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Food Regulation

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Страница 1 Table of Contents List of Tables List of Illustrations Guide Pages Страница 7Страница 8Страница 9Страница 10Страница 11Страница 12Страница 13Страница 14 1 INTRODUCTION TO FOOD REGULATION IN THE UNITED STATES 1.1 INTRODUCTION 1.2 A SHORT HISTORY OF FOOD REGULATION IN THE UNITED STATES 1.2.1 Why Do We Have Food Laws? 1.2.2 The 1906 Pure Food and Drug Act 1.2.3 Evolution of the Food Statutes NOTE 1.3 THE U.S. LEGAL SYSTEM 1.3.1 The Constitution ¹⁷ 1.3.2 Statutes 1.3.3 Regulations 1.3.4 Case Law and Common Law 1.3.5 Federalism 1.4 AGENCY PROCEDURAL REGULATION 1.4.1 The Administrative Procedure Act 1.4.2 Rulemaking 1.4.3 Adjudication 1.4.4 Judicial Review 1.4.5 Federal Advisory Committee Act (FACA) NOTES AND QUESTIONS 1.4.6 Freedom of Information Act (FOIA) 1.4.7 Constitutional Limitations on Agency Power Free Speech Searches Self‐Incrimination Due Process Just Compensation for the Taking of Private Property Equal Protection Privacy Rights 1.5 AGENCY JURISDICTION 1.5.1 Food and Drug Administration ⁴⁸ (FDA) Oversees Food Safety Role 1.5.2 Centers for Disease Control and Prevention (CDC) Food Safety Role 1.5.3 USDA Food Safety and Inspection Service (FSIS) Oversees Food Safety Role 1.5.4 U.S. Environmental Protection Agency (EPA) Oversees Food Safety Role 1.5.5 National Marine Fisheries Service (NMFS) Oversees Food Safety Role 1.5.6 Alcohol and Tobacco Tax and Trade Bureau (TTB) Oversees Food Safety Role 1.5.7 U.S. Customs and Border Protection (CBP) Oversees Food Safety Role 1.5.8 U.S. Department of Justice (DOJ) Food Safety Role 1.5.9 Federal Trade Commission (FTC) Oversees Food Safety Role NOTE 1.5.10 State and Local Governments QUESTION 1.6 MAJOR FEDERAL LAWS 1.6.1 The Main Statutes Food, Drug, and Cosmetic Act (FD&C Act) Federal Meat Inspection Act (FMIA) Poultry Products Inspection Act (PPIA) Egg Products Inspection Act (EPIA) 1.6.2 Other Statutes The Food Additive Amendment of 1958 The Color Additive Amendment of 1960 Food Quality Protection Act (FQPA) in 1996 FDA Modernization Act of 1997 Food Safety Modernization Act (FSMA) in 2011 1.6.3 The Regulations 1.7 INFORMATIONAL RESOURCES 1.7.1 Government Agencies 1.7.2 Associations and Trade Groups 1.7.3 Other Sources APPENDIX: CONSTITUTIONAL AMENDMENTS I THROUGH X (THE BILL OF RIGHTS) Notes 2 WHAT IS FOOD? 2.1 INTRODUCTION TO THE FOOD, DRUG, AND COSMETIC ACT 2.1.1 Definitions 2.1.2 FDA’s Jurisdiction and the Definition of Food NOTE AND QUESTION 2.1.3 Specific Food Classifications Meat, Poultry, and Processed Eggs Water 2.2 WHAT MAKES AN ARTICLE A FOOD OR A DRUG? 2.3 THE CENTRAL ROLE OF INTENDED USE 2.3.1 Products Ordinarily Considered Foods 2.3.2 Evidence of Intended Use 2.4 OTHER CONSIDERATIONS 2.4.1 Products Intended to Be Processed into Food 2.4.2 Products No Longer Fit for Food 2.4.3 Packaging Materials DISCUSSION QUESTIONS Notes Страница 95 3 FOOD LABELING 3.1 INTRODUCTION 3.2 LEGAL AUTHORITIES 3.3 LABELING TERMINOLOGY 3.3.1 Label Versus Labeling The Scope of Labeling 3.3.2 Labeling Versus Food