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 (âFDAâ or âthe Agencyâ) 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 policyâwhich represents a sudden and drastic departure from past Agency practiceâis legally invalid. As such, FDA should revert to its longstanding policy of allowing manufacturers to market products containing NAC as dietary supplements.
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