Nutrition Facts Panel

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

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 191 PowerPoint Presentation… Under the Store tab, select Training • Will be made available on the Legal Suites web site. Resources / Workshop Support, then http://www.legalsuites.com (to be provided) purchase the Food Suite® Smart Tools US Food Labelling (Foods Additional Resources… Under FDA) and Food Suite® Microsites, then purchase the Food • Additional resources are provided for the convenience Suite® US Microsites with your of the attendees. This includes the Food Suite® US Food coupon code. New users must also Labelling Microsite. create an account. Exiting users should log in. When logged in you http://www.legalsuites.com (to be provided) will see the active support page under the Workshops/Workshop Coupon Code… Support tab. • See below. Coupon code permits access at no additional costs. COUPON CODE = NS7B87

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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 4 By end of day… of 191 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 are to be labeled.

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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 8 Authorities… of 191 General… 1. Levels of Foods in the US are governed by Government FOCUS both Federal and State 2. Authorities Our focus authorities. Local authorities, is on federal (cities and municipalities), also jurisdiction 3. Jurisdiction under the have authority to govern food. authority 4. Legislation of FDA 5. Compliance Resources FEDERAL STATE 6. Compare & Contrast

. Domestic, Imports & Exports . Retail & Institutional (non retail) FDA & USDA . Fresh & Manufactured *Governs food in interstate State (certain foods & beverages)… commence.

. Environmental (packaging, recyclable, redemption) The National . Alcoholic Beverages Bioengineered Food . State Meat Disclosure . California’s “Proposition 65” Law . Vermont’s Act 120 (GMO Labeling) – now pre-empted Municipal (some foods & beverages)…

. Foodservice / In Store Bakery / Manufacturing

Meet the FEDS Note: This USDA is a list of principal (United States Department of 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 13 Authorities… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 14 Authorities… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 15 Authorities… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 16 Authorities… of 191 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 authority, • Animal and Plant Health Inspection Service (APHIS) (e.g. products • Meat and poultry as defined (beef, pork, lamb/sheep with chicken, turkey). insignificant • Foods in interstate commerce. meat content) are • Food Inspection - Import and Export. under FDA. • National Organic Program. • COOL (Country of Origin Labeling).

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 17 Authorities… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 18 Authorities… vs of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 19 Authorities… vs of 191 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.

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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 24 Federal Legislation… of 191 Select State Considerations… LEGISLATION… APPLICABILITY… California’s Proposition 65 Requires notices to be posted for foods that exceed threshold levels of substances STATE recognized as carcinogens or reproductive LEGISLATION toxins, (e.g. acrylamide, lead, etc.) Some high- State Environmental Redemption and recyclability of food lighted state considerations. Regulations containers, (e.g. beverages) State and Certain States and Non consumer, foodservice foods. municipal laws municipalities have bans or apply only in programs to eliminate trans fat. their respective justification. State and local alcoholic Covers the state importation and beverage legislation distribution of alcoholic beverages. Vermont Act 120* Mandatory GMO labeling of packaged food. * Pre-empted by National Bioengineered Food Disclosure Standard

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 27 Authorities… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 28 Authorities… of 191 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.

SUBJECT CANADA USA Nutrition • Very Prescriptive • Prescriptive Labeling • Prohibits US + other • Prohibits other formats formats • USDA & FDA different EXAMPLES • All foods same rules • Some RDI’s differed from The following • Some RDI’s differed from US Canada are a few • Exemptions limited • More exemptions examples of • Applies only to pre- • Labeling menus & some packaged food vending machines. differences • Includes non consumer • Does not include non between Canada packaged food consumer packaged food. and the US. There are Standards • Many under numerous • Many standards under others. legislation. FDA and USDA • Many differ from US • Many differ from standards. Canada.

