US Food Labeling Overview an Overview of the Labeling of Packaged Human Foods Under the Authority of U.S

US Food Labeling Overview An overview of the labeling of packaged human foods under the authority of U.S. FDA & USDA

936081 Airport Road, Mulmur, Ontario, L9V 0L3 Tel: (705) 435-2041 / Fax: (705) 435 -1467 [email protected] Food Labelling Compliance Series Slide 2 Support… of 197 PowerPoint Presentation… • Will be made available. ►Contact Trainer for questions. Presentation Support… E-MAIL: [email protected] TEL: (705) 435-2041

• Understand how packaged food labeling is governed in the U.S. under FDA & USDA. • Be introduced to Federal authorities with responsibility over food. FOCUS • Better appreciate U.S. food regulations under U.S. FDA Our focus and USDA. is on • Learn more about some handy compliance resources. federal legislation. • Get a better understanding of food labeling basics. • Explore the new nutrition facts panel under FDA.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 4 By end of day… of 197 The broad goal by the end of day one is to gain a better understanding of how packaged foods under the authority of U.S. FDA and USDA are to be labeled.

FFDCA= Federal Food, Drug and Cosmetic Act CFR = Code of Federal Regulations

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 8 Authorities… of 197 General… 1. Levels of Foods in the US are governed by Government FOCUS both Federal and State Our focus 2. Authorities is on authorities. Local authorities, federal jurisdiction (cities and municipalities), also 3. Jurisdiction under the authority have authority to govern food. of FDA & 4. Legislation USDA 5. Compliance Resources FEDERAL STATE 6. Compare & Contrast

. Domestic, Imports & Exports . Retail & Institutional (non retail) FDA & . Fresh & Manufactured USDA *Governs State (certain foods & beverages)… food in interstate commence. . Environmental (packaging, recyclable, redemption) . Alcoholic Beverages . State Meat . California’s “Proposition 65” . Vermont’s Act 120 (GMO Labeling) – now pre-empted Municipal (some foods & beverages)…

. Foodservice / In Store Bakery / Manufacturing

Meet the FEDS Note: This USDA (United States Department of is a list of principal Agriculture) authorities, but not a comprehensive list. FTC (Federal Trade Commission)

Meet the FEDS Note: This TTB (Alcohol and Tobacco and Trade Bureau) is a list of principal authorities, but not a comprehensive list. APHIS (Animal and Plant Health Inspection Services)

Meet the FEDS Note: This Homeland Security is a list of principal authorities, but not a compre- National Oceanic and Atmospheric hensive list. Administration

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 13 Authorities… of 197 FDA Presides Over… . Federal Food, Drug, and Cosmetic Act (US Code) FDA Federal pre- • Title 21 Code of Federal Regulations (CFR) emption applies to certain food labeling . No meat or poultry, other than game regulations. meat (deer, bison, rabbit, quail, wild States may not create turkey, geese, ostrich). regulations beyond the scope of federal . Fish and seafood. regulations. . Foods in interstate commerce.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 14 Authorities… of 197 FDA Divisions of Interest… . Office of Regulatory Affairs (ORA) . Center for Food Safety and Applied Nutrition (CFSAN)* • Office of Food Safety • Office of Compliance • Office of Food Additive Safety • Office of Nutritional Products, Labeling and Dietary Supplements*

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 15 Authorities… of 197 FDA - Office of Nutritional Products, Labeling and Dietary Supplement (FDA - CFSAN – ONPLDS)… . Food Labeling, Standards & Compliance* . Nutrition Programs & Labeling* . Infant Formula & Medical Foods

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 16 Authorities… of 197 USDA - Presides Over… . Federal meat and poultry legislation. . USDA has various subdivisions governing foods. USDA • FSIS (Food Safety Inspection Service)* Products exempt • Agricultural Marketing Service (AMS) from USDA’s • Food and Nutrition Service authority, (e.g. • Animal and Plant Health Inspection Service (APHIS) products . Meat and poultry as defined (beef, pork, lamb/sheep with chicken, turkey). insignificant meat . Foods in interstate commerce. content) are under FDA. . Food Inspection - Import and Export. . National Organic Program. . COOL (Country of Origin Labeling).

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 17 Authorities… of 197 CBP (Customs and Border Protection) - Presides Over… . Obviously governs the importation of products into the US. OTHER Outside of FDA . Statutory authority is the Tariff Act 1930. and USDA there are other . Regulatory Authority governing country of Federal agencies origin labeling under CBP is in that involved with compliance. 19 CFR Part 134. A few additional example are . Rules of country of origin can be complex. shown here. These involve NAFTA rules as well if applicable. . Country of origin, (outside of USDA’s COOL), is required to be marked on all imported goods unless exempt.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 18 Authorities… vs of 197 U.S. Classification & Jurisdiction… FDA USDA (a) POULTRY... Meat and Poultry as defined. • < 2 % cooked poultry meat MEAT & • less than 10 % cooked poultry skins, (a) Meat or poultry under FDA could be POULTRY giblets or fat, separately under voluntary inspection. JURISDICTION • less than 10 % cooked poultry skins, giblets, fat and poultry meat (limited to This slide is not less than 2 %) in any combination (b) Also not covered by USDA... a comprehensive Bouillon cubes, dehydrated meat soups, Note: For dried products % is based on the moist list. cooked chicken when ready to serve prepared cheese balls with pepperoni, pork and according to the directions on label (consumer). beans, closed-face sandwiches, mince REFERENCE (b) MEAT... meat, bagel dogs, and pepperoni rolls. FSIS SLP Book • < 2 % cooked meat, § 381.15 • 3 percent or less raw meat. •  30 % fat, tallow or meat extract 9 C.F.R. § 381.15; 9 C.F.R. § 301.2 (c) Game Meats (deer, bison, rabbit, quail, USDA, Standards and Labeling Policy Book. wild turkey, geese, ostrich) 21 U.S.C. §§ 453(f), 601(j).

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 19 Authorities… vs of 197 U.S. Classification & Jurisdiction… FDA USDA PRIOR LABEL APPROVAL IS NOT PRIOR LABEL APPROVAL IS REQUIRED REQUIRED • Applies to meat and poultry products • Generic approvals may apply • Exported product approval.

Lighter Side – It can disastrous working in food labeling without knowing the rules!

LEGISLATION… APPLICABILITY… Federal Food, Drug Act cosmetic Act All foods in interstate commence. FEDERAL • 21 CFR All levels of trade. LEVELS OF Fair Packaging and Labeling Act Retail consumer food. TRADE • 15 CFR e.g. Made in USA guidelines Retail, food service, further Tariff Act of 1930 (19 CFR) Country of origin labeling manufacture. Federal Meat Inspection Act USDA – Foods in interstate and FEDERAL PRE- • 9 CFR international commerce EMPTION Poultry Products Inspection Act USDA – Foods in interstate and EXAMPLE Gluten Free 21 • 9 CFR international commerce CDR § 101.91. COOL (Section 10816 of the 2002 USDA –AMS country of origin Farm Bill (7 B.SC.. 1638 ) labeling

LEGISLATION… APPLICABILITY HIGHLIGHTS… Nutrition labeling (21 CFR – Final May 2016) Revise nutrition labeling, serving sizes and reference amounts Gluten Free labeling (2014) Established gluten free claims criteria

FDA Food Safety Modernization Act (FSMA -2011) Food safety related - various

Patient Protection and Affordable Care Act of 2010 Menu and vending machine Calorie and nutrition labeling Food Allergen Labeling and Consumer Protection Allergen labeling (2004) Public Health Security and Bioterrorism Facility registration and prior import Preparedness and Response Act Of 2002 notice for food (FDA)

LEGISLATION… APPLICABILITY… 9 CFR Part 316 — Marking Products and their Marking of meat products and container, Containers official inspection legend, etc. 9 CFR Part 317 — Labeling, Marking Devices, Meat product regulations concerning and Containers labeling, etc. 9 CFR Part 319 — Definitions and Standards Meat regulations concerning standards, of Identity or Composition labeling, etc. 9 CFR Part 381 — Poultry Products Inspection Poultry products regulations concerning Regulations standards, labeling, etc. 9 CFR Part 424.21 — Food Ingredients and Additives and sources of radiation permitted Sources of Radiation in meat products.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 26 Federal Legislation… of 197 Select State Considerations… LEGISLATION… APPLICABILITY… California’s Proposition 65 Requires notices to be posted for foods STATE that exceed threshold levels of LEGISLATION substances recognized as carcinogens, Some high- (e.g. acrylamide, lead, etc.) lighted state State Environmental Regulations Redemption and recyclability of food considerations. containers, (e.g. beverages) State and municipal laws Certain States and municipalities have Non consumer, foodservice foods. apply only in bans or programs to eliminate trans fat. their respective justification. State and local alcoholic beverage Covers the state importation and legislation - – now redundant as sate and local distribution of FDA rescinded GRAS for PHO alcoholic beverages. Vermont Act 120 – now pre- Mandatory GMO labeling of packaged empted food.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 29 Authorities… of 197 Select US Web Resources… . FDA Food Labeling Guide • A good practical overview of FDA food labeling. . Code of Federal Regulations (National Archives)… • Includes a all federal regulations, (e.g. 7 CFR, 9 CFR, 19 CFR, 21 CFR). . U.S. Code (FD&C Act Chapter IV: Food)… • US Food, Drug and Cosmetic Act. . USDA Food Standards and Labeling Policy Book… • A view of USDA meat and poultry standards and labeling. . ORA FDA Compliance Policy Guides… • FDA compliance guides provided supplemental views on compliance.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 30 Authorities… of 197 Select Other Resources… . Food Suite Smart Tools – US Food Labeling • A comprehensive guide to US FDA food labeling and related resources. Now online. . Legal Information Institute Cornel University… • On line resource for Federal and State laws and regulations.

