On April 22, 2022, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance on the policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).
The draft guidance, when finalized, will outline how the FDA will exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing dietary supplements. The enforcement policy would apply to products that would be lawfully marketed as 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).
Historically, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. With regards to the drug classification, N-acetyl-L-cysteine (NAC) has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.
The FDA received two citizen petitions asking the agency to reconsider its position on the use of NAC as a dietary supplement and has since been conducting a review of the ingredient and any potential safety concerns. If the FDA does not identify safety-related concerns following review of the available data and information on NAC, a rule may be proposed providing that NAC is not excluded from the definition of dietary supplement.
NAC-containing products represented as dietary supplements have been sold in the United States for over 30 years and consumers continue to seek access to such products. In the interim, the FDA issued this draft guidance to explain the policy regarding products labeled as dietary supplements that contain NAC.
Unless the FDA identifies safety-related concerns on the use of NAC in dietary supplements, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: completion of notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement or denying the citizen petition’s request for rulemaking. If the FDA determines that this enforcement discretion policy is no longer appropriate, stakeholders will be notified by withdrawing or revising the guidance.
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