FDA Agrees to Change NDI Draft Guidelines : Cheers Go Up from the Rooftops!

The Natural Products Industry collectively breathed a sigh of relief today as the Food and Drug Administration announced that it would revisit and revise the New Dietary Ingredients draft guidance it had put forth nearly a year ago.The NDI draft guidance the FDA had drafted in 2011 has been very controversial, in part because it was expected to render many commonly available dietary supplements illegal unless they complied with unrealistic requirements set forth by the government.

According to a statement issued by New Hope 360 “FDA has agreed to issue a new, revised New Dietary Ingredients draft guidance after a top-level meeting including Sens. Tom Harkin and Orrin Hatch and Commissioner Margaret Hamburg.”

“It is deeply gratifying to hear that FDA has decided to rethink its approach to good guidance on this important element of DSHEA,” said Michael McGuffin, president of the American Herbal Products Association. “We look forward to working more closely with the agency in the development of the kind of guidance that is needed by the supplement trade to ensure compliance with this important safety feature of the law.”

“It would be premature for industry to celebrate, but we should be buoyant,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “This is an indication that FDA has heard the industry and will work with the industry.”

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