Some dietary supplement firms have marketed products for which a premarket NDI notification was required, but never submitted
The US Food and Drug Administration (FDA) has announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
The FDA wants consumers who use dietary supplements to know that this draft guidance, if finalised, will advise the dietary supplement industry that the agency intends to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification.
By providing industry with an opportunity to correct past failures to submit required safety information, the FDA can gain more safety information about the dietary supplement marketplace 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, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace.”
For dietary supplements that do not contain an 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 firms have marketed products for which a premarket NDI notification was required, but never submitted.
Image credit- shutterstock