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    Online Exclusives

    FDA Issues NAC Enforcement Discretion Guidance

    The agency maintains NAC was first approved as a new drug before it was marketed as a dietary supplement, but may issue a rule following NPA request.

    FDA Issues NAC Enforcement Discretion Guidance
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    By Mike Montemarano, Associate Editor04.21.22
    The U.S. Food and Drug Administration (FDA) has issued draft guidance for dietary supplement manufacturers, distributors, and other stakeholders regarding its enforcement discretion over products containing N-acetyl-L-cysteine (NAC). FDA is accepting comments on the draft guidance by May 22. 

    On Mar. 31, FDA issued a joint response to two citizen petitions, from the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA), rejecting requests that the agency conclude NAC be considered a lawful dietary supplement under section 201(ff)(3)(B) of the Food, Drug, and Cosmetic Act (FD&C).

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