrient a health claim to appear on a front panel, (fiber) and to a disease (cancer). as long as other required elements of the claim appear elsewhere on the label and What about third-party references that a reference is included with the I might want to use on my label to abbreviated claim as to where the other indicate that health experts believe that important information necessary for fresh fruits and vegetables are good for understanding the claim can be found. you? 21 C.F.R. § 101.14(d)(2)(iv). “Third-party references” are product endorsements made by a person or What is the jelly bean rule? organization that is not related to the company making the claim. Whether The jelly bean rule is a general these references are health claims requirement that applies to all health depends on whether they can reasonably claims. The rule requires that food be understood to characterize the products making a health claim contain a relationship between a substance and a minimum of 10% of the Daily Value for disease or health-related condition. at least one of the following six nutrients: fiber, protein, vitamin A, vitamin C, calcium, iron. It is called the
Updated 2009 216 “jelly bean” rule because it prevents The law firm of Keller and Heckman, foods that do not offer “good” nutrition which represents PMA and assisted in profiles, such as jelly beans, from the preparation of this document, is making health claims. FDA wants available to answer your particular products bearing health claims to be a regulatory/ technical questions. Direct good source of least one of the six your questions to Melvin S. Drozen nutrients identified above. 202-434-4222. Fees associated with Keller and Heckman’s assistance with 21 C.F.R. § 101.14(e)(6). your questions will be discussed when you contact the firm. Is it true that some products are disqualified from making health claims because they contain disqualifying levels of certain nutrients? NET QUANTITY
The flip-side of the jelly bean rule is OF CONTENTS another rule that prohibits health claims for foods containing high levels of STATEMENT certain nutrients. One may not make health claims for a food product if any of This Q & A presents information the following disqualifying levels are relating to the requirements of the Food exceeded: 13.0 g of fat; 4.0 g of and Drug Administration on declaration saturated fat; 60 milligrams of of net quantity of contents. Some of the cholesterol; 480 mg of sodium (all answers below include citations that the amounts per reference amount). reader may refer to for additional information about a particular 21 C.F.R. § 101.14(a)(5). requirement. The “C.F.R.” refers to the All citations are to the Code of Federal Code of Federal Regulations. All other Regulations (C.F.R.) unless otherwise references are presented in non- noted. abbreviated form.
Information contained in this document One of the Food and Drug concerning labeling requirements has Administration’s (FDA) primary been synopsized specifically for fruits labeling requirements is that the net and vegetables and represents our best quantity of contents must be declared on interpretation of the rules in this area. food packages. The net quantity of However, administrative and judicial contents statement must generally appear interpretations, as well as the rules within the bottom 30% of the front panel themselves, are subject to change. Some of the food label, and must be in a type states have laws that also impact on food size proportional to the area of the front labeling. The general presentation of panel. FDA’s rules in this document does not constitute legal advice for particularized See Section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act. facts. For your specific labeling needs, contact your legal counsel. However, FDA and the states share responsibility for the enforcement of the regulations, and many states are active in
Updated 2009 217 monitoring the marketplace to assure be seen by consumers at the time of compliance with net quantity of contents purchase. requirements and in checking the accuracy of NQC statements. States are The NQC statement must be a distinct permitted to use different enforcement and easy-to-find item on the PDP. It guidelines in terms of how accurate must be separated from surrounding NQC statements must be, and many in printed material (1) by a distance, above fact do use guidelines different from and below, equal to at least the height of those of the FDA. Most states have a the capital letter “N” of a style of type “Weights and Measures” division that used in the NQC statement; and (2) by a can be contacted for specific state distance, on either side, equal to at least compliance guidelines. twice the width of the letter “N” of the style of type used in the NQC statement. What must I include in the net quantity of contents statement? 21 C.F.R. §§ 101.1 and 101.105(f).
