Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry; Availability, 87 FR 24170

Summary

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry.” The draft guidance, when finalized, will explain our intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain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