food and drug law - gbv · food and drug law cases and materials second edition by peter barton...
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FOOD AND DRUG LAW
Cases and Materials
SECOND EDITION
By
PETER BARTON HUTT
Covington & Burling, Washington, D.C.
and
RICHARD A. MERRILLAlbert C. Tate, Jr. Professor of Law, University of Virginia
Westbury, New YorkTHE FOUNDATION PRESS, INC.
1991
SUMMARY OF CONTENTS
PagePREFACE TO THE 1980 EDITION xxi
PREFACE TO THE 1991 EDITION xxv
ACKNOWLEDGEMENTS ..xxxiTABLE OF CASES lxix
CHAPTER I. HISTORICAL BACKGROUND
A. EARLY REGULATION OF FOOD AND DRUGS 1B. STATUTORY AND INSTITUTIONAL HISTORY 4
1. The Food and Drug Administration 42. The Evolution of Federal Food and Drug Legislation .... 63. Other Laws Enforced by FDA. 14
C. FDA'S STRUCTURE AND ORGANIZATION 15D. THE REGULATORY ENVIRONMENT 18E. FDA'S MISSION AND RESOURCES 21
CHAPTER II. FOOD
A. DEFINITION OF "FOOD" 23B. REGULATION OF FOOD LABELING 36
1. Historical Overview 362. Scope of "Labeling" 433. Labeling Requirements of Section 403 514. Deceptive Packaging 635. Weight Labeling 696. Ingredient Labeling 747. Label Warnings 82
C. REGULATION OF FOOD IDENTITY AND QUALITY 841. Premises of Regulation.. 842. Economic Adulteration 883. Food Standards of Identity 964. Food Names 1175. "Imitation" Labeling 129
D. REGULATION OF THE NUTRIENT CONTENT OF FOOD 1351. Nutritional Status of Americans.. 1362. Nutrition Labeling 1383. Other Nutrition Information 1474. Definition of "Imitation" 1495. Common or Usual Names 1546. Nutrient Fortification of Food... 1617. Nutritional Quality Guidelines 1788. Disease Prevention Claims 1809. Medical Food 188
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D. REGULATION OF THE NUTRIENT CONTENT OF FOOD—Continued
10. Future Issues — - 191E. REGULATION OF VITAMIN-MINERAL SUPPLEMENTS... 204
1. Deceptive Marketing Practices 2042. FDA's Vitamin-Mineral Regulations —- 2113. Regulation of Hazardous Nutrients 225
F. FOOD SANITATION 2281. Aesthetic Adulteration - - 2332. The Issue of "Blending". 2543. Pathogenic Microorganisms 2594. Good Manufacturing Practices.... 2695. Emergency Permit Control 277
G. SAFETY OF FOOD CONSTITUENTS 2831. Historical and Statutory Background 2842. Poisonous or Deleterious Substances 2873. Environmental Contaminants 2954. Pesticide Residues 3065. Intentional Functional Ingredients 3196. Food Processing and Packaging Substances 3467. Color Additive Regulation 3578. Animal Drug Residues 3769. Ranking Food Risks 376
CHAPTER III. HUMAN DRUGS
A. HISTORICAL BACKGROUND 378B. GENERAL REQUIREMENTS FOR DRUGS 380
1. Definition of "Drug".... 3802. Regulation of Therapeutic Claims 3883. Adequate Directions for Use 3974. Prescription Drug Labeling 4045. Prescription Drug Promotion 4526. Drug Product Sanitation and Integrity 468
C. FDA LICENSURE OF NEW DRUGS 4751. Background... 4752. Implementation of the New Drug Premarket Approval
Requirements 4773. The Coverage of the New Drug Provisions..... 4884. The Approval Process for New Drugs 5135. The AIDS Revolution 5526. Orphan Drugs 5667. The Abbreviated New Drug Process 5718. Impact of the 1962 Drug Amendments.. . ."""™"™.""" 580
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D. REGULATION OF OVER-THE-COUNTER DRUGS 5881. The OTC Review 5882. The OTC Drug Review and FTC Regulation of Drug
Advertising— 5993. OTC Drug Indications 6014. Legality of Category III.... 6045. Completion of the OTC Drug Review 6096. OTC Drug Product Tampering 614
E. REGULATING PHYSICIAN PRESCRIBING.. 6161. Physician Prescribing Habits.. 6162. FDA Control of Physician Prescribing 6183. Controls Over Distribution 632
CHAPTER IV. ANIMAL FEED AND DRUGS
A. GENERAL STATUTORY REQUIREMENTS 636B. THE ANIMAL DRUG AMENDMENTS OF 1968 638C. GENERIC ANIMAL DRUG AND PATENT TERM RESTORA-
TION ACT 645D. ADMINISTRATION OF CARCINOGENIC DRUGS TO FOOD-
PRODUCING ANIMALS 646E. ANTIBIOTICS IN ANIMAL FEED 646F. PRESCRIPTION ANIMAL DRUGS 655
CHAPTER V. BIOLOGICS AND BLOOD PRODUCTS
A. HISTORICAL AND STATUTORY BACKGROUND... 660B. THE BIOLOGICS REVIEW...... 669C. BLOOD AND BLOOD PRODUCTS 677
1. Regulatory Jurisdiction 6772. The Regulatory Mechanism 6793. Safety of Donated Blood 6844. Protecting the Blood Supply in the Era of Aids 689
D. ORGAN AND TISSUE TRANSPLANTS 692E. NATIONAL IMMUNIZATION POLICY 697
1. Manufacturer Liability 6972. Government Liability 7033. Formulation of a National Policy.. 7104. The Swine Flu Act of 1976 7165. National Childhood Vaccine Injury Act of 1986 718
CHAPTER VI. MEDICAL DEVICES
A. HISTORICAL BACKGROUND 720B. THE 1938 ACT DEFINITION OF "DEVICE" 723C. ENFORCEMENT OF THE 1938 ACT 735
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D. THE 1976 MEDICAL DEVICE AMENDMENTS 7421. Background 7422. Overview of the 1976 Amendments 7453. The Definition of "Device" — 7464. Classification and Reclassification 7505. Regulation of Market Introduction... 7526. Requirements for Preenactment Class II and Class III
Devices —- 7727. General Regulatory Controls for all Devices 7788. Rules for Specific Marketed Devices.. 792
E. RADIATION CONTROL FOR HEALTH AND SAFETY ACTOF 1968 - - - 794
F. ASSESSMENT OF MEDICAL DEVICE TECHNOLOGY 806
CHAPTER VII. COSMETICS
A. HISTORICAL AND STATUTORY BACKGROUND. 814B. DEFINITION OF "COSMETIC" 824C. ADULTERATED COSMETICS 831D. MISBRANDED COSMETICS...... 841E. COSMETIC INGREDIENT LABELING 849F. VOLUNTARY "REGULATION" OF COSMETICS 853G. COAL TAR HAIR DYES 859
CHAPTER VIII. REGULATION OF CARCINOGENS
A. HISTORICAL BACKGROUND 863B. FDA POLICY PRIOR TO I960.... 864C. THE DELANEY CLAUSE 866
1. The Incidence of Human Cancer 8662. Enactment of the 1958 Delaney Clause 8683. Legislative History of the Color Additives Delaney Clause 872
D. REGULATION OF DIETHYLSTILBESTROL (DES).... 8771. The General Safety Standard..... 8772. The Delaney Clause..... 879
E. QUANTITATIVE RISK ASSESSMENT.. 8901. Carcinogenic Animal Drugs 8912. Carcinogenic Contaminants of Food 9043. Carcinogenic Coal Tar Hair Dyes 9084. Carcinogenic Constituents of Color and Food Additives.. 9155. Carcinogenic Color and Food Additives 9226. Carcinogenic Natural Foods 9487. Carcinogenic Drugs and Devices. 9508. Characterization and Classification of Carcinogens 9519. Use of Quantitative Risk Assessment by Other Govern-
ment Agencies . . 953F. SECONDARY CARCINOGENS 956
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PageG. FUTURE ISSUES 960
CHAPTER IX. REGULATION OF BIOTECHNOLOGY
A. HISTORICAL AND TECHNICAL BACKGROUND 964B. NIH REGULATION OF RECOMBINANT DNA RESEARCH 972C. REGULATING THE PRODUCTS OF BIOTECHNOLOGY 973
CHAPTER X. STATE LAWS AND THEIR RELATION TOFEDERAL LAW
A. HISTORICAL BACKGROUND 986B. THE 1906 ACT.. 994C. THE 1938 ACT 1003D. ADMINISTRATIVE PREEMPTION BY FDA 1028E. PREEMPTION UNDER THE 1962 DRUG AMENDMENTS ..1031F. WAIVERS OF PREEMPTION UNDER THE 1976 MEDICAL
DEVICE AMENDMENTS 1033G. PREEMPTION UNDER THE 1990 FOOD LABELING