Lighter Side – Having eyes in the back your head helps here!

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 33 DEFINITIONS… of 197 The term “food” means [FDAC]… (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

NOTE: Be aware that there is a definition for “drug” that is also important to consider in order not to bring a food into a “drug” status. The term “person” means [FDAC]… … includes individual, partnership, corporation, and association

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 34 DEFINITIONS … of 197 The term “label” means [FDAC]… … a display of written, printed, or graphic matter upon the “immediate container” of any article; and a NOTE requirement made by or under authority of this Definitions chapter that any word, statement, or other exist are also 21 information appear on the label shall not be CFR & considered to be complied with unless such word, FPLA (slightly statement, or other information also appears on the different). outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 35 DEFINITIONS … of 197 The term “labeling” means [FDAC]… … all labels and other written, printed, or NOTE graphic matter Definitions exist are also 21 (1) upon any article or any of its containers CFR & or wrappers, or FPLA (slightly (2) accompanying such different). article

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 36 DEFINITIONS … of 197 The term “food additive” means [FDAC]… … any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 37 DEFINITIONS … of 197 The term “food additive” excludes [FDAC]… (1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or (2) a pesticide chemical; or (3) a color additive; or (4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21 B.SC.. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 B.SC.. 601 et seq.]; (5) a new animal drug; or (6) an ingredient described in paragraph (ff – dietary supplement) in, or intended for use in, a dietary supplement.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 38 DEFINITIONS … of 197 A “color additive” includes [FDAC]… (1) a material which— (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 39 DEFINITIONS … of 197 A “color additive” continued [FDAC]… (2) The term “color” includes black, white, and intermediate grays. (3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 40 DEFINITIONS… [21 CFR §101] of 197 The term “area of the principal display panel”… … the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; (c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, that where such container presents an obvious ‘‘principal display panel’’ such as the top of a triangular or circular package of cheese, the area shall consist of the entire top surface.

NOTE: Exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 41 DEFINITIONS… [21 CFR §101] of 197 The term “principal display panel”… … means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 42 DEFINITIONS… [9 CFR §317.2 & §381.116] of 197 The “20% Panel” – USDA only… … this is a specific area defined for cylindrical containers under USDA where certain information may be otherwise be located. It is defined as… A panel of a width not greater than 20 percent of the circumference , (the height of which is as high as the container), that is to the right or left of a PDP, (the width of 1/3 the circumference and the height of which is as high as the container). The 20% panel is reserved for the following information which may be shown on this panel as opposed to the PDP. 1. Ingredient List 2. Domicile Statement 3. Inspection legend

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 43 DEFINITIONS… [21 CFR §101] of 197 The term “information panel”… … means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the “principal display panel” with the following exceptions: (1) If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used. (2) If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel. (3) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.

Lighter Side – Something's just have to be read from cover to cover, over and over AGAIN!

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 47 LABEL BASICS… of 197 Shipping Containers [FDA vs USDA]… … Under FDA shipping contains used to transport fully labeled inner containers (immediate container), are not required to include any other mandatory information, with the NOTE The comment exception of proper storage conditions, (e.g. “keep frozen”). above on USDA shipping containers is not … Under USDA shipping contains may be required to include a additional information other than just storage conditions, comprehensive review of all (e.g. “keep frozen”). For example domestic inspected requirements. products will require an inspection legend. Imported poultry products will require the name of the food, the foreign establishment number, the country of origin, and inspection legend.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 48 LABEL BASICS… of 197 Language [21 CFR §101]… … English (official = mandatory) … Others optional … When other languages are used on labeling (e.g. Spanish), then all mandatory information as required will need to be included in that language in addition to English

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 49 LABEL BASICS… of 197 Labeling & Exemptions… … All foods held for sale unless exempt in whole or in part (a few examples below – subject to special NOTE considerations) These are just a 1. Penny Candy (one bite) sample of some 2. The unit containers in a multiunit labeling exceptions. 3. Random Weight Packaged (net Q - retail weighed) 4. Fruit Juice Beverages (placement of Net Q on lower 1/3)

Statement of Identity… [21 CFR §101.3] … Name

1. By Standard Name LINK (e.g. “spaghetti”) 2. Common or Usual Name (e.g. “ginger ale”) 3. Appropriate Descriptive (e.g. “fruit filled granola bar”)

NOTE: An established and well recognized fanciful name can also be used “Coca Cola®”

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 51 LABEL BASICS - PDP… of 197 Statement of Identity… [21 CFR §101.3] … special considerations 1. Imitation Foods (include “imitation”) (when nutritional inferior) 2. Optional Forms (e.g. whole versus sliced) 3. Specific Unstandardized Names (21 CFR§ 102) (e.g. Juice labeling / peanut spreads) 4. FDA guidance on unstandardized names (e.g. “chow mein noodles”) 5. Primary Recognizable Flavor

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 52 LABEL BASICS - PDP… of 197 Statement of Identity… [21 CFR §101.3] … Display 1. On PDP 2. Bold 3. Generally parallel to base 4. Reasonably proportional to the largest type on the PDP

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity. .

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 54 LABEL BASICS - PDP… of 197 USDA Summary Specific qualifying statements may need to be considered. The following are a few examples. . GEOGRAPHIC TERMS: Can generally only be used if the food is from that geographic are. Otherwise used “style”. NOTE This is not . STYLE: Can only be used if the “style” if set out USDA’s (FSIS) Food as a Standards and Labeling Policy Book or is recognized by a reputable compre- culinary institutes. hensive . SMOKE FLAVOR: When artificial smoke flavoring or a smoke flavoring is listing of naming added to a poultry product, the statement ‘‘Artificial Smoke Flavoring consider- Added’’ or ‘‘Smoke Flavoring Added,’’ as applicable must in prominent ations. letters contiguous to the name of the product. (9 CFR § 381.119) . UNSTANDARDIZED FOOD: Foods like PIZZA (now unstandardized) can use terms like PIZZA modified by the major ingredients or non traditional features of the type of pizza, (e.g. “Bacon, Reduce Fat Cheddar Cheese, Hickory Flavored Sauce, and Sourdough Pizza”).

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 55 LABEL BASICS - PDP… of 197 USDA Summary (more) . BONELESS POULTRY: Boneless poultry products must be labeled as such (9 CFR § 381.117(d)). . WHITE & DARK MEAT: Poultry products containing both light and dark meat in other than natural proportions must include a qualifying NOTE This is not statement with the product name indicating the type of meat actually as a used, except that the qualifying statement is not required if the product compre- contains less than 10 percent cooked, deboned poultry, or the light and hensive dark meats are indistinguishable. (9 CFR § 381.117(c).) listing of naming . IRRADIATION: For irradiated meat and poultry products, if the product consider- name includes the word irradiated. (e.g., “irradiated ground beef”), the ations. label is not required to bear the irradiation disclosure statement, (i.e. “treated by irradiation” or “treated with radiation”), but is required to bear the radura logo.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 56 LABEL BASICS - PDP… of 197 USDA Summary (more) . TITANIUM DIOXIDE: When Titanium Dioxide is used in poultry salads, a qualifying phrase should appear under the product name stating that the product has been “Artificially Whitened“ or “Artificially Lightened.“ (USDA SLPB) NOTE This is not as . PREPARATION: Product, (identified by descriptive name), which has a compre- been prepared by salting, smoking, drying, cooking, chopping, or hensive otherwise shall be so described on the label unless the name of the listing of product implies, or the manner of packaging shows that it was naming consider- subjected to such preparation. ations. . ANTIOXIDANT: When an antioxidant is added to a product, a statement showing the name of the antioxidant and the purpose it is added for, such as ‘‘BHA added to help protect the flavor.’’ must appear in prominent letters contiguous to the name of the product. (9 CFR § 317.2(j), § 381.120)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 57 LABEL BASICS - PDP… of 197 Net Contents… [FPLA + 21 CFR §101.105] … Units 1. Avoirdupois + Metric (e.g. “Net Wt. 8 oz (227 g)”) 2. Largest Unit (e.g. “1.25 pt (591 mL)”) (e.g. “48 fl oz (1.41 L)”) = proposed 3. Dual (1- 4 lb / 1 pint and 1 gallon) (e.g. “Net Wt. 24 oz (1 lb 8 oz) / 680 g”) LINK 4. Multi Unit Packages (“3 x16 oz (454 g) tins (Net Wt. 48 oz (1.36 kg)”)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 58 LABEL BASICS - PDP… of 197 Net Contents… [FPLA + 21 CFR §101.105] … Display 1. On lower 1/3 of PDP 2. Bold (conspicuous) 3. Prefix “Net Wt” (proposed to remove – include for USDA) 4. The ratio of height to width (of the letter) shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide). 5. A space above and below. 6. When fractions are used the numerator and denominator must be at least ½ the type height of that required.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 59 LABEL BASICS - PDP… of 197 Net Contents… [FPLA + 21 CFR §101.105] … Display 7. Type size is related to area of the PDP

AREA OF PDP… MINIMUM TYPE SIZE… 5 square inches or less. 1/16 inch (1.6 mm)

More than 5 but not more than 25 in2 1/8 inch (3.2 mm)

More than 25 but not more than 100 in2 3/16 (4.8 mm)

More than 100 not more than 400 in2 ¼ inch (6.4 mm)

More than 400 in2 ½ inch (12.7 mm)

EXAMPLES

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity. .

