Comments On Petition As Good As Public Hearing On NAC’s Use As Dietary Ingredient – US FDA
Agency Tells Sen. Lee ‘Other Mechanisms At Stakeholders’ Disposal To Interact With FDA’
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.
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FDA ODSP details “data, research results, and other information” it needs on NAC that could sway proposing a rulemaking to allow its continued use in supplements. One detail missing is what the agency’s asking for are NDI notifications for NAC.
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.
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.