CRN has 'very constructive' meeting with FDA on NDI issue

A meeting between the U.S. Food and Drug Administration (FDA) and the Council for Responsible Nutrition on the subject of the draft New Dietary Ingredients (NDI) guidance was called “very constructive” by one of the participants, Steve Mister, president and CEO for CRN.

The on-record meeting, which took place Tuesday, Feb. 7, included a number of FDA officials, chief among them Mike Landa, director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). FDA’s Office of Dietary Supplements, the authors of the draft NDI guidance, falls under Landa’s jurisdiction.

FDA also had a meeting recently on the NDI issue with Sens. Orrin Hatch, (R-UT) and Tom Harkin, (D-IA), the authors of the Dietary Supplement Health and Education Act (DSHEA).

“What we found is that there is an opportunity for a constructive dialogue with the agency,” Mister said. “We had an extensive presentation about our views on the NDI guidance. We summarized what we had put in the written comments.”

CRN’s written comments on the draft NDI guidance, like the comments from other industry sources, were submitted to the federal docket prior to the Dec. 2, 2011 deadline.

Mister said that there was a frank back-and-forth on CRN’s position during the meeting.

“They asked questions. They probed some of the things we said to see if we could back them up,” he said. “I think there is an appreciation of the industry’s position now. I felt that there was genuine interest and concern in the industry’s viewpoint, and that they were interested in understanding why we took the position that we did.

“I am concerned that the message that industry might be getting is that it is time to take up arms. And I don’t think that’s the case,” he said.