The net quantity of contents (NQC) What type size should be used for the statement must provide consumers with NQC statement? information about the amount of food in the container or package. This The minimum type size for the NQC information is generally reported using statement is related to the area of the units of weight (if the food is a solid) PDP as follows: and units of volumetric measure (if the Min. Height of food is a liquid). However, for fresh Area of PDP Any Letter or Number fruits and vegetables, FDA permits the < 5 sq. in. 16th inch use of “dry” volumetric measures (i.e., 5-25 sq. in. 1/8th inch pints, bushels) if a particular produce 25-100 sq. in. 3/ 16th inch item is customarily sold by dry over 100 sq. in. 1/4 inch measures. Id. If there is an established industry practice to declare a particular 21 C.F.R. § 101.105(i). produce by numerical count (e.g., “3 Tomatoes”) such a declaration may be My company sells random weight used as long as it facilitates value packages. May I provide the NQC comparisons for consumers. Id. statement in terms of count (e.g., “3 Tomatoes”) instead of by weight? 21 C.F.R. § 101.105(a). FDA’s regulations permit NQC Where must the NQC statement be statements to be provided in terms of placed on the label? numerical count as long as it will facilitate value comparisons for FDA requires the NQC statement to be consumers. Thus, if a particular placed within the bottom 30% of the commodity is usually declared by principal display panel (PDP) of a food weight, it may not be possible to use package. 21 C.F.R. § 101.105(f). The numerical count since consumers would principal display panel is that portion of not be able to readily compare the value the package label that is most likely to of the product versus competitive products.
Updated 2009 218 21 C.F.R. § 101.105(a). When the NQC statement is declared in terms of units of weight or volume, the Must the NQC statement be provided in largest whole customary English unit both pounds/ounces and in metric should be used. For example, “32 units? ounces” should be expressed as “2 pounds.” Yes. With the passage of the American Technology Preeminence Act of 1991, When a quantity does not divide evenly declaration of net quantity of contents into a whole unit, the remainder may be must now be reported in both English expressed using either fractions of the and metric units. Either system may be largest whole unit or in terms of the next used first in a particular NQC statement, smaller whole unit. A third option would i.e., either “1 lb (454 g)” or “454 g (1 be to use decimals. For example, the lb)” is appropriate. NQC statement for a package weighing 24 ounces could be expressed as either What conversion factors should I use to “1 1/2 lb” or “1 pound 8 oz” or “1.5 lb.” convert a pound/ounce measurement to metric units? If I use decimals, how many places after the decimal should I use? FDA-approved conversion factors for mass (weight) are as follows: (1) to Decimals should never be extended convert ounces to grams multiply by more than three places. Care should be 28.3495231; (2) to convert ounces to taken when using decimals not to kilograms multiply by 0.02834952; (3) express a quantity with a degree of to convert pounds to grams multiply by precision that the manufacturer cannot 453.59237; (4) to convert pounds to justify. For example, a declaration of kilogram multiply by 0.45359237. For 2.567 kg would mean that the more information, please see FDA’s manufacturer is sure of the weight of a Compliance Policy Guide 7150.17, package to the nearest gram, i.e., the Section 140.500 Metric Declarations of weight is closer to 2567 g, than it is to Quantity of Contents on Product Labels, 2,568 g or 2,566 g. On the other hand, a available at, declaration of 2.56 kilograms only http://www.fda.gov/ora/compliance_ref/ assures precision to the nearest 10 cpg/cpggenl/cpg140-500.html. grams, and 2.5 kg to the nearest 100 grams. What abbreviations should I use in expressing English and metric units of How close should the declared weight measure? be to the actual weight of the product?
FDA-approved abbreviations are as The NQC statement should accurately follows: (1) “oz” for ounces; (2) “lb” for reveal the quantity of food in a package pounds; (3) “g” for grams; and (4) “kg” exclusive of wrappers and other for kilograms. materials packed therein.
