HBW Insight

FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

25 Jun 2012

• By Elizabeth Crawford

Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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FDA will revise its new dietary ingredient notification draft guidance to address industry concerns and further clarify the agency’s expectations, beginning with the issue of industry’s responsibility for proving the grandfathered status of ingredients.

“We are planning on promulgating a revised draft NDI guidance to address points that may need further clarity to avoid...