SUBJECT CANADA USA Net • Metric system • US & metric except USDA. Contents • Average System • Compliance Guidelines • Canadian Imperial • US fluid measures differ EXAMPLES measures differ from US from Canadian Imperial The following fluid measures measures. are a few • Manner of label • Manner of declaration is examples of declarations different different than Canada. some than US. differences between Canada Ingredients • Food additives strictly • Food additives rules more and the US. governed. liberal (e.g. GRAS) There are • Colors are food additive. • Color strictly governed. others. • Novel Food Regulations • Novel food guidelines • Declaration of • Ingredient rules differ, ingredients have including processing aids different rules. and incidental additives.

SUBJECT CANADA USA Food • Priority Allergens differ • US food allergens include Allergens from US . Include shell more tree nuts than in fish, sesame and Canada including coconut. EXAMPLES mustard. • No specific gluten labeling. The following • Includes gluten labelling. • Sulphite labeling based on are a few • Sulphite labelling differs 10 ppm. examples of and is more complex some Claims • Many claims such as • US claims on “fresh” may differences between Canada “natural” differ. Canada be more prohibitive than in and the US. is more prohibitive. Canada. There are • Juice representations by • Defined juice labeling others. guidelines. Nutrient • Highly regulated and • Regulated and prohibitive. Claims prohibitive Differ from Canada • No “healthy” claims • Healthy claims defined

SUBJECT CANADA USA Health Claims • Very limited and • Regulated, prohibitive but prohibitive. generally more liberal than in Canada. EXAMPLES Organic • Similar and mostly • Similar and mostly The following harmonized with harmonized with Canada. are a few US. • Certification required. examples of • Certification some required. differences between Canada Advertising • Covered by food • Not covered by food and the US. regulations and food regulations. Authority is There are authorities such as FTC. others. CFIA. • Broadcast ads • Broadcast ads need independently reviewed review.

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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 37 DEFINITIONS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 38 DEFINITIONS … of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 39 DEFINITIONS … of 191 The term “labeling” means [FDAC]… … all labels and other written, printed, or graphic matter NOTE Definitions exist are (1) upon any article or any of its containers or also 21 wrappers, or CFR & FPLA (slightly (2) accompanying such different). article

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 40 DEFINITIONS … of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 41 DEFINITIONS … of 191 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 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 42 DEFINITIONS … of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 43 DEFINITIONS … of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 44 DEFINITIONS… of 191 [21 CFR §101] 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.

The term “principal display panel”… [21 CFR §101] … 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 46 DEFINITIONS… [21 CFR §101] of 191 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.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 50 LABEL BASICS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 51 LABEL BASICS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 52 LABEL BASICS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 54 LABEL BASICS - PDP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 55 LABEL BASICS - PDP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 57 LABEL BASICS - PDP… of 191 NEW Net Contents… [FPLA + 21 CFR §101.7] … 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 58 LABEL BASICS - PDP… of 191 NEW Net Contents… [FPLA + 21 CFR §101.7] … Display 1. On lower 1/3 (bottom 30%) of PDP 2. Bold 3. Prefix “Net Wt” (proposed to remove) 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 59 LABEL BASICS - PDP… of 191 NEW Net Contents… [FPLA + 21 CFR §101.7] … 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. .

Lighter Side – Ingredient labeling is like brewing up something new every time –what's in your food!

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 64 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 65 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 66 LABEL BASICS - IP… of 191 Ingredients… [21 CFR §101.4] … Common Name Exit 1. Standard / Common Name / Specific 21 CFR 101 (*special considerations for standards*) (wheat)

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

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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 68 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 69 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 70 LABEL BASICS - IP… of 191 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)]).

Ingredients… [21 CFR §101.4] … Incidental Additives (IA) Need not be declared • 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

Ingredients… [21 CFR §101.4] … Special Labeling Considerations 1. Infant Foods 2. Hypoallergenic Foods (provide names of specific spice, etc.) 3. Allergen Labeling

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 73 LABEL BASICS - PDP… of 191 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. .

Lighter Side – Food allergens can be in disguise!

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 76 LABEL BASICS - IP… of 191 Allergen Labeling… [FALCP 2004] … “Major 8 food allergens” 1. Milk LINK 2. Egg 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

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.)

