DeWitty on Dietary Supplement Law

Front Matter

• Front Matter

PART I The United States Legal Structure

• PART I The United States Legal Structure

CHAPTER 1 The United States Legal Structure

• CHAPTER 1 The United States Legal Structure
• §1.1 Sources and Hierarchy of Law
• §1.2 The Judiciary
• §1.3 State Governments
• §1.4 Judicial Review
• §1.5 Arbitrary and Capricious Standard; De Novo Review
• §1.6 Nature and Scope of De Novo Judicial Review
• §1.7 Judicial Review of FDA Final Agency Action or Inaction ("Final Action")

PART II Development of United States Food and Drug Law; Food Additives; Dietary Supplements

• PART II Development of United States Food and Drug Law; Food Additives; Dietary Supplements

CHAPTER 2 Legal Development Prior to 1994

• CHAPTER 2 Legal Development Prior to 1994
• §2.1 Defining "Food" and "Drug" Mid-to-Late 19th Century
• §2.2 Adulteration and Misbranding Under 1906 Act
• §2.3 Act of 1938
• §2.4 Technology, Market Segmentation, and Food Law: 1938-1958
• §2.5 Foods for Special Dietary Uses and Food Additives: 1970-1990

CHAPTER 3 Scientific Aspects of Dietary Supplements

• CHAPTER 3 Scientific Aspects of Dietary Supplements
• §3.1 Natural Products and Herbs
• §3.2 Method of Treatment Using Natural Products and Herbs
• §3.3 Chemicals in Plants and Food (e.g., Fertilizers and Preservatives)
• §3.4 Dietary Supplement Market in the United States

PART III The 1994 Dietary Supplement and Health Education Act; New Dietary Ingredients; Pre-Market Notification

• PART III The 1994 Dietary Supplement and Health Education Act; New Dietary Ingredients; Pre-Market Notification

CHAPTER 4 Legislation Leading to DSHEA: 1990-1994

• CHAPTER 4 Legislation Leading to DSHEA: 1990-1994
• §4.1 Enactment of NLEA
• §4.2 Judicial Rulings
• §4.3 Enactment of the Dietary Supplement and Health Education Act of 1994 (DSHEA)

CHAPTER 5 Pre-market Notification

• CHAPTER 5 Pre-market Notification
• §5.1 "Pre-market Notification" for New Dietary Ingredients
• §5.2 "A dietary supplement . . ."
• §5.3 ". . . shall be deemed adulterated . . ."
• §5.4 ". . . under Section 402(f) unless it meets on of the following . . ."
• §5.5 First Scenario to Overcome Assumption of Adulteration: ". . . contains . . . dietary ingredients . . . which have been present in the food supply . . . in a form . . . [that] has not been chemically altered . . ."
• §5.6 Second Scenario to Overcome Assumption of Adulteration: Pre-market Notification Filing
• §5.7 The Manufacturer's or Distributor's Conclusion

CHAPTER 6 Filing Pre-market Notifications FDA Procedural Regulations (Henceforth "Manufacturer")

• CHAPTER 6
• §6.1 Name and Complete Address of Manufacturer or Distributor (Henceforth "Manufacturer")
• §6.2 The Name of the New Dietary Ingredient and the Latin Binomial Name (Including Author) of Any Herb or Other Botanical
• §6.3 A Description of the Dietary Supplement Containing the New Dietary Ingredient
• §6.4 Submission of Information Showing History of Use or Other Evidence of Safety
• §6.5 Signature of Person Designated by Manufacturer
• §6.6 Method of Filing Pre-market Notifications COSM

CHAPTER 7 Post-notification Filings

• CHAPTER 7 Post-notification Filings
• §7.1 After Submission
• §7.2 "Approval" Letter or "Rejection" Letter?
• §7.3 Responding to Communications Received from FDA
• §7.4 De Novo Judicial Review

CHAPTER 8 Intellectual Property Protection and Ancillary Issues Relating to Dietary Supplements and New Dietary Ingredients

• CHAPTER 8 Intellectual Property Protection and Ancillary Issues Relating to Dietary Supplements and New Dietary Ingredients
• §8.1 Intellectual Property (IP) Backgrounder
• §8.2 Petition for Issuance of Order
• §8.3 Affect of "Rejected" Notification on Dietary Supplement with New Dietary Ingredient Importation

CHAPTER 9 Marketing Material, Labeling, and Labels for Dietary Supplements with New Dietary Ingredients

• CHAPTER 9 Marketing Material, Labeling, and Labels for Dietary Supplements with New Dietary Ingredients
• §9.1 Scientific Studies as Marketing Material
• §9.2 Structure/Function Claims
• §9.3 Health Claims
• §9.4 Formatting Dietary Ingredient Labels and Labeling

CHAPTER 10 Pertinent U.S. Federal Agencies and Offices

• CHAPTER 10 Pertinent U.S. Federal Agencies and Offices
• §10.1 U.S. Department of Justice (DOJ)
• §10.2 Food and Drug Administration (FDA)
• §10.3 Center for Food Safety and Applied Nutrition (CFSAN)
• §10.4 Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS)
• §10.5 National Institute of Health (NIH)
• §10.6 Office of Dietary Supplements
• §10.7 U.S. Customs & Border Protection (CBP)
• §10.8 Federal Trade Communication (FTC)

PART IV Special Topics

• PART IV Special Topics

CHAPTER 11 Brief: Codex Alimentarius (Codex) Commission

• CHAPTER 11 Brief: Codex Alimentarius (Codex) Commission
• §11.1 History
• §11.3 Food for Special Dietary Uses
• §11.4 Claims
• §11.5 Nutrient Claims

CHAPTER 12 Cannabis-Derived Products as Dietary Supplements

• CHAPTER 12 Cannabis-Derived Products as Dietary Supplements
• §12.1 Overview
• §12.2 Enforcement and Regulation of Cannabis-Derived Ingestible Products
• §12.3 State Regulation of Cannabis-Derived Ingestible Products, Including Hemp-Derived Supplements, CBD Containing Products, and THC Containing Products

Table of Cases

• Table of Cases

Index

• Index