Draft Guidance Released
The FDA is announcing the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). The draft guidance, when finalized, will explain our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that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. 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). Learn more at FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products.
Original Constituent Update
March 31, 2022
Today, the U.S. Food and Drug Administration (FDA) denied the request in two citizen petitions, from the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), asking the agency to determine that products containing N-acetyl-L-cysteine (NAC) are not excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
While the FDA’s response to the citizen petitions confirmed NAC is excluded from the definition of a dietary supplement, the agency has not yet reached a decision on the NPA citizen petition’s alternative request that the agency undertake rulemaking to allow the use of NAC in dietary supplements. The FDA continues to review this request. The agency’s November 24, 2021 tentative response to the petitions requested data, research results, and other information related to the safe use of NAC in products marketed as dietary supplements, and any safety concerns, to help us evaluate NPA’s rulemaking request. Once the FDA has completed its review of NPA’s alternative request, including review of additional information submitted to the docket in response to the request for information, the agency will respond to the remaining request in the NPA Petition.
In the interim, in light of the absence of safety concerns based on our review to date, among other factors, the FDA is considering exercising enforcement discretion for NAC-containing products labeled as dietary supplements that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of dietary supplement and are not otherwise violative of the FD&C Act. The FDA intends to issue guidance about its policy on NAC-containing products labeled as dietary supplements in the near future.
For Additional Information:
- Response to Council for Responsible Nutrition (CRN)
- Response to Natural Products Association (NPA)
- Council for Responsible Nutrition (CRN) Incoming Petition
- Natural Products Association (NPA) Incoming Petition
- Council for Responsible Nutrition (CRN) Tentative Response
- Natural Products Association (NPA) Tentative Response
- Dietary Supplements