Abstract:
On July 1, 2011, the U.S. Food and Drug Administration (“FDA”) published its long-awaited Draft Guidance on New Dietary Ingredient (“NDI”) notifications for dietary supplements (“Draft Guidance”). The Draft Guidance can be found on FDA’s website by clicking here. The notice of availability of the Draft Guidance was published in the Federal Register on July 5, 2011. While comments on the guidance may be submitted to the agency at any time, to ensure consideration by the agency, comments should be submitted by October 3, 2011.
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