Allergen Labeling… [FALCP 2004] … “Tree Nut Allergen”…

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)

Allergen Labeling… [FALCP 2004] … “Tree Nut Allergen” continued…

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)

Allergen Labeling… [FALCP 2004] … “Tree Nut Allergen” continued…

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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 81 LABEL BASICS - IP… of 191 Allergen Labeling… [FALCP 2004] … Allergen Declaration (options) FORMAT 1. “Contains” statement An allergen contains (e.g. Contains: Milk, Egg and Pecans) statement must be 2. Ingredient List adjacent to the list of (e.g. “Ingredients: Butter (Milk), Soy Lecithin…”) ingredients

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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) LABEL BASICS - IP… Slide 82 [Federal Register Volume 73, 154 of 191 Cautionary Allergen Labeling… (Friday, August 8, 2008)] 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) vs Slide 83 LABEL BASICS - IP… of 191 Common Food Allergens Summary… CANADA USA • almonds, Brazil nuts, • almond, beech nut, brazil nut, butternut, WHEAT cashews, hazelnuts, cashew, chestnut (Chinese, American, , Includes macadamia nuts, European, Seguin), chinquapin, coconut, cereal pecans, pine nuts, filbert/hazelnut, gingko nut, hickory nut, plants from pistachios or walnuts lychee nut, macadamia nut/bush nut, the genus pecan, pine nut/pinon nut, pili nut, “Triticum”, pistachio, sheanut, walnut (English, which Persian, black, Japanese, California), includes heartnut, butternut kamut, • peanuts • peanuts spelt, etc.

• eggs • eggs

CANADA USA USA • sesame seeds • Not listed • wheat or triticale • wheat The US regulates • milk • milk sulfites as • soybeans • soybeans incidental additives in • mustard seeds • not listed 21 CFR 101 • crustaceans • crustacean shellfish (FDA). If less than 10 ppm • shellfish (molluscs) • not listed need not • fish • fish declare.

Lighter Side – Nutrition labelling isn't just magic out of a hat!

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 87 LABEL BASICS - IP… of 191 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)

. Foods for Children 1 through 3 years (special labeling) NOTE . Medical Foods / Infant Formula / Dietary Supplement If claims (sp. labeling) are made exemption . Bulk Retail (on card) / Bulk Foods Institutional may be (exempt) revoked. . Small Packages (< 12 in sq) . Raw Fruits and Vegetables . Packaged single-ingredient products of fish or game meat.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 89 LABEL BASICS - IP… of 191 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).

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 90 LABEL BASICS - IP… of 191 Nutrition Facts…[21 CFR §101.9] … Format 1. Standard (works everywhere) EXIT Exit 2. Simplified (8 or more core insignificant) FS Guide Examples 3. Tabular (insufficient vertical space) 4. Abridged (1 or more core declared as zero) 6. Dual (different size, as prepared) 7. Aggregate (multi unit)

CURRENT NEW

PROPOSED NEW

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 95 LABEL BASICS - IP… of 191 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 Facts Labels; Serving Sizes of Foods That Can Reasonably Be Came into Consumed at One Eating Occasion; Dual-Column Labeling; effect July Updating, Modifying, and Establishing Certain Reference 26, 2016. Amounts Customarily Consumed; Serving Size for Breath Pre- Mints; and Technical Amendments; Final Rules published May 20, • Food Labeling: Serving Sizes of Foods That Can Reasonably Be 2016 Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 96 LABEL BASICS - IP… of 191 New Nutrition Facts… [21 CFR §101.9] … Format Highlights • Enhanced Calorie display NEW • Enhanced Serving Size display Came into • Included added sugars and percent DV for added sugars effect July 26, 2016. • Calories from fat no longer a feature. • 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 98 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 99 LABEL BASICS - IP… of 191 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]

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 103 LABEL BASICS - IP… of 191 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.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 107 LABEL BASICS - IP… of 191 Nutrition Facts – New… [21 CFR §101.9] • Used in the case of multi unit packages or those with separately packaged inner units of food.

Nutrition Facts – [21 CFR §101.9] New…

• Used for food 200% and up to 300% of the reference amount.