Metric Required Metric Optional NOTE Dual Optional Dual Required This is not as a compre- 1 Tolerances (administrative1,2) Tolerances hensive listing of naming 1 - CPG (CPG 7120.19) 562.300 Foods 1 - National Institute of Standards consider- - Net Weight and Technology (NIST) ations. 2 - Federal Register / Vol. 62, No. 42 / Handbook 133, ‘‘Checking the Tuesday, March 4, 1997 / Net Contents of Packaged Proposed Rules Goods,’’ Third Edition, September 1988

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 63 LABEL BASICS - PDP… of 197 Net Contents… USDA Summary Exemptions and Special Considerations . Individually–Wrapped, Random–Weight, Consumer-Size Packages Shipped in Bulk Containers: Exempt, but on shipper and need to NOTE included on consumer unit before sale to consumer. Also exempt from This is not as type size, placement and dual declaration a compre- . Certain Meat and Poultry Products Subject to Shrinkage Through hensive listing of Moisture Loss: Exempt, but on shipper and need to included on naming consumer unit before sale to consumer. Also exempt from type size, consider- placement and dual declaration. ations. . Small Packages: Individually-wrapped and labeled packages of less than ½ ounce net weight and random weight consumer size packages are exempt, provided that the packages are in a shipping container that expresses accurately the net quantity of contents in the container and is not otherwise false or misleading.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 64 LABEL BASICS - PDP… of 197 Net Contents… USDA Summary Exemptions and Special Considerations . Sliced, Shingle-Packed Bacon in Rectangular Packages: Exempt from placement, as long as on PDP, dual declaration and type size. NOTE . Margarine in One Pound Rectangular Packages (except packages This is not as containing whipped or soft margarine or packages containing more a compre- than four sticks): Exempt from placement, as long as on PDP, dual hensive listing of declaration and type size. naming . Certain Types of Consumer Packages of Poultry Products: On a case consider- by case basis special provisions may be approved. The shipping case ations. includes the statement “Net weight to be marked on consumer packages prior to display and sale” and “Tare weight of consumer package” in close proximity to the tare weight of the consumer packaging, weighed to the nearest 1/8 ounce or less. The individual unit before sale to consumers will include a net content declaration.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 65 LABEL BASICS - PDP… of 197 Net Contents… USDA Summary Exemptions and Special Considerations (more) . Multiunit Retail Package (MRP): Which include fully labeled identical products must also include the following. NOTE • The number of individual units; This is not as • The quantity of each individual unit; and a compre- • In parenthesis, the total quantity of contents of the multiunit hensive listing of package, except that the declaration of total quantity need not be naming expressed as a “dual declaration” (e.g., the declaration in ounces consider- need not be followed by an additional parenthetical declaration ations. in terms of the largest whole U.S. customary units.).

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 67 LABEL BASICS - PDP… of 197 Inspection Legend (USDA)… [9 CFR § 312.2, § 381.96] … Applies to meat and poultry products (USDA)

. Location (PDP or 20% Panel) . Legend vs Establishment Number The USDA legend may be as noted above with an indication that the establishment number is located elsewhere, (“See tray for EST No.”). . Presentation: Must be legible. The color and size may vary as long as it is proportional.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 68 LABEL BASICS - IP… of 197 Lighter Side – Ingredient labeling is like brewing up something new every time –what's in your food!

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 70 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Format (when two or more ingredients) 1. Complete (ingredients & components) LINK NOTE: Components may be shown as ingredients. 2. Accurate (using proper common names) Exit CPG 3. Order (descending proportion by weight) 505.100 4. Heading (“Ingredients” for prominence) 5. Catch – All (Assortments – CPG 505.100) 6. Some foods have special status (e.g. Butter – additives not declared.)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 71 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Presentation 1. Location (PDP or Information Panel*) 2. Type Height (no less than 1/16 in) 3. Type Face (mixed case OK, easily legible) * Grouped together with other mandatory information such as domicile and nutrition facts.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 72 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Common Name Exit 1. Standard / Common Name / Specific 21 CFR 101 (*special considerations for (wheat) standards*)

(e.g. SUGAR = “SUCROSE” / SALT = NaCl) 2. Class Names (special provision) 3. Collective Names (special provision)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 73 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Class Names 21 CFR §101.4(b) examples 1. Milk, concentrated milk, reconstituted milk, and dry whole milk may be declared as ‘‘milk’’ 2. Dried whole eggs, frozen whole eggs, and liquid whole eggs may be declared as ‘‘eggs’’.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 74 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Special Considerations (examples) 1. Fat and Oils (identify name - soybean) (hydrogenated / partially hydrogenated) 2. Preservatives (identified) (“preservative”, “to retard spoilage”, etc.) 3. Protein Hydrolysates (“hydrolyzed soy protein”, “autolyzed yeast extract”) 4. Caseinate (nondairy) (“sodium caseinate (a milk derivative)”) 5. MSG (monosodium glutamate)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 75 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Special Considerations (examples) 6. Artificial Flavor (identify as such) 7. Nutritive Flavor Ingredients (“onion powder” not “spice” or “flavor”) 8. Spice (21 CFR §101.22) (if color as “spice and color” or name “turmeric”) 9. Natural Flavor (21 CFR §101.22) 10. Standard Specific (“cocoa processed with alkali”)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 76 LABEL BASICS - IP… of 197 Ingredients… [21 CFR §101.4] … Color Considerations 1. Certified Color As “FD&C Yellow No. 5, “Yellow 5”, if lake “Blue Lake 1” 2. Colors Not Certified As “artificial color”, “color added” or by name “caramel color” (not just “caramel” as it must be indicated that the agent is added as color). 3. Cochineal Extract & Carmine (red color) As of January 5, 2011, these must be identified by name, ("cochineal extract" or "carmine." [21 CFR 73.100 (d)(2)]).

Need not be declared (NOTE: USDA does not have definition of incidental additive) • It is an incidental additive (IA) as per 21 CFR §101.100 • IA include processing aid and other (see definition) • Sulphites – IA when less than 10 ppm

1. Infant Foods [21 CFR §106.65]

2. Hypoallergenic Foods [21 CFR §106.65] (provide names of specific spice, etc.) 3. Allergen Labeling

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 79 LABEL BASICS - PDP… of 197 Ingredients… [21 CFR §101.4] … Ingredient Specific Statements 1. Aspartame (PHENYLKETONURICS: CONTAINS PHENYLALANINE [PDP or IP, bold 21 CFR § 172.804) 2. Sorbitol (When daily ingestion > 50 g, “Excess consumption may have a laxative effect.” 21 CFR § 184.1835). 3. Mannitol (When daily ingestion > 20 g, “Excess consumption may have a laxative effect.” 21 CFR § 180.25). 4. Olestra (An asterisk shall follow vitamins A, D, E, and K in the listing of ingredients. Immediately following the ingredient list an asterisk and statement, ‘‘Dietarily insignificant’’. 21 CFR § 172.867).

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity. .

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 81 LABEL BASICS - PDP… of 197 Ingredient List… USDA Summary and Special Considerations . Exempt: When the name of the food identifies all ingredients, (i.e. “Chicken Breasts with Rosemary Extract”), is not needed. NOTE . Two Meats Ingredients: When two meat ingredients constitute at least This is not as 70% of the meat and meat by-product ingredients of a formula, and a compre- when neither ingredient is less than 30% by weight of the total meat hensive listing of and meat by-products used, these meat ingredients may be naming interchanged in the formula without a change to the ingredients consider- statement. In such cases, the word “and” must be used in lieu of a ations. comma between the two ingredients. . Flavorings: Can include spices and spice extract. . Species (kind) Identify: The species must be identified, (i.e. dried beef broth).

