FDA guidance for N-Acetyl-L-cysteine in Dietary Supplements

A final guidance has been issued by the FDA regarding its policy on products labelled as dietary supplements which contain N-acetyl-L-cysteine (NAC).

The FDA is intending to exercise enforcement discretion impacting the sale and distribution of dietary supplements containing NAC.

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“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).”

Previously, the FDA ruled out NAC from the dietary supplement definition under the FD&C act, as NAC was firstly approved as a drug (September 14, 1963), before it was used in dietary supplements or as a food. The FDA is not aware of any evidence that NAC was used in dietary supplements prior to 1963, therefore building up their case that NAC cannot be used as a dietary ingredient.

According to the guidance, the enforcement discretion does not apply to products containing NAC, labelled as a dietary supplement, but intended to be used for diagnosis, cure, mitigation, treatment, or prevention of disease, therefore a drug under section 201(g)(1)(B) of the FD&C Act.

Currently, the FDA is considering rulemaking under section 201(ff)(3)(B) of the FD&C Act to permit the use of NAC as a dietary ingredient, in response to a citizen petition submitted by the Natural Products Association (NPA).

“Unless we identify safety-related concerns during our ongoing review, FDA intends to exercise enforcement discretion until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (should we move forward with such proceedings) or we deny the NPA citizen petition’s request for rulemaking. Should we determine that this enforcement discretion policy is no longer appropriate, we will withdraw or revise this guidance in accordance with 21 CFR 10.115.”
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Mihai Inceu