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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 112 LABEL BASICS - IP… of 191 Nutrition Facts – New… [21 CFR §101.9] • Format for children 1 through 3 years of aged.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 116 LABEL BASICS - IP… [21 CFR §101.9] of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 117 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 118 LABEL BASICS - IP… of 191 Nutrition Facts – FDA Review of Dietary Fiber… • REVIEW: FDA included in its scientific literature review the following 26 isolated and synthetic non-digestible carbohydrates…

• Gum Acacia • Karaya Gum • High Amylose Corn/Maize Starch • Alginate • Oat Hull Fiber (Resistant Starch 2) • Apple Fiber • Pea Fiber • Retrograded Corn Starch • Bamboo Fiber • Polydextrose (Resistant Starch 3) • Carboxymethylcellulose • Soluble Corn Fiber • Resistant Wheat and Maize Starch • Corn Hull Fiber • Soy Fiber (Resistant Starch 4) • Cottonseed Fiber • Sugar Beet Fiber • Xylooligosaccharides • Galactooligosaccharides • Sugar Cane Fiber • Inulin/Oligofructose/Synthetic Short Chain • Potato Fibers • Wheat Fiber Fructooligosaccharides • Pullulan • Xanthan Gum • Rice Bran Fiber These 26 fibers are being reviewed by FDA in view of their efficacy as dietary fiber. The definition of dietary fiber in the CFR will need to be amended before they are formally recognized.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 119 LABEL BASICS - IP… [21 CFR §101.9] of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 120 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 122 LABEL BASICS - IP… of 191 Nutrition Facts… [21 CFR §101.9] … When space is limited (< 40 in sq) abbreviation's may be used.

ITEM ABBREVIATION ITEM ABBREVIATION EXIT Serving size Serv size Dietary fiber Fiber Exit FS Guide Servings per container Servings Soluble fiber Sol fiber Calories from saturated fat Sat fat cal Insoluble fiber Insol fiber A few examples. Saturated fat Sat fat Sugar alcohol Sugar alc Monounsaturated fat Monounsat fat Potassium Potas Polyunsaturated fat Polyunsat fat Includes* Incl. Cholesterol Cholest Vitamin* Vit Total carbohydrate Total carb

* Abbreviation can also be used on dual-column displays.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 123 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) vs Slide 124 LABEL BASICS - IP… of 191 Nutrition Facts… [21 CFR §101.9] … US vs Canada (proposed changes) NUTRIENT DAILY VALUE Canada1 US2 Canada US (former) (former) (new) (new)3 Fat 65 g 4 65 g 75 g 78 g

Saturated 20 g 20 g 20 g 20 g Fat (sum of (the sum of saturated + saturated + Trans Fat trans fat) no DV trans fat) no DV

Cholesterol 300 mg 300 mg 300 mg 300 mg (optional (optional declaration) declaration) Sodium 2,400 mg 2,400 mg 2,300 mg 2,300 mg

NUTRIENT DAILY VALUE Canada1 (former) US2 (former) Canada US (new) (new)3 Carbohydrates 300 g 300 g no DV 275 g

Fibre 25 g 25 g 28 g 28 g

Sugars no DV no DV 100 g no DV

Added Sugars no DV no DV no DV 50 g (Not listed) (Not listed) (Not listed) Protein no DV 50 g5 no DV 50 g5

The proposed 100 gram DV is equivalent to 20% of energy based on a 2,000 Calorie diet. According to dietary intake data (CCHS 2.2), approximately half of Canadians consume more than 20 % of their energy as sugars, with the highest intakes reported in younger age groups (<19 years).

Nutrition Facts… [21 CFR §101.9] … US vs Canada (proposed changes - Footnotes)

1 - Based on the reference standards published in Section B.01.001.1 of the FDR. 2 - Based on the US Reference Daily Intakes published in Code of Federal Regulations, 101.9(c)(8)(iv). 3 - As per final regulations 81 FR 33741. 4 - Based on a 2,000-Calorie diet 5 - In the US, the % DV for protein is only required when a protein claim is made for the product or if the product is to be used by infants or children under 4 years of age.

