Submission of New Dietary Supplement Notifications

A manufacturer or distributor of a New Dietary Ingredient (NDI), or a dietary supplement that contains the NDI, is required to submit a premarket notification to FDA at least 75 days before the product enters the market, unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered”. The FDA is then able to evaluate whether it is reasonably expected to be safe.

NDI Notifications, much like food GRAS submissions are technical, requiring extensive supporting safety data as part of the packet submission to FDA. Our team of former FDA consumer safety officers and toxicologists are available to prepare and submit NDIs to FDA for review.