CRN meets FDA on NDIs: We won’t budge on synthetics but there may be middle ground elsewhere

By Elaine Watson

- Last updated on GMT

Related tags Draft ndi guidance

CRN: We are not going to give on synthetics issue... but there may be some middle ground on supplement vs ingredient submission issue
CRN: We are not going to give on synthetics issue... but there may be some middle ground on supplement vs ingredient submission issue
Food and Drug Administration (FDA) officials were “engaged” and “receptive” during a meeting with the Council for Responsible Nutrition (CRN) this week about its controversial draft guidance on new dietary ingredients (NDIs), says the CRN.

Speaking to NutraIngredients-USA this morning, CRN chief executive Steve Mister Mister said: “There were about nine officials from the FDA at our meeting on Tuesday​ [Feb 7] including Dan Fabricant, so we were very pleased with that.

“The meeting was at our request and we presented to them for over an hour. It was very interactive. They asked a lot of questions and were very engaged and receptive, so we hope that this kind of dialogue can continue.

“We are all trying to understand where there is room for common ground. What can we live with? Where is there room in the middle? We’ve got to find a way to get to a document that does what it should do.”

We won’t budge on synthetics

He would not go into specifics about the meeting, but said both parties were keen to find a “constructive solution​” over the key sticking point of whether NDI submissions should be end-product- or ingredient-specific.

He added: “We still think that ingredients suppliers should file NDI submissions and finished products people should be able to piggyback off that.

“But maybe in certain cases where the finished product manufacturer’s use is so different from the NDI filing that maybe he should file his own. So maybe there is some room for compromise and a constructive solution here.”

However, the CRN flatly disagreed with the FDA’s view that synthetic botanical constituents - even if they are chemically identical to their ‘natural’ counterparts - are not dietary ingredients.

He said: “We are not going to give on the synthetics issue.”

The CRN would also continue to push for the definition of which processes do NOT constitute chemical alteration to be opened up, he said.

“We believe that the FDA got this wrong. We think the FDA’s definition is too limiting and it is not what Congress intended.

We will also continue to look for some way to get grandfathered lists recognized.”

Enforcement and next steps

As for enforcement, the FDA was within its rights to enforce the law with or without the draft guidance, pointed out Mister.

But he added: “What we have urged them to do on enforcement is to focus on things are patently illegal – so truly new ingredients for which there is no NDI notification on file – rather than on the nuances of the new draft guidance.”

In the meantime, CRN was continuing to engage with members of Congress to urge them to keep up political pressure on the FDA as well, said Mister.

“Direct engagement with the FDA is only one part of our strategy.”

UNPA: We need NDI policy that is practical and efficient

United Natural Products Alliance (UNPA) executive director Loren Israelsen said: “All efforts are being made to work toward an NDI policy that is practical and efficient.

“I believe that can be done and we will continue to encourage all interested parties to stay focused on that goal.”

He added: “At the moment FDA has a lot of comments to read and we respect that this will take time.”

The Natural Products Association (NPA) said: "NPA is scheduled to meet with FDA on February 17 to discuss our concerns with its draft NDI guidance. We look forward to a frank and productive meeting with the agency."

Related topics Regulation NDI draft guidance

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