On April 3, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance is the FDA’s response to the dietary supplement industry’s requests for specific guidance on recommendations about master files for new dietary ingredient notifications (NDINs).
According to the FDA, NDIN Master Files are not required by statute or regulation, but the draft guidance explained that master files can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in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. 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The recommendations in the draft guidance expand upon and replace the recommendations related to master files in the FDA’s revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”
“CHPA is pleased to see FDA move forward on its commitment to release a separate draft guidance document this year on master files,” said Duffy MacKay, senior vice president of dietary supplements for the Consumer Healthcare Products Association (CHPA). “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“CHPA is currently reviewing the draft guidance in detail, but is generally pleased with the concept, while also recognizing FDA enforcement of the NDI regulation is critical for the master file system to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.”
Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register to ensure that FDA considers each comment on the draft guidance before it begins work on the final version of the guidance. Electronic comments can be submitted to www.regulations.gov to docket number FDA-2024-D-0706. Written comments can be sent to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852. According to the FDA, all written comments should identify the docket number FDA-2024-D-0706.
For more information, visit www.fda.gov.
