Framework To Protect NDI Notifications With Master Files Proposed By CHPA, CRN And UNPA
Consumer Healthcare Products Association, Council for Responsible Nutrition and United Natural Products Alliance model proposed NDI-master file framework on US Drug Master File FDA has accepted for decades. System would not be administered by FDA, but the agency’s support is critical for helping manufacturers protect their investments in research for information supporting NDI notifications.
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Align Supplement Industry Regulation With DSHEA, Groups Tell FDA In 'Responsible Innovation' Comments
Targeted guidance on questions around NDINs and using import alerts to keep violative products off market are among supplement industry trade groups' suggestions for improving FDA oversight of the industry. Groups also continue asserting that the agency can strengthen its VMS product manufacturing and marketing oversight with its existing authorities.
"Can we maybe as an industry, and I guess the FDA, agree not to overcomplicate the NDI process in the sense that it's actually pretty easy to navigate the process and understand what you have," says Frank Jaksch, Chromadex co-founder and executive chairman. "I want to encourage companies to do the right thing," says Mark LeDoux, founder, CEO and chairman of Natural Alternatives Internationa. "Our firm spent millions of dollars and went through the front door of the FDA. … This is not a difficult process to do the right thing."
In a supplemental comment to FDA, the Natural Products Association presses the agency to address three areas of greatest concern on new dietary ingredient notifications in a revised draft guidance: synthetic botanicals, definition of chemical alteration and a “master file” approach to submissions.