Advertising 3.3.3 The Internet and Labeling QUESTIONS AND NOTES 3.4 AFFIRMATIVE LABEL REQUIREMENTS 3.4.1 Label Terms Principal Display Panel (PDP) Information Panel 3.4.2 Statement of Identity Prominence Standardized Foods Undefined Foods—Common or Usual Name Forms of a Food Fanciful Names Misleading Names QUESTIONS What’s in a Name? Lean Finely Textured Beef A.K.A. “Pink Slime” NOTES AND QUESTIONS Artificially Flavored Imitation Beverages Containing Juice 3.4.3 Net Quantity Metric Moisture Loss NOTE 3.4.4 Ingredient Declaration NOTES 3.4.5 Name and Address of the Responsible Party 3.4.6 Labeling Special Circumstances Product Dates and Codes NOTES 3.5 MISBRANDED FOOD: PROHIBITED REPRESENTATIONS 3.5.1 SEC. 403. Misbranded DISCUSSION QUESTION DISCUSSION QUESTIONS False or Misleading as a Matter of Law NOTES AND QUESTIONS Discussion NOTES AND QUESTIONS The Battles Over Labeling Substitute Foods Soymilk You Say Meat, I Say ‘Schmeat 3.6 DECEPTIVE PACKAGING 3.7 WARNING STATEMENTS 3.7.1 Product Requiring Warning Statements 3.7.2 Food Labeling Warning and Notice Statements, 21 C.F.R. 101.17 NOTES 3.8 ALLERGENS Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) 3.8.1 Petitions for Exemption 3.8.2 Notifications for Exemption NOTES 3.8.3 Gluten Gluten Free NOTE 3.9 ALCOHOLIC BEVERAGES Allergen Labeling General Labeling Requirements Label Approval Warning Statement Wine Coolers versus Flavored Wine NOTES 3.10 USDA FSIS 3.10.1 Labeling Approval 3.10.2 “Generic” Approvals (Labels Without Prior Approval) 3.10.3 Safe Food Handling Instructions Raw Meat and Poultry Safe Handling Instructions 3.10.4 Additional Information Required 3.10.5 Recordkeeping Notes 4 NUTRITIONAL LABELING AND NUTRIENT LEVEL CLAIMS 4.1 INTRODUCTION NOTES AND QUESTIONS 4.2 THE NUTRITION LABELING AND EDUCATION ACT (NLEA) 4.3 THE NUTRITION FACTS PANEL 4.3.1 The Nutrients 4.3.2 Daily Value (DV) DRVs RDIs 4.3.3 Nutrition Facts Format ⁶ Standard Dual Column8 Simplified Format Food for Infants and Children Small and Intermediate‐Size Packages Shortened Format11 Aggregate Display 4.3.4 Serving Sizes RACC Discrete Units 50 Percent or Less of the RACC13 More Than 50 Percent but Less Than 67 Percent of the RACC14 67 to 200 Percent of the RACC15 200 Percent or More of the RACC16 Additional Rules on Determining Serving Size Individual Units in a Multiserving Package20 Products Sold in Individual Containers Containing Less Than 200 Percent of the RACC21 4.3.5 Declaration of Serving Size Common Household Measures 4.3.6 Specific Exemptions to Nutrition Facts Labeling Small Businesses No Nutritional Significance26 Dietary Supplements27 Medical Foods28 Bulk Shipments29 Raw Fruits and Vegetables and Fish30 Small Packages31 Bulk Containers32 DISCUSSION QUESTION 4.4 TRANS FATS 4.4.1 Background on Trans Fat 4.4.2 Petition to Ban Hydrogenated Oil 4.4.3 The Trans Fat Labeling Rule 4.4.4 Partially Hydrogenated Oil De‐GRASed 4.5 NLEA AND RESTAURANTS 21 C.F.R. § 101.10 Nutrition labeling of restaurant foods DISCUSSION QUESTION 4.6 MENU AND VENDING MACHINE LABELING REQUIREMENTS 4.6.1 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 4.6.2 Calorie Labeling