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FDA Issues Draft Guidance on NDIN Master Files for Dietary Supplements
On April 3, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance is the FDA’s response to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient notifications ...
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 ...
NPA Seeks Vitamin Inclusion in WIC Program
The Natural Products Association (NPA) recently submitted comments to the Institute of Medicine advocating for expanding access to vitamins for low-income mothers and children. NPA submitted its comments as part of a Congressionally mandated study that will examine the impact of expanding the supplemental nutrition program for women, infants, and children (WIC) to cover certain ...
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