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.
Where does the NDI process go from here?
“You never want to walk away from the negotiating table and declare war when you have an opportunity to get somewhere that’s constructive,” Mister said.
“We think that we need to keep the heat on the agency. We need to keep both the political and legal pressure on the agency. But we need to give them the opportunity to get to where they need to go.”
In a December press release accompanying the filing of its comments, CRN called for withdrawal of the guidance. In its comments, the organization said the guidance would put significant burdens on the industry, stifle innovation and curtail industry growth—without conferring additional safety benefits to consumers.
The comments also cited the following as specific areas of concern:
- The imposition of an unreasonable burden of proof on industry to establish an ingredient’s non-NDI status
- The inability for the supplement industry to market nature-identical synthetic botanicals
- The requirement of unnecessary and duplicative NDI notifications
- The inappropriate expansion of the number of dietary ingredients defined as NDIs
- The morphing of the NDI notification process into a premarket proof of safety requirement mirroring the requirement for a food additive
Despite these serious divisions, Mister said he sees a way forward through negotiation.
“We have to be able to negotiate from a position of strength. And I think that our legal arguments, as we expressed in the comments, give us that position of strength,” he said.
“It’s not say that we are going to cave on this and we are just seeking to appease the agency. When we need to be aggressive we can be aggressive. But we also think that when there are some negotiations to be had, we should pursue that,” Mister said.
“We do want an NDI guidance,” he said. ”We don’t want that guidance, the one that was issued last July.
“At the end of the day the NDI requirement is in the law. We will have to live with it and we do need a common understanding with the agency about what’s required.”
Are you optimistic about the future of the NDI guidance? Leave a comment.