of Articles of Food in Vending Machines 4.6.3 State and Local Preemption 4.6.4 Voluntary Election Covered by the Law NOTE 4.7 NUTRIENT CONTENT CLAIMS (NUTRIENT LEVEL DESCRIPTORS) 4.7.1 Definition 4.7.2 Express versus Implied Claims 4.7.3 Core Nutrient Level Descriptors Relative Claims83 Sugar Claims84 Inherent Claims85 Nutrient Statements That Are Not Nutrient Content Claims 4.7.4 Meals and Main Dishes 4.7.5 Modifications of Standardized Foods 4.7.6 Disclosure Statements ⁹⁰ 4.7.7 Foods Intended for Infants 4.7.8 Exemptions Brand Names Diet Soft Drinks Terms in Standardized Food Names 4.7.9 Statements That Are Not Implied Claims 4.7.10 New Nutrient Content Claim Approvals Authoritative Statement (FDAMA) Claims Choline Content Claims Omega‐3 Nutrient Content Claims 4.7.11 Nutrient Content Claims Absent a Daily Value 4.8 FDA’S FORTIFICATION POLICY NOTE DISCUSSION QUESTIONS AND NOTES Notes 5 HEALTH CLAIMS 5.1 BACKGROUND 5.2 DEFINITIONS 5.2.1 The Categories of Health Claims 5.2.2 Summary of the General Requirements for Health Claims 5.2.3 Disqualifying Levels of Nutrients 5.2.4 Jelly Bean Rule 5.3 HEALTH‐RELATED CLAIMS THAT ARE NOT REGULATED AS HEALTH CLAIMS 5.3.1 General Well‐Being Claims 5.3.2 Structure–Function Claims 5.3.3 Dietary Guidance 5.3.4 Nutrient Content Claims 5.4 PREAPPROVED HEALTH CLAIMS (NLEA) 5.4.1 Calcium and Osteoporosis ¹⁶ Claim Requirements 5.4.2 Dietary Fat and Cancer ¹⁷ Requirements 5.4.3 Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease ¹⁸ Requirements 5.4.4 Sodium and Hypertension (High Blood Pressure)¹⁹ Requirements 5.4.5 Fiber‐Containing Grain Products, Fruits, and Vegetables and Cancer ²⁰ Requirements 5.4.6 Fruits, Vegetables, and Grain Products that Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease ²¹ Requirements 5.4.7 Fruits and Vegetables and Cancer ²² Requirements 5.4.8 Folate and Neural Tube Birth Defects ²³ Requirements 5.4.9 Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries (Cavities)²⁴ Requirements 5.4.10 Dietary Soluble Fiber, Such As That Found in Whole Oats and Psyllium Seed Husk, and Coronary Heart Disease ²⁵ Requirements 5.4.11 Soy Protein and Coronary Heart Disease ²⁶ Requirements 5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols ²⁷ Requirements 5.5 AUTHORITATIVE STATEMENTS – FDA MODERNIZATION ACT 5.6 QUALIFIED CLAIMS 5.6.1 Restricting Commercial Speech 5.6.2 Compelling Commercial Speech NOTE 5.6.3 Pearson v. Shalala ³⁸ NOTES AND QUESTIONS 5.6.4 FDA’s Changes After Pearson 5.6.5 The FDA‐Accepted Qualified Health Claims NOTES AND DISCUSSIONS 5.6.6 The Pearson Claims Revisited 5.6.7 Assessing Significant Scientific Agreement NOTES 5.6.8 Guidance for Qualified Health Claims NOTE AND DISCUSSION 5.7 SUBSTANTIATION OF CLAIMS 5.7.1 FDA’s Evidence‐Based Review System 5.7.2 Substantiation of Dietary Supplement Claims Example 1: Example 2: Example 3: Example 4: Example 5: Example 10: 5.8 MEDICAL FOODS 5.9 THERAPEUTIC AND RELATED DISEASE CLAIMS 5.9.1 Marketing an Unapproved New Drug 5.9.2 Misbranded Drug Violations Based on Inadequate Directions for Use Notes {buyButton}

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