Introduction

This guide is designed to provide an introduction to researching the U.S. Food and Drug Administration (FDA) (e.g., regulations, guidance, administrative decisions).

Getting Started

The following sources provide a good introduction to food, drug, and cosmetic law.

• James T. O'Reilly, Food and Drug Administration (3rd ed. 2007) (KF 3871 .O7 2007) Also available on Westlaw (FDADMIN) This two-volume treatise is updated regularly and overviews the organization of the FDA, FDA enforcement procedures, as well as general overviews of relevant regulatory areas. Appendixes also include forms and tables of cases, statutes, and regulations.

• Food , Drug, and Cosmetic Explanations Available on CCH IntelliConnect (Food, Drugs, and Devices > Food, Drugs and Cosmetics Explanations)
• A Practical Guide to Food and Drug Law and Regulation (3rd ed. 2008) (KF1900.Z9 P73) One-volume guide published by the Food and Drug Law Institute.
• Federal Procedure, Lawyers' Edition (KF8835 .F43) Also available on Westlaw (FEDPROC) See Chapter 35 (Food, Drugs, and Cosmetics)

Primary Law

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 .

The FDA website also contains information on the FDCA and its amendments as well as the numerous other laws affecting the agency.

Selected Important Statutes

* For a comprehensive and useful guide to this new law, see FDA Food Safety Modernization Act: Law, Explanation, and Analysis (available on CCH IntelliConnect).

Legislative Histories of the Federal Food, Drug, and Cosmetic Act (1938)

The following is a select list of legislative histories of the FDCA:

• A Legislative History of the Federal Food, Drug, Cosmetic Act and Its Amendments (1979) (KF3864.56 .A15) Also available through HeinOnline A large thirty-four volume collection of legislative history documents, including bills, hearings, reports, and more.
• Charles Wesley Dunn, Federal Food, Drug, and Cosmetic Act: A Statement of its Legislative Record (1987) (KF3864.A15 D8 1987r)
• David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Probs. 2 (1939).

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 or Legislative History Tutorial .

Administrative Materials

Regulations

Codified federal regulations on food, drugs, and cosmetics can be found in Title 21 the Code of Federal Regulations.

For information on accessing the Code of Federal Regulations and researching U.S. federal regulations generally, see Georgetown Law Library's Administrative Law Research Guide or the Administrative Law Tutorial.

Other FDA Administrative Materials

The Food and Drug Administration is 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 and is comprised of nine primary centers and offices responsible for regulatory oversight and enforcement:

• Office of the Commissioner
• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health
• Center for Drug Evaluation and Research
• Center for Food Safety and Applied Nutrition
• Center for Tobacco Products
• Center for Veterinary Medicine
• National Center for Toxicological Research
• Office of Regulatory Affairs

Some materials offered by the FDA on their website include:

• FDA Enforcement Reports (2004 - ) Also available on CCH IntelliConnect (1999 - ) (Food, Drugs, and Devices > Food, Drugs, and Cosmetics Primary Source Materials > FDA Issuances > Enforcement Reports)
• FDA Guidance Documents Some of these materials are also available on CCH IntelliConnect (Food, Drugs, and Devices > Food, Drugs, and Cosmetics Primary Source Materials)
• FDA Warning Letters (1996 - ) Also available on CCH IntelliConnect (1995 - ) (Food, Drugs, and Devices > Food, Drugs, and Cosmetics Primary Source Materials > FDA Issuances > Food, Drugs and Cosmetics Guide: Warning Letters) Letters sent to companies or others marketing regulated products when marketed products fail to meet the standards of FDA regulations. The FDA notes that many of the letters may be subject to subsequent interaction between the agency and the recipient, thus, for the most accurate information, the FDA should be contacted.

