FDA's Oversight of Dietary Supplements

The Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act, gives the Food and Drug Administration (FDA) the authority to regulate dietary supplements that are marketed in the United States. While FDA does not have the authority to approve dietary supplements before they are marketed, FDA's role in regulating dietary supplements includes activities such as inspecting dietary supplement facilities; investigating complaints; monitoring the dietary supplement marketplace; and reviewing adverse event reports to identify products that may be unsafe. For the first phase of work, we will identify the number of domestic and foreign dietary supplement facilities: (1) registered with FDA by type, (2) due for inspection by FDA, and (3) that were inspected by FDA. For the second phase of work, we will conduct an audit to determine whether FDA's oversight of select dietary supplement facilities complied with Federal requirements.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
November 2025	FDA	FDA's Oversight of Dietary Supplements	Office of Audit Services	OAS-25-05-133	2027