Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace
The U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
If the draft guidance is finalized without change, the enforcement discretion period to submit a late notification would start when the guidance is published, would last 180 days, and would apply only to products on the market when the Federal Register notice announcing the draft guidance was published. Along with this draft guidance, the FDA is also developing a new submission type through the CFSAN Online Submission Module to provide a dedicated pathway for stakeholders to electronically submit their late notifications..
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