Nutrition Facts (vitamins)… [21 CFR §101.9]

NUTRIENT DAILY VALUE (4 YEARS OF AGE UNITS DAILY VALUE (4 YEARS OF AND OLDER) AGE AND OLDER) Canadaa USb New (US & Canada) Canada New US Newc (current) (current) Vitamin A 1,000 RE 5,000 IU Micrograms RAE1 (mcg) 900 900 Vitamin C 60 mg 60 mg Milligrams (mg) 90 90 Vitamin D 5.0 mcg 400 IU Micrograms (mcg)2 20 20 Vitamin E 10 mg 30 IU Milligrams (mg)3 15 15 Vitamin K 80 mcg 80 mcg Micrograms (mcg) 120 120 Thiamin 1.3 mg 1.5 mg Milligrams (mg) 1.2 1.2 Riboflavin 1.6 mg 1.7 mg Milligrams (mg) 1.3 1.3 Niacin 23 NE 20 mg Milligrams NE4 (mg) 16 16

Vitamin B6 1.8 mg 2.0 mg Milligrams (mg) 1.7 1.7 Folate5 220 mcg 400 mcg Micrograms DFE6 (mcg) 400 400

Vitamin B12 2.0 mcg 6.0 mcg Micrograms (mcg) 2.4 2.4 Biotin 30 mcg 300 mcg Micrograms (mcg) 30 30 Pantothenic acid 7.0 mg 10 mg Milligrams (mg) 5 5 Choline - - Milligrams (mg) 550 550

Nutrition Facts (minerals)… [21 CFR §101.9]

NUTRIENT DAILY VALUE (4 YEARS OF AGE UNITS DAILY VALUE (4 YEARS OF AGE AND OLDER) AND OLDER) Canadaa USb New (US & Canada) Canada New US Newc (current) (current) Calcium 1,100 mg 1,000 mg Milligrams (mg) 1,300 1,300 Iron 14 mg 18 mg Milligrams (mg) 18 18 Phosphorus 1,100 mg 1,000 mg Milligrams (mg) 1,250 1,250 Iodine 160 mcg 150 mcg Micrograms (mcg) 150 150 Magnesium 250 mg 400 mg Milligrams (mg) 420 420 Zinc 9.0 mg 15 mg Milligrams (mg) 11 11 Selenium 50 mcg 70 mcg Micrograms (mcg) 55 55 Copper 2.0 mg 2.0 mg Milligrams (mg) 0.9 0.9 Manganese 2.0 mg 2.0 mg Milligrams (mg) 2.3 2.3 Chromium 120 mcg 120 mcg Micrograms (mcg) 35 35 Molybdenum 75 mcg 75 mcg Micrograms (mcg) 45 45 Chloride 3,400 mg 3,400 mg Milligrams (mg) 2,300 2,300 Potassium 3,500 mg 3,500 mg Milligrams (mg) 4,700 4,700

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) vs Slide 129 LABEL BASICS - IP… of 191 Nutrition Facts (footnotes)… a. Based on the reference standards published in Section B.01.001.1 of the FDR. b. Based on the US Reference Daily Intakes published in Code of Federal Regulations, 101.9(c)(8)(iv). c. As per final regulations 81 FR 33741. 1 - 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. 2 - 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. 3 - 1 mg α-tocopherol (label claim) = 1 mg α-tocopherol = 1 mg RRR- α-tocopherol = 2 mg all rac-α- tocopherol . 4 - NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan. 5 - “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. 6 - DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 130 LABEL BASICS - IP… of 191 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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 135 LABEL BASICS - IP… of 191 Nutrition Facts – FDA Suggested Rounding… Recommendations for declaration of quantitative amounts of vitamins and minerals on the Nutrition and Supplement Facts labels using RDIs for adults and children ≥ 4 years

