This week, the FDA announced the availability of final guidance for the dietary supplement industry regarding procedures and timeframes for premarket safety notifications, commonly referred to as new dietary ingredient notifications (NDINs). Aimed at improving the rate of compliance with the new dietary ingredient (NDI) notification requirement, the quality of NDI notifications, and ensuring the protection of public health by limiting consumer exposure to new ingredients with unknown safety profiles, FDA’s latest guidance is intended to assist distributors and manufacturers of new dietary ingredients and dietary supplements to prepare and submit NDINs to FDA.
As a reminder and as background, manufacturers and distributors who seek to market dietary supplements (including traditional supplements, beauty/cosmetic supplements, and more) that contain a new dietary ingredient are required to notify the FDA about these ingredients. A dietary ingredient is defined as a vitamin, mineral, herb or botanical, amino acid, dietary substance used by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the list stated herein. An NDI is a dietary ingredient that was not marketed in the U.S. prior to October 15, 1994.
U.S. law requires that manufacturers or distributors of a new dietary ingredient that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, to submit a premarket safety notification to FDA at least 75 days prior to introducing the product into interstate commerce. The notification must generally include information that provides the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
FDA advised that one key goal of the final guidance is to improve the rate of compliance with the NDI notification requirement given the substantial number of dietary supplements that have come on the market since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) coupled with the recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements. Not surprisingly, the number of products on the market has moved from a few thousand in 1994, to estimates of over 55,000 products in 2012, and has been growing ever since. Given the rate of increase of marketed dietary supplements, FDA’s emphasis on the importance of submitting NDINs as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles, is critical for dietary supplement supply chain parties to understand and effectuate.
The Agency also advised that a secondary goal is to improve the quality of NDINs, and to ensure that NDINs contain complete information for FDA to evaluate whether a dietary supplement containing an NDI is reasonably expected to be safe, as required under DSHEA.
FDA’s guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance, along with several related questions from other sections of the draft guidance. In the Final Guidance, FDA addresses what qualifies as an NDI and when an NDI notification is required, including providing questions and answers about parts of the definition of dietary supplement that can trigger whether a particular substance may be marketed as a dietary supplement.
For additional questions on FDA’s guidance, new dietary ingredient notifications, or other dietary supplement compliance and enforcement issues, please contact us at info@garg-law.com.
