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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2022-D-0490
- Docket Number:
- Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of 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. As described below, the 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).
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.