The Food and Drug Administration (FDA) regulates the safety of prescription and over-the-counter drugs, medical devices, food additives, and cosmetics through the Food, Drug, and Cosmetic Act.
Drugs: The FDA requires scientific data from manufacturers documenting that any new prescription or over-the-counter drug product is both safe and effective before it can be sold in the United States. (In addition to nonprescription medicines, the over-the-counter drug category includes some personal care products that you may not usually think of as drugs—for example, sunscreens, antidandruff shampoos, fluoride toothpaste, antibacterial soaps, and antiperspirants.)
Laboratory animal tests play an important role in drug development because the effects of a new compound must be measured in a living system before it is given to human volunteers in clinical studies. Animal tests help determine what dosage levels are safe and measure how the entire body reacts to a substance. The final assurance of safety comes from a combination of non-animal tests, laboratory animal studies, and finally, carefully controlled clinical studies using human volunteers. Similar rules regulate the safety of medical devices and food additives such as artificial sweeteners.
Cosmetics: Food and Drug Administration regulations state that “each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing.” The Food, Drug, and Cosmetic Act prohibits the distribution of “adulterated or misbranded” cosmetic products. (Cosmetics include makeups and non-drug personal care products such as hair and skin care products.) A product is adulterated if it contains a substance that makes it harmful to consumers under normal use conditions.To prevent marketing a harmful product, a manufacturer must confirm product safety by conducting appropriate evaluations before selling a new cosmetic. However, this safety information does not have to be sent to the FDA for “premarket” approval as is required for new drugs and food additives. Also, the Food, Drug, and Cosmetic Act does not specify the exact test procedures that must be used.
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