FDA Issues Draft Policy Regarding N-acetyl-L-cysteine: Guidance for Industry

The Food and Drug Administration (FDA) is announcing the availability of draft guidance for the industry entitled “Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry.” The draft guidance, when finalized, will explain the FDA’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and 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 that is not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Comments can be sent by May 23, 2022.

FDA has determined that, under section 201(ff)(3)(B)(i) of the FD&C Act (21 U.S.C. 321(ff)(3)(B)(i)), NAC is excluded from the dietary supplement definition because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. FDA received two citizen petitions requesting that we conclude that NAC is not excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the FD&C Act. On March 31, 2022, FDA denied this request.