Regulation

The OTC medicine, dietary supplement, and consumer medical device industries are regulated by several government agencies, including the U.S. Food and Drug Administration, the U.S. Federal Trade Commission, and the U.S. Consumer Product Safety Commission. CHPA serves as a resource to regulators by providing access to research and experts to ensure that regulatory decisions are informed, transparent, and fair.

The U.S. Food and Drug Administration is an agency within the U.S. Department of Health and Human Services. FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, cosmetics, and our nation’s food supply. Over-the-counter medicines, including generic drugs, are regulated by FDA's Center for Drug Evaluation and Research. Dietary supplements, which are under the "umbrella" of foods, are overseen by FDA's Center for Food Safety and Applied Nutrition.

white tablets being shaken from a bottle into a hand
Regulation of OTC Medicines
three different kinds of dietary supplement capsules
Regulation of Dietary Supplements