Nutrient Unit of Measure RDI for Adults and for Adults and Children ≥ 4 years Recommended Increment Vitamin A Micrograms RAE (mcg) 900 Nearest 10 mcg Vitamin C Milligrams (mg) 90 Nearest mg Calcium Milligrams (mg) 1,300 Nearest 10 mg Iron Milligrams (mg) 18 Nearest .1 mg Vitamin D Micrograms (mcg) 20 Nearest .1 mcg Vitamin E Milligrams (mg) 15 Nearest .1 mg Vitamin K Micrograms (mcg) 120 Nearest mcg Thiamin Milligrams (mg) 1.2 Nearest .1 mg Riboflavin Milligrams (mg) 1.3 Nearest .1 mg Niacin Milligrams NE (mg) 16 Nearest .1 mg Vitamin B6 Milligrams (mg) 1.7 Nearest .1 mg Folate Micrograms DFE (mcg) 400 Nearest 5 mcg Vitamin B12 Micrograms (mcg) 2.4 Nearest .1 mcg Biotin Micrograms (mcg) 30 Nearest mcg Pantothenic acid Milligrams (mg) 5 Nearest .1 mg Phosphorous Milligrams (mg) 1,250 Nearest 10 mg Iodine Micrograms (mcg) 150 Nearest mcg Magnesium Milligrams (mg) 420 Nearest 5 mg Zinc Milligrams (mg) 11 Nearest .1 mg Selenium Micrograms (mcg) 55 Nearest mcg Copper Milligrams (mg) 0.9 Nearest .1 mg Manganese Milligrams (mg) 2.3 Nearest .1 mg Chromium Micrograms (mcg) 35 Nearest mcg Molybdenum Micrograms (mcg) 45 Nearest mcg Chloride Milligrams (mg) 2,300 Nearest 10 mg Potassium Milligrams (mg) 4,700 Nearest 10 mg Choline Milligrams (mg) 550 Nearest 10 mg 1 The quantitative amount may be declared to the nearest hundredth or thousandth of a mg or mcg when that level of specificity is necessary to attain a value that is at least 2 percent of the RDI in a serving of the food, and therefore, sufficient to declare the quantitative amount of the nutrient on the Supplement Facts label. 2 This table provides recommendations for the declaration of quantitative amounts of vitamins and minerals using only the RDIs that have been established for adults and children 4 years of age and older. Our regulations, at 21 CFR 101.9(c)(8)(iv), provide RDIs for infants through 12 months, children 1 through 3 years, and pregnant and lactating women. The declaration recommendations provided in this guidance can also be applied to the RDIs for these subpopulations. US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 136 LABEL BASICS - IP… of 191 Nutrition Facts – Rounding (NOTES)…

(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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 139 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 140 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 141 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 142 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 143 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 144 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 145 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 146 LABEL BASICS - IP… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 147 LABEL BASICS - IP… of 191 Nutrition Facts… [21 CFR §101.9] … Compliance Basics - Tolerances Class I*[vitamin, mineral, protein or dietary fiber]: The nutrient content of the composite NEW sample must at least equal to the value of FDA defines nutrient as declared on the label. exogenous and endogenous *NOTE: Added sugars would be a Class I nutrient under 21 sources of CFR §101.9(g)(3)(i). It is not listed 21 CFR §101.9(g)(4)(i), so would not be evaluated based on an amount at least nutrients, (i.e. equal to the value as declared on the label as other Class I vitamin, nutrients noted above. Instead, added sugars would be mineral, evaluated based on documentation when both added and protein, or indigenous sugars are present in a food, since no reliable dietary fiber) analytical methods exists to quantify the difference. In other cases where total sugars equals added sugars, compliance would be based on the 20% tolerance as per 21 CFR §101.9(g)(5).

