Nutrition Labeling

1. Nutrition Labeling Presented by: Camille Brewer, Associate Director, Office of Nutritional Products, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, College Park, MD

2. Points to Cover The Nutrition Labeling and Education Act of 1990 (NLEA) • Background • Framework for Decision-making • Education • Next Steps

3. Background

4. Rulemaking in the US Triggering Events Law Regulations Tri

5. NLEA Triggering events • Lack of national labeling laws • Increased national focus on the importance of nutrition • Consumer activism

6. Notice and Comment Rulemaking LAW ANPRM Final Rule Proposed Rule

7. Federal Responsibility for Nutrition Labeling

8. Advertising

9. Federal Trade Commission • Enforcer of federal truth-in-advertising laws. • Enforcement activities focus on: • Claims for foods, ,drugs dietary supplements, and other products promising health benefits. • Health fraud on the Internet. • Weight-loss advertising • Advertising and marketing directed to children.

10. NLEA Objectives • Clear up consumers’ confusion about food label • Aid consumers in making healthy food choices, and • Encourage product innovation by giving manufacturers an incentive to improve the quality of the food and make more healthy food choices available to consumers • Federal pre-emption

11. Framework for Decision Making

12. Framework • Nutrition Science • Law • Consumer Studies

13. Framework: Nutrition ScienceCriteria for Mandatory Status • Quantitative intake recommendations have been made in scientific consensus documents. • Nutrient is of particular public health significance • Considered relative priority in order of presentation

14. Framework: Nutrition Science “The Report’s major conclusion is that over consumption of certain dietary components is now a major concern for Americans. While many food factors are involved, chief among them is the disproportionate consumption of foods high in fats, often at the expense of foods high in complex carbohydrates and fiber that may be more conducive to health.”

15. Framework: Law • Nutrition information is mandatory • Standard format • Exemptions and special formats

16. Framework: Law Nutrition Information is required for all products: • Intended for human consumption; and • Offered for sale • Unless there is an exemption or special labeling provision

17. Framework: LawExemptions & Special Labeling Provisions Small businesses based on gross sales (after May 8, 1995, retailers only) Low volume food products • Food served or sold in establishments that serve for immediate consumption • Ready-to-eat foods not for immediate consumption • Foods of no nutritional significance

18. Exemptions & SpecialLabeling Bulk foods for further manufacturing Raw fruits, vegetables, and seafood Custom processed fish and game meat Small packages (less than 12 sq.in.) Food sold from bulk containers (nutrition information on display)

19. Framework: Law • Nutrition information must comply with specified format when on a package • Nutrition information must be displayed at the point of purchase when not in a package form • All nutrient and food component quantities shall be declared in relation to a serving

20. Framework: Law Calories Dietary fiber*Calories from fat* Sugars*Total fat Protein*Saturated fat* Vitamin A*Trans fat (required 1/1/06) Vitamin C*Cholesterol* Calcium*Sodium Iron* Total carbohydrate • Must be declared if present in more than insignificant amount or an alternative format may be used

21. Trans fat declaration Separate line No % Daily Value

22. Voluntary Nutrients • Calories from saturated fat • Polyunsaturated fat • Monounsaturated fat • Potassium • Soluble Fiber • Insoluble fiber • Sugar Alcohol • Other Carbohydrate • Other vitamins and minerals for which RDIs have been established • Beta-carotene (as % of Vitamin A)

23. Claims Trigger Nutrition Labeling If a food, including dietary supplements, bears a nutrient content or health claim or other nutrition information it cannot use an exemption and must have nutrition labeling

24. Pre-NLEA Voluntary Nutrition Information

25. Framework: LawDaily Values Reference Daily Intakes (RDIs) Based on NAS Recommended Dietary Allowances Daily Reference Values (DRVs) Fat Saturated Fat Cholesterol Total carbohydrate Fiber Sodium Potassium Protein

26. Nutrition Label: Footnote • Percent Daily Values are based on a 2000 calorie diet • Daily values may be higher or lower depending on caloric needs. • List of DRV nutrients with DV for 2000 and 2500 calorie diet • Voluntary calorie conversion information (i.e., calories per gram for fat, carbohydrate, and protein)

27. Framework: Consumer Studies Nutrition Facts

28. Framework: Consumer StudiesOverall Value of Consumer Studies • Emphasis on consumer behavior • Helps distinguish between consumer preference for information and the information used by consumers to make judgments on nutritional content

29. Framework: Consumer Studies %DV • Percent Daily Value • Few consumers were able to interpret absolute amounts of nutrient (e.g. g or mg) to assist with purchase decisions. • % Daily Value concept resulted in more accurate use of label information for choices based on nutrition.

30. Framework: Consumer Studies%DV • Effective use of %Daily Value improves with educational material. • Useful to determine high and low for a nutrient • Can be used to estimate context for total diet • %Daily Value is linked to Nutrient Content claims

31. Format • The graphic requirements of the nutrition label is specified in the regulations • Includes information on: • Bolding • Hairlines • Type size • Case • Order

32. Package has more than 40 square inches of space available for labeling At least 3 continuous vertical inches Full Vertical Format

33. “Bilingual” • Separate Nutrition Facts panel may be used, or combined • Second language following the English • Numeric characters identical in both languages need not be repeated • All required nutrition information must be included in both languages

34. Tabular format Full vertical format does not fit on package Insufficient continuous vertical space for the requirement components, including the mandatory declaration of iron

35. Aggregate format Three different food products

36. Ingredients: Cod fish oil, gelatin, water, and glycerin.

38. Education

39. NUTRITION: To know the facts . . . . . . Use the food label

40. Next Steps?

41. Prominence of Calorie information The current Daily Values are based on Reference values in the Code of Federal Regulations. Now mandatory Modernization ofNutrition Facts Serving size information

42. Emerging Scientific Information

43. Next Steps: Expansion of Consumer Studies and Education • Relationship of “front” to “back” label • Symbols • Use of Web for education • Continued collaboration in integrating Dietary Guidelines, Food Guidance System (myPyramid), and Labeling Educational Messages

44. Nutrition Facts LabelA Public Health Success • Clear up consumers’ confusion about food label • Consumers use the label to compare foods • Aid consumers in making healthy food choices Public health benefits estimated as high as • $26 billion • Encourage product innovation by giving manufacturers an incentive to improve the quality of the food and make more healthy food choices available to consumers • NLEA fostered product innovation • Established Federal pre-emption

46. Thank you!