The Food and Drug Administration (FDA) is different from the other U.S. Department of Health and Human Services (DHHS) agencies in that its programs are designed primarily for consumer protection. FDA’s mission is to ensure that food is safe, pure, and wholesome; that human and animal drugs, biological products, and therapeutic devices are safe and effective; and that radiological products and procedures for the use of these products do not result in unnecessary exposure to potentially harmful radiation.

The extent and the type of toxicity testing required for a food additive or other hazardous material depend on its potential adverse effects on human health. The Delaney clause of the Federal Food, Drug, and Cosmetic Act amended in 1958 requires that FDA adopt a “no-risk” approach for carcinogenic food additives. FDA toxicologists and chemists are also required to cooperate with the agency’s field force to monitor food products and to identify hazardous, unavoidable contaminants or natural toxicants. In addition, approval of a new drug, biologic, or medical device requires an extensive review and assessment of the scientific evidence by FDA. These scientific data or studies include: chemical, manufacturing, and control information; pharmacologic and toxicologic information from animals and in vitro systems; preclinical testing; clinical trials; and postmarketing surveillance.

Examples of RA activities performed by FDA include: D&C Green No. 6; diethylstilbestrol; orthopedic implants; and moxalactam (U.S. DHHS, 1986).