The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry titled New Dietary Ingredient Notification Master Files for Dietary Supplements. FDA said the guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs).

"NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential future NDIN," FDA explained in its update. "The intent of the guidance, once finalized, will be to help industry comply more easily with the NDIN requirement by providing recommendations on the content, submission, and use of Master Files. The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the FDA’s revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues."

Related: FDA Issues Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes

As WholeFoods has reported, in 2020, CRN, along with the United Natural Products Alliance (UNPA), and the Consumer Healthcare Products Association (CHPA), proposed a framework for an NDI master file with the goal of addressing the protection of innovation. The associations said this tool would “streamline the collection and protection of data investments made by ingredient manufacturers. It provides a way to keep secured confidential information such as safety data related to an NDI and enables companies to authorize others to properly reference master file data. Without proof of authorization, a company cannot claim to have the same ingredient as another. With use of the NDI-MF, FDA would be able to identify and enforce against certain marketers of NDIs that fail to comply with the notification requirement.”

Industry Groups Respond to Draft Guidance on NDIN Master Files

"It's a positive development to see the FDA moving ahead with this draft guidance," said CRN President and CEO Steve Mister, in a statement. "In 2020, CRN developed an NDI master file framework for dietary supplements to protect our members' investments and intellectual property, and this is clearly a step in the right direction, incorporating many of the elements we put forward. But as we have previously stated, meaningful enforcement alongside guidance is crucial in supporting responsible companies desiring to innovate, to protect investment while doing so, and to fairly compete. FDA must deter bad actors who circumvent the law thereby posing risk to public safety. So, while we welcome this draft guidance, we, at the same time, strongly urge FDA to publicly announce its resolve to enforce the proper use of master files." (Background: CRN Submits Letter to FDA on Planned Draft Guidance for Industry on Dietary Supplement Master Files)

CHPA also released a statement: “CHPA is pleased to see FDA move forward on its commitment to release a separate draft guidance document this year on master files,” said SVP of Dietary Supplements Duffy MacKay. “We have been a longtime supporter of a master file system for NDINs that will establish a framework to safeguard scientific data supporting an NDIN on a specific ingredient, preventing its unauthorized use by firms marketing similar, but not identical, ingredients. A well implemented master file system has the potential to benefit both industry and FDA by increasing submissions, enhancing public safety, and spurring product innovation and investments in science. Overall, this system should encourage companies to increase investments in research that demonstrate the safety of new ingredients and finished products.

“CHPA is currently reviewing the draft guidance in detail, but is generally pleased with the concept, while also recognizing FDA enforcement of the NDI regulation is critical for the master file system to realize its full potential. We appreciate FDA's ongoing efforts to advance this guidance, which will foster innovation and scientific development.”

Call for Comments

FDA shared: "Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. Submit electronic comments to to docket number FDA-2024-D-0706. Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2024-D-0706."