Ullman Gives His Input on NDI Filings

July 6, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “NDI filings coming in at expected rate, FDA says, but questions on GRAS process remain.” The article focuses on the FDA’s belief that there will not be a significant change in how many companies are choosing to go through the process to file NDIs.

“I have been told by FDA that they have been seeing fewer of the silly NDI notifications because people seem to be taking advantage of the pre notification procedure. As a result they get few facially ridiculous NDI notifications, like someone saying, ‘ I want to do an NDI for vitamin C.’ That’s going to push the numerator down,” Ullman said.

“As positive as I am about what is going on with the prenotification meetings, I continue to be baffled by FDA’s lack of clarity on this. I think this is something the agency absolutely needs to speak to. I have personally seen situations where companies get a ‘bad day’ letter from FDA with serious, substantiative questions on their NDI. And they show up with a self -affirmed GRAS on the same ingredient and the ingredient is being sold in supplements shortly thereafter,” Ullman said.

Click here to read the full article.

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