NAC’s Longevity In US Dietary Supplement Market Swings On Comments As NDI Notifications
FDA Serves Up Request For Comments In Pre-Holiday Announcement Dish
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.
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MetroBiotech argues it and other drug developers and manufacturers are harmed as FDA allows NAD+ use in dietary supplements without requiring new dietary ingredient notifications and despite DSHEA’s preclusion clause.
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.
As CFSAN warned seven marketers, supplement products from numerous other businesses advertised as hangover remedies, or as formulations to prevent symptoms associated with overindulgence, remained available to US consumers. Like one business FDA warned, numerous companies are offering OTC intravenous treatments for hangovers, available at locations accepting walk-in or by-appointment customers.