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 82 LABEL BASICS - PDP… of 197 Ingredient List… USDA Summary and Special Considerations (more) . Smoke Flavor Added: The expressions “artificial smoke flavoring added” or “smoke flavoring added” must be on the label next to the product NOTE name and identified in the ingredients statement. This is not as . Color & Antioxidants: In specific cases these must be identified in the a compre- ingredient list as well as in the name of the product on the PDP. hensive listing of . Proteolytic Enzymes: When added may trigger statement by name such naming as “Tenderized with [naming the approved enzyme]”. considerations. . Mechanically Separated: Mechanical separated meat or poultry would conform to the standard thereof and be identified on the label as such. . Riser Panel: In cases such as consumer pizza, frozen dinners, etc. boxes, ingredient may be on front riser panel, if “see ingredients” with arrow is pointing in that direction is included on the PDP.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 84 LABEL BASICS - IP… of 197 Allergen Labeling… [FALCP 2004] USDA … “Major 8 food allergens” Does not have 1. Milk allergen labeling. LINK Encourages this 2. Egg voluntarily 3. Fish (e.g., bass, flounder, or cod), 4. Crustacean shellfish (e.g., crab, lobster, or shrimp), 5. Tree nuts (e.g. almonds, pecans, walnuts, etc.) + coconut 6. Wheat, 7. Peanuts, 8. Soybeans

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 85 LABEL BASICS - IP… of 197 Allergen Labeling… [FALCP 2004] … “Wheat allergen means any species in the genus Triticum”, which includes… Common Wheat Scientific Name wheat (Triticum aestivum L.) durum wheat (Triticum durum Desf.) club wheat (Triticum compactum Host.) spelt (Triticum spelta L.), semolina (Triticum durum Desf.), Einkorn (Triticum monococcum L. subsp. monococcum ), emmer ( (Triticum turgidum L. subsp. dicoccon (Schrank) Thell) kamut (Triticum polonicum L.) triticale ( x Triticosecale ssp. Wittm.)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 86 LABEL BASICS - IP… of 197 Allergen Labeling… [FALCP 2004] … “Wheat allergen means any species in the genus Triticum”, which includes… Common Wheat Scientific Name wheat (Triticum aestivum L.) durum wheat (Triticum durum Desf.) club wheat (Triticum compactum Host.) spelt (Triticum spelta L.), semolina (Triticum durum Desf.), Einkorn (Triticum monococcum L. subsp. monococcum ), emmer ( (Triticum turgidum L. subsp. dicoccon (Schrank) Thell) kamut (Triticum polonicum L.) triticale ( x Triticosecale ssp. Wittm.)

Common or Usual Name Scientific Name Almond Prunus dulcis (Rosaceae) Beech nut Fagus spp. (Fagaceae) Brazil nut Bertholletia excelsa (Lecythidaceae) Butternut Juglans cinerea (Juglandaceae) Almond Prunus dulcis (Rosaceae) Beech nut Fagus spp. (Fagaceae) Cashew Anacardium occidentale (Anacardiaceae) Chestnut (Chinese, American, Castanea spp. European, Seguin) (Fagaceae)

Common or Usual Name Scientific Name Chinquapin Castanea pumila (Fagaceae) Coconut Cocos nucifera L. (Arecaceae (alt. Palmae)) Filbert/hazelnut Corylus spp. (Betulaceae) Ginko nut Ginkgo biloba L. (Ginkgoaceae) Lichee nut Litchi chinensis Sonn. Sapindaceae Macadamia nut/Bush nut Macadamia spp. (Proteaceae) Pecan Carya illinoensis (Juglandaceae)

Common or Usual Name Scientific Name Pine nut/Pinon nut Pinus spp. (Pineaceae) Canarium ovatum Engl. in A. DC. Pili nut (Burseraceae) Pistachio Pistacia vera L. (Anacardiaceae) Vitellaria paradoxa C.F. Gaertn. Sheanut (Sapotaceae) Walnut ( English, Persian, Black, Juglans spp. Japanese, (Juglandaceae) California), Heartnut, Butternut

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 90 LABEL BASICS - IP… of 197 Allergen Labeling… [FALCP 2004] … Allergen Declaration (options) 1. “Contains” statement FORMAT An allergen (e.g. Contains: Milk, Egg and Pecans) contains statement 2. Ingredient List must be adjacent to (e.g. “Ingredients: Butter (Milk), Soy the list of Lecithin…”) ingredients

NOTE: Elective statements such as “may contain…” is optional under acceptable conditions only.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 91 LABEL BASICS - IP… of 197 Cautionary Allergen Labeling… [FALCP 2004] 1. “Allergy Information: May contain peanuts.” 2. “May Contain Peanuts.” FORMAT 3. “Manufactured on the same equipment as foods that An allergen contain peanut.” contains 4. “Produced in a facility with an allergy control plan. The statement must be possibility of contact with allergenic ingredients has been adjacent to minimized. May still contain trace amount of peanut.” the list of ingredients NOTE: The use of elective cautionary allergen statements are not regulated. Based on current FDA views, statement 1 is an example of what consumers relate best, as it uses as signaling statement “Allergy Information”. FDA will most likely provide further guidance or regulations in the future.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 94 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Foods Unless Exempt (examples) . Insignificant Nutrients (0) LINK . Small Business (retail < 500K or foods <50K) . Restaurant Foods . Food Service Distributor . Low Volume (< 100 employees, <100K units, FDA notice) . Foods for infants through 12 months (special labeling)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 95 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Foods Unless Exempt (examples) . Foods for Children 1 through 3 years (special labeling) . Medical Foods / Infant Formula / Dietary Supplement (sp. labeling) NOTE If claims . Bulk Retail (on card) / Bulk Foods Institutional are made (exempt) exemption may be . Small Packages (< 12 in sq) revoked. . Raw Fruits and Vegetables . Packaged single-ingredient products of fish or game meat.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 96 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Special Consideration (examples) . Gift Labeling (Facts in inner package, and other such as small units). . Multi Unit Retail (Inner Packages Exempt / See through is OK) . Small Package (< 12 in sq) (Toll free number or address on label). . Shell Eggs (Under Carton where irregular).

1. Standard (works everywhere) EXIT 2. Simplified (8 or more core insignificant) Exit FS Guide 3. Tabular (insufficient vertical space) Examples 4. Abridged (1 or more core declared as zero) 6. Dual (different size, as prepared) 7. Aggregate (multi unit)

OLD NEW

ORIGINAL NEW AS PROPOSED

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 102 LABEL BASICS - IP… of 197 New Nutrition Facts… [21 CFR §101.9] … Rules published in Federal Register on Friday May 27, 2016. NEW • Food Labeling: Revision of the Nutrition and Supplement Comes Facts Labels; Serving Sizes of Foods That Can Reasonably Be into effect Consumed at One Eating Occasion; Dual-Column Labeling; July 26, Updating, Modifying, and Establishing Certain Reference 2016. Amounts Customarily Consumed; Serving Size for Breath Pre- Mints; and Technical Amendments; Final Rules published • Food Labeling: Serving Sizes of Foods That Can Reasonably Be May 20, Consumed At One Eating Occasion; Dual-Column Labeling; 2016 Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments

• Enhanced Calorie display NEW • Enhanced Serving Size display Comes into effect • Included added sugars and percent DV for added sugars July 26, • Calories from fat no longer a feature. 2016. • Trans fat still included, despite removal of partially hydrogenated fats from a GRAS status. • Dietary fibre now includes naturally occurring and those added with demonstrated physiological health benefits

• Added sugars to be declared, “Includes X g Added NEW Sugars”. Comes • Vitamin A and Vitamin C no longer core nutrients. Iron into effect and Calcium still core nutrients. July 26, 2016. • Potassium and Vitamin D now core nutrients • Actual amounts, in addition to percent Daily Value of vitamin D, calcium, iron and potassium are required. The amount for other vitamins and minerals may be declared voluntarily).

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 105 LABEL BASICS - IP… of 197 New Nutrition Facts… [21 CFR §101.9] … Format Highlights • New footnote “*The % Daily Value tells you how much a NEW nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”. Comes into effect • Updates to reference amount’s customarily consumed. July 26, • New rules for serving sizes on smaller packages that can 2016. be consumed in one or more occasions. . New dual format (per serving and per package). . Package contains 200% to 300% of the standard serving size. . For packages between 1 and 2 servings would present nutrition information per package.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 106 LABEL BASICS - IP… of 197 New Nutrition Facts… [21 CFR §101.9] … Format Highlights • Manufacturers must maintain records for added sugars, NEW certain fibers, vitamin E, folic acid and folate and how Comes into they have been accounted for. effect July • Rules come into to effect July 26, 2016. 26, 2016. . All business have 2 years to implement the changes, 2 year (July 26, 2018). transition provided, 3 . Small businesses, those with less than 10 million years for dollars in food sales have been granted 3 years (July small 26, 2019). companies.