What rules apply when expressing the When FDA tests the accuracy of net weight of my product? For example, weight statements, it will permit may I use fractions? reasonable variations caused by loss or
Updated 2009 219 gain of moisture during the course of rules not only add metric labeling good distribution practice or by requirements, but would also make unavoidable deviations in good several other significant changes to the manufacturing practice. During law in this area. These proposed rules compliance checks, FDA will use an have not yet been finalized, but FDA’s “average concept” where 48 units of Office of Food Labeling has informally product are examined. If the average is advised individuals to follow the short weight by 1% or more, FDA may proposed rule issued on December 21, take action against the product, unless it 1993 pending issuance of a final rule. can be shown that storage or shipping The requirements found in the December conditions, or variations in tare weights 21, 1993 proposal are reflected in this (i.e., the weight of packaging), was a document. significant contributing factor to the short weight problem. See FDA Information contained in this document Compliance Policy Guide 7120.19. concerning labeling requirements has been synopsized specifically for fruits For compliance purposes, many states and vegetables and represents our best use a different set of guidelines based on interpretation of the rules in this area. the National Institute of Standards and However, administrative and judicial Technology’s (KIST) Handbook 133 interpretations, as well as the rules “Checking the Net Contents of Package themselves, are subject to change. Many Goods.” Handbook 133 also employs an states also have laws that import on food averaging concept, but adds a second labeling. The general presentation of key factor, the “Maximum Acceptable FDA’s rules in this document does not Variation” concept, that prohibits any constitute legal advice for particularized single package from being too far below facts. For your specific labeling needs, the declared weight. contact your legal counsel.
Is a NQC statement (and metric The law firm of Keller and Heckman, labeling) necessary on shipping which represents PMA and assisted in containers as well as on consumer the preparation of this document, is packages? available to answer your particular regulatory/ technical questions. Direct FDA does not require NQC statements your questions to Melvin S. Drozen on shipping cartons, provided the 202-434-4222. Fees associated with shipping cartons do not serve as “retail Keller and Heckman’s assistance with units” that are directly purchased by your questions will be discussed when consumers. you contact the firm. Citations in this document are to the Code of Federal Regulations (C.F.R.) unless otherwise noted. FDA issued NUTRITION several proposed rules in 1993 to implement metric labeling requirements. LABELING See 58 Federal Register 29716 (May 21, 1993) and 58 Federal Register 674.44 This Q & A presents information (December 21, 1993). The proposed relating to the requirements of the Food
Updated 2009 220 and Drug Administration on nutrition Retailers are urged to participate in the labeling. Some of the answers below voluntary program for nutrition labeling include citations that the reader may that Congress and FDA have established refer to for additional information about for raw agricultural commodities. As a particular requirement. The “C.F.R.” part of this program, retailers provide refers to the Code of Federal nutrition information for the top 20 Regulations. All other references are selling fruits and top 20 selling presented in non-abbreviated form. An vegetables. Nutrition labeling may be excellent source for this information is provided by means of signs, posters, PMA’s Nutrition and Produce Labeling brochures, notebooks, etc. at the point of Guide. purchase.
One of the Food and Drug 21 C.F.R. § 101.42-101.45. Administration’s (FDA) primary requirements for a food label is to Are there any abbreviations permitted provide nutrition labeling for the product when voluntarily declaring nutrition as packaged. An exemption to nutrition information at retail? labeling exists for raw agricultural commodities whether packaged or not, When retailers provide nutrition provided that no nutrient content or information for more than one raw fruit health claims are made on the label, or in or vegetable (on signs, posters, labeling or advertising. brochures, notebooks or leaflets), the listing of saturated fat, trans fat, and As a trade-off for exempting raw cholesterol may be omitted if the agricultural commodities from following footnote is used: “Most fruits mandatory nutrition labeling, Congress and vegetables provide negligible and FDA have established a voluntary amounts of saturated fat, trans fat, and program whereby retailers provide cholesterol; avocados provide 0.5g of nutrition information for the top 20 saturated fat per ounce.” The footnote selling fruits and top 20 selling may also contain information about the vegetables. FDA surveys retail stores polyunsaturated and monounsaturated every two years to determine whether fat content of avocados. there is “substantial compliance” with the voluntary program. If, during any of 21 C.F.R. § 101.45(a)(3)(iii). these surveys, FDA were to find that retailers are no longer in substantial What degree of processing will result in compliance with the voluntary program, my product losing its status as a “raw the Agency will initiate rulemaking to agricultural commodity” exempt from require nutrition labeling for raw fruits nutrition labeling? and vegetables. The law defines “raw agricultural What is the responsibility of retailers commodity” as any food in its raw or with respect to providing nutrition natural state, including all fruits that are information for fresh fruits and washed, colored, or otherwise treated in vegetables? their unpeeled natural form prior to marketing. Waxed fruits and vegetables that receive little or no processing
Updated 2009 221 qualify as “raw agricultural foods. Similar to the exemption for raw commodities” and are subject to the agricultural commodities, many of these voluntary program. Similarly, fruit and other exemptions are lost if a nutrient vegetables that are trimmed and/or content or health claim is made on the packaged by the retailer (e.g., carrot label, or in labeling or advertising. sticks or broccoli stalks) are also subject to the voluntary program. 21 C.F.R. § 101.90).
