FDA Seeks More Safety Information On New Dietary Supplements with Draft Guidance

Most dietary supplement manufacturers have failed to heed a 1d994 requirement to notify the FDA about products that include new dietary supplement ingredients

A new proposal by federal regulators would allow manufacturers to submit late safety data about dietary supplements that are being sold with new ingredients, even if the manufacturers should have submitted the information to the agency in years ago.

On May 19, the FDA announced a draft guidance, which seeks to improve the oversight of dietary supplement ingredients and the safety of the products.

According to the agency, only about 25% of new dietary ingredients have been submitted to the FDA since a 1994 rule, which required companies to provide safety data for products they manufacture or sell. The new draft guidance aims to improve that.

The FDA should have received more than 4,600 new dietary ingredient (NDI) notifications since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. Instead, the FDA has received approximately 1,200 NDIs, or less than 25% of what should have been submitted, according to the agency.

The new draft guidance focuses on changing that by allowing manufacturers that marketed supplements with NDIs to submit updated safety data. This goal of the proposal is to increase the amount of safety information the agency receives about dietary supplements in the marketplace. It allows the submission of late new dietary ingredient notifications and offers the FDA expanded regulatory measures.

According to the DSHEA Act, the FDA requires updated safety information for any new ingredient that has not been used on the market before, or is being used in a new way. The safety information must be updated 75 days before the product goes to market. However, a lack of oversight has allowed the majority of supplements with new ingredients to come to market without updated safety information being reviewed by the FDA.

The NDI process is the only opportunity for the FDA to evaluate the safety of a dietary supplement before it enters the market and is offered to consumers.

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If finalized, the guidance will allow the companies to submit necessary NDIs, and the FDA to begin exercising enforcement discretion for manufacturers to correct past failures. This guidance applies for a limited time and in limited circumstances, but will help improve enforcement actions against supplements not in compliance with NDI notification requirements, according to the agency.

“We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers,” Cara Welch, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) said in a press release. “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.”

The enforcement period would start when the final guidance is published and continue 180 days, applying only to products on the market when the Federal Register notice is published.

The FDA is also developing a new submission type through the CFSAN Online Submission Module to provide an avenue for late notifications to be submitted.

Comments will be accepted until July 19, 2022, and can be submitted to:
Dockets management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852


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