FDA has submitted the following proposed: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, collection of information to OMB for review and clearance.

May 3, 2023

The Secretary of Health and Human Services has the authority to issue regulations outlining what constitutes good manufacturing practice for dietary supplements, per section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which was added by the Dietary Supplement Health and Education Act (Pub. L. 103-417). 

Such restrictions shall be patterned after the CGMP requirements for food and shall not impose standards for which there is no current and generally available analytical methodology, as provided in Section 402(g) of the FD&C Act. 

If a dietary supplement is not manufactured, packaged, or stored in accordance with current good manufacturing practice, it is considered adulterated under Section 402(g)(1) of the FD&C Act.

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