NPA Bolsters Case For Synthetic Botanicals, NDI Master Files
This article was originally published in The Tan Sheet
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presses the agency to address three areas of greatest concern on new dietary ingredient notifications in a revised draft guidance: synthetic botanicals, definition of chemical alteration and a “master file” approach to submissions.
You may also be interested in...
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.
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.
FDA’s warning letters to 10 marketers of DMAA-containing products might have a silver lining for the supplement industry as they suggest the agency may be flexible on its controversial interpretation of some provisions in the new dietary ingredient notification requirement.