FDA Draft Guidance On Premarket Safety Notifications For Dietary Supplements
The U.S. Food and Drug Administration Thursday issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient (one that was not marketed in the United States before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration. Dietary supplements are considered adulterated if they contain an NDI not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.
The FDA estimates that there are more than 55,600 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year. However, the agency has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994. An initial draft guidance, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was released in 2011. After considering the feedback received on that draft, the FDA revised the draft guidance to clarify several important points that were misunderstood or not fully explained, to describe the public health significance of the recommendations, and to request additional comment before publishing a final guidance. (dpa)
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