AMENDMENTS 1038
CHAPTER XI. FDA ENFORCEMENT
A. PROHIBITED ACTS 10401. Section 301 .10402. FDA Regulatory Philosophy and Compliance Policy 10413. Industry-Wide Enforcement 10454. FDA Discretion to Enforce the FD&C Act. 10555. Role of the Justice Department 10626. The Emerging Role of the HHS Inspector General 1065
B. ENFORCEMENT JURISDICTION 10661. Introduction into Interstate Commerce 10662. Held for Sale After Shipment in Interstate Commerce... 10703. Oleomargarine 10804. Medical Devices 10815. Biologies 1083
C. REGULATION OF FOREIGN COMMERCE 10841. Importation into the United States 10842. Exportation from the United States 10903. Export of New Drugs, New Animal Drugs, Biological
Products, and Medical Devices 1096D. FACTORY INSPECTION 1101
1. Constitutional Limitations 11022. Scope of Section 704 Inspections 11113. Mode of Inspection— 1118
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E. SEIZURE - 11211. Governing Principles 11212. Multiple Seizures 11253. Proof Required for Condemnation 11304. Transfer of Proceedings 11325. Salvaging 11336. Effectiveness of Seizures 11367. Administrative Detention 1137
F. INJUNCTIONS 1137G. CRIMINAL LIABILITY 1148
1. Philosophy of Prosecution 11482. Standard of Liability 11503. The Guaranty Clause 11654. Section 305 Hearings 1169
H. CIVIL PENALTIES 11711. The Radiation Control for Health and Safety Act of 1968 11722. The Prescription Drug Marketing Act of 1987 1174
I. RESTITUTION .1175J. RECALLS 1178K. INFORMAL ENFORCEMENT 1188L. PUBLICITY.. 1194M. FDA ENFORCEMENT STATISTICS. 1205N. RES JUDICATA AND RELATED DOCTRINES ....1206
1. Res Judicata in FDA Cases 12062. Effect of Suits by Other Agencies 12103. Simultaneous Government Proceedings... 12134. Estoppel Against the Government ..1215
O. PRIVATE ENFORCEMENT OF THE FD&C ACT 12171. Implied Private Causes of Action 12172. The Effect of the 1938 Act on Common Law Suits 12203. Suits Against the Government 12224. Suits Under the Lanham Act 1227
P. STATE ENFORCEMENT OF THE FD&C ACT..... ...1235
CHAPTER XII. FDA PRACTICE AND PROCEDURE
A. FDA'S APPROACH TO REGULATION 12361. Overview. 12362. FDA's Procedural Regulations .....12383. Planning and Priorities ..12394. FDA, Regulated Firms, and the Pub l i c . . . 12405. FDA and Other Federal Regulatory Agencies ....1243
B. SECTION 701(a) RULEMAKING ....12441. HHS and OMB Supervision of FDA Rulemaking..... 12452. Informal Rulemaking Requirements 12473. Failure to Promulgate Regulations ...1254
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B. SECTION 701(a) RULEMAKING—Continued4. Ripeness for Judicial Review 12585. Effect of Section 701(a) Regulations 1262
C. FORMAL RULEMAKING AND ADJUDICATION 12641. Justification for an Evidentiary Hearing 12652. Hearing Procedures 1271
D. PRIMARY JURISDICTION 12761. Introduction 12762. Suits Against FDA 12773. FDA Enforcement Suits.... 1279
E. ADVISORY COMMITTEES 12841. FDA Reliance on Advisory Committees 12842. The Federal Advisory Committee Act 1286
F. PUBLIC ACCESS TO FDA RECORDS 12991. Overview..... 12992. Trade Secrets..... 1301
G. ENVIRONMENTAL CONSIDERATIONS 1309H. REGULATORY REFORM 1313
Appendices
App.
A. Laws Applicable to Producers of Food, Drugs, Cosmetics, andMedical Devices 1327
B. Delegations of Authority to the Commissioner of Food andDrugs ...1337
Index 1347
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PREFACE TO THE 1980 EDITION xxi
PREFACE TO THE 1991 EDITION xxv
ACKNOWLEDGEMENTS xxxiTABLE OF CASES lxix
CHAPTER I. HISTORICAL BACKGROUND
A. EARLY REGULATION OF FOOD AND DRUGS 1Hutt, Government Regulation of the Integrity of the Food
Supply... 1B. STATUTORY AND INSTITUTIONAL HISTORY 4
1. The Food and Drug Administration 42. The Evolution of Federal Food and Drug Legislation.... 6
a. State and Local Laws in the 19th Century 6b. Enactment of the First Federal Laws 7
Hayes and Ruff, The Administration of the FederalFood and Drug Act 9
c. The Federal Food, Drug, and Cosmetic Act of 1938 101917 Report of the USDA Bureau of Chemistry 101933 Report of the Food and Drug Administration 11
d. Post-1938 Amendments 133. Other Laws Enforced by FDA 14
C. FDA'S STRUCTURE AND ORGANIZATION 15D. THE REGULATORY ENVIRONMENT... 18
Merrill, Risk-Benefit Decisionmaking by the Food and DrugAdministration 19
E. FDA'S MISSION AND RESOURCES 211990 Agriculture, Rural Development, and Related Agencies
Appropriation Bill 21
CHAPTER II. FOOD
A. DEFINITION OF "FOOD" 23Senate Report: Food, Drugs, and Cosmetics 23Nutrilab, Inc. v. Schweiker 24National Nutritional Foods Ass'n v. Mathews— 29
Specific Food Categories 34Cultural Influences on Food Regulation 35
B. REGULATION OF FOOD LABELING 361. Historical Overview 36
Hutt, Regulating the Misbranding of Food 37Jurisdiction over Food Advertising 43
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B. REGULATION OF FOOD LABELING—Continued2. Scope of "Labeling" 43
Kordel v. United States 43United States v. 24 Bottles "Sterling Vinegar & Honey,"
Etc. - 45United States v. Articles of Drug . . . Century Food
Co - 483. Labeling Requirements of Section 403 51
a. Prohibited Representations.... 51United States v. Ninety-five Barrels of . . . Apple
Cider Vinegar 51United States v. 432 Cartons . . . Candy Lollipops 54United States v. An Article of Food . . . "Manis-
chewitz . . . Diet Thins" 56Special Labeling Issues — 58"Natural" and "Organic" Food Claims 59
b. Affirmative Disclosures 60Food Labeling, 21 C.F.R. Part 101... . . 61
4. Deceptive Packaging 63Lamb, American Chamber of Horrors 63United States v. 116 Boxes . . . Arden Assorted Candy
Drops 64United States v. 174 Cases . . . "Delson Thin Mints" 65Note, Federal Regulation of Deceptive Packaging: The
Relevance of Technological Justifications 67Marquis, Fair Packaging and Consumer Protection 68
Food Tampering. 695. Weight Labeling..... 69
a. Gain and Loss of Moisture. — 70b. Drained Weight 70
Drained Weights for Processed Fruits and Vegeta-bles, 40 Fed.Reg. 52172... 70
Drained Weight or Solid Content Weight for CannedFruits and Vegetables, 42 Fed.Reg. 62282 72
6. Ingredient Labeling 74Cavers, The Food, Drug, and Cosmetic Act of 1938: Its
Legislative History and its Substantive Provisions 75Science Magazine: Food Additives and Hyperactivity— 75
Ingredient Labeling for Alcoholic Beverages 78Food Labeling: Ingredient Labeling Exemptions, 42
Fed.Reg. 43095 797. Label Warnings — 82
C. REGULATION OF FOOD IDENTITY AND QUALITY 841. Premises of Regulation 84
Carotene Products Co. v. United States 84
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C. REGULATION OF FOOD IDENTITY AND QUALITY—Con-tinued
2. Economic Adulteration 88United States v. 88 Cases . . . Bireley's Orange Bever-
age 88United States v. 1200 Candy Bars . . . "Sta-Trim"... 94
3. Food Standards of Identity 96Developments in the Law—The Federal Food, Drug, and
Cosmetic Act 96a. Operation of Food Standards 97