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 148 LABEL BASICS - IP… of 191 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 must be at least equal to nutrients. 80 percent of the value for that nutrient 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) [21 CFR §101.9] Slide 149 LABEL BASICS - IP… of 191 Nutrition Facts… vs FDA USDA NOTE • Trans fat mandatory • Trans fat optional • No provision for stearic acid • Stearic acid optional (under This slide is • FDA Reference Amounts (RA) sat fat) not a comprehen • • Strict with reference Own Meat and Poultry RA sive list. amounts • Flexibility to select applicable • No meal type (has main RA dish) RA • Meal type and main dish RA • Basis as sold • Basis as sold, but may in some cases be bases solely • Simplified format based on 8 on food as prepared or more mandatory • Simplified format based any nutrients being one mandatory, non core “insignificant”. nutrient being “insignificant”.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 152 LABEL BASICS - IP… of 191 Domicile Information… [21 CFR §101.5] 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)

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 153 LABEL BASICS - IP… of 191 Domicile Information… [21 CFR §101.5] 4. Location (PDP or Information Panel*) 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.

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.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 157 OTHER LABELING… of 191 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 Height COOL (Section and subordinate regulations in 19 CFR 134. 10816 of the 2002 • Few exceptions, (e.g. coffee) Farm Bill (7 B.SC.. • Customs Rulings Online Search System 1638) (CROSS)

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 158 OTHER LABELING… of 191 Country of Origin… [Customs & Border 19 CFR + COOL] • Marking must be permanent. • Must be anywhere on package/container readily visible ORIGIN Also to ultimate purchaser. Best included next to domicile covered on statement, particular where domicile is of US origin and COOL product is of foreign origin. (Section 10816 of • USA COOL is separate and applies to fish and agriculture the 2002 Farm Bill (7 products such as… B.SC.. 1638) Muscle cut and ground meats: lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 160 OTHER LABELING… of 191 Cautions & Warnings… 1. Shelled Eggs (safe handling/storage) 2. Pressurized Containers 3. Unpasteurized Juices

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 161 OTHER LABELING… of 191 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

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 162 OTHER LABELING… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 163 OTHER LABELING… of 191 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 name of the (The term artificial must be no less than ½ the type of food will the flavor, and grouped together wherever it appears, need to “artificial raspberry flavor”). identify that it is flavored, (e.g. 3. If natural … “artificial (The term natural may be used but the term flavor raspberry must be used “natural raspberry flavor” wherever it flavored hot cocoa mix”). appears).

• 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.”)

• 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 Meat Meal/Main Dish TOTAL FAT low fat < 5 g fat /RACC & /100g low fat SATURATED FAT low sat fat < 2 g sat fat /RACC & low sat 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 167 NUTRIENT CONTENT CLAIMS… of 191 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.

NEW - Conditions for the Use of "Healthy" A. Low Fat… … we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim “healthy” meet the low fat requirement (§101.65(d)(2)(i)), provided that:

(1) The amounts of mono and polyunsaturated fats are declared on the label and

(2) The amounts declared constitute the majority of the fat content.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 169 NUTRIENT CONTENT CLAIMS… of 191 Healthy (FDA Enforcement discretion)… NEW - Conditions for the Use of "Healthy" B. Beneficial Nutrients… … we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim “healthy” contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least ten percent of the DV per RACC of potassium or vitamin D. If a manufacturer has already implemented the updated Nutrition Facts label, they must use the new, updated DVs for potassium and vitamin D. In either case, if a food is basing its eligibility for bearing a “healthy” claim on potassium or vitamin D, whichever nutrient is being used as the basis for eligibility should be declared in the Nutrition Facts label.

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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 172 HEALTH CLAIMS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 174 OTHER LABEL STATEMENTS… of 191 Descriptive Terms… 1. ORGANIC: • USDA’s AMS (Agricultural marketing Service) National Organic Program (NOP) • 7 CFR §205 2. FRESH: (21 CFR § 101.95) 3. NATURAL: • FDA Policy – no synthetics, artificial flavor or coloring, minimal processing not considered

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 175 OTHER LABEL STATEMENTS… of 191 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 • 21 U.S.C. § 343(h)(3)

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 176 OTHER LABEL STATEMENTS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 177 OTHER LABEL STATEMENTS… of 191 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 under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 180 OTHER THOUGHTS… of 191 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 be in store in the future. FDA does exercise some enforcement discretion. 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. * Pre-empted by National Bioengineered Food Disclosure Standard

