Food and Drug Law Outline

 
Muchmore, Food and Drug Regulation Fall 2013
 
Outline of Class Sessions
 
            Introduction
1)  Regulatory Categorization
2)  Administrative Practice and Procedure
3)  Guidance Documents and 1906/1938 Statutes
 
            Food and Dietary Supplements
1) Adulteration and Misbranding; Labeling
2) Food Standards; Imitation Food
3) Nutrient Content Labeling
4) Introduction to Dietary Supplements
5) Food Safety
6) Label Claims for Food and Dietary Supplements
7) Food and Color Additives
8) Agricultural Biotechnology
 
            Drugs, Biologics, Medical Devices, and Cosmetics
1) Introduction to Human Drugs
2) Drug Development and Approval
3) Pioneers and Generics
4) Over-the-Counter and Prescription Drugs
5) Advertising
6) Off-Label Use
7) Post-Market Surveillance
8) Animal Drugs
9) Intro to Biologics
10) Vaccines
11) Blood; Human Tissue; Other Biologics
12) Device Classification
13) Pre-Market Approval
14) Substantial Equivalence
15) Postmarket Surveillance
16) Radiation-emitting Products
17) Cosmetics
 
            Additional Concerns
1) FDA Enforcement
2) State Regulation and Private Enforcement
3) Federal Preemption
4) False Claims Act
5) Affirmative Civil Enforcement
6) Imported Products
 
Historic Timeframe
 
Important Food and Drug Statutes
§  Food and Drugs Act (1906)
§  Federal Food, Drug, and Cosmetic Act (1938)
§  Kefauver-Harris Drug Amendments (1962)
§  Medical Device Amendments (1976)
§  Food & Drug Administration Act (1988)
§  Dietary Supplement Health and Education Act (1994)
§  Family Smoking Prevention and Tobacco Control Act (2009)
§  FDA Food Safety Modernization Act (2010)
 
Three Phases of Federal Food and Drug Law
First Phase (1906-1937)
            Pure Food and Drug Act
            Meat Inspection Act
            Gould Amendment
            McNary-Mapes Amendment
Second Phase (1938-1975)
            Federal, Food, Drug, and Cosmetic Act
            Wheeler-Lea Act
            Miller Pesticide Amendment
            Poultry Products Inspection Act
            Food Additives Amendment (including the Delaney/0 carcinogen Clause)
            Color Additives Amendment
Third Phase (1976-Today)
            Medical Device Amendments
            Food and Drug Administrative Act
            Nutrition Labeling and Education Act (NELA)
            Dietary Supplement and Health Education Act (DSHEA)
            Food and Drug Administration Modernization Act
            Food Allergen Labeling and Consumer Protection Act
            FDA Food Safety Modernization Act         
 
 
 
 
 
 
 
 
 
 
 
 
List of Key Cases
 
1)     U.S. v. Bacto-Unidisk
2)     Abbott Labs
3)     National Ass’n of Pharma Mfrs v. FDA
4)     Central Hudson v. Public Service Commission of New York
5)     Shalala
6)     Whitaker v. Thompson
7)     Gardner v. Toilet Goods
8)     Abigail Alliance v. Von Eschenbach
9)     Weinberger v. Bentax
10)American Public Health v. Veneman
11)United States v. Generix
12)Washington Legal Foundation v. Henney
13)United States v. Caronia
14)Gardner v. Toilet Goods
15)Heckler v. Chaney
16)U.S. v. Park
 
 
FDA Regulation
 
            Two Primary Sources
                        1) Federal Food, Drug, & Cosmetic Act (FFDCA)
                                    – Source of FDA’s authority
                        2) FDA Regulations (Title 21 of Code of Federal Regulations)
 
            One Secondary Source
1)     Guidance Documents (Not law, but still matter)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Core Definitions
 
            Food à FFDCA 201(f)
(1)  Articles used for food or drink
(2)  Chewing gum
(3)  Articles used for components of any such article
 
            Drug à FFDCA 201(g)(1)
                        (B) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
                       
            Device à FFDCA 201(h)(1)
                        An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, including a component or part, or o