Nutrition Facts – New… [21 CFR §101.9]

• 8 or more core insignificant • 6 or more when the NFP is for infants and children 1 through 3 years • Minimum requirement is to include Calories, total fat, sodium, total carbohydrate and protein. • The example here demonstrates a declaration of saturated fat and trans fat as they are not insignificant. • Polyunsaturated fat and monounsaturated fat declared voluntarily or because of claims.

Nutrition Facts – New… [21 CFR §101.9]

• May be used when standard vertical format does not fit on a label in a vertical orientation.

Nutrition Facts – New… [21 CFR §101.9]

• May be used on small packages with a surface area available to bear labeling less than 40 square inches.

Nutrition Facts – New… [21 CFR §101.9]

• May be used on small packages with a surface area available to bear labeling less than 12 square inches, such as when nutrition information is triggered.

• Used in the case of multi unit packages or those with separately packaged inner units of food.

Nutrition Facts – New… [21 CFR §101.9]

• May be used when vertical dual format do not fit on a label in a vertical orientation.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 118 LABEL BASICS - IP… [21 CFR §101.9] of 197 Nutrition Facts – New RDIs (footnotes)… 1 - RDIs are based on dietary reference intake recommendations for infants through 12 months of age. 2 - RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental β- carotene, 12 micrograms β-carotene, or 24 micrograms α-carotene, or 24 micrograms β-cryptoxanthin. 3 - The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg. 4 - 1 mg α-tocopherol (label claim) = 1 mg α-tocopherol = 1 mg RRR- α-tocopherol = 2 mg all rac-α-tocopherol . 5 - NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan. 6 - “Folate” and “Folic Acid” must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid. 7 - DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid. 8 - Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 119 LABEL BASICS - IP… of 197 Nutrition Facts – New Dietary Fiber… • DEFINED: Dietary fiber is defined as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and RECORDS lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) Must keep determined by FDA to have physiological effects that are records if applicable. beneficial to human health.

• EFFECT: Determined by FDA to have physiological effects that are beneficial to human… [beta]-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 120 LABEL BASICS - IP… [21 CFR §101.9] of 197 Nutrition Facts – New Added Sugars Include… • sugars (free, mono- and disaccharides) • sugars from syrups and honey RECORDS • sugars from concentrated fruit or vegetable juices that are in excess of Must keep what would be expected from the same volume of 100 percent fruit or records if vegetable juice of the same type applicable. . except that fruit or vegetable juice concentrated from 100 percent juices sold to consumers, . fruit or vegetable juice concentrates used towards the total juice percentage label declaration under §101.30 or for Brix standardization under §102.33(g)(2), . fruit juice concentrates which are used to formulate the fruit component of jellies, jams, or preserves in accordance with the standard of identities set forth in §§150.140 and 150.160 or . the fruit component of fruit spreads shall not be labeled as added sugars.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 121 LABEL BASICS - IP… [21 CFR §101.9] of 197 Nutrition Facts – Record Keeping… … The manufacturer must make and keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label

• FIBER: When a mixture of dietary fiber, soluble fiber, insoluble fiber and added non- digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food, the manufacturer must account for total non-digestible carbohydrate(s) added to the food. • ADDED SUGARS: When a mixture of naturally occurring and added sugars is present in the food, a manufacturer must make and keep written records of the amount of added sugars added to the food during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient). • ADDED SUGARS - PROCESSING: When the amount of sugars added to food products is reduced through non-enzymatic browning and/or fermentation, manufacturers must maintain a detailed scientific bases accounting for add sugars or petition for an alternate means of compliance.

Nutrition Facts – Record Keeping (more)… • TOCOPHEROL: When a mixture of all rac-α-tocopherol and RRR-α-tocopherol is present in a food, manufacturers must make and keep written records of the amount of all rac- α-tocopherol added to the food and RRR-α-tocopherol in the finished food.

• FOLATE & FOLIC ACID: When a mixture of folate and folic acid is present in a food, manufacturers must make and keep written records of the amount of synthetic folate and/or folic acid added to the food and the amount of naturally-occurring folate in the finished food.

• RECORDS: Records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Such records must be provided to FDA upon request. These records must be accurate, indelible, and legible. No Records = Misbranded food

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 123 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … When space is limited (< 40 in sq) abbreviation's may be used • Serving size — Serv size EXIT • Servings per container — Servings Exit FS Guide • Calories from fat — Fat cal • Calories from saturated fat — Sat fat cal A few examples. • Saturated fat — Sat fat • Monounsaturated fat — Monounsat fat • Potassium – Potas • Includes - Incl. • Vitamin - Vit

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 124 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … When space is limited (< 40 in sq) abbreviation's may be used (more) EXIT • Polyunsaturated fat — Polyunsat fat Exit • Cholesterol — Cholest FS Guide • Total carbohydrate — Total carb Examples • Dietary fiber — Fiber • Soluble fiber — Sol fiber • Insoluble fiber — Insol fiber • Sugar alcohol — Sugar alc • Other carbohydrate — Other carb

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 125 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … presentation EXIT 1. Location (PDP or Information Panel*) Exit 2. Type Height FS Guide (see FDA enhanced version) Examples Enhanced 3. Type Face NFP (mixed case, single style easily legible, letter never touch, etc.) 4. Box (hairline) & Rules * Grouped together with other mandatory information such as domicile and ingredients list. May be on alternate panel where space on IP is limited.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 126 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Presentation Rounding Rules EXIST As (see FS Guide) applicable. Reference Amounts (see 21 CFR §101.12)

NOTE: A presumption exists that a food has a reference amount. Please refer to 21 CFR for determining a reference amount for unique conditions (e.g. aerated food, packages with 2 or more foods).

NUTRIENT/ SERVING (M) (V) CORE UNITS ROUNDING*** INSIGNIFICANT RELEVANT INFORMATION Calories† M  cal < 5 cal - express as zero < 5 cal 101.9(c)(1)(i)  50 cal - express to nearest 5 cal increment > 50 cal - express to nearest 10 cal increment Calories from V cal < 5 cal - express as zero < 5 cal 101.9(c)(1)(ii) saturated fat  50 express to nearest 5 cal increment > 50 cal - express to nearest 10 cal increment Total fat M  g < 0.5g - express as zero < 0.5 g 101.9(c)(2) < 5g - express in nearest 0.5g increment  5g - express to nearest 1g increment Saturated fat M g < 0.5g - express as zero < 0.5 g 101.9(c)(2)(i) < 5g - express to nearest 0.5g increment  5g - express to nearest 1g increment Trans fat M g < 0.5g - express as zero < 0.5 g 101.9(c)(2)(ii) < 5g - express to nearest 0.5g increment  5g - express to nearest 1g increment Polyunsaturated & V g < 0.5g - express as zero < 0.5 g 101.9(c)(2)(iii)& Monounsaturated < 5g -express to nearest 0.5g increment (iv) fat  5 g - express to nearest 1g increment Cholesterol M mg < 2 mg - express as zero < 2 mg 101.9(c)(3) 2 - 5 mg - express as "less than 5 mg“ > 5 mg - express to nearest 5 mg increment

Nutrition Facts - Rounding…[21 CFR §101.9]

NUTRIENT/ SERVING (M) CORE UNITS ROUNDING*** INSIGNIFICANT RELEVANT (V) INFORMATION Sodium M  mg < 5 mg - express as zero < 5 mg 101.9(c)(4) 5 - 140 mg - express to nearest 5 mg increment > 140 mg - express to nearest 10 mg increment Fluoride V mg < 0.1 mg - express as zero < 5 mg 101.9(c)(5) 0.1 – 0.8 mg - express to nearest 0.1 mg increment > 0.8 mg - express to nearest 0.2 mg increment Total carbohydrate M  g < 0.5g - express as zero < 1 g 101.9(c)(6) < 1g - express as "Contains less than 1g" OR "less than 1g“  1g - express to nearest 1g increment Dietary fiber M g < 0.5g - express as zero < 1 g 101.9(c)(6)(i) < 1g - express as "Contains less than 1g" OR "less than 1g“  1g - express to nearest 1g increment NOTE: Must meet the definition of dietary fiber as recognized by FDA. Soluble & Insoluble V g < 0.5g - express as zero < 1 g 101.9(c)(6)(i)(A) fiber < 1g - express as "Contains less than 1g" OR "less than 1g“ & (B)  1g - express to nearest 1g increment NOTE: Must meet the definition of dietary fiber as recognized by FDA.

