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NDI Or GRAS? Supplement Label But A Drug Claim? Answers Unclear For Some Regulatory Questions

 
• By Malcolm Spicer

“We try to interpret the language that is given to us and if Congress would make it more clear to us, we would absolutely carry that forward,” ODSP's Cara Welch says about whether FDA regulations require NID notifications or self-GRAS submissions for dietary ingredients yet to be used in supplements.

The US Food and Drug Administration expects questions about problem products and companies in the dietary supplement sector could be answered not only from industry stakeholders’ input but also through congressional clarification.

“Clarification of statutory language is often helpful. We admit that clarification is helpful,” said Cara Welch, acting director of the...

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