Which act officially established the FDA as an agency in DHHS?

• A. FDA Act 1988
• B. Food, Drug, and Cosmetic Act 1938
• C. Orphan Drug Act 1983
• D. Prescription Drug User Fee Act 1992

Answer: (A)

Understanding where an agency sits within the federal government is defined by the statute that establishes or confirms its organizational home. The act in question here explicitly placed the FDA as an agency within the Department of Health and Human Services, making its position in DHHS official and binding. That act is the FDA Act of 1988, which clarified the FDA’s status and structure under DHHS.

The Food, Drug, and Cosmetic Act of 1938 gave FDA its regulatory authority to oversee foods, drugs, and cosmetics, but it did not designate its placement within DHHS. The Orphan Drug Act of 1983 and the Prescription Drug User Fee Act of 1992 address programmatic incentives and funding, not where the FDA sits administratively.