However, we have not yet reached a final decision on one petitioner’s request to issue a regulation to permit the use of NAC in dietary supplements, and we are considering initiating rulemaking to provide by regulation that NAC is not excluded from the definition of dietary supplement. 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).Īs we discussed in a recent response to two citizen petitions, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. The draft guidance, when finalized, will explain our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. Food and Drug Administration (FDA) is announcing the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). Please see the Federal Register Notice for additional information. This finalizes the draft guidance on this policy from April 2022. This enforcement discretion policy applies 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). This guidance explains our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. The FDA is announcing the availability of a final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).
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