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.

Additional Reading

• CDER Small Business Assistance
• "Bringing an Over-the-Counter (OTC) Drug to Market" training course
• Information about public meetings at FDA's White Oak Campus
• White Oak Campus information (includes a campus map)
• FDA Online Label Repository
• DailyMed website
• "Tainted Supplements" — A list, developed by FDA's Center for Drug Evaluation and Research, of tainted supplements from the past several years

• Chronology: OTC Meetings and Events to NDAC and Other Advisory Committees