What happens to the exemption for raw Where should nutrition information agricultural commodities if I make appear on the label? nutrition claims on my label or in advertising? Nutrition information may appear either on the front panel of a packaged food, or Nutrition claims (i.e., nutrient content on the side panel immediately to the claims and health claims) subject a raw right of the front panel. Most agricultural commodity to mandatory manufacturers place nutrition nutrition labeling. information on the right side panel. If the right side panel is already crowded with 21 C.F.R. § 101.90)(10). other mandatory labeling information, companies have the option of placing We package fresh vegetables and want nutrition information on any other panel to provide information only on the level where it is reasonable to expect it to be of vitamin C in our products. May we seen at the time of purchase. do this without having to use a complete Nutrition Facts box? 21 C.F.R.§ 101.2(c).
No. FDA requires that, when any What type size requirements apply to nutrition information is provided on a nutrition labeling? label, consumers must be provided with the “whole picture.” Thus, information FDA has established very specific on the level of one nutrient in a product typesetting requirements for the triggers the need for a complete Nutrition Facts box. These requirements Nutrition Facts box. are too detailed to present here. The PMA Nutrition and Produce Labeling Are any other exemptions available Guide or FDA’s regulations at 21 C.F.R. from nutrition labeling for my product § 101.9(d) can be consulted for this if it does not qualify as a raw information. agricultural commodity? What should I do if the standard FDA has established approximately 20 “NUTRITION FACTS” box does not exemptions from nutrition labeling. fit on my label? Exemptions of potential relevance in addition to the one for raw agricultural Packages with surface area available to commodities include those for small bear labeling of 40 or less square inches businesses, small packages, products are permitted to use an “abbreviated primarily processed and prepared at the format” for providing nutrition retail establishment, and restaurant information. These formats: permit the use of abbreviations for the names of
Updated 2009 222 nutrients/food components, allow the use example, for a salad kit containing of an abbreviated footnote at the bottom lettuce, dressing, and croutons, the of the Nutrition Facts box, and provide manufacturer could calculate nutrient flexibility in terms of how the Nutrition levels for a single serving of the Facts box must be formatted. assembled salad based on the proportions of each of the components. 21 C.F.R. § 101.90)(13). Another alternative would be to use an “aggregate format” whereby separate Most Nutrition Facts boxes that I have columns are provided for each of the seen provide information for 14 components of the salad kit. mandatory food components/nutrients and they also contain a lengthy 21 C.F.R. §§ 101.9(d)(13) and footnote. Do I have to include all of this 101.9(h)(1). information on my labels, or may I cut down on the information that I report? How do I go about getting nutrition values for my products? FDA permits the use of a “simplified format” if a product contains fewer than Nutrient values for many raw 8 nutrients. agricultural commodities may be obtained from PMA’s database. For 21 C.F.R. § 101.9(f). processed foods, and raw agricultural commodities not covered by PMA’s My product is sold from bulk database, it may be possible to utilize containers and I must provide nutrition other databases for this information. information because I make nutrient Where reliable databases do not exist, content claims for the product. How do analytical testing of the product may I provide nutrition information? need to be conducted.
