Jason Sapsin was quoted in the NutraIngredients-USA article "Warning Letter Shows NDI Enforcement Here to Stay." While the full text can be found in the February 13, 2014, issue of NutraIngredietns-USA, a synopsis is noted below.
The FDA recently posted a warning letter to a company signaling its intention to hold companies' feet to the New Dietary Ingredient fire. Among the many violations cited in the letter, the agency specifically called out the company's failure to file a NDI notification on a constituent of one of its sports supplements.
Sapsin said a problem with an ingredient's NDI status might not be a casus belli for FDA in and of itself. But unlike in years past, FDA will delve into this aspect of a company's formulations while it is the plant for other reasons, he said.
"I don't think it is necessarily the case that you would see a warning letter go out if (an NDI issue) was the only reason," Sapsin said. "But if the agency is in your facility and they begin to see problems that is one of the things that is going to get their attention."
There have been several such letters in the last couple of years following long stretches when the NDI pot simmered gently on one of FDA's back burners. The issue is unlikely to return to its former place in the scheme of regulatory priorities, Sapsin said.
"It is evidence of a shift. The agency's intent to signal its seriousness about a facet of regulation. I think it is a warning," he said.
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