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.

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Introduction

This guide is designed to provide an introduction to researching the area of Food, Drug, and Cosmetic Law, and focuses heavily on the U.S. Food and Drug Administration (FDA) (e.g., regulations, guidance, administrative decisions), the administrative agency primarily tasked with enforcing food, drug, and cosmetic law and regulations. The FDA is an agency within the Department of Health and Human Services. Please note, the FDA underwent a major restructuring effort in 2019 to align the organizational structure with the agency's mission. This change completely restructured the agency, and again, on October 1, 2024, the FDA developed and implemented an even deeper change called the Human Foods Program

This area of law requires research in several domains including case law, administrative decisions and guidance, and statutes. There are many relevant tools to use, including: 

  • VitalLaw's Food, Drug, and Cosmetics Dashboard
    • This dashboard assembles a number of relevant tools, including news, FDA documents and guidance, relevant cases, forms, regulations, treatises, and agency rules all in one place. 
  • ProQuest Congressional
    • ProQuest Congressional provides access to a vast collection of U.S. congressional documents, including bills, hearings, reports, and legislative histories, as well as CRS reports and member biographies. It is designed for researchers needing comprehensive coverage of U.S. legislative activity and related publications.

  • ProQuest Legislative Insight

    • ProQuest Legislative Insight, on the other hand, focuses specifically on legislative histories for enacted laws, offering access to all relevant documents from the legislative process, including bill versions, debates, reports, and more. Unlike ProQuest Congressional, which covers a wide range of congressional documents, Legislative Insight is tailored for in-depth research on the legislative process of individual laws. There are not compiled legislative histories for every law in the United States, but it certainly provides coverage for most larger laws.

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Update History

Updated 6/2014 (SG)
Updated 8/2023 (MK)

Updated 10/3/2024 (RM)