CRN petition asks FDA to change how it interprets drug preclusion clause
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The Council for Responsible Nutrition (CRN) has submitted a citizen petition to FDA, requesting sweeping changes in how the agency interprets a clause in federal law that essentially precludes ingredients from dietary supplements if the “article” has been first approved as a drug or authorized for investigation as a new drug.
The Washington, D.C.-based trade association argues FDA’s interpretation of the race-to-market clause in the law has been misapplied to dietary supplement ingredients that FDA previously acknowledged as lawfully marketed, endangering future innovation. CRN cites examples of specific ingredients, including N-acetyl cysteine (NAC) and beta-nicotinamide mononucleotide (NMN).