NUTRIENT/ SERVING (M) CORE UNITS ROUNDING*** INSIGNIFICANT RELEVANT (V) INFORMATION Sugars M g < 0.5g - express as zero < 1 g 101.9(c)( < 1g - express as "Contains less than 1g" OR "less than 1g“ 6)(ii)  1g - express to nearest 1g increment NOTE: When less than 1 gram and no claims are made about sweeteners, sugars, or sugar alcohol content, may ‘‘Not a significant source of total sugars’’ would be placed at the bottom of the NFP in the same type size. Added Sugars M g < 0.5g - express as zero < 1 g 101.9(c)( < 1g - express as "Contains less than 1g" OR "less than 1g“ 6)(iii)  1g - express to nearest 1g increment NOTE: When less than 1 gram and no claims are made about sweeteners, sugars, or sugar alcohol content, may ‘‘Not a significant source of added sugars’’ would be placed at the bottom of the NFP in the same type size. Sugar alcohol V g < 0.5g - express as zero< 1g - express as "Contains less < 1 g 101.9(c)( than 1g" OR "less than 1g" 1g - express to nearest 1g 6)(iv) increment

NUTRIENT/ SERVING (M) CORE UNITS ROUNDING*** INSIGNIFICANT RELEVANT INFORMATION (V) Protein M X g < 0.5g - express as zero < 1 g 101.9(c)(7) < 1g - express as "Contains less than 1g" OR "less than 1g“  1g - express to nearest 1g increment Vitamins & Minerals M % DV < 2% of RDI - may be expressed as < 2% RDI Vitamins and minerals (1) zero other than vit D, calcium, (2) an asterisk that refers to statement "Contains less than 2% of the iron & potassium, listed Daily Value of this (these) nutrient (nutrients)” in (8)(iv), are mandatory (3) for Vit D, calcium, iron & potassium: statement "Not a significant if added as nutrient source of __ (listing the vitamins or minerals omitted)“ supplement in food or if  10% of RDI - express to nearest 2% increment claim is > 10% -  50% of RDI - express to nearest 5% increment made 101.9(c)(8)(iii) & > 50% of RDI - express to nearest 10% increment (iv) Vitamins & Minerals M Q Mandatory for vit D, calcium, iron, potassium and where fluoride is < 2% RDI Vitamins and minerals include. Optional in all other cases. other than vit D, calcium, iron & potassium, listed NOTE: Fluoride does not have a RDI established and as such would not in (8)(iv), are mandatory show a percent DV in the NFP. if added as nutrient supplement in food or if • Express in applicable units of mg or mcg. claim is • Round to the degree of significance in 101.9(c)(8)(iv). Additional made 101.9(c)(8)(iii) & degree of significance may be warranted, (i.e. declare zinc to nearest (iv) 10th of a gram. • If < 2% of RDI - may be expressed as zero when declared as 0% of the DV, as above. Beta-carotene V % Vit  10% of Vit. A - express to nearest 2% increment N/A 101.9(c)(8)(vi) A > 10% -  50% of Vit A - express to nearest 5% increment > 50% of Vit A - express to nearest 10% increment

(M) = Mandatory and (V) = Voluntary ** To express to the nearest 1g increment, amounts exactly halfway between two whole number or higher (e.g. 2.50 to 2.66g) round up (e.g. 3g) and amounts less than halfway between two whole numbers (e.g. 2.01 to 2.49g) round down (e.g. 2g). (Q) = Quantitative amount of vitamins and minerals. The values are based on applicable units, g, mg or mcg and rounded to the degree of significance in 101.9(c)(8)(iv). *** NOTES FOR ROUNDING % Daily Value (DV): (1) To calculate % DV, divide either the actual (unrounded) quantitative amount or the declared (rounded) amount by the appropriate RDI or DRV. Use whichever amount will provide the greatest consistency on the food label and prevent unnecessary consumer confusion 109.9(d)(7)(2). (2) When %DV values fall between two whole numbers, rounding shall be as follows: • for values exactly halfway between two whole numbers or higher (e.g. 2.5 to 2.990 the values shall round up (e.g. 3%) • for values less than halfway between two whole numbers (e.g. 2.01 to 2.49) the values shall round down (e.g. 2%). - for values less than halfway between two whole numbers (e.g. 2.01 to 2.49) the values shall round down (e.g. 2%).

Nutrition Facts – New Serving Size… [21 CFR §101.9]

Nutrition Facts – New Single Serving …[21 CFR §101.9]

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 134 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Serving Size Considerations (examples) EXIST • Discrete Units (e.g. Muffins)* As • Large Discrete Units (common fraction) applicable. (e.g. 1/8 pizza) • Single Serving Packages* • Maraschino Cherries (1 cherry) • Varying Sizes (varied) NOTE: Serving is typically a household measure that most closely relates to the RA.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 135 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Serving Size Discrete Units (examples) 1. where a unit weighs 50 percent or less of the reference amount, the serving shall be the number of whole units that most closely approximates the reference amount 2. where a unit weighs more than 50 percent, but less than 67 percent of the reference amount, the manufacturer may declare one unit or two units as the serving size 3. where a unit weighs 67 percent or more, but less than 200 percent of the reference amount, the serving size is one unit

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 136 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Serving Size Discrete Units NEW. 4. If a unit weighs at least 200 percent and up to and including 300 percent of the applicable reference amount, the serving size shall be • the quantitative and percent DV amount that approximates the reference amount on a serving size basis, • the quantitative and percent DV amount in a second column per individual unit, • some exceptions apply.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 137 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Single Serving Dual Format Exceptions NEW. • This provision does not apply to products that meet the requirements to use the tabular format or linear format in paragraph (j)(13)(ii)(A)(1) & (2. • This provision does not apply to raw fruits, vegetables, and seafood for which voluntary nutrition labeling is provided in the product labeling or advertising or when claims are made about the product.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 138 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Single Serving Dual Format Exceptions • products that require further preparation and provide an NEW. additional column of nutrition information (dual format), • products that are commonly consumed in combination with another food and provide an additional column of nutrition information (dual format), • products that provide an additional column of nutrition information for two or more groups for which RDIs are established (e.g., both infants and children less than 4 years of age) • popcorn products that provide an additional column of nutrition information per 1 cup popped popcorn, or • varied-weight products.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 139 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Single Serving Dual Format vs Claims • When a nutrient content claim or health claim is made on NEW. the label of a product that uses a dual column, the claim must be followed by a statement that sets forth the basis on which the claim is made, except that the statement is not required for products when the nutrient that is the subject of the claim meets the criteria for the claim based on the reference amount for the product and the entire container or the unit amount. • ‘‘good source of calcium per serving’’ or ‘‘per X [insert unit]_serving’’) or per reference amount (e.g., ‘‘good source of calcium per [insert reference amount (e.g., per 8 ounces)]), • When a health claim is made, the statement shall be ‘‘A serving of _ounces of this product conforms to such a diet.’’

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 140 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Serving Size Format Common Household measure (Metric) e.g. “1 slice (28 g)” e.g. “1 slice (28 g/1 oz)” = optional e.g. “1/2 cup hazelnuts without shells (30 g / about ¾ cup with shells)” = optional

NOTE: Clarifications may be provided if not misleading.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 141 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Compliance Basics - Samples REF • 12 subsamples (consumer units), are 101.9(g)(2) taken 1 each from each of 12 different randomly chosen shipping cases, to be representative of a lot • composites shall be analyzed by appropriate methods as given in the ‘‘Official Methods of Analysis of the AOAC International,’’ or, if no AOAC method is available or appropriate, by other reliable and appropriate analytical procedures

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 142 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Compliance Basics - Tolerances Class I [vitamin, mineral, protein or NEW FDA defines dietary fiber]: The nutrient content of exogenous and the composite sample must at least endogenous sources of equal to the value of nutrient as declared nutrients, (i.e. on the label. vitamin, mineral, protein, or dietary fiber)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 143 LABEL BASICS - IP… of 197 Nutrition Facts… [21 CFR §101.9] … Compliance Basics - Tolerances Class II [vitamin, mineral, protein, total carbohydrate, NEW dietary fiber, other carbohydrate, polyunsaturated or Applies to monounsaturated fat or potassium. The nutrient exogenous content of the composite sample must at least equal 80nutrients. percent of the value of nutrient as declared on the label. Other [calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium]. The nutrient content of the composite sample must not exceed 120 percent of the value of nutrient as declared on the label. NOTE: Nutrient data bases or analysis may be suitable.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 144 LABEL BASICS - IP… of 197 Nutrition Facts… vs FDA USDA • Trans fat mandatory • Trans fat optional NOTE • No provision for stearic acid • Stearic acid optional (indented • Visual units in ounces maybe under sat fat) This triggered • No visual units in ounces triggered slide is • FDA Reference Amounts (RA) • Own Meat and Poultry RA not a • Strict with reference amounts • Flexibility to select applicable RA com- • No meal type (has main dish) RA • Meal type and main dish RA prehen • Basis as sold • Basis as sold, but may in some cases -sive be bases solely on food as prepared list. • Simplified format based on 8 or • Simplified format based any one more mandatory nutrients being mandatory, non core nutrient being “insignificant”. “insignificant”. • Has Class 1 nutrients due to • No Class 1 nutrients as no fortification. fortification.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [9 CFR § 381.400 & 317.300] Slide 145 LABEL BASICS - IP… of 197 Nutrition Facts – USDA Summary… SUMMARY • FSIS is not under NLEA • Separate RACC (poultry 9 CFR § 381.412 & meat 317.312) • Servings Size… 1. > 50% but < 200% of RACC = 1 Serving 2. < 50% = number of units/amount closest to RACC 3. > 50% but < 67% = 1 or 2 servings 4. < 200% = declare as 1 serving 5. > 150% but < 200% = 1 or 2 servings where RACC > 100 g 6. > 200% = 1 or more servings (manufacturer’s discretion) • Household measures use cups, tablespoons discrete units, common fractions (1/2, 1/3 , 1/4, 1/5, 1/6 and divisible by 2 or 3), of unit of food, (i.e. quiche), as is most appropriate. If this is not possible, ounces rounded to the nearest 0.5 oz is used.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [9 CFR § 381.400 & 317.300] Slide 146 LABEL BASICS - IP… of 197 Nutrition Facts – USDA Summary… SUMMARY NOTE • Exemptions & Special Considerations… 1. Small business based ( 500 people) This slide is 2. Low volume sales ( 100,000 lb of all meat products) not a comprehen 3. Products for further processing sive list. 4. Not for sale to consumers 5. Small packages, less than ½ ounce. 6. Custom slaughter 7. Export. 8. Prepared and sold at retail (RTE packaged or portioned at retail, multi-ingredients foods processed at retail).

