Import Supplement Safety Concerns Spark NDI Notification Request
This article was originally published in The Tan Sheet
Imported ingredients lacking NDI notifications raise potential safety issues and unfairly compete with properly notified products. Rep. Steve Stockman asks FDA to require NDI notifications for the products.
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Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.