Federal Security Adm'r v. Quaker Oats Co 97Columbia Cheese Co. v. McNutt 101Merrill and Collier, "Like Mother Used to Make": An
Analysis of FDA Food Standards of Identity 103b. Effects of Food Standards 107
Label Declarations on Standardized and Non-standardized Foods: Notice of Denial of Petition, 37Fed.Reg. 5131 107
Hamilton, Rulemaking on a Record by the Food andDrug Administration 108
Comment, The Federal Food, Drug, and Cosmetic Actas an Experiment in Quality Control 109Temporary Marketing Permits 109
c. Alternative Approaches to Food Standards 110Frozen Raw Breaded Shrimp, 21 C.F.R. § 161.175... 110"Safe and Suitable" Food Ingredients: General Defi-
nition, 39 Fed.Reg. 17304 110Wade, Ice Cream: Dairymen Imperiled by FDA's
Recipe 113Milnot Co. v. Richardson 115
4. Food Names 117Common or Usual Names for Nonstandardized Foods, 38
Fed.Reg. 6964 118Common or Usual Name for Nonstandardized Foods, 21
C.F.R. Part 102 119American Frozen Food Institute v. Mathews 121Compliance Policy Guide No. 7108.16 128
5. "Imitation" Labeling 12962 Cases of Jam v. United States 129United States v. 651 Cases . . . Chocolate Chil-Zert.. 130
Meat Food Names 134D. REGULATION OF THE NUTRIENT CONTENT OF FOOD 135
1. Nutritional Status of Americans 136Senate Report: The Food Gap: Poverty and Malnutrition
in the United States 136
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D. REGULATION OF THE NUTRIENT CONTENT OF FOOD—Continued
2. Nutrition Labeling ~ - 138Nutrition Labeling, 38 Fed.Reg. 2125.... 138
Cholesterol and Fat Labeling 144Sodium Labeling 146
3. Other Nutrition Information.. —. 147Hutt and Sloan, Final Regulations Governing Label State-
ments for Foods Represented as Useful in Reducing orMaintaining Caloric Intake or Body Weight 148
Hypoallergenic Food Claims 1494. Definition of "Imitation" — 149
Report on the White House Conference on Food, Nutritionand Health 149
Imitation Foods, Application of Term "Imitation": Pro-posed Rulemaking, 38 Fed.Reg. 2138 150
Federation of Homemakers v. Schmidt 1515. Common or Usual Names 154
Hutt and Sloan, FDA Regulation of Vegetable ProteinProducts... 154
Substitutes for Milk, Cream, and Cheese; Withdrawal ofProposed Standards of Identity, 48 Fed.Reg. 37666.... 157
6. Nutrient Fortification of Food 161Statement of Policy with Respect to the Addition of Nutri-
tive Ingredients to Foods, 8 Fed.Reg. 9170... 162United States v. 119 Cases . . . "New Dextra Brand
Fortified Cane Sugar". 165Improvement of Nutrient Levels of Enriched Flour, En-
riched Self-Rising Flour, and Enriched Breads, Rolls orBuns, 38 Fed.Reg. 28558 170
Iron Fortification of Flour and Bread: Tentative Order, 42Fed.Reg. 59513 172
FDA Regulation of Infant Formulas 1777. Nutritional Quality Guidelines 178
Nutritional Quality Guidelines for Foods, 21 C.F.R. Part104 178
8. Disease Prevention Claims 180Hutt, Government Regulation of Health Claims in Food
Labeling and Advertising 181Hutt, Health Claims for Foods—An American Perspective 183Food Labeling; Public Health Messages on Food Labels
and Labeling, 52 Fed.Reg. 28843 185FTC Regulation of Food Advertising 187
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D. REGULATION OF THE NUTRIENT CONTENT OF FOOD—Continued
9. Medical Food 188A Review of Foods for Medical Purposes: Specially For-
mulated Products for Nutritional Management of Medi-cal Conditions 188
10. Future Issues 191Senate Report: Dietary Goals for the United States 191NRC: Designing Foods: Animal Product Options in the
Marketplace 194Specter, Food Labels Often Light on Nutrition Information 197Food Labeling, 54 Fed.Reg. 32610 199
The Nutrition Labeling and Education Act of 1990 200E. REGULATION OF VITAMIN-MINERAL SUPPLEMENTS... 204
1. Deceptive Marketing Practices 204V.E. Irons, Inc. v. United States 204United States v. "Vitasafe Formula M" 207
2. FDA's Vitamin-Mineral Regulations 211Lamb, American Chamber of Horrors 211Cavers, The Food, Drug, and Cosmetic Act of 1938: Its
Legislative History and its Substantive Provisions 211Goodrich, The Coming Struggle over Vitamin-Mineral Pills 212Hamilton, Rulemaking on a Record by the Food and Drug
Administration. 214National Nutritional Foods Ass'n v. FDA 215Conference Report: Health Research and Health Services
Amendments of 1976 221National Nutritional Foods Ass'n v. Kennedy 223
3. Regulation of Hazardous Nutrients 225National Nutritional Foods Ass'n v. Kennedy 226
FDA Regulation of Vitamins A and D 227F. FOOD SANITATION 228
Hutt, The Importance of Analytical Chemistry to Food andDrug Regulation 228
Lamb, American Chamber of Horrors 230House Hearings: Federal Food Inspections are Lagging 231House Hearings: FDA Oversight—Food Inspection 232
1. Aesthetic Adulteration 233a. Filth 233
United States v. 484 Bags, More or Less 233De Minimus Filth 235
Natural or Unavoidable Defects in Food for HumanUse that Present no Health Hazard: Public Availa-bility of Information, 37 Fed.Reg. 6497 237
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F. FOOD SANITATION—ContinuedUnited States v. Capital City Foods, Inc. 239
Predaceous Insects ~ - 240b. Decomposition ~ - - 241
United States v. An Article of Food . . . 915 Car-tons of Frog Legs - 241
c. Insanitary Conditions — 242United States v. 1,200 Cans . . . Pasteurized Whole
Eggs, Etc. 242United States v. Certified Grocers Co-Op 246
d. Otherwise Unfit for Food... 250United States v. 298 Cases . . . Ski Slide Brand
Asparagus... — 250e. An Alternative Approach.... 253
Hinich and Staelin, Regulation of the U.S. Food Indus-try 253
2. The Issue of "Blending".... 254Sugarman v. Forbragd ~ 254Corn Shipped in Interstate Commerce for use in Animal
Feeds; Action Levels for Aflatoxins in Animal Feeds—Revised Compliance Policy Guide, 54 Fed.Reg. 22622.. 258
3. Pathogenic Microorganisms 259Miller, The Saga of Chicken Little and Rambo 260Public Citizen v. Heckler 263
FDA Cooperative Food Sanitation Programs 2664. Good Manufacturing Practices 269
United States v. Nova Scotia Food Products Corp 269Current Good Manufacturing Practice in Manufacturing,
Processing, Packing, or Holding Human Food: ProposedRulemaking, 44 Fed.Reg. 33238.... 272
5. Emergency Permit Control.. 277FDA: Public Warning 277Ross, Remember That Vichyssoise? 278Emergency Permit Control, 39 Fed.Reg. 3748..... 279Subpart B—Specific Requirements and Conditions for Ex-
emption from or Compliance with an Emergency Permit 281G. SAFETY OF FOOD CONSTITUENTS 283
1. Historical and Statutory Background 2842. Poisonous or Deleterious Substances 287
a. Added Substances 287United States v. Lexington Mill & Elevator Co. ... 287
b. Nonadded Substances 290United States v. 1232 Cases American Beauty
Brand Oysters 290United States v. Anderson Seafoods, Inc. 293
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PageG. SAFETY OF FOOD CONSTITUENTS—Continued
3. Environmental Contaminants 295Poisonous or Deleterious Substances in Food: Notice of
