Roseann B. Termini, Esq.

Transcription

1 Food Labeling and Food Safety Kind, Naked and Legal Issues... Do you Know who Really regulates Your Pizza and Where Your Beef is From? What is Smart About FOP Labelling? Roseann B. Termini, Esq.

2 Roseann B. Termini, Food and DrugLaw: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulations c Roseann B. Termini, Esq., All rights reserved. Unauthorized use strictly prohibited by law. 2

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4 Key Objective Make it COOL 4

5 Real Objectives Increase Awareness Discuss Current Issues Predict the Future 5

6 Overview Historical Perspective Regulations and Definitions Product Label Exercise Future Trends 6

7 Historical Perspective 1906 Federal Food and Drugs Act 1913 The Gould Amendment 1924 In U.S. v. 95 Barrels Alleged Apple Cider Vinegar 1938 The Federal Food, Drug, and Cosmetic Act 1957 The Poultry Products Inspection Act authorizes USDA 7

8 Historical Perspective - Continued 1966 The Fair Packaging and Labeling Act 1960 s White House Conference: Food and Nutrition 1967 Federal Meat Inspection Act 1977 Saccharin Study & Labeling Act 1988 Surgeon General C. Everett Koop formal recognition of the role of diet in certain chronic diseases 1988 Official FDA agency with Presidential appointment of the FDA Commission 8

9 Historical Perspective 1990 Nutrition Labeling and Education Act 1992 Policy Statement Applicable to Foods Developed from New Plant Varieties 1993 FDA issues the final regulations implementing NLEA 1993 Seven Health Claims approved 1994 Nutrition labeling of meat and poultry Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) 9

10 MILESTONE LEGISLATION 1997 Food and Drug Administration Modernization Act 2007 FDA Amendments Act 2010 Mandatory Restaurant Labelling 2011 Food Safety Modernization Act 2014 FDA Safety and Innovation Act 10

11 Who REALLY has Jurisdiction over your Pizza? What type of pizza? Who has primary jurisdiction? What issues are involved with Jurisdictional Overlap? 11

12 Overview FDA responsible for assuring safety, wholesomeness, and labeling of foods sold in the US (includes imports) Labeling terminology defined by FDA Most foods must bear nutrition labeling Specific compliance is required for nutrient and health claims Food industry responsibility to keep current Federal Register, Title 21CFR101 annual updates, FDA 12

13 Regulations and Definitions Function of Labels Compliance with regulations (21CFR101) Provide information about the product Differentiate product from competitors Inform consumers on how to use or prepare product Warn consumers about potential problems or improper use Provide manufacturer contact information 13

14 Regulations and Definitions Nutritional Label 14

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16 Original Proposed

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19 Regulations and Definitions Nutrient Claims Government defines core terms Free Low Lean Extra Lean High Good Source Reduced Less Fewer Light More Healthy 19

20 Regulations and Definitions Nutrient Claims Other Terminology New and improved Fresh Imitation Juice/Drink/Beverage 20

21 Regulations and Definitions Health Claims Any claim on the package label or on other labeling of a food that characterizes the relationship of any nutrient or other substance in the food to a disease or healthrelated condition 21

22 Approved Health Claims Significant Scientific Agreement Calcium and Osteoporosis - amended to include Vitamin D Dietary Saturated Fat and Coronary Heart Disease Risk Dietary non-carcinogenic Carbohydrate Sweeteners and Dental Caries Fiber Containing Grain Products, Fruits and Vegetables- Reduced Risk of Cancer 22

23 Approved Health Claims Significant Scientific Agreement Folic acid and Decreased Neural Tube Defects Fruits, Vegetables and Cancer Soluble Fiber and Reduced Coronary Heart Disease Risk Sodium and Hypertension Soy Protein and Reduced Risk of Coronary Heart Disease Stanols/Sterols and Reduced Risk of Coronary Heart Disease 23

24 Health Claims FDAMA Health Claims Authoritative Statement Authoritative Statement Scientific Authority Examples: Choline Potassium and High Blood Pressure Stroke Risk Whole Grain Foods and Cancer and Heart Disease Risk 24

25 Health Claims Qualified FDA Categories: GRADES B Evidence not conclusive C Evidence is limited D Evidence is little Where is Category A? 25

26 Health Claims Qualified Claim Example Nuts and Heart Disease 26

27 Structure Function Claims Role of nutrient or dietary ingredient intended to affect normal structure in humans Example: Calcium builds strong bones 27

