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FDA Releases Draft Guidance on NAC Enforcement

On April 21, the US FDA announced the issuance of draft guidance regarding dietary supplements containing N-acetyl cysteine (NAC). The guidance details the agency’s intent to exercise enforcement discretion on the sale and distribution of such products. In 2020, FDA sent several warning letters around NAC and drug claims. Recently FDA confirmed in a response to a citizen petition that NAC is excluded from the definition of a dietary supplement but has yet to reach a decision about the use of a petitioner’s request to use NAC as a dietary supplement. NAC has been sold for thirty years with a full safety review in progress. Currently, FDA is accepting comments on the draft guidance.

Draft regulatory documents can be monitored with our Regulatory Trends AI-based Monitoring System.

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Posted on 2 May 2022