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 181 OTHER THOUGHTS… of 191 Patient Protection and Affordable Care Act: [21 CFR § 101.8, § 101.10, § 101.11] FDA • FDA has finalized regulations as of November 25, Compliance date 2014. December 1, 2016. FDA to begin • Restaurants and similar retail food establishments, enforcement on (menus), and vending machines, with 20 or more May 5, 2017. Glass front locations are to report the total Calories. vending machines • Calories from fat, fat, saturated fat, trans fat, extended until cholesterol, sodium, carbohydrate, sugars, dietary July 26, 2018. 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.

harmonized Canadian and US food 2. Considerations label that addresses all considerations in either jurisdiction. This is true in the 3. Co-Packers case of consumer package foods. In the 4. Enforcement case of non consumer foods this ? may ? be a possibility.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 185 OTHER THOUGHTS… of 191 Meat & Poultry Products … . Packers should be federally inspected in order sell products interstate/provincial and internationally. STRATEGY A few . Meat and poultry products may require label thoughts on registration with USDA. This may include products compliance for export to Canada. strategies related to co-packers Fish & Seafood Products … ability to sell . Fish products are subject to HACCP/QMPs. Import products. permits are required to export to Canada. Co- packers must be eligible to export to Canada and the US. This means that in Canada they will be under Federal inspection.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 186 OTHER THOUGHTS… of 191 Processed Fruit & Vegetable Products … . Packers should be federally inspected in Canada in order sell products interprovincially and internationally, (products subject to the Processed Products Regulations). This does not STRATEGY apply to products exported to Canada. A few thoughts on . Facilities in Canada that export FDA foods to the US and the compliance strategies US facilities involved in interstate commerce of food, must related to register facilities and processes with FDA for eligible low acid co-packers and acidified foods. ability to sell products. US Bioterrorism Act … . Business involved with FDA foods in Canada to be exported to the US must register all facilities and file prior shipment notices before exporting to US. Facilities in the US must also be registered.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 187 OTHER THOUGHTS… of 191 Product Development… . When developing products it is critical to evaluate what legislation may be applicable as this will STRATEGY expose additional consideration that may influence A few the sale of the products in various provinces/states thoughts on compliance or in either Canada nor the US. strategies related to . Foods manufactured in federally registered co-packers facilities will likely cost more to produce. ability to sell products. . If developing products (e.g. poultry, wheat products, dairy products etc.), considerations in view of import classification should be considered to address potential tariff rated import quotas.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 188 OTHER THOUGHTS… of 191 Co-packers… . In general co-packers should be federally inspected where applicable. This provides the ability to provide STRATEGY A few products in markets not otherwise possible. thoughts on compliance . Co-packers that have Canadian and US product strategies development experience will facilitate the related to co-packers development of one product for both markets. This ability to sell may not always be possible, (additives, nutrients, etc.). products. . Co-packers may be a good initial point of contact on regulatory matters. However, always have a qualified contact review products, labels and advertising.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 189 OTHER THOUGHTS… of 191 Co-packers… . In Canada the legal agent of the product assumes responsibility for the product. There are “due STRATEGY A few diligence” clauses in some legislation that may thoughts on preclude criminal prosecution should there be an compliance strategies issue. However, an issue is always the legal agents related to responsibility. co-packers ability to sell . In the US co-packers, (e.g. FDA foods), take on more products. responsibly for compliance than perhaps in Canada, but in general the legal agent is also ultimately responsible for issues.

US Food Labeling under FDA 2017 © 2017 Legal Suites Inc. (www.legalsuites.com) Slide 190 OTHER THOUGHTS… of 191 CFIA, FDA, FTC, USDA… . If there is a serious food safety issue both Canadian and US officials could require a product recalled. STRATEGY A few . Other enforcement action could include the detention thoughts on of products until corrective measures are made. compliance strategies . Criminal prosecution is generally the last resort. related to co-packers . Certain violations in Canada could be subject to ability to sell administrative monetary penalties should there be products. issues, (e.g. Health of Animals). . Products crossing international borders, particularly entering the US, are under more scrutiny than domestic products.