Audit of the Food and Drug Administration's Oversight of Dietary Supplements

OBJECTIVE

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.

TIMELINE

• November 1, 2025
  Announced
• Today
  Office of Audit Services In-Progress
• Est FY2027
  Estimated Fiscal Year for Project Completion

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