Proposed Rulemaking, 39 Fed.Reg. 42743 298Action Level for Mercury in Fish and Shellfish, 39
Fed.Reg. 42738 300Young v. Community Nutrition Institute 304
4. Pesticide Residues 306United States v. Bodine Produce Co 307United States v. Ewig Bros. Co 311Tolerances and Exemptions from Tolerances for Pesticide
Chemicals in or on Raw Agricultural Commodities, 47Fed.Reg. 42956 314
Wall Street Journal: How a PR Firm Executed the AlarScare 316
Pesticide Regulation Under FIFRA 3195. Intentional Functional Ingredients 319
House Report: Investigation of the Use of Chemicals inFoods and Cosmetics 320
a. The Food Additives Amendment 321Senate Report: Food Additives Amendment of 1958 321
b. Food Additives. 323United States v. An Article of Food 324
Interim Food Additives 331c. GRAS Ingredients... 332
United States v. An Article of Food 333General Recognition of Safety and Prior Sanctions for
Food Ingredients, 41 Fed.Reg. 53600 335GRAS Status of Sulfite and Caffeine 339
FMALI Herb, Inc. v. Heckler 340d. Prior Sanctioned Ingredients 342
Proposal Regarding Regulation of Prior-SanctionedFood Ingredients, 37 Fed.Reg. 16407 342Prior Sanctions for Nitrite and Nitrate 344
6. Food Processing and Packaging Substances 346United States v. Articles of Food Consisting . . . of
Pottery 347Housewares 347
Natick Paperboard Corp. v. Weinberger 349Monsanto Co. v. Kennedy 351
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PageG. SAFETY OF FOOD CONSTITUENTS—Continued
7. Color Additive Regulation 357a. The 1906 Act. - 357b. The 1938 Act - —- 357
Flemming v. Florida Citrus Exchange 358c. The 1960 Amendments ~ ~ 360
Certified Color Mfrs. Ass'n v. Mathews 363Provisionally Listed Color Additives: Notice of Pro-
posed Rulemaking, 41 Fed.Reg. 41860 366Mcllwain v. Hayes 369
FD&C Red No. 3 372FD&C Yellow No. 5: Labeling in Food and Drugs for
Human Use, 44 Fed.Reg. 37212 3738. Animal Drug Residues 3769. Ranking Food Risks 376
CHAPTER III. HUMAN DRUGS
A. HISTORICAL BACKGROUND.... 378Act of June 26, 1848 378Munch, A Half-Century of Drug Control 379
B. GENERAL REQUIREMENTS FOR DRUGS 3801. Definition of "Drug" 380
United States v. 46 Cartons . . . Fairfax Cigarettes.. 380Action on Smoking and Health v. Harris.. 382United States v. An Article of Drug . . . OVA II 386
2. Regulation of Therapeutic Claims 388United States v. Johnson 390Seven Cases of Eckman's Alterative v. United States.. 390Cavers, The Food, Drug, and Cosmetic Act of 1938: Its
Legislative History and its Substantive Provisions 392Research Laboratories, Inc. v. United States. 393
3. Adequate Directions for Use 397Alberty Food Products Co. v. United States 397United States v. Article of Drug . . . Designated B-
Complex Cholinos Capsules 4014. Prescription Drug Labeling 404
a. Limitation to Prescription Sale 404Temin, The Origin of Compulsory Drug Prescriptions 405United States v. El-O-Pathic Pharmacy 407United States v. Article of Drug . . . "Decholin" 411Hutt, A Legal Framework for Future Decisions on
Transferring Drugs from Prescription to Nonpre-scription Status 418
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B. GENERAL REQUIREMENTS FOR DRUGS—Continuedb. Warnings for Prescription Drugs 422
Sterling Drug, Inc. v. Yarrow 423MacDonald v. Ortho Pharmaceutical Corp 426Bradley v. Weinberger 429Labeling: Failure to Reveal Material Facts, 39
Fed.Reg. 33229 433c. Patient Labeling for Prescription Drugs 438
Statement of Policy Concerning Oral ContraceptiveLabeling Directed to Users, 35 Fed.Reg. 9001 438
Pharmaceutical Manufacturers Ass'n v. FDA 441Prescription Drug Products: Patient Labeling Re-
quirements, 44 Fed.Reg. 40016 444Prescription Drug Products: Revocation of Patient
Package Insert Requirements, 47 Fed.Reg. 39147 446d. Name of Manufacturer 451
5. Prescription Drug Promotion... 452a. Generic Name Disclosure 452
Administered Prices—Drugs, S.Rep.No. 448 452b. Prescription Drug Advertising to Professionals 454
21 C.F.R. § 202.1 454Senate Select Comm. on Small Business, Competitive
Problems in the Drug Industry: Summary andAnalysis... 459
Speech by Kenneth R. Feather, Annual Meeting of thePMA Marketing Section 462
c. Advertising Prescription Drugs to Consumers 465Direct-to-Consumer Advertising of Prescription
Drugs: Withdrawal of Moratorium, 50 Fed.Reg.36677 465
d. Counterfeit, Imitation, and Diverted PrescriptionDrugs. 466
6. Drug Product Sanitation and Integrity 468United States v. An Article of Drug . . . White
Quadrisect 468Human and Veterinary Drugs: Current Good Manufactur-
ing Practice in Manufacture, Processing, Packing orHolding, 43 Fed.Reg. 45014 469
United States v. Morton-Norwich Products, Inc. 472C. FDA LICENSURE OF NEW DRUGS 475
1. Background 475Cavers, The Food, Drug, and Cosmetic Act of 1938: Its
Legislative History and Its Substantive Provisions 476Drug Efficacy and the 1962 Drug Amendments 476
2. Implementation of the New Drug Premarket ApprovalRequirements 477
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PageC. FDA LICENSURE OF NEW DRUGS—Continued
3. The Coverage of the New Drug Provisions 488a. The General Standard 488
United States v. Article of Drug . . . "Mykocert" 488Hoffmann-LaRoche, Inc. v. Weinberger 492United States v. Generix Drug Corp. 495
b. The "Grandfather" Clauses 496United States v. Allan Drug Corp 497USV Pharmaceutical Corp. v. Weinberger 499American Public Health Ass'n v. Veneman 503
c. Jurisdiction to Determine New Drug Status 506Weinberger v. Bentex Pharmaceuticals, Inc. 506dba Corp. v. Weinberger 508
d. The Practice of Pharmacy 510Compliance Policy Guide 7132.06.. 510
4. The Approval Process for New Drugs 513a. Clinical Investigation 513
House Subcom. on Science, Research, and Technology,The Food and Drug Administration's Process forApproving New Drugs 514
b. The New Drug Application 519House Subcom. on Science, Research, and Technology,
The Food and Drug Administration's Process forApproving New Drugs 519
Regulation of Antibiotic Drugs 521c. The Safety Standard 522
House Gov't Operations Subcommittee, Drug Safety 522d. The Effectiveness Standard 525
Adequate and Well-Controlled Studies, 21 C.F.R.§ 314.26 525
e. Priority for Review 529Staff Manual Guide BD4820.3 529
f. FDA Approval or Denial 531Ubiotica Corp. v. FDA... 532
Prescription Drug Controlled Substances 535g. Postapproval Requirements 537
Mattison and Richard, Postapproval Research Re-quested by the FDA at the Time of NCE Approval,1970-1984.... 537
h. Withdrawal of Marketing Approval 539Weinberger v. Hynson, Westcott & Dunning, Inc. 539Statement of Joseph F. Sadusk, Jr., M.D., Drug Safe-
ty Hearings 544i. Immediate Ban of an "Imminent Hazard" 547
Forsham v. Califano 547
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C. FDA LICENSURE OF NEW DRUGS—Continued5. The AIDS Revolution 552
Morbidity and Mortality Weekly Report 552a. Use of Investigational Drugs in Patient Treatment 553
