FDA Nutrition & Labeling Regulations Update. Elizabeth (Betty) Campbell Independent Advisor

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1 FDA Nutrition & Labeling Regulations Update Elizabeth (Betty) Campbell Independent Advisor

2 The changes EAS Consulting Group, LLC 2

3 Summary of the Major Provisions Increasing the prominence of Calories Removing the declaration of Calories from fat Defining dietary fiber Changing Sugars to Total Sugars and declaring Includes X g Added Sugars Updating the list of mandatory and voluntary vitamins & minerals Updating certain Daily Values for nutrients New footnote Requiring the maintenance of records for certain nutrients Re-evaluating RACCs Dual Column nutrient declaration for certain containers EAS Consulting Group, LLC 3

4 Vertical Standard Formats EAS Consulting Group, LLC 4

5 Vertical Dual Columns for container 200% of RACC EAS Consulting Group, LLC 5

6 Tabular Format for Smaller Packages Small packages < 40 sq in are exempt from footnote declaration; % DV = % Daily Value may be used. - Not in reg text, that amount for vit/min not required, but Response 507 states that on intermediate packages absolute amounts are not required EAS Consulting Group, LLC 6

7 Linear Format for Smaller Packages EAS Consulting Group, LLC 7

8 Impact on Claims How will changes in DVs, RACCs and Serving Sizes affect nutrient content and health claims? Will product lose qualification for current claims? For which additional claims will product qualify? Will larger RACC/serving exceed disclosure/disqualifier level? Will serving now be different from RACC and trigger additional statement of definition of claim? EAS Consulting Group, LLC 8

9 Dietary Fiber EAS Consulting Group, LLC 9

10 Dietary Fiber Dietary Fiber Definition: (1) Non-digestible soluble and insoluble carbohydrates, of 3 or more monomeric units, and lignin that are intrinsic and intact in plants; or (2) Isolated and synthetic non-digestible carbohydrates with beneficial physiological effect Physiologic effects improved laxation, blood cholesterol attenuation, post-prandial blood glucose attenuation, reduced blood pressure, increased satiety EAS Consulting Group, LLC 10

11 Dietary Fiber Non-digestible carbs determined by FDA to have beneficial physiologic effects - Blood cholesterol attenuation Oat and barley Beta-glucan Psyllium husk Guar gum Pectin Locust bean gum Hydroxypropyl methylcellulose Improved laxation Cellulose EAS Consulting Group, LLC 11

12 Dietary Fiber Where a food contains a mixture of dietary fiber and added non-digestible carbs that do not meet the definition for dietary fiber, the manufacturer must make and keep written records to verify the dietary fiber content. FDA recognizes AOAC Official Method , or an equivalent as the primary quantitative analytical methods for determining dietary fiber content. EAS Consulting Group, LLC 12

13 Fiber Guidance Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30) (Nov. 2016) Science Review of Isolated and Synthetic Non- Digestible Carbohydrates (Nov. 2016) EAS Consulting Group, LLC 13

14 26 Isolated/synthetic non-digestible carbohydrates under review 1. Gum Acacia 15. Pullulan 2. Alginate 16. Rice Bran Fiber 3. Apple Fiber 17. High Amylose Corn/Maize Starch 4. Bamboo Fiber (Resistant Starch 2) 5. Carboxymethylcellulose 18. Retrograded Corn Starch 6. Corn Hull Fiber (Resistant Starch 3) 7. Cottonseed Fiber 19. Resistant Wheat and Maize Starch 8. Galactooligosaccharides (Resistant Starch 4) 9. Inulin/Oligofructose/Synthetic Short 20. Soluble Corn Fiber Chain Fructooligosaccharides 21. Soy Fiber 10. Karaya Gum 22. Sugar Beet Fiber 11. Oat Hull Fiber 23. Sugar Cane Fiber 12. Pea Fiber 24. Wheat Fiber 13. Polydextrose 25. Xanthan Gum 14. Potato Fibers 26. Xylooligosaccharides EAS Consulting Group, LLC 14

15 Added Sugars EAS Consulting Group, LLC 15

16 16 Added Sugars Declaration of Includes x g Added Sugars indented after Total Sugars mono- & disaccharides sucrose, sugars from honey & syrups, sugars from fruit juice concentrates (as sweeteners), other nutritive sweeteners %DV based on 50 g Records required to verify declaration EAS Consulting Group, LLC 16

