SILVER SPRING, MD., May 19, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration announced the availability of draft guidance aimed at increasing the amount of safety information the agency has in the dietary supplement market. providing industry with the ability to submit late new food ingredient (NDI) notifications.
The FDA wants consumers who use dietary supplements to know that today’s draft guidance, if finalized, will notify the dietary supplement industry that the agency intends to exercise its discretion , for a limited time and under limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. By providing industry with the opportunity to correct past failures to submit required safety information, the FDA can gain more information about the safety of the dietary supplement market and better protect public health.
“We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “The resulting notifications the agency receives during this discretionary period will help increase the amount of safety information we have about NDI-containing dietary supplements on the market.”
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors wishing to market a dietary supplement containing an NDI to notify the FDA prior to marketing, unless there is a legal exception. The notification must contain the safety information on which a manufacturer has relied to conclude that the dietary supplement containing the NDI is reasonably expected to be safe. The NDI notification process is the FDA’s only chance to assess the safety of a dietary supplement before it is made available to consumers. For dietary supplements that do not contain NDI, the law does not require manufacturers to submit safety information to the FDA before marketing. The FDA is aware that in the more than 27 years since the requirement was established, some dietary supplement companies have marketed products for which a premarket NDI notification was required but never submitted.
The discretionary enforcement policy proposed in these draft guidelines relates only to failure to submit an NDI notification. For example, this would not extend to dietary supplements containing NDI that are adulterated for safety reasons or violate any other regulatory requirement for dietary supplements. This temporary policy should also facilitate enforcement action against those who fail to comply with NDI’s notification requirements after the end of the discretionary enforcement period..
In a February 2019 statement on new efforts to strengthen the regulation of dietary supplements through modernization and reform, the FDA emphasized the need to ensure that our regulatory framework is flexible yet comprehensive enough to effectively assess product safety, while promoting innovation. The FDA also said promoting the submission of NDI notifications would be key to this effort. These draft guidelines are an essential first step in encouraging such submissions.
If the draft guidance is finalized without change, the discretionary application deadline for submitting a late notification would begin when the guidance is published, last for 180 days, and apply only to products in the market when the Federal Register notice announcing the draft guidelines was published. Along with these draft guidelines, the FDA is also developing a new type of submission through the CFSAN online submission module to provide a dedicated pathway for stakeholders to electronically submit their overdue notifications.
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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products..
SOURCE US Food and Drug Administration