Investigational New Drug, Antibiotic, and BiologicalDrug Product Regulations: Treatment Use andSale, 52 Fed.Reg. 19466 554Use of Laetrile for Cancer 557
b. Expedited Approval of Life-Saving Drugs 559Investigational New Drug, Antibiotic, and Biological
Drug Product Regulations: Procedures for DrugsIntended to Treat Life-Threatening and SeverelyDebilitating Illnesses, 53 Fed.Reg. 41516 560
c. Importation of Unapproved New Drugs 561d. Enforcement Discretion 563
Kolata, An Angry Response to Actions on AIDSSpurs F.D.A. Shift 564
6. Orphan Drugs 566Genentech, Inc. v. Bowen 567
7. The Abbreviated New Drug Process 571Hutt, Landmark Pharmaceutical Law Enacted 571
FDA Regulation and Promotion of Generic Drugs .. 5768. Impact of the 1962 Drug Amendments 580
a. The "Drug Lag". 580Statement of Sam Peltzman before Senate Monopoly
Subcommittee 580b. Impact on "Freedom of Choice" 583
Tutoki v. Celebrezze 584Hutt, Laetrile Decision Ignores Constitutional Ques-
tion 585Crout, The Nature of Regulatory Choices 586Kinsley, The FDA: Too Cautious, Not Too Bold 587
D. REGULATION OF OVER-THE-COUNTER DRUGS 5881. The OTC Review 588
Over-the-Counter Drugs: Proposal Establishing Rule Mak-ing Procedures for Classification, 37 Fed.Reg. 85 589
Procedures for Classification of Over-the-Counter Drugs,37 Fed.Reg. 9464 590
Over-the-Counter Human Drugs Which are Generally Rec-ognized as Safe and Effective and not Misbranded, 21C.F.R. BA330 593
2. The OTC Drug Review and FTC Regulation of DrugAdvertising 599
3. OTC Drug Indications 601Labeling of Drug Products for Over-the-Counter Human
Use, 50 Fed.Reg. 15810 601
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D. REGULATION OF OVER-THE-COUNTER DRUGS—Contin-ued
4. Legality of Category III - - 604Cutler v. Kennedy — 605
5. Completion of the OTC Drug Review 609Cutler v. Hayes - 609
6. OTC Drug Product Tampering 614Tamper-Resistant Packaging Requirements for Certain
Over-the-Counter Human Drug and Cosmetic Products,47 Fed.Reg. 50442..... 614
E. REGULATING PHYSICIAN PRESCRIBING 6161. Physician Prescribing Habits ~ 6162. FDA Control of Physician Prescribing 618
House Gov't Operations Subcommittee, New Drugs Usedfor Nonapproved Purposes (Methotrexate for Psoriasis) 618
Legal Status of Approved Labeling for PrescriptionDrugs; Prescribing for Uses Unapproved by the Foodand Drug Administration: Notice of Proposed RuleMaking, 37 Fed.Reg. 16503.... 619
United States v. An Article of Drug . . . Diso-Tate~ 623United States v. Evers.. 624United States v. Evers.. 627
Physician Civil Liability for Deviating from the Pack-age Insert 630
3. Controls Over Distribution 632American Pharmaceutical Ass'n v. Weinberger 632
CHAPTER IV. ANIMAL FEED AND DRUGS
A. GENERAL STATUTORY REQUIREMENTS 636B. THE ANIMAL DRUG AMENDMENTS OF 1968.. 638
House Report: Animal Drug Amendments 638C. GENERIC ANIMAL DRUG AND PATENT TERM RESTORA-
TION ACT 645D. ADMINISTRATION OF CARCINOGENIC DRUGS TO FOOD-
PRODUCING ANIMALS 646E. ANTIBIOTICS IN ANIMAL FEED 646
Hopkins, Keeping the Kick in Antibiotics..... 647Antibiotic and Sulfonamide Drugs in Animal Feeds: Proposed
Statement of Policy, 37 Fed.Reg. 2444 647Antibiotic and Sulfonamide Drugs in the Feed of Animals, 38
Fed.Reg. 9811 649Restriction on Subtherapeutic use of Antibacterials in Animal
Feeds: Intent to Propose Rules and Calls for EnvironmentalImpact Data, 42 Fed.Reg. 27264 651
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F. PRESCRIPTION ANIMAL DRUGS 655Draft Guideline for Veterinary Prescriptions and Other Orders;
Draft Guideline Withdrawn, 50 Fed.Reg. 19382 656FDA, Compliance Policy Guide 7125.06 656
CHAPTER V. BIOLOGICS AND BLOOD PRODUCTS
A. HISTORICAL AND STATUTORY BACKGROUND 660Hecht, Making Sure Biologicals Are Safe 661
B. THE BIOLOGICS REVIEW.... 669Biological Products: Procedures for Review of Safety, Effec-
tiveness, and Labeling, 37 Fed.Reg. 16679 670Procedures for Review of Safety, Effectiveness, and Labeling,
38 Fed.Reg. 4319 671Bacterial Vaccines and Bacterial Antigens With No U.S. Stan-
dard of Potency: Revocation of Licenses and Reclassification,43 Fed.Reg. 50247 673
Bacterial Vaccines and Bacterial Antigens With "No U.S. Stan-dard of Potency," 44 Fed.Reg. 1544 674
C. BLOOD AND BLOOD PRODUCTS 6771. Regulatory Jurisdiction 6772. The Regulatory Mechanism 679
Rodell, Overview of the Regulatory Process in the Manu-facture of Plasma and Plasma Derivatives 679
FD&C Act Requirements Applicable to Blood Prod-ucts 681
Safety Standards for Blood Products 6823. Safety of Donated Blood..... 684
Whole Blood and Red Blood Cells: Label Statement toDistinguish Volunteer From Paid Blood Donors, 40Fed.Reg. 53040 684
Whole Blood and Components of Whole Blood Intended forTransfusion; Donor Classification Labeling Require-ments, 43 Fed.Reg. 2142. 686
4. Protecting the Blood Supply in the Era of AIDS 689D. ORGAN AND TISSUE TRANSPLANTS 692
Statement by the Food and Drug Administration Concerning itsLegal Authority to Regulate Human Organ Transplants andto Prohibit Their Sale, House Subcommittee on Investigationsand Oversight 693
E. NATIONAL IMMUNIZATION POLICY 6971. Manufacturer Liability 697
Reyes v. Wyeth Laboratories 6972. Government Liability 703
Berkovitz v. United States 703
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PageE. NATIONAL IMMUNIZATION POLICY—Continued
3. Formulation of a National Policy.... 710Mortimer, Immunization Against Infectious Disease. 710Report and Recommendations of the National Immuniza-
tion Work Groups on Liability (DHEW, 1977) 7124. The Swine Flu Act of 1976... 716
Baynes, Liability for Vaccine Related Injuries: PublicHealth Considerations and Some Reflections on theSwine Flu Experience — 716
5. National Childhood Vaccine Injury Act of 1986 718
CHAPTER VI. MEDICAL DEVICES
A. HISTORICAL BACKGROUND 720Janssen, The Gadgeteers 720Cooper, Device Legislation 721
B. THE 1938 ACT DEFINITION OF "DEVICE". 723United States v. 23 . . . Articles 723United States v. Undetermined Quantities of Article of De-
vice 724United States v. An Article of Drug . . . Bacto-Unidisk 731
New Drug Status of Certain Intrauterine Devices, 38 Fed.Reg.6137 733
House Intergovernmental Relations Subcommittee: Regulationof Medical Devices (Intrauterine Contraceptive Devices) 734
C. ENFORCEMENT OF THE 1938 ACT 735House Report: Medical Device Legislation—1975 735Founding Church of Scientology v. United States 738
D. THE 1976 MEDICAL DEVICE AMENDMENTS..... 7421. Background 742
House Report: Medical Device Amendments of 1976 742Study Group on Medical Devices, Medical Devices: A
Legislative Plan 7442. Overview of the 1976 Amendments 7453. The Definition of "Device" 746
Pregnancy Test Kits: Transfer of Responsibility from theBureau of Biologies to the Bureau of Medical Devices,44 Fed.Reg. 10133.. 746
Draft Policy Guidance for Regulation of Computer Prod-ucts, 52 Fed.Reg. 36104. 747
4. Classification and Reclassification 750a. Classification 750b. Reclassification 751