In addition to Warning Letters, the FDA can initiate the following types of enforcement actions:

• FDA Initiated Recalls: Recalls are originally reported in FDA Enforcement Reports (see above). The FDA also offers on their website a database of all recalls issued by the FDA in the prior 60 days. The Federal Government also provides a general information website for consumers regarding recalled products.
• Debarment: A company that has submitted false research data to the FDA or otherwise severely violating FDA regulations may be "debarred" from future FDA product approvals in the generic drugs program. The FDA provides a list of debarred persons.
• Disqualification: Disqualification bans an individual or organization from all future FDA-regulated research. The FDA provides a list of totally disqualified clinical investigators.
• Detention/Import Refusals: The temporary suspension of the movement of a particular device or food item pending a full FDA enforcement hearing. Import detentions are reported in the Import Refusal Reports.
• Withdrawal of Product Licenses: See also the FDA Enforcement Reports (see above); The FDA also offers a database of all withdrawals issued by the FDA in the prior 60 days.
• FDA Civil Penalty Authority: See related statutes which delegate to the FDA Civil Penalty Authority.
• Seizures: See Enforcement Reports (see above)

Cases

Cases involving the FDCA and other federal food, drug, and cosmetic laws can generally be found in the same sources and using the same techniques as other cases. For information on researching U.S. case law generally, see Georgetown Law Library's Case Law Research Guide or the Case Law Research Tutorial .

Additionally, cases on this subject can be found in specialized reporters:

• CCH Food, Drug, and Cosmetics Law Reporter (KF3868.5 .C6 1963) (print cancelled in 2008) Also available through CCH Intelliconnect (Food, Drugs, & Devices --> Primary Source Materials --> FDA Court Decisions) and Westlaw (CCH-DCLR) Reports decisions related to food, drug, and cosmetic law from all courts. It includes many cases that are not separately reported by other reporters.

Additional Secondary Sources

Subject Law Reviews and Journals

Food and Drug Law Journal (K6 .O281) (1992-2008, print subscription cancelled) Available on Westlaw (FOODDLJ, selected coverage from 1989), LexisNexis (1996 - ), and HeinOnline, 1946 - ) Published by the Food and Drug Law Institute Journal of Food Law and Policy (K10.O3696) (2005-2008, print subscription cancelled) Also available electronically (2005 - )

For information on search and locating relevant articles in other legal and non-legal periodicals generally, see Georgetown Law Library's Using Articles for Legal and Non-Legal Research Guide or the Law Reviews Tutorial.

Current Awareness Sources

• Food and Drug Law Weekly (2004 - )
• Drug Law Weekly (2004 - )
• Update: Food and Drug Law, Regulation, and Education (KF3866.3 .F44) (2000 - ) Published by the Food and Drug Law Institute six times per year
• FDA Consumer Magazine (1988-2007)FDA stopped publishing this magazine in 2007. Information for consumer is now available online at FDA: Consumer Updates.
• Food, Drug, Cosmetic Law Reports Available on CCH IntelliConnect (2006 - ) (Food, Drugs, and Devices > News > Food, Drug, and Cosmetic Newsletters)
• Food and Drug Law Institute Seeks to educate regarding law and policy related to food and drug law.
• See the ABA Journal Blawg Directory: Health Law for links to a number of legal blogs on food, drug, and cosmetic law.

Cosmetic Laws

See the above information for how to find statues, regulations, and cases related to cosmetics.

Additionally, there is a section of the FDA's website devoted to Cosmetics. The website includes links to the following:

• Compliance and Enforcement Enforcement news and recall information
• Guidance, Compliance, and Regulatory Information Laws and regulations, guidance documents, and an overview of FDA authority
• Information about cosmetic products and ingredients
• Information about cosmetic labeling and claims that can be made on labels

Advocacy Organizations

• Personal Care Products Council National trade association for the cosmetic and personal care products industry. Website has a lot of useful information, but some of it is only available to members.
• The Campaign for Safe Cosmetics Comprised of a national coalition of nonprofit health care and environmental organizations. Their stated goal is to phase out use of chemicals associated with increased health risks in the cosmetics industry. Their website includes links to not only federal laws regarding cosmetic regulation, but also state laws, EU laws and Canadian laws.
• Skin Deep: A cosmetic safety database maintained by the Environmental Working Group that allows you to search for ingredients in cosmetics, particular products, or companies.