FDA to Issue Revised NDI Guidance

The American Herbal Products Association (AHPA) was informed last night (June 19) that the U.S. Food and Drug Administration plans to disseminate a revised draft guidance on new dietary ingredients (NDIs) used in dietary supplements.

The guidance, originally issued July 5, 2011, was widely criticized by the industry, which claimed that it was a flawed attempt by the agency to reinterpret the NDI section of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

AHPA stated that if the guidance was implemented in its original state, it would “change the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no concomitant benefit for consumers."

A reissue of the guidance was decided during a meeting between senators Orrin Hatch (R-UT), Tom Harkin (D-IA) and senior FDA officials including commissioner Margaret Hamburg, M.D.

“The dietary supplement industry should once again recognize the commitments of Senators Hatch and Harkin to ensure continued access to a broad range of dietary supplements,” said AHPA president Michael McGuffin. “Please join me in thanking our champions for once again standing up for the dietary supplement industry and the many Americans who include supplements in their health care.”

FDA did not say when the reissued NDI guidance will be released.


Published in WholeFoods Magazine Online, 6/20/12