As WholeFoods Magazine has reported, U.S. Food and Drug Administration (FDA) issued a draft guidance for industry titled New Dietary Ingredient Notification Master Files for Dietary Supplements.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"NDIN Master Files are not required by statute or regulation, but, as explained in today’s draft guidance, can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to the FDA for use in evaluating a potential future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 The recommendations in this draft guidance expand upon and replace the recommendations related to Master Files in the FDA’s revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues."
In April, Industry Groups responded to the draft guidance. Read more here.
In June, the Consumer Healthcare Products Association (CHPA) shared comments that it has submitted to FDA on the guidance. "As CHPA made clear in our 2016 comments, FDA must take a number of actions to ensure the protection of trade secrets and confidential commercial information for those developing NDIs that invest in the necessary studies to support the safe use of products containing the NDIs,” said CHPA SVP of Dietary Supplements Duffy MacKay. “While we welcome FDA’s attention to the important and outstanding issues associated with the NDIN requirement, the Guidance is incomplete and does not do enough in describing the master file system. This is why CHPA urges FDA to revise the Guidance in a way that addresses and clarifies several key issues to ensure that master files serve the purpose of supporting the safety of dietary supplement products.
“We appreciate FDA's ongoing efforts to advance this Guidance and will continue to emphasize that a well-executed master file system stands to benefit both industry stakeholders and the Agency, by fostering increased NDI submissions, bolstering public safety, and stimulating innovation and scientific investments. Ultimately, this framework should protect companies and increase research investments to demonstrate the safety of new ingredients and final products. While this Draft Master File Guidance certainly sets the stage, there is more work to be done to get companies interested in filing.”
Read CHPA’s full comment letter.