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PageD. THE 1976 MEDICAL DEVICE AMENDMENTS—Continued
5. Regulation of Market Introduction 752a. Substantial Equivalence 754b. Premarket Approval 756
Investigational Devices 756Russell, Temporary Heart Implanted: Tucson Oper-
ation Lacked FDA Approval 757Guidance for the Emergency Use of Unapproved
Medical Devices; Availability, 50 Fed.Reg. 42866 759Premarket Approval Applications 762
Clinical Laboratory Improvement Act of 1967 767Product Development Protocols 768
Medical Devices; Product Development ProtocolAvailability of Guidelines, 45 Fed.Reg. 62555.... 768Use of Data in One PMA Application to Approve
a Subsequent PMA Application 769c. Reclassification 770
Humanitarian Device Exemption 7726. Requirements for Preenactment Class II and Class III
Devices —. 772a. Performance Standards and Special Controls for Class
II Devices 772Medical Devices: Performance Standards Activities,
41 Fed.Reg. 34099 772Voluntary Standards Policy for Medical Devices; Re-
quest for Comments, 45 Fed.Reg. 7490 773Policy Statement; Class II Medical Devices, 50
Fed.Reg. 43060 774Special Controls 777
b. Approval of Preenactment Class III Devices. 7777. General Regulatory Controls for all Devices 778
a. Adulteration and Misbranding 778Electrical Muscle Stimulators, FDA Talk Paper 779American Speech and Hearing Ass'n v. Califano 779Medical Devices; Labeling for Menstrual Tampons;
Ranges of Absorbency; Reproposed Rule, 54Fed.Reg. 25076 782
b. Establishment Registration and Listing 785c. Good Manufacturing Practice (GMP) 785d. Restricted Devices.. 786e. Records and Reports 787f. Banned Devices 788g. Notification and Repair, Replacement, or Refund.... 788
In Re Proctor & Gamble Co.: Consent Agreement 789h. Administrative Detention 791i. Postmarketing Surveillance 791
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D. THE 1976 MEDICAL DEVICE AMENDMENTS—Continuedj . Mandatory Recalls —- 791k. Device Tracking — —- - 7911. Reports of Removals or Corrections — 791m. Civil Penalties — —- 792
8. Rules for Specific Marketed Devices - 792a. Custom Devices — - 792b. Cardiac Pacemaker Registry. 792c. Patent Term Restoration - 793d. Orphan Devices —. 793
E. RADIATION CONTROL FOR HEALTH AND SAFETY ACTOF 1968 - - - 794
Diagnostic X-Ray Systems: Proposed Amendment of Assemblyand Reassembly Provisions, 44 Fed.Reg. 22755 —. 795
Medical Radiation Exposure of Women of Childbearing Age:Advance Notice of Proposed Guideline Publication, 40Fed.Reg. 58151... 799
FDA Guidelines for Radiation Exposure... 800Sunlamp Products; Performance Standard, 50 Fed.Reg. 36548 802Use of Video Display Terminals by Pregnant Women, FDA
Talk Paper 804Other Radiation Control Programs 805
F. ASSESSMENT OF MEDICAL DEVICE TECHNOLOGY 806Their, New Medical Devices and Health Care 806OTA, Development of Medical Technology: Opportunities for
Assessment 808Institute of Medicine, Computed Tomographic Scanning 809Technology Assessment by Federal Agencies 812
CHAPTER VII. COSMETICS
A. HISTORICAL AND STATUTORY BACKGROUND 814Senate Report No. 361 __„ 814Larrick, Some Current Problems in the Regulation of Cosmetics
Under the Federal Food, Drug, and Cosmetic Act — 815House Report: Investigation of the Use of Chemicals in Foods
and Cosmetics 816Mayham, Chemicals in Cosmetics 818GAO, Lack of Authority Hampers Attempts to Increase Cos-
metic Safety 819Statement of the Cosmetic, Toiletry and Fragrance Assoc, Inc.,
House Hearings 821B. DEFINITION OF "COSMETIC" 824
Hutt, Reconciling the Legal, Medical, and Cosmetic ChemistApproach to the Definition of a "Cosmetic" 824
United States v. An Article . . . Sudden Change 825lviii
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C. ADULTERATED COSMETICS 831United States v. An Article of Cosmetic . . . "Beacon Cas-
tile Shampoo . . ." 831Aerosol Drug and Cosmetic Products Containing Zirconium, 42
Fed.Reg. 41374.. 837Nitrosamine-Contaminated Cosmetics; Call for Industry Action;
Request for Data, 44 Fed.Reg. 21365 839D. MISBRANDED COSMETICS 841
Preservation of Cosmetics Coming in Contact with the Eye:Intent to Propose Regulations and Request for Information,42 Fed.Reg. 54837. 841
Food, Drug, and Cosmetic Products: Warning Statements, 40Fed.Reg. 8912 842
Almay, Inc. v. Califano 846E. COSMETIC INGREDIENT LABELING 849
Voluntary Ingredient Labeling: Notice to Cosmetic Manufac-turers and Distributors, 37 Fed.Reg. 16208 849
Cosmetic Ingredient Labeling, 38 Fed.Reg. 28912 849F. VOLUNTARY "REGULATION" OF COSMETICS 853
Voluntary Registration of Cosmetic Product Establishments;Voluntary Filing of Cosmetic Product Ingredient and Cosmet-ic Raw Material Composition Statements, 37 Fed.Reg. 7151 853
Voluntary Filing of Cosmetic Product Experiences, 38 Fed.Reg.28914.. 854
Elder, The Cosmetic Ingredient Review—A Safety EvaluationProgram 856
Statement of Robert L. Elder, SC.D., House Hearings 858G. COAL TAR HAIR DYES 859
Toilet Goods Ass'n v. Finch 860
CHAPTER VIII. REGULATION OF CARCINOGENS
A. HISTORICAL BACKGROUND.... 863B. FDA POLICY PRIOR TO 1960 864
Lehman, et al., Procedures for the Appraisal of the Toxicity ofChemicals in Foods 865
C. THE DELANEY CLAUSE 8661. The Incidence of Human Cancer 8662. Enactment of the 1958 Delaney Clause 8683. Legislative History of the Color Additives Delaney Clause 872
D. REGULATION OF DIETHYLSTILBESTROL (DES) 8771. The General Safety Standard 877
Bell v. Goddard 877
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D. REGULATION OF DIETHYLSTILBESTROL (DES)—Contin-ued
2. The Delaney Clause 879Hess & Clark, Division of Rhodia, Inc. v. FDA 881Diethylstilbestrol: Withdrawal of Approval of New
Animal Drug Application, 44 Fed.Reg. 54852.. 885E. QUANTITATIVE RISK ASSESSMENT 890
1. Carcinogenic Animal Drugs 891Chemical Compounds in Food-Producing Animals: Criteria
and Procedures for Evaluating Assays for CarcinogenicResidues, 44 Fed.Reg. 17070... 892
Sponsored Compounds in Food-Producing Animals; Crite-ria and Procedures for Evaluating the Safety of Carcino-genic Residues, 50 Fed.Reg. 45530 899
2. Carcinogenic Contaminants of Food 904Aflatoxins in Shelled Peanuts and Peanut Products Used
as Human Foods: Proposed Tolerance, 39 Fed.Reg.422748. 904
3. Carcinogenic Coal Tar Hair Dyes 908Cosmetic Product Warning Statements: Coal Tar Hair
Dyes Containing 4-MMPD, 44 Fed.Reg. 59509 9094. Carcinogenic Constituents of Color and Food Additives.. 915
Policy for Regulating Carcinogenic Chemicals in Food andColor Additives: Advance Notice of Proposed Rulemak-ing, 47 Fed.Reg. 14464 915
Scott v. Food and Drug Administration 9205. Carcinogenic Color and Food Additives 922
Saccharin and its Salts: Proposed Rule Making, 42Fed.Reg. 19996 924
Lead Acetate; Listing as a Color Additive in Cosmeticsthat Color the Hair on the Scalp, 45 Fed.Reg. 72112.. 928
Listing of D&C Orange No. 17 for Use in ExternallyApplied Drugs and Cosmetics, 51 Fed.Reg. 28331 932
