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Citizen petition to FDA to reverse policy change on supplements containing N-Acetyl-L-Cysteine

USA

Jul 01, 2021

The Council for Responsible Nutrition (CRN), submits this Citizen Petition pursuant to 21 C.F.R. § 10.30 requesting that the Food and Drug Administration (“FDA” or “the Agency”) reverse its recently adopted position that the Federal Food, Drug, and Cosmetic Act (FDCA) prohibits manufacturers from marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements. This policy—which represents a sudden and drastic departure from past Agency practice—is legally invalid. As such, FDA should revert to its longstanding policy of allowing manufacturers to market products containing NAC as dietary supplements.

Check the full text of the documents (in English), click on the  Link

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