Window Of Opportunity Opened Narrowly For Continued Use Of NAC As Dietary Ingredient In US
FDA Doesn’t Wave A White Flag, But Offers Cautionary Call For Comments
FDA will “determine if rulemaking to make NAC lawful as a dietary supplement is appropriate.” Agency issued tentative responses to Council for Responsible Nutrition and Natural Products Association’s petitions asking for halt to warnings and other enforcement against firms marketing supplements containing NAC.
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American Herbal Products Association submits comments to on CRN and NPA petitions encouraging FDA to grant an industry request to issue a regulation finding NAC is a lawful dietary ingredient.
Agency "does not believe a hearing is necessary at this time given the other mechanisms at stakeholders’ disposal to interact with FDA on this issue, including submission of comments" for citizen petition CRN submitted on NAC, Andrew Tantillo, acting associate commissioner for legislative affairs, tells Sen. Mike Lee.
Utah Republican Mike Lee suggests attention to N-acetyl-L-cysteine as dietary ingredient FDA has shown for overhauls of its supplement industry regulation, Rx-to-OTC switch process and OTC monograph drug program as well as for cannabinoids and its NDI notification requirement.