Required Text

1. Introduction
   1. History and Overview
      1. Peter Hutt, The Transformation of United States Food and Drug Law
   2. Product Categories and Intended Use
      1. Drugs
         1. Handouts
         2. United States v. An Article of Drug . . . Bacto-Unidisk
         3. United States v. Article of Drug . . . Ova II
         4. Example: Complaint for Forfeiture, In Rem: United States v. Undetermined Quantities of Boxes
         5. Problem #1: The Battle Against Bad Breath
      2. Role of "Intended Use" in Regulation
         1. Problem #2: Toothbrush Gum Disease Claims
         2. Problem #3: Lollipops With Licorice to Prevent Tooth Decay, handouts
         3. Problem #4: Genetically Modified Bacteria to Prevent Tooth Decay, handouts
      3. Cosmetics
         1. U.S. Food and Drug Administration, Center for Applied Nutrition, Is It A Cosmetic, A Drug, Or Both?
         2. Lecture: Chemical Components of Cosmetics and Lack of Premarket Testing
         3. Problem #5: Age Intervention Eyelash, by Jan Marini, handouts
      4. Nanotechnology and Cosmetics
         1. Products Liability Overview Lecture
         2. Problem #6: Chanel Precision Calming Emulsion, handouts
         3. Problem #7: Product Liability for New Technologies: What about the Canaries?
      5. Dietary Supplements
         1. Nutritional Labeling and Education Act, handouts; Dietary Supplements Health Education Act Overview, handouts
         2. Whitaker v. Thompson
         3. United States v. Lane Labs-USA, Inc.
         4. Nutraceutical Corp. v. Von Eschenbach
         5. Problem #8: Orexus: Dietary Supplement Marketing Exercise
         6. Problem #9: Caffeine
         7. FDA Warning Letters, handouts
      6. Medical Devices
         1. Alabama Tissue Center v. Sullivan
         2. United States v. Bowen
         3. United States v. An Undetermined Number of Unlabeled Cases
      7. New Drugs
         1. United States v. 50 Boxes More or Less
   3. Adulteration, Misbranding, and the Practice of Medicine
      1. United States v. An Article . . . Acu-dot
      2. United States v. Evers
      3. Retkwa v. Orentreich
   4. Food
      1. Food
      2. Food Additives
      1. Handouts
      2. United States v. Two Plastic Drums
      3. Genetically Modified Foods
         1. What are GM Foods?
         2. Product Liability for GM Foods:
            1. The Introduction of Biotech Foods to the Tort System, pp. 1668-1705
            2. What About the Canaries: Part II
   5. FDA Practice and Procedures
      Peter Barton Hutt, The Transformation of United States Food & Drug Law
      1. Adjudication
         1. United States v. Alcon Laboratories
         2. United States v. Superpharm Corp.
         3. United States v. Universal Management Services, Inc.
         4. United States v. Dotterweich
      2. Rulemaking
         1. National Association of Pharmaceutical Mfrs. v. FDA
      3. Informal Mechanisms
         1. United States v. Bioclinical Systems, Inc.
         2. Washington Legal Foundation v. Kessler
   6. Other Actors
      1. Federal Agencies
         1. American Pharmaceutical Association v. Weinberger
      2. State Regulators
         1. Rayford v. Texas
         2. Dowhal v. SmithKline Beecham Consumer Healthcare
         3. Committee of Dental Amalgam Mfrs. v. Stratton
         4. Whalen v. Roe