notice
Industry Questions FDA Policy Notice on NDIs
On May 20, FDA’s (U.S. Food and Drug Administration) Center for Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft ...
FDA Considering Vinpocetine Ineligible as a Dietary Ingredient
The U.S. Food and Drug Administration (FDA) recently released an unprecedented Federal Register (FR) notice (Docket No: FDA-2016-N-2523) with major implications for acknowledged new dietary ingredient (NDI) notifications. FDA appears to be attempting to shift the burden of demonstrating reasonable expectation of safety for vinpocetine on the industry by using the hook that it can’t ...
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