Food, Drug, and Cosmetic Law Research Guide

This research guide assists with research in food, drug, and cosmetic law, in particular federal law arising since the 1938 Food, Drug, and Cosmetic Act and subsequent regulations.

Contents

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Statutes

The federal Food, Drug, and Cosmetic Act and other food and drug laws are codified in Title 21 of the United States Code.

For information on accessing the United States Code and researching U.S. statutory law generally, see Georgetown Law Library's Statutes Research Guide or the Statutory Research Tutorial.

 

SELECTED IMPORTANT STATUTES 

As a note, the following statutes were selected for their importance; however, there are plenty of other amendments to the FDCA that might be relevant not noted here.

Name and Year of Legislation Public Law Number Statutes at Large Citation
Food, Drug and Cosmetic Act (1938) P.L. 75-717 52 Stat. 1040
Food Additives Amendment of 1958 P.L. 85-929 72 Stat. 1784
Radiation Control for Safety and Health Act P.L. 90-602 82 Stat. 1173
Drug Price Competition and Patent Term Restoration Act of 1984 P.L. 98-471 98 Stat. 1585
Nutrition Labeling and Education Act (1990) P.L. 101-535 104 Stat. 2353
Safe Medical Device Amendments of 1990 P.L. 101-629 104 Stat. 4511
Food and Drug Administration Revitalization Act P.L. 101-635 104 Stat. 4583
Dietary Supplement Health and Education Act (1994) P.L. 103-417 108 Stat. 4332
Food and Drug Administration Modernization Act of 1997 P.L. 105-115 111 Stat. 2296
Food and Drug Administration Amendments Act of 2007 P.L. 110-85 121 Stat. 823
FDA Food Safety Modernization Act * P.L. 111-353

124 Stat. 3885

21st Century Cures Act P.L. 114-225 130 Stat. 1033
FDA Reauthorization Act of 2017 P.L. 115-52  131 Stat. 1005-1090

*For an extensive explanation and analysis of the FDA Food Safety Modernization Act, please see the following on VitalLaw: FDA Food Safety Modernization Act: Law, Explanation, and Analysis.

Legislative History

Comprehensive legislative histories of all the laws listed above are available through ProQuest Legislative Insight. These histories include PDF versions of the Public Law, all versions of enacted and related bills, Congressional Record excerpts, and committee hearings, reports, and documents. The database can be searched using the popular name of the law, the Public Law number, or the Statutes at Large citation.

For assistance with finding additional information on the legislative history of the FDCA or finding legislative history of subsequent amendments and other food, drug, and cosmetic laws, see the Georgetown Law Library's Legislative History Research Guide and Legislative History Tutorial.

The following are selected legislative histories of the FDCA:

ProQuest Legislative Insight Tutorial