FDA allows foods sold from bulk What if I have analytical data containers to display the required demonstrating that the nutrition nutrition information on the outside of information for my product is different the container or on posters, counter from the FDA-approved values? cards, tags, or by using similar measures. Small deviations from the FDA values 21 C.F.R. § § 101.9(a)(2) and can be ignored. When FDA reviewed 101.9(j)(9). PMA’s database for fruits and vegetables, the Agency took into account How should nutrition labeling be that there is often variation in nutrition provided for salad kits and other information for fresh fruits and multi-component food packages? For vegetables. The values that have been example, for my salad kit, should I approved have taken this variation into provide separate NUTRITION FACTS account. In addition, FDA’s nutrition boxes for the croutons and salad labeling rules permit some deviation dressing? between declared values and actual values for nutrients. Manufacturers have several options in this situation. First, a single set of nutrition values could be provided. For
Updated 2009 223 How do I calculate the serving size to Nutrition Facts box could be used where use as the basis for reporting nutrition the number of servings and nutrition labeling for my products? values are provided separately for each vegetable. Another alternative would be The first step in determining serving size to provide a single, composite set of is to consult FDA’s regulations for values. This second alternative would be reference amounts customarily accomplished by using the 85 gram consumed (RACCs) at 21 C.F.R. § reference amount for raw vegetables to 101.12(b). RACCs are converted to determine an appropriate serving size for serving sizes by applying FDA’s rules at the product. For example, perhaps the 21 C.F.R. § 101.9(b). These rules are too serving size would be “3.0 oz (84 detailed to present here. Details about g)(about 10 pieces of vegetables).” The these rules can be found in the composite nutrition information would above-cited regulations or in the PMA be computed as in example 1 above, i.e., Nutrition and Produce Labeling Guide. use the relative percentages of each vegetable to calculate the composite How do I provide nutrition labeling if values. my product contains a mixture of various fruits or vegetables? What are the values for labeling fresh cut items, like salad or chopped onions? This question might best be answered by providing several examples. FDA has informally approved the use of values from the FDA/PMA database for First, consider a “fruit salad” product, these items. consisting of 20% grapes, 40% watermelon, and 40% cantaloupe, with a All citations are to the Code of Federal serving size of 100 grams. The nutrition Regulations (C.F.R.) unless otherwise values for the entire fruit salad product noted. may be determined by calculating the nutrient levels (using the approved data Information contained in this document base values) in 20 g of grapes, 40 g of concerning labeling requirements has watermelon, and 40 g of cantaloupe. been synopsized specifically for fruits These values are then added to provide a and vegetables and represents our best “composite” set of values for the fruit interpretation of the rules in this area. salad. However, administrative and judicial interpretations, as well as the rules Second, consider a mixture of cut carrot themselves, are subject to change. Some sticks, celery sticks, and radishes. Note states have laws that also impact on food that the difference between this product labeling. The general presentation of and the fruit salad product above is that FDA’s rules in this document does not this product is not properly thought of as constitute legal advice for particularized a single food item (i.e., a “salad”), but facts. For your specific labeling needs, rather is a mixture of several different contact your legal counsel. food items (i.e., carrots, celery, and radishes). The nutrition information for The law firm of Keller and Heckman, the vegetable mixture could be provided which represents PMA and assisted in in one of two ways. First, an “aggregate” the preparation of this document, is
Updated 2009 224 available to answer your particular other container is the “shipping regulatory/ technical questions. Direct container” and must bear the required your questions to Melvin S. Drozen labeling. 202-434-4222. Fees associated with Keller and Heckman’s assistance with Information contained in this document your questions will be discussed when concerning labeling requirements has you contact the firm. been synopsized specifically for fruits and vegetables and represents our best interpretation of the rules in this area. However, administrative and judicial PESTICIDE interpretations, as well as the rules themselves, are subject to change. Some LABELING states have laws that also impact on food labeling. The general presentation of This Q & A presents information FDA’s rules in this document does not relating to the requirements of the Food constitute legal advice for particularized and Drug Administration on pesticide facts. For your specific labeling needs, labeling. contact your legal counsel.
When must pesticides be declared on The law firm of Keller and Heckman, the label? which represents PMA and assisted in the preparation of this document, is If a pesticide chemical was applied to available to answer your particular raw produce after harvest, the food is regulatory/ technical questions. Direct misbranded unless its shipping container your questions to Melvin S. Drozen bears a label statement declaring the 202-434-4222. Fees associated with presence of the chemical by its common Keller and Heckman’s assistance with or usual name and its function. Once the your questions will be discussed when produce has been removed from the you contact the firm. shipping container and is being held or displayed for sale at retail out of the container, the labeling is no longer required.
What is considered a “shipping container” for purposes of this rule?
When individual bags, berry boxes, or similar containers of raw agricultural commodities that are products of the soil are packed into master cartons for shipment, only the master carton is considered the shipping carton that must bear the required labeling. If the bags, boxes, or other packages are not packed into other containers, but are shipped individually, each individual bag or
Updated 2009 225 Nutrition & Produce Labeling Guide
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Updated 2009