1. Unit 2 Seminar NS440-01 March 9, 2011 Amy Bridges, MS, RD, LDN

2. The Nutrition Labeling and Education Act (NLEA) Requires most foods have nutrition labeling Requires food labels that state health claims to comply with certain guidelines FDA is responsible for regulating food labels Regulations are frequently updated and it is the food industries responsibility to remain current with legal requirements All updated requirements are published in the Federal Register prior to effective date and summaries are posted on FDA’s website

3. Federal Laws The laws governing food products under FDA’s jurisdiction are: FDCA (Food, Drug, and Cosmetic Act) FPLA (Fair Packaging and Labeling Act)

4. What is required on the label? Name of food Net content Name and address of manufacturer or distributor

5. “The purpose of food-labeling laws and regulations is to ensure that consumers are able to make informed decisions about a product based on its label and labeling.” Do you feel believe manufacturers have the consumer’s best interest in mind?

6. The Food label Principal Display Panel (PDP): Area most likely to be on display for retail ▫Example: Front of cereal box Common or the usual name is required ▫Form of the food is required if optional forms exist ▫% from fruit juice required (flavored beverages are exempt) Imitation ▫Resembles another product but is nutritionally inferior Statement of identity: tells the consumer what they are buying ▫FDA established name ▫Use common name ▫Descriptive terms may be used if no established/common name exists

7. The Food Label Net Quantity ▫Must appear on PDP ▫Liquid, solid, or dry measurements Information Panel ▫Address of manufacturer, ingredient list, nutrition label ▫Part of the label, to the right of PDP Ingredients ▫All are required (for all foods composed of 2 or more ingredients) ▫Listed in descending order ▫Identifies allergens (FALCPA)

8. The Food Label Ingredients Present in Amounts of 2% or Less by Weight Use of Collective or Generic Ingredient Names Foods with Standard of Identity Allergens Name and Address of Manufacturer, Packer or Distributer Country of Origin ▫If foreign in origin Artwork ▫May not be misleading

9. The Food Label

10. Nutritional Labeling Nutrition Labeling & Education Act (NLEA 1990) Failure to comply resulted in mislabeled/misbranded foods Intended to be universal in the marketplace Show how foods fit into a balanced diet To allow credible health claims to be made Must be contained in Nutrition Facts box Must be located on PDP or information panel

11. Nutritional Labeling Must declare: ▫Serving size ▫Calorie information  Calories and calories from fat (if >0.5g fat/serving)  Trans fat (not listed if <0.5g trans fat/serving) ▫Nutrient Declarations  Weight in grams/%DV ▫Percent Daily Value  Declared for each nutrient  Based on 2000 calorie diet ▫Format Modifications  Package size, Omissions,

12. Nutrition Claims- What do they really mean? Free ▫Calorie: less than 5 calories/serving ▫Sugar: less than 0.5 g/serving ▫Sodium: less than 5 mg/serving ▫Fat: less than 0.5 g/serving ▫Saturated fat: less than 0.5 g per referenced amount ▫Cholesterol: less than 2 mg/serving Low ▫Calorie: less than 40 calories/serving ▫Sodium: less than 140 mg/serving ▫Very low sodium: 35mg or less ▫Fat: less than 3 g/serving ▫Saturated fat: less than 1 g/serving ▫Cholesterol: less than 20 mg/serving and 2 g or less saturated fat

13. Nutrition Claims- What do they really mean? Lean & Extra Lean ▫Lean: less than 10 g fat, 4.5 g saturated fat, and 95 mg cholesterol per serving/per 100 g ▫Extra lean: less than 5 g fat, 2 g saturated fat, and 95 mg cholesterol per serving/per 100 g High ▫Must contain >20% DV for that nutrient ▫“Rich in” ▫“High” ▫“Excellent source of”

14. Nutrition Claims- What do they really mean? Reduced ▫Must contain at least 25% less of the nutrient or calories than that of the referenced product More ▫Must contain a nutrient that is at least 10% of the DV or more than the referenced product ▫“Fortified, enriched, and added” nutrients

15. Nutrition Claims- What do they really mean? Light ▫Must be nutritionally altered ▫40 calories or less, 3 grams of fat, and 50% less sodium than the original product % Fat Free ▫Must be a low-fat or fat-free product ▫The claim must reflect the amount of fat in 100 grams of the food ▫i.e. if a food has 2.5 grams of fat in 50 grams the claim is 95% fat free Healthy or Fresh ▫Has a specific meaning related to special foods.

16. Can you name any foods you recently consumed making any these nutrition claims?

17. Health Claims A food is misbranded if a claim is made in relation to a nutrient and disease if not approved by FDA. Including: ▫Third party references ▫Written statements ▫Symbols ▫Vignettes

18. Approved Health Claims Calcium/Osteoporosis Fat/Cancer Saturated fat/cholesterol/CHD Fiber/Cancer Fiber/Risk for CHD Sodium/HTN Fruits & Vegetables/Cancer Folic acid/Neural tube defects Sugar alcohols/Dental caries Fiber from whole oats/CHD

19. USDA Regulated Products Regulated by FSIS Packaging requires: ▫Name of product ▫List of ingredients in descending order ▫Name/place of business or the manufacturer ▫Net quantity of contents ▫Nutrition label including Nutrition Facts box ▫Safe handling statements

20. DSHEA Dietary Supplement Health Education Act (1994) Allowed manufacturers of dietary supplements to make health claims which describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans Examples: “Calcium builds strong bones”

21. DSHEA Characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function Example: “fiber maintains normal bowel function” or “antioxidants maintain cell integrity

22. DSHEA Describe general well-being from consumption of a nutrient Claim could also describe a benefit related to a nutrient deficiency ▫Example: vitamin C and scurvy

23. DSHEA: What it really means… Expanded the legal definition of a dietary supplement to include herbal, botanical, and diet products Manufacturers no longer had to demonstrate the safety of the product before selling The FDA had to prove product was unsafe before it was taken off the market

24. Requirements for Claims #1: You can make the claims if you have substantiated that the claims are truthful and not misleading (not specified) #2: Must notify the FDA w/in 30 days of using the claim #3: Must have disclaimer

25. Health Claim vs. Disease Claim Disease claim ▫Requires the product to be regulated by the FDA as a drug ▫Clinical trials to prove safety and efficacy Health Claim: ▫CANNOT mention and specific disease or identifiable signs/sx of a specific disease ▫CANNOT use word such as treat, diagnose, prevent, cure, or mitigate

26. Disease Claim Criteria 1.Claims an effect on a disease or class of diseases 2.Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology 3.Claims an effect on a condition associated with a natural state or process 4.It is an implied disease claim because of the product name, formulation, use of pictures, or other factors 5.Claims that a product belongs to a class of products that is intended to diagnose, mitigate, treat, cure or prevent a disease 6.Claims to be a substitute for a product that is a therapy for a disease 7.Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure or prevent a disease 8.Has a role in the body’s response to a disease or to a vector of disease 9.Claims to treat, prevent or mitigate adverse events associated with a therapy for a disease 10.Otherwise suggests an effect on a disease or diseases

27. Consequences of Deregulation May or may not work ▫Manufacturer doesn’t prove efficacy May contain harmful ingredients or may not contain active ingredient Examples ▫ Vitamin A ▫Vitamin E ▫Ephedra

28. Question Does it make sense to regulate supplements in this way? What should we tell consumers?