17 Added Sugar Does Not Include: Whole fruit, fruit pieces, pulps, purees Fruit/veg juice concentrate sold to consumers Fruit/veg juice concentrates used for Brix standardization Fruit juice concentrates used to formulate the fruit component of jellies, jams, preserves, or fruit spreads 100% fruit/veg juice Dairy products containing lactose EAS Consulting Group, LLC 17

18 Added Sugar Guidance Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (January 2017) EAS Consulting Group, LLC 18

19 Not added Fruit/veg Ingredients Fruit ingredient contains all components of a whole fruit or vegetable, processed so that plant material is physically broken down into smaller pieces or water is removed Added Fruit or vegetable processed so that it no longer contains all components of whole fruit or vegetable that is typically eaten (e.g., the pulp from the fruit has been removed) and the sugars have been concentrated EAS Consulting Group, LLC 19

20 Fruit/veg Ingredients For ingredient processed so that it no longer contains all components of the original whole fruit or vegetable and is concentrated, sugars in excess of what would be expected from 100 percent fruits or vegetables, must be declared as added sugars. Where manufacturers are processing different ingredients made from whole fruits or vegetables, FDA would need to consider specific information about how an ingredient has been processed. EAS Consulting Group, LLC 20

21 Compliance Issues A food that already contains some indigenous sugar and additional added sugars, either directly or as a component in an ingredient, such as sweetened fruit added to yogurt, would be misbranded if the actual Total Sugars amount is greater than 20 percent in excess of the value for that nutrient declared on the label, or the records requirements for Added Sugars are not met. EAS Consulting Group, LLC 21

22 Sweetener Claim A sweetener claim triggers added sugars declaration of less than 1 g What does FDA consider to be a sweetener? Ingredients that provide sweetness to a food regardless of whether they provide calories both caloric and non-caloric sweeteners sugar alcohols EAS Consulting Group, LLC 22

23 Record Requirements Where there are no analytical methods able to verify amounts of declared nutrients, manufacturers must make and keep written records. Records must be kept 2 yrs after food is introduced into interstate commerce Records must be provided to FDA upon request during an official inspection EAS Consulting Group, LLC 23

24 Record Requirements ADDED SUGARS when product contains both naturally occurring and added sugars DIETARY FIBER when product contains both non-digestible carbs that meet definition of dietary fiber and those that do not. VITAMIN E when product contains both - natural RRR-α-tocopherol and all rac-αtocopherol [synthetic] FOLATE when product contains both folates and folic acid EAS Consulting Group, LLC 24

25 Who is responsible for recordkeeping? A firm that labels the product, whether manufacturer or a private labeler, must know, for each nutrient declared, the amount in a serving of food to ensure the label is accurate. A firm that does not manufacture the product, but that is responsible for labeling the product, is expected to have access to and retain records that are sufficient to verify the nutrient declarations. EAS Consulting Group, LLC 25

26 Rounding Vit/Min Amounts EAS Consulting Group, LLC 26

27 Levels of Significance Refers to the degree of accuracy when rounding nutrients to declare quantitative amounts of vitamins and minerals on the label Includes consideration of practical level of precision in the amount of the nutrient present. Not statistical testing EAS Consulting Group, LLC 27

28 Rounding Amounts RDI range Nutrients covered Rounding interval per serving Comment < 25 mg or mcg iron, vitamin D, vitamin E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, pantothenic acid, zinc, copper, and manganese >25 - <250 mg or mcg vitamin C, vitamin K, biotin, iodine, selenium, chromium, and molybdenum 0.1 mg or mcg nearest 0.01 or mg or mcg when that necessary to attain a value that is at least 2% of the RDI per serving 1mg or mcg > <500 mg or mcg folate, magnesium 5 mg or mcg > 500 mg or mcg vitamin A, calcium, phosphorous, chloride, potassium, and choline 10 mg or mcg EAS Consulting Group, LLC 28

29 Percent DV May calculate the percent DV (except protein) using either the amount of nutrient declared on the label or actual amount of nutrient (i.e., before rounding) Goal is to provide for the greatest amount of consistency on the food label EAS Consulting Group, LLC 29

30 Compliance Date July 26, 2018 for > $10 million annual food sales July 26, 2019 for < $10 million Products that are labeled on or after date must comply Products that are labeled before date do not need to comply Compliance date is the date the food product was labeled regardless of where it is in the distribution chain at the manufacturing facility awaiting distribution at a warehouse awaiting further distribution in transit to the United States to be offered for import on the store shelf of a U.S. retail establishment EAS Consulting Group, LLC 30