Correction of Listing of D&C Orange No. 17 for Use inExternally Applied Drugs and Cosmetics, 52 Fed.Reg.5081 939
Public Citizen v. Young 9406. Carcinogenic Natural Foods 9487. Carcinogenic Drugs and Devices 9508. Characterization and Classification of Carcinogens - 9519. Use of Quantitative Risk Assessment by Other Govern-
ment Agencies 953F. SECONDARY CARCINOGENS !.!"!!!!!"!.""™""""!!.. 956
Selenium in Animal Feed; Proposed Food Additive Regulation,38 Fed.Reg. 10458 956
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PageG. FUTURE ISSUES 960
Hutt, Food and Drug Law: A Strong and Continuing Tradition 960
CHAPTER IX. REGULATION OF BIOTECHNOLOGY
A. HISTORICAL AND TECHNICAL BACKGROUND..... 964Office of Technology Assessment, Commercial Biotechnology:
An International Analysis 964Olson, Biotechnology: An Industry Comes of Age 967Food Biotechnology: A Scientific Status Summary 971
B. NIH REGULATION OF RECOMBINANT DNA RESEARCH 972C. REGULATING THE PRODUCTS OF BIOTECHNOLOGY..... 973
Hutt, Existing Regulatory Authority to Control the Processesand Products of Biotechnology.... 973
Statement of Policy for Regulating Biotechnology Products, 51Fed.Reg. 23309 976
CHAPTER X. STATE LAWS AND THEIR RELATION TOFEDERAL LAW
A. HISTORICAL BACKGROUND 986Hutt, The Basis and Purpose of Government Regulation of
Adulteration and Misbranding of Food 986FDA, State Programs and Services in Food and Drug Control 989Hinich and Staelin, Regulation of the U.S. Food Industry 990Austern, Federalism in Consumer Protection: Conflict or Coor-
dination? 992B. THE 1906 ACT 994
Plumley v. Massachusetts 995The Intended Impact of the 1906 Act 996
Savage v. Jones . „ . 997McDermott v. Wisconsin.. 998
C. THE 1938 ACT.... .....1003Cloverleaf Butter Co. v. Patterson 1004Florida Lime & Avocado Growers, Inc., v. Paul 1006Jones v. Rath Packing Co 1009Cosmetic, Toiletry and Fragrance Ass'n, Inc. v. Minnesota 1014
Preemption under the FHSA 1017Grocery Mfrs. of America, Inc. v. Gerace.... 1018Hillsborough County v. Automated Medical Labs., Inc 1022
D. ADMINISTRATIVE PREEMPTION BY FDA .1028Pregnant or Nursing Women; Amendment of Labeling Re-
quirement for Over-the-Counter Human Drugs, 47 Fed.Reg.54750 - 1028
E. PREEMPTION UNDER THE 1962 DRUG AMENDMENTS ..1031
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F. WAIVERS OF PREEMPTION UNDER THE 1976 MEDICALDEVICE AMENDMENTS. 1033
House Report: Medical Device Amendments of 1976 — 1034Exemptions from Federal Preemption of State and Local Device
Requirements, 43 Fed.Reg. 18661 1034Kievlan v. Dahlberg Electronics .1037
G. PREEMPTION UNDER THE 1990 FOOD LABELINGAMENDMENTS. - - 1038
CHAPTER XI. FDA ENFORCEMENT
A. PROHIBITED ACTS ....10401. Section 301 10402. FDA Regulatory Philosophy and Compliance Policy 1041
Hutt, Philosophy of Regulation Under the Federal Food,Drug and Cosmetic Act 1041
Austern, Philosophy of Regulation: A Reply to Mr. Hutt 1042FDA Compliance Philosophy 1042Compliance Policy Guide 7150.10 1043
3. Industry-Wide Enforcement 1045Hutt, Philosophy of Regulation Under the Federal Food,
Drug and Cosmetic Act. 1045Over-the-Counter Drugs: Proposal Establishing Rule Mak-
ing Procedures for Classification, 37 Fed.Reg. 85 1046North American Pharmacol, Inc. v. Department of
HEW 1047Ivy-Reed Co., Inc.: Steer-oid; Opportunity for Hearing, 44
Fed.Reg. 1462 1049United States v. Undetermined Quantities of an Article
of Drug Labeled as Exachol 10504. FDA Discretion to Enforce the FD&C Act 1055
Hutt, FDA Reduces Economic Regulation of Food Indus-try 1055
Heckler v. Chaney 10575. Role of the Justice Department... 1062
House Hearings: Food and Drug Administration Act ....10626. The Emerging Role of the HHS Inspector General .1065
B. ENFORCEMENT JURISDICTION 10661. Introduction into Interstate Commerce 1066
United States v. 7 Barrels . . . Spray Dried WholeEgg.. 1066
United States v. Sanders.. 10682. Held for Sale After Shipment in Interstate Commerce—1070
United States v. Phelps Dodge Mercantile Co 1070United States v. Sullivan 1071United States v. Wiesenfeld Warehouse Co 1075
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B. ENFORCEMENT JURISDICTION—ContinuedUnited States v. 40 Cases . . . "Pinocchio Brand 757°
Corn, Peanut Oil and Soya Bean Oil Blended with25% Pure Olive Oil" 1076
FDA Jurisdiction Over Restaurants 10783. Oleomargarine 1080
Senate Report: Repealing the Taxes on Oleomargarine..10804. Medical Devices 1081
United States v. Undetermined Quantities of An Articleof Device . . . "Depilatron Epilator" 1081
5. Biologies 1083United States v. Calise 1083
C. REGULATION OF FOREIGN COMMERCE 10841. Importation into the United States 1084
Sugarman v. Forbragd 1084L & M Industries, Inc. v. Kenter 1085Goodwin v. United States 1087
2. Exportation from the United States 1090United States v. Kent Food Corp 1090United States v. An Article . . . Enriched Rice 1091Compliance Policy Guide No. 7127.02 1092Carl Borchsenius Co. v. Gardner 1093United States v. 76,552 Pounds of Frog Legs 1095
3. Export of New Drugs, New Animal Drugs, BiologicalProducts, and Medical Devices 1096
a. New Human and Animal Drugs Prior to 1986 1096United States v. An Article of Drug . . . Ethion-
amide-INH 1097b. Medical Devices 1098
Conference Report: Medical Device Amendments of1976 1098
c. A Revised Export Policy for Drugs 1099Statement of HEW Secretary Joseph A. Califano, Jr.,
House Hearings 1099The Drug Export Amendments Act of 1986 1100Export of Antibiotic Drugs 1101
D. FACTORY INSPECTION 11011. Constitutional Limitations 1102
United States v. Cardiff 1102United States v. Jamieson-McKames Pharmaceuticals,
Inc. 1104United States v. Thriftimart, Inc 1108Mechanical Requirements of Inspection 1110
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D. FACTORY INSPECTION—Continued2. Scope of Section 704 Inspections 1111
United States v. 75 Cases . . . Peanut Butter, Labeled. . . "Top Notch Brand" - 1112
Triangle Candy Co. v. United States .1114United States v. ACRI Wholesale Grocery Co 1116
3. Mode of Inspection ....1118Report on the White House Conference on Food, Nutrition
and Health 1118Innovations in Factory Inspection 1119
E. SEIZURE...... - - - ....11211. Governing Principles 1121
Four Hundred and Forty-Three Cans of Frozen EggProduct v. United States.. 1121
United States v. 893 One-Gallon Cans . . . LabeledBrown's Inhalant 1123
United States v. 3 Unlabeled 25-Pound Bags Dried Mush-rooms 1124
2. Multiple Seizures 1125Ewing v. Mytinger & Casselberry, Inc 1125Parke, Davis & Co. v. Califano 1127
3. Proof Required for Condemnation 1130United States v. 43V% Gross Rubber Prophylactics La-
beled in Part "Xcello's Prophylactics" 11304. Transfer of Proceedings. .1132
Clinton Foods, Inc. v. United States 11325. Salvaging 1133
United States v. 1322 Cans . . . of Black RaspberryPuree 1133
Buticaps, Inc. v. United States ...11346. Effectiveness of Seizures 1136
