news August 12, 2021

‘GRAS loophole’ rears head in FDA supplements letter

“The majority of self-GRAS reports—the majority—are garbage,” Bass proclaimed in an interview. “Some are good, but how many? I’m guessing a very small percentage.”

Ashish Talati, a lawyer with Amin Talati Wasserman LLP, said he vigorously disagreed with that conclusion.

“I have worked on over 100-plus GRAS/self-GRAS projects and have seen a lot of them, and they’re not garbage,” he said in an interview. “They’re actually very well done.”

And if he notified FDA about those GRAS projects, the agency would not object to them, Talati predicted.

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