31 FDA.gov Search References Industry Resources on the Changes to the Nutrition Facts Label on/guidancedocumentsregulatoryinformati on/labelingnutrition/ucm htm EAS Consulting Group, LLC 31

32 Other FDA Issues EAS Consulting Group, LLC 32

33 What s New? Vending Machine Foods Labeling Final Rule Menu Labeling Final Rule Guidance on Labeling of Cane Sweetener Natural Genetically Engineered Food EAS Consulting Group, LLC 33

34 Vending Machine Foods Labeling Final Rule Compliance date December 1, 2016 Extended to July 26, 2018 for foods sold from glass-front vending machines that have visible FOP labeling can be used to meet the calorie labeling requirements on vending machines. Allows food companies to make all nutrition changes to their food labels at one time. EAS Consulting Group, LLC 34

35 Menu Labeling Effective Date Because of 2016 appropriations bill FDA could not begin enforcing the final rule until 1 year after final guidance Final guidance Q &A issued May 5, 2016 compliance date May 5, 2017 FDA extended compliance date to May 7, 2018 in keeping with the Administration's policies consideration of ways to reduce costs and enhance flexibility beyond what is in the final rule comment by July 3 EAS Consulting Group, LLC 35

36 Labeling of Cane Sweetener Common or usual name for ingredient being declared as evaporated cane juice includes the term sugar and does not include the term juice Sugar, preceded by optional truthful, nonmisleading descriptors (e.g., cane sugar ) could distinguish the ingredient from white sugar and other sugars by describing characteristics such as source, color, flavor, or crystal size could be a coined term EAS Consulting Group, LLC 36

37 Natural Request for Comments Notice published November 12, Asked 16 questions about use of the term natural in food labeling Nearly 8000 comments Comments closed, but not absolute EAS Consulting Group, LLC 37

38 Genetically Engineered Food On November 19, 2015 FDA issued Final Guidance on voluntary labeling of foods from plant products Draft Guidance on voluntary labeling of foods from Atlantic Salmon produced through genetic engineering On July 29, 2016, National Bioengineered Food Disclosure Standard directed USDA to establish a national standard to disclose certain food products or ingredients that are bioengineered EAS Consulting Group, LLC 38

39 FDA Enforcement Priorities 1. Safety concerns: failure to identify major food allergen failure to declare other ingredients for which there are adverse reactions (e.g., Yellow 5, sulfiting agents] failure to have required warning statements 2. Failure to bear nutrition labeling, without having exemption 3. Unauthorized nutrient content claims or health claims 4. Products labeled as dietary supplements, but represented as conventional foods. Products labeled as medical foods but do not meet the definition EAS Consulting Group, LLC 39

40 FDA Enforcement Priorities 5. Bears authorized nutrient content or health claim, but product fails to qualify 6. Significant deficiencies in the nutrition or other mandatory labeling requirements, e.g., absence of trans fat; serving size; failure to declare ingredient that is not major food allergen 7. Products labeled as juice that do not bear percent juice labeling. EAS Consulting Group, LLC 40

41 FDA Enforcement How do labels come to FDA s attention? Establishment inspections Special assignments to address possible problem Consumer or industry complaints EAS Consulting Group, LLC 41

42 FDA Enforcement What does FDA do with problem food labels? Warning Letter Information (Untitled) letter Import detention Seizure Recall Injunction Prosecution EAS Consulting Group, LLC 42

43 FDA Enforcement About Warning Letters FDA considers identified violations to be worthy of further action if not corrected WL says respond in 15 working days to explain how and when you will make corrections FDA will evaluate response & negotiate timing for label change EAS Consulting Group, LLC 43

44 FDA Enforcement Additional risks after WL Litigation Competitors use WL against you EAS Consulting Group, LLC 44

45 Thank You EAS Consulting Group, LLC 45

CUTTING THROUGH LABELING CONFUSION

esha presents CUTTING THROUGH LABELING CONFUSION A GUIDE FOR UNDERSTANDING THE FDA'S CHANGES TO NUTRIENTS, DAILY VALUES, AND FORMATTING OF NUTRITION FACTS LABELS An ebook from esha RESEARCH CONTENTS What