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Nutrition & Produce Labeling Guide

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Nutrition & Produce Labeling Guide 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
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