CHPA Responds to FDA Draft Guidance on NDIN Master Files for Dietary Supplements

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(WASHINGTON, D.C.) – The Consumer Healthcare Products Association released the following statement today in response to draft guidance released from the U.S. Food and Drug Administration (FDA) on New Dietary Ingredient Notification (NDIN) Master Files for Dietary Supplements: “CHPA is pleased to see FDA move forward on its commitment to release a separate draft guidance document this year on master files,” said SVP of Dietary Supplements Duffy MacKay.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in research that demonstrate the safety of new ingredients and finished products.“CHPA is currently reviewing the draft guidance in detail, but is generally pleased with the concept, while also recognizing FDA enforcement of the NDI regulation is critical for the master file system to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.”

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit