“Systemic” Disregard For Basic Dietary Ingredient Rule Troubles FDA
This article was originally published in The Tan Sheet
FDA dietary supplement program chief Daniel Fabricant surveyed the agency’s top and developing concerns at the SupplySide MarketPlace conference. DMAA and adulterated products reflect a flouting of the principle that only dietary ingredients should occur in supplements, he says.
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USPlabs says it will reformulate its DMAA supplements, although it “stands by the safety and legality” of the products. FDA says “credible science” shows DMAA is not a botanical, not a dietary ingredient and will not be accepted in an NDI notification.
FDA issues a consumer warning about the potentially lethal effects of DMAA, and promises to use “all available tools at its disposal to ensure the dietary supplements containing” the stimulant “are no longer distributed and available for sale.”
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