Food and Drug Administration

FOOD AND DRUG ADMINISTRATION

The Food and Drug Act of 1906, which prohibited the interstate trade of misbranded or tainted food, drinks, and drugs, was passed by Congress on the same day as the Meat Inspection Act. At this time there was no Federal Drug Administration, but there was a Bureau of Chemistry. In 1927 a separate enforcement agency known as the Food, Drug and Insecticide Administration was create and in 1930 it was renamed the Food and Drug Administration (FDA). In 1938 after five years of battle with Congress, the Federal Food, Drug, and Cosmetic Act was passed. According to the FDA's Web site, it contained the following new provisions:

• Extending control to cosmetics and therapeutic devices
• Requiring new drugs to be shown safe before marketing—starting a new system of drug regulation
• Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
• Providing that safe tolerance is set for unavoidable poisonous substances
• Authorizing standards of identity, quality, and fill-of-container for foods
• Authorizing factory inspections
• Adding the court injunctions to the previous penalties of seizures and prosecutions

Later the FDA's jurisdiction was expanded to include microwaves and any radiation-emitting consumer products, as well as veterinary drugs and pet food. The agency monitors the manufacture, transportation, and sale of food and drugs. To ensure its efficiency, the FDA operates in 157 cities and employs approximately 9000 people. Among its employees are chemists, microbiologists, and investigators who visit 15,000 locations each year.

FDA inspectors visit businesses that are regulated by the FDA. If a problem exists, the FDA allows the company to voluntarily correct the problem or recall the faulty product. If the company refuses to cooperate, the FDA can go to court to force cooperation. Court action can include criminal prosecution if necessary.

In the area of drug control, the FDA does not conduct its own experiments but closely examines the results of the company's research. FDA inspectors conduct three types of inspections: study oriented, investigation oriented, and bioequivalence inspections. Study-oriented inspections are needed in case of new drug or new-product applications for approval. An investigator-oriented inspection may be ordered if other investigators looking at the same study think the findings are inconsistent. If one study is the sole basis for a marketer request, a bioequivalence study is conducted.

Once a drug or device is approved, the agency's responsibility does not end. The FDA monitors any complaints and looks for any adverse reactions associated with the product. As a result, approximately 3,000 products are recalled each year.

In addition to ensuring the quality of the product itself, the FDA has had a major influence on businesses

---

and the way goods are packaged. For example, medicines and products dangerous to children are now packaged in childproof bottles, and labels on containers of food products must list the nutritional contents and their amounts.

Any company that produces a product that is under the jurisdiction of the FDA has felt the pressure of its regulations, and complaints have been made about the slowness of the FDA's procedures. However, no country's citizens enjoy more protection regarding the products they use than U.S. citizens.

More information is available from the Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or http://www.fda.gov.

see also Consumer Advocacy and Protection

bibliography

Food and Drug Administration. Frequently Asked Questions. Retrieved October 18, 2005, from http://www.fda.gov/opacom/faqs/faqs.html.

Food and Drug Administration. Information Sheets, "Guidance for Institutional Review Boards and Clinical Investigators". Retrieved October 18, 2005, from http://www.fda.gov/oc/oha/IRB/toc.html.

Food and Drug Administration. Milestones in United States Food and Drug Law History. Retrieved October 18, 2005, from www.fda.gov/opacom/backgrounders/miles.html.

Food and Drug Administration. Small Business Guide to FDA. Retrieved October 18, 2005, from http://www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm..

Food and Drug Administration. Warning Letters. Retrieved October 18, 2005, from http://www.fda.gov/foi/warning.htm..

Val Hinton

Mary Jean Lush