(Washington, D.C.) – Today, the Consumer Healthcare Products Association (CHPA) released the following statement after submitting comments to the U.S. Food and Drug Administration (FDA) in response to draft guidance the Agency released in April on New Dietary Ingredient Notification (NDIN) Master Files for Dietary Supplements:
“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.”
CHPA’s full comment letter can be found HERE.