NOTE: Exemption revoked if nutrient contend claims are made. An application for exemption is not required.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [9 CFR § 381.400 & 317.300] Slide 147 LABEL BASICS - IP… of 197 Nutrition Facts – USDA Summary… SUMMARY NOTE • Basis of Nutrition Information… . As sold. This slide is . Raw single ingredient foods can be based on values as not a comprehen prepared. sive list. . Bacon with a cook shrink of at least 60% and pork sausages with cook shrink of at least 24% would present nutrition information on as a prepared basis. Cooking direction are required. . All products may use a dual column nutrition facts panel based on the product as sold and as prepared, where cooking directions are clearly stated.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [9 CFR § 381.400 & 317.300] Slide 148 LABEL BASICS - IP… of 197 Nutrition Facts – USDA Summary… SUMMARY NOTE • Special RACCs accepted by FSIS… . Appetizers (e.g., Meat (or poultry) hors d’oeuvers, mini This slide is eggrolls, mini pizza rolls, bagel pizza) - 85 grams RACC not a comprehen . Beans with meat (or poultry), plain or in sauce - 130 grams sive list. for beans in sauce or canned in liquid and refried beans prepared; 90 grams for others prepared; 35 grams dry RACC . • Meat hot dog (or poultry hot dog) chili sauce – 2 tbsp RACC . Paste for garnishing - 15 grams RACC . Stuffed cherry peppers - 30 grams RACC . Vegetables, sauce, and bacon bits (or poultry bacon bits) - 110 grams RACC . Rendered poultry fat – 1 tbsp RACC

 40 sq inches or more space available for labelling NOTE Examples for illustrative purposes.

 40 sq inches or more space available for labelling but less than 3 inch of vertical space.

 Less than 40 sq inches or more space available for labelling.

 40 sq inches or more space available for labelling but less than 3 inch of vertical space

 When nutrients are insignificant, listed in footnote.

 Simplified, 5 core nutrient always declared (Calories, Total Fat, Sodium, Total Carbohydrate, Protein) .

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) [9 CFR § 381.400 & 317.300] Slide 152 LABEL BASICS - IP… of 197 Nutrition Facts Formats – USDA…  Simplified, 5 core nutrient always declared (Calories, Total Fat, Sodium, Total Carbohydrate, Protein), at least 7 that are insignificant. These are example of the former FDA versions.

 Simplified, when less than 40 sq inches of space FDA FORMATS available for label and insufficient space for vertical format.

 Dual format. Minimum based on product as sold.

FDA FORMATS

Aggregate for multiunit food. 

 Linear format is used when generally everything else is not possible. When (< 40 in sq surface area available to bear labeling where mini tabular format can not be displayed, or less than (< 12 in sq ).

FDA FORMATS

Dual language formats acted, (e.g. English first then Spanish) 

 For children less than 2 years of age.

This can be on one line. > > This is incorrect.

FDA FORMATS

For children 2 – 4 years of age. 

1. Complete Name (ABC Food Inc.) LINK 2. Address (city, state, zip – street address may be required as well country of dear if foreign) 3. PRODUCT OF (if the product is imported the country of origin must be included on the label. A good location is grouped with the domicile statement)

5. Type Height (no less than 1/16 in)

6. Type Face (mixed case OK, easily legible).

NOTE: Grouped together with other mandatory information such as domicile and nutrition facts.

NOTE: For USDA can be on riser panel.

Domicile Information… [21 CFR §101.4]

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity.

Domicile Information… [21 CFR §101.4]

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity.

Country of Origin… [Customs & Border 19 CFR] • Not covered under FDA, unless matter ORIGIN related to misbranding. Also covered on • Covered under the Tariff Act of 1930 COOL (Section Height and subordinate regulations in 10816 of the 2002 19 CFR 134. Farm Bill (7 B.SC.. • Few exceptions, (e.g. coffee) 1638) • Customs Rulings Online Search System (CROSS)

Country of Origin… [Customs & Border 19 CFR = COOL] • Marking must be permanent. • Must be anywhere on package/container readily visible to ORIGIN ultimate purchaser. Best included next to domicile statement, Also particular where domicile is of US origin and product is of covered on COOL foreign origin. (Section 10816 of • USA COOL is separate and applies to fish and agriculture the 2002 products such as… Farm Bill (7 muscle cut and ground meats: lamb, goat, and chicken; wild B.SC.. and farm-raised fish and shellfish; fresh and frozen fruits and 1638) vegetables; peanuts, pecans, and macadamia nuts; and ginseng.

NOTE: Pork, ground pork, beef and ground beef withdrawn from covered commodities subject to COOL, (February 2016).

• On an immediate container for an ORIGIN Also imported food must be immediately covered on COOL under name on main panel. (Section 10816 of the 2002 • On an outside container must be Farm Bill (7 B.SC.. accompanied by the product name and 1638) establishment number.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 167 OTHER LABELING… of 197 Cautions & Warnings… 1. Shelled Eggs (safe handling/storage) 2. Pressurized Containers 3. Unpasteurized Juices

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 168 OTHER LABELING… of 197 Cautions & Warnings… 4. Refrigerated Food Group A – IMPORTANT Must Be Kept Refrigerated To maintain Safety Group B – IMPORTANT Must Be Refrigerated After Opening To Maintain Safety Group C – Refrigerate for quality NOTE: There are no explicit regulations under FDA that prescribe the inclusion of storage conditions on a label. It is however an essential consideration in the proper handling of food.

Cautions & Warnings… [9 CFR § 317.2(k) & 9 CFR § 381.125(a)] 5. Handling Statements USDA • Statements such as “Keep Refrigerated” “Keep Frozen” or “Perishable—Keep Refrigerated or Frozen” are required. • Include on shipping container. • When thawed for retail sale, the shipper is marked “Keep Frozen” and the inner units as “Previously Handled Frozen for Your Protection, Refreeze or Keep Refrigerated.”. • In the case of perishable canned products, the statement must appear in upper case letters, ¼ inch in height, for containers with a net weight of 3 pounds or less, or ½ inch in height for containers with a net weight over 3 pounds.

SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly. 2. Raw & not Ready to Eat (RTE) Meat and Poultry under FSIS [9 CFR § 317.2(l) & 9 CFR § 381.125(b]) • Not to be used on RTE products. • See example next slide.

• Prominent & Conspicuous • 1/16 inch minimum • Large heading • Set out in a border • Some adjust as needed can be made, (i.e. “Do not thaw product, cook from frozen” or “Do not thaw” or “No refrigeration necessary” or “Refrigerate after opening” as case may be.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 172 OTHER LABELING… of 197 Juice Labeling… 1. When foods purport to contain Juice (claim, color, vignettes, etc.) 2. % Juice declaration top of IP followed by Nutrition Facts (“contains 5 % juice” / bold, in the largest type on the IP with the exception of Nutrition Facts, Calories, UPC, brand name or logo)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 173 OTHER LABELING… of 197 Primary Recognizable Flavor… [21 CFR § 101.22] 1. When foods purport to contain a flavor (statement, vignettes, etc.) NOTE In both 2. If artificial… cases the (The term artificial must be no less than ½ the type of the flavor, name of the food will and grouped together wherever it appears, “artificial raspberry need to flavor”). identify that it is flavored, 3. If natural … (e.g. “artificial (The term natural may be used but the term flavor must be used raspberry “natural raspberry flavor” wherever it appears). flavored hot cocoa mix”).

