The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. The FDA is headed by acting commissioner Dr. Lester Crawford.

One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels implicates the First Amendment, FDA must balance concerns about the public health with the right to free speech. Dan Troy, a lawyer who was Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.

FDA and the public

According to the Small Business Guide to FDA, "Anyone may request or petition FDA to change or create an Agency policy or regulation under 21 CFR Part 10.30." This is called a Citizen's Petition and it is one method used to challenge specific approvals by the FDA.^[4]

History

• 1927 — The "Bureau of Chemistry" is reorganized into two separate entities. Regulatory functions are located in the "Food, Drug, and Insecticide Administration", and nonregulatory research is located in the "Bureau of Chemistry and Soils".

• 1930 — The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.

• The Naval Ordnance Laboratory White Oak site was taken over by the FDA to become its new headquarters. However, budget reductions have delayed the move to White Oak for many FDA offices.

Related legislation

• 1938 — Federal Food, Drug, and Cosmetic Act
• 1951 — Food, Drug, and Cosmetics Act Amendments PL 82–215
• 1953 — Flammable Fabrics Act PL 83–88
• 1960 — Federal Hazardous Substances Labeling Act PL 86–613
• 1962 — Food, Drug, and Cosmetics Act Amendments PL 87–781
• 1965 — Federal Cigarette Labeling and Advertising Act PL 89–92
• 1966 — Fair Packaging and Labeling Act PL 89–755
• 1966 — Child Protection Act PL 89–756
• 1970 — Federal Cigarette Labeling and Advertising Act Amendments PL 91–222
• 1972 — Consumer Products Safety Act PL 92–573
• 1976 — Medical Device Regulation Act PL 94–295
• 1986 — Comprehensive Smokeless Tobacco Health Education Act PL 99–252
• 1988 — Anti—drug Abuse Act PL 100–690
• 1990 — Nutrition Labeling and Education Act PL 101–535
• 1992 — Prescription Drug User Fee Act PL 102–571

External links

• http://www.fda.gov/
• http://www.fdareview.org/
• End the FDA's Monopoly by David R. Henderson

Articles

• US drug safety checks 'slack'

References

1. CHI World Pharmaceutical Congress 2005 Website and final agenda in print form. Verified 03-07-2005.
2. ^  How to Petition the FDA. Retrieved 2005-03-20.
3. ^  FDAReview.org
4. ^  Friedman, Milton & Rose (1979). Free to Choose. New York: Harcourt Brace Jovanovich. ISBN 0-15-133481-1.