Jason Sapsin was quoted in the NutraIngedients-USA article "High NDI Failure Rate Putting More Emphasis on GRAS Status for New Ingredients." Full text can be found in the February 10, 2015, issue, but a synopsis is below.

The high rate of failure in New Dietary Ingredient notifications has some companies seeking workarounds by increasingly leaning on GRAS status as a way to avoid having to enter the NDI realm.

Many companies are looking at ways to come to market legally with new ingredients without having to run through the NDI gauntlet. Some are leaning on the GRAS mention in the original draft of the NDI guidance stating that a notification for a NDI is not required in the ingredient is listen or affirmed by the FDA as GRAS, is self-affirmed GRAS, or is approved as a direct food additive.

In both cases – NDIs and GRAS substances – the issue revolves around the safety of the ingredient. The difference is a proper understanding of what 'generally recognized' means," said Jason Sapsin.

"It means there is a consensus in the scientific community that the ingredient is safe. For that, the data you bring forward has to be public so that this consensus might reasonably develop," he noted.

GRAS comes in two flavors: self-affirmed, in which a company convenes its own panel of experts to assess the ingredients safety, and "FDA no objection" in which the dossier is submitted to the agency. Sapsin notes that it is important to keep in mind the distinction between the two.

"When you self-affirm and you don't send it into the agency you are betting that if the agency asked to see your material they would agree with you. You are not establishing the agency's position on it; you are establishing your own position on it. If you have done a good job it might not be an issue, and the agency might have no choice but to agree, though the agency doesn't really offer an opinion, they just agree to not object your conclusion.

"In GRAS you are saying everybody else has decided this is reasonably certain to be safe. In an NDI you are saying that I have decided this is reasonably expected to be sage and the data I am using to show that might or might not be public."

Sapsin explains that the issue becomes less clear for GRAS notifications that seem to be undertaken solely as a legal basis to bring in a new dietary supplement ingredient to the market. "That's not the end of the story. While the product may be GRAS, the intake level of the NDI may or may not be the same as to how the product has been recognized as GRAS in the food supply."

Sapsin believes this related more to experimental cutting-edge nature of dietary supplement development.

"I think part of that has to do with the fact that people are constantly trying to push the envelope on NDIs," he said. "That could be why the standard seems to be higher. It could be that NDI notifications are filed on marginal kinds of products."

"We keep forgetting that the tradeoff was made when the dietary supplement category was created," he said. "The tradeoff was always along the following lines: the law will allow you to make certain kinds of claims on what is essentially a food product that ordinarily would be impossible. The stuff for which you make those claims should be 'organic' and food-like."

Although the new NDI draft guidance might bring some clarity to the picture, it is unlikely to relieve the tension that the process of chemical synthesis are placing on the system.

"The starting point was the ingredient existed in nature and usually from where it was in the food supply. The purpose was not to go into the lab and cook up a new molecule. When you start doing that, you ae trying to fit your product into a structure for which it was not intended," Sapsin says.

Originally published by NutraIngedients-USA.

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