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FDA Responds to Citizen Petitions

On March 31, FDA released a constituent update about NAC (N-acetyl-L-cysteine) for use as a dietary supplement ingredient. FDA denied the two citizen petitions, both from trade associations. One was one from the Council for Responsible Nutrition (CRN) and the other came from Natural Products Association (NPA). The FDA update confirmed that NAC is excluded from the definition of a dietary supplement. The FDA intends to issue guidance about its policy on NAC-containing products labeled as dietary supplements in the near future. NAC is an antioxidant that is believed to reduce inflammation, and it was approved as a drug in 1963.

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Posted on 6 April 2022