28 Nutrient Content Claims Characterizes LEVEL of a nutrient in a food Key is consistency Example lite 28

29 Regulations and Definitions Labeling Exemptions Some food served for immediate consumption Read-to-eat foods not for immediate consumption but prepared on site Food shipped in bulk if not for sale in that form Medical foods Plain coffee and tea, some spices and flavor extracts, and other foods with no significant nutrient content 29

30 Preemption And now we interrupt your regular TV show to bring you a special program on. 30

31 Preemption 31

32 The Restaurant Disclosure Dilemma Settled by the 2010 Health Care Legislation Patient Protection and Affordable Care Act of 2010, 4205 Chain restaurants 32

33 Impetus for Legislation- New York City Board of Health disclosure regulation Other local governments and states followed NY City Board of Health. 33

34 Disclosure 20 or more locations Disclosure- nutrient content information Vending Machines and Restaurants Regulations effective date of Dec extended until Final Guidance issued. 34

35 Product Statement on Labeling and Packaging Labels can comply with existing regulations; however, confusing- misleading to consumers. Ex. Real Fruit 35

36 The "Fruit Juice" Statement and the Displayed Images Williams v. Gerber Products Company 36

37 WILLIAMS V. GERBER Think about this: Do you agree with the court s decision that the pictures of real fruit and other labeling constituted misbranding? 37

38 Kind What do you think? Kind Warning Letter c Roseann B. Termini, Esq., All rights reserved. Unauthorized use strictly prohibited by law. 38

39 Naked Name Implications c Roseann B. Termini, Esq., All rights reserved. Unauthorized use strictly prohibited by law. 39

40 Smart Choices Program 40

41 Smart Choices Program The 17 Warning Letters

42 Smart Choices Program Request for Comments for Front of Package Labelling c 42

43 Smart Choices Program 2016 Smart is Back Think About It... Could the FOP Smart Choice Program work in Tandem with the FDA Proposed Label? c 43

44 C O O L Background Country of Origin Labelling (COOL) Farm Security and Rural Investment Act (2002 Farm Bill) Amended the Agricultural Marketing Act Suppliers provide information to Retailers Retailer notification for Shellfish and Fish: April

45 C O O L Exemption: If Covered Commodity is an Ingredient in Processed Food Item 45

46 C O O L 2008 Farm Bill expanded food commodities Requires the retailers to notify consumers of the country of origin of beef, lamb, pork, chicken, goat meat, peanuts, pecans, macadamia nuts, fruits and vegetables, ginseng Applies to domestically produced commodities 46

47 How to notify COOL Notification label, sticker, twist tie Product of the United States Grown in Mexico 47

48 C O O L Who must keep COOL records? Suppliers Retailers 48

49 COOL Enforcement Industry outreach Fines imposed only after finding that retailer and or supplier failed to make good faith effort to comply Willful violation 49

50 COOL and WTO Beef and Pork: COOL Rescinded H.R Consolidated Appropriations Act, Why COOL Rescinded- WTO barriers 50

51 Gluten-Free Labeling of Foods Voluntary Labelling Must Meet Specified Parameters 51

52 PHOs Partially Hydrogenated Oil FDA 2015 Determination Not GRAS (not generally recognized as safe) How Issued-Order specific to Ban 3 year phase out 52

53 Hot Topic ISSUES FSMA GE/GMO/Biotechnology still controversial ex. Vermont Functional Foods/Pharmafoods/Nutraceuticals Cloned meat safety issues and consumer perception Natural definition 53

54 Food Safety Modernization Act Final Rules Administrative Detention (2013) Preventive Controls Risk Based and CGMPs (2015) Produce Safety (2015) Foreign Supplier Verification for Importers-Animal and Human Food(2015) Accreditation-3 rd Party (2015) 54

55 FSMA Proposed Rule Focused Mitigation Strategies to Protect Food Against Intentional Adulteration 55

56 GMO Controversy: Industry vs. Right to Know State vs. Federal Vermont as an Example 56

57 Natural How to Define Historical Background FDA did not define Why not? Why address now? 57

58 OPEN FORUM DISCUSSION Communication Cooperation Coordination Proactive 58

59 Clarity 59

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63 Roseann B. Termini, Food and DrugLaw: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulations (2015) c Roseann B. Termini, Esq., All rights reserved. Unauthorized use strictly prohibited by law. 63

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65 Contact Information Publications SSRN Author page All Topics Food and Drug Law Blog