AHPA Offers Hard Copy Supporting NAC's Use In Dietary Supplements Pre-DSHEA
Also Suggests First-Time Use Of Authority To Order A Dietary Ingredient Lawful
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.
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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.
Trade group asked FDA six months ago to reverse position it revealed in July 2020 that products containing NAC cannot be marketed as dietary supplements. After Amazon in May reported pulling NAC supplements from its site, CRN decided to ask again.