Hutt, Philosophy of Regulation Under the Federal Food,Drug, and Cosmetic Act 1136
7. Administrative Detention 1137F. INJUNCTIONS ...1137
House Report: Food, Drug, and Cosmetic Act 1138United States v. Odessa Union Warehouse Co-Op 1138United States v. Chattanooga Bakery, Inc. 1141United States v. Lit Drug Co. 1143United States v. 184 Barrels Dried Whole Eggs 1146United States v. 47 Bottles Jenasol RJ Formula '60' 1147
G. CRIMINAL LIABILITY ..11481. Philosophy of Prosecution 1148
Kallet and Schlink, 100,000,000 Guinea Pigs 1148Fine, The Philosophy of Enforcement 1149
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PageG. CRIMINAL LIABILITY—Continued
2. Standard of Liability 1150United States v. Dotterweich 1150United States v. Park 1155
Proposals to Change the Criminal Liability Standardll63Authorized Criminal Penalties 1164
3. The Guaranty Clause 1165United States v. Crown Rubber Sundries Co 1165United States v. Balanced Foods, Inc 1166United States v. Walsh 1167
4. Section 305 Hearings 1169Enforcement Policy, Practices, and Procedures: Informal
Hearing Before Report on Criminal Violation, 41Fed.Reg. 14769 1169
Other Statutes Invoked in Criminal Enforcement ofthe FD&C Act 1171
H. CIVIL PENALTIES— 11711. The Radiation Control for Health and Safety Act of 1968 1172
United States v. Hodges X-Ray, Inc. 11722. The Prescription Drug Marketing Act of 1987 1174
I. RESTITUTION 1175United States v. Parkinson 1175
J. RECALLS 1178United States v. C.EB. Products, Inc. 1178United States v. K-N Enterprises, Inc 1181Enforcement Policy, Practices, and Procedures: Recall Policy
and Procedures, 41 Fed.Reg. 26924 1183GAO, Lack of Authority Limits Consumer Protection: Problems
in Identifying and Removing from the Market ProductsWhich Violate the Law 1187
K. INFORMAL ENFORCEMENT 1188Memorandum for the Attorney General Re: Proposed Phasing
Out of Nitrites in Foods 1189Enforcement Policy for Certain Compliance Correspondence, 43
Fed.Reg. 27498 1192L. PUBLICITY 1194
Kallet and Schlink, 100,000,000 Guinea Pigs 1194Hoxsey Cancer Clinic v. Folsom 1195Ajay Nutrition Foods, Inc. v. FDA 1196Administrative Practices and Procedures: Publicity Policy, 42
Fed.Reg. 12436 1198United States v. Abbott Laboratories 1202
M. FDA ENFORCEMENT STATISTICS 1205lxv
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PageN. RES JUDICATA AND RELATED DOCTRINES 1206
1. Res Judicata in FDA Cases -1206United States v. 17 Cases . . . of Nue-Ovo 1206
Res Judicata Based on Prior Civil Actions 1207United States v. Gramer 1208
Res Judicata Based on Prior Criminal Case 1209Res Judicata Based on Association Suits 1210
2. Effect of Suits by Other Agencies 1210United States v. Willard Tablet Co... 1210
3. Simultaneous Government Proceedings 1213Warner-Lambert Co. v. Federal Trade Commission 1213
4. Estoppel Against the Government ....1215United States v. 354 Bulk Cartons . . . Trim Reducing-
Aid Cigarettes. 1215Administrative Practices and Procedures: Notice of Pro-
posed Rule Making, 40 Fed.Reg. 40682 .....1216O. PRIVATE ENFORCEMENT OF THE FD&C ACT 1217
1. Implied Private Causes of Action 1217Florida Ex Rel. Broward County v. Eli Lilly & Co. ...1217
2. The Effect of the 1938 Act on Common Law Suits 1220Orthopedic Equipment Co. v. Eutsler 1220
3. Suits Against the Government 1222Merrill, Compensation for Prescription Drug Injuries 1222Gray v. United States 1223
Federal Tort Claims Act Cases 1224Mizokami v. United States 1225
4. Suits Under the Lanham Act 1227a. Prior to 1988 1227
Potato Chip Institute v. General Mills, Inc. 1227Proctor & Gamble Co. v. Chesebrough-Pond's Inc. 1228McNeilab, Inc. v. American Home Products Corp. 1230
b. 1988 Revision of the Lanham Act 1233Suits Under RICO 1234
P. STATE ENFORCEMENT OF THE FD&C ACT .1235
CHAPTER XII. FDA PRACTICE AND PROCEDURE
A. FDA'S APPROACH TO REGULATION 12361. Overview .12362. FDA's Procedural Regulations 12383. Planning and Priorities .1239
User Fees .1240
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A. FDA'S APPROACH TO REGULATION—Continued4. FDA, Regulated Firms, and the Public 1240
Review Panel on New Drug Regulation, Final Report ...1241Final Report of the National Committee to Review Proce-
dures for Approval of New Drugs for Cancer andAIDS 1242
5. FDA and Other Federal Regulatory Agencies 1243B. SECTION 701(a) RULEMAKING 1244
1. HHS and OMB Supervision of FDA Rulemaking.... 12452. Informal Rulemaking Requirements 1247
United States v. Nova Scotia Food Products Corp 1247Informal Rulemaking Procedures 1251
3. Failure to Promulgate Regulations 1254Community Nutrition Institute v. Young 1254
4. Ripeness for Judicial Review 1258Abbott Laboratories v. Gardner 1258
5. Effect of Section 701(a) Regulations 1262C. FORMAL RULEMAKING AND ADJUDICATION 1264
1. Justification for an Evidentiary Hearing 1265Dyestuffs and Chemicals, Inc. v. Flemming 1265Regulations for the Enforcement of the Federal Food,
Drug, and Cosmetic Act, and the Fair Packaging andLabeling Act: Ruling on Objections, 32 Fed.Reg. 13276 1267
2. Hearing Procedures 1271a. Limits on Cross Examination.... 1272b. Alternative Informal Hearings 1273
Administrative Practices and Procedures, 40 Fed.Reg.40682 ..1274
D. PRIMARY JURISDICTION 12761. Introduction. 1276
Hutt, FDA Court Actions and Recent Legal Develop-ments 1276
2. Suits Against FDA 1277IMS, Ltd. v. Califano 1277
3. FDA Enforcement Suits. 1279United States v. Alcon Labs 1279
E. ADVISORY COMMITTEES 12841. FDA Reliance on Advisory Committees .1284
Statement of Commissioner Alexander M. Schmidt, M.D.,House Hearings 1284
2. The Federal Advisory Committee Act 1286a. Coverage of FACA 1286
Consumers Union of United States, Inc. v. Depart-ment of HEW 1287
National Nutritional Foods Ass'n v. Califano 1290
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E. ADVISORY COMMITTEES—Continuedb. Composition of Advisory Committees 1295
Public Citizen v. National Advisory Committee.... 1295F. PUBLIC ACCESS TO FDA RECORDS 1299
1. Overview - - 1299Hutt, Public Information and Public Participation in the
Food and Drug Administration 12992. Trade Secrets 1301
a. The Definition of "Trade Secret" 1302b. Predisclosure Notification 1303
Pharmaceutical Manufacturers Ass'n v. Weinberger 1303House Report: Freedom of Information Act Requests
for Business Data and Reverse-FOIA Lawsuits.... 1308G. ENVIRONMENTAL CONSIDERATIONS .1309
Environmental Defense Fund, Inc. v. Mathews 1310H. REGULATORY REFORM 1313
Hutt, Safety Regulation in the Real World ....1315Rothschild, the Newest Regulatory Agency in Washington....1317Statement of Alexander M. Schmidt, M.D., Commissioner of
Food and Drugs, Senate Hearings 1318CompMance with Statutory Deadlines .1319Interagency Coordination 1324
AppendicesApp.
A. Laws Applicable to Producers of Food, Drugs, Cosmetics, andMedical Devices. ..1327
B. Delegations of Authority to the Commissioner of Food andDrugs..... 1337
INDEX 1347
lxviii