Friday, April 22, 2022


  • Thursday, the FDA announced the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine. The draft guidance, when finalized, will explain the agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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