• Prohibited unless authorized by FDA FDA First reviews • No more than 2x height of name. and approves claims for • Reasonable variations are possible. these. See FDA GUIDE • Disclosure statement may be applicable, (e.g. “See nutrition information for fat content.”)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 175 NUTRIENT CONTENT CLAIMS… of 197 Nutrition Facts… vs FDA USDA NOTE • Enriched and fortified are defined. • Enriched not defined by USDA. This slide is • “% fat free”. • “% lean” can be used for “% fat not a free”. comprehen • The reference food for light may sive list. include another brand. • The reference food for “Light” claims may not be another brand, • Requires a disclosure statement , but based a leading brand, top (e.g. “See nutrition information for three leading brands or valid data ___ content”), when the nutrients for representative food. in the following table meets or exceed the noted threshold. • No requirement for a disclosure, except in the case of fiber claims where food is not low in fat. The amount of fat in grams is declared with the claim.

• In general is a nutrient content claim. FDA First reviews • 21 CFR § 101.65(d)(2) and approves claims for • Healthfully, healthfulness, healthier, these. See healthiest, healthily, healthiness. FDA GUIDE.

Conditions for the Use of "Healthy" Individual Food Seafood/Game Meal/Main Dish Meat TOTAL FAT low fat < 5 g fat /RACC & low fat /100g SATURATED low sat fat < 2 g sat fat /RACC low sat fat FAT & /100g

Conditions for the Use of "Healthy" Individual Food Seafood/Game Meal/Main Dish Meat SODIUM ≤ 480 mg /RACC and /l.s.; ≤ 480 mg /RACC ≤ 600 mg /l.s. or /50 g, if RACC is small and /l.s.; or /50 g, if RACC is small CHOLESTEROL ≤ disclosure level < 95 mg /RACC & ≤ 90 mg /l.s. /100 g FORTIFICATION Per 21 CFR 104.20 Per 21 CFR 104.20 Per 21 CFR 104.20

NOTE: l.s. = labeled serving; RACC = Reference Amount Customarily Consumed per Eating Occasion; small RACC = 30 g or less, or 2 tablespoons or less.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 178 NUTRIENT CONTENT CLAIMS… of 197 Healthy (continued)… Conditions for the Use of "Healthy" Individual Food Seafood/Game Meal/Main Dish Meat BENEFICIAL Contains at least 10% of DV /RACC Contains at least Contains at least 10% NUTRIENTS for vitamins A, C, calcium, iron, 10% of DV /RACC of the DV /l.s. of two protein, or fiber except: raw fruits for vitamins A, C, nutrients (for a main and vegetables; or a single calcium, iron, dish product) or of ingredient or mixture of frozen or protein, or fiber three nutrients (for a canned single ingredient fruits and meal product) of vit. A, vegetables (may include vit. C, calcium, iron, ingredients whose addition does protein, or fiber. not change the nutrient profile of the fruit or vegetable); enriched cereal-grain products that conform to a standard of identity in 21 CFR 136, 137, or 139.

Conditions for the Use of "Healthy" BASIC… Food meet the requirements for ‘‘low fat’’ and ‘‘low saturated fat,’’ (single-ingredient, raw products may meet the total fat and saturated fat criteria for ‘‘extra lean’’ ). CHOLESTEROL…  60 mg of cholesterol per RA & serving (for foods with reference amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50 g - for dehydrated products that must be reconstituted the per 50 g criterion refers to the prepared form).  90 mg of cholesterol per labeled serving size for main-dish and meal-type products, (including meal-type products that weigh more than 12 oz per serving (container)). Single-ingredient, raw products may meet the cholesterol criterion for ‘‘extra lean’’ in § 381.462.

Conditions for the Use of "Healthy" SODIUM… (does not apply to single-ingredient, raw products)BASIC…  480 mg of sodium per RA and serving (foods with RA of 30 g or less or 2 tbsp or less, per 50 g, where for reconstituted dehydrated products the per 50 g criterion refers to the prepared form).  600 mg of sodium per labeled serving size for main-dish product and meal-type product (including meal-type products that weigh more than 12 oz per serving (container). DRV & RDI… The product shall contain 10 percent or more of the Reference Daily Intake or Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per RA prior to any nutrient addition A main-dish product and including meal-type products that weigh less than 10 oz per serving (container), shall meet the level for two of the nutrients per labeled serving size A meal-type product shall meet the level for three of the nutrients per labeled serving size.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 182 NUTRIENT CONTENT CLAIMS… of 197 USDA Nutrient Content Statements… • Accommodates statements of the amount of omega 3 and omega 6 fatty acids in mg or grams (1/1000) on a label. • Prohibits low carbohydrate claims, but accommodates statements like “low carbohydrate lifestyles”, “Net carbs”, “Carb conscious”, etc. • Prohibits whole grain claims that are viewed to express an amount, such as “High in Whole Grains” or even “Contains X g Whole Grains”. Statements like “Made with Whole Wheat Spaghetti” are accepted.

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity. .

• Prohibited unless authorized by FDA FDA First reviews • Many unique considerations. and approves claims for • Disqualifying nutrient levels, per labeled these. See serving &, small RACC = 30 g or less, or 2 FDA GUIDE tablespoons or less.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 185 HEALTH CLAIMS… of 197 Basic Considerations… • NLEA Claims*: Those brought into being as part of NLEA (Nutrition Labeling and Education Act. Authorized by regulation. • Authoritative Health Claims*: Claims based on an authoritative statement" by a scientific body or Academy of Science. • Qualified Health Claim*: These are claims with supportive but not conclusive proof, are so identified. • Structure Function Claims: (e.g. vitamin C help the growth of bone and teeth”)

Health Claims Specs… [FPLA + 21 CFR §101.14]

QUICK SPECS The following is a summary of presentation specifications related to the statement of identity. .

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 187 HEALTH CLAIMS… of 197 Health Claims USDA Summary… SUMMARY • Health Claims… . FSISI has not established any health claims. . May accommodate FDA’s health claims. e.g. “Meets American Heart Association food criteria for saturated fat and cholesterol for healthy people over age 2. While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.”

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 188 OTHER LABEL STATEMENTS… of 197 Descriptive Terms… 1. ORGANIC: (USDA’s AMS [Agricultural marketing Service] National Organic Program [NOP]) 2. FRESH: (21 CFR § 101.95) 3. NATURAL: (FDA Policy – no synthetics, artificial flavor or coloring, minimal processing not considered. USDA has consideration for minimal processing)

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 189 OTHER LABEL STATEMENTS… of 197 Descriptive Terms… 4. GMO: (FDA Guidelines – Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering) 5. PASTEURIZED: (FD&CA – more than just thermal)

Gluten Free… [21 CDR § 101.91] "gluten-free" means the food either is inherently gluten free or does not contain an ingredient that is… 1) a gluten-containing grain (e.g., wheat, rye, barley, or hybrids like triticale); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

NOTE: Also, any unavoidable presence of gluten in the food must be less than 20 ppm.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 191 OTHER LABEL STATEMENTS… of 197 Gluten Free (more)… [21 CDR § 101.91] A “gluten free” or similar (e.g. “no gluten”, “without gluten, “free of gluten”, etc.), is not permitted when… • the food contains 20 ppm or more gluten; • The food is made with a gluten containing ingredient regardless of the level of gluten, (e.g. wheat starch).

NOTE: Wheat starch processed to remove gluten can be present in a food so long as the level of gluten in the finished food is less than 20 ppm. A clarifying statement is needed to identify the ingredient is processed to meet the criteria for gluten-free.

NOTE: Statements such “made with no gluten-containing ingredients” or similar can still be made if truthful. More rules coming for fermented and hydrolyzed foods.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 194 OTHER THOUGHTS… of 197 Use of Symbols to Communicate Nutrition Information: FDA is reviewing the use of front of label symbols and programs that relate to nutrition communication. Further FDA guidance or possible regulations could in store in the future. Mandatory GMO Labeling: Various states, such as Connecticut and Maine have passed legislation on labeling foods with GMO. Vermont’s act 120 goes into effect July 1, 2016. New York and almost 2 dozen other states are contemplating such labeling as well.

NOTE: These laws are and would be pre-empted by the National Bioengineered Food Disclosure Standard. USDA to draft regulations on matter by about 2018, with a 1 year transition after final regulations are made. All foods under FDA and USDA would be subject to mandatory GMO labeling.

US Food Labeling 2016 (Special) © 2016 Legal Suites Inc. (www.legalsuites.com) Slide 195 OTHER THOUGHTS… of 197 Patient Protection and Affordable Care Act: [21 CFR § 101.8, § 101.10, § 101.11] FDA • FDA has finalized regulations as of November 25, On March 9, 2016 FDA noted 2014. that implementation • Restaurants and similar retail food establishments, of menu (menus), and vending machines, with 20 or more labelling rules will be 1 year locations are to report the total Calories. after final guidance is • Calories from fat, fat, saturated fat, trans fat, issued by FDA cholesterol, sodium, carbohydrate, sugars, dietary That guidance is sill pending. fiber and protein must also be provided on request for restaurant foods.

NOTE This is generally not true. The Law was designed to regulate the killing of animals for recreational and commercial purposes.