Posted 20 June 2012
By Alexander Gaffney
The US Food and Drug Administration's (FDA) much-discussed New Dietary Ingredient (NDI) draft guidance could be receiving a series of significant revisions after a meeting this week between members of Congress and the agency.
In a press statement, the Natural Products Association (NPA), a trade group representing numerous dietary supplement manufacturers, said it was aware of a 19 June meeting between FDA Commissioner Margaret Hamburg, FDA Deputy Commissioner Mike Taylor and Sens. Tom Harkin (D-IA) and Orrin Hatch (R-UT).
In the meeting, "FDA acknowledged [industry] concerns and recognized that a substantially revised draft [of the NDI guidance] is necessary," wrote NPA. "The FDA officials specifically singled out the issue of establishing an agreed upon list of grandfathered ingredients as an area where they would like to begin work in the next two weeks."
Both Harkin and Hatch were instrumental in the establishment of the Dietary Supplement Health and Education Act (DSHEA)-a 1994 law establishing the regulation of dietary supplements as food, rather than pharmaceutical, products. While the law also established the need for manufacturers to test their products to ensure their safety before marketing them to the public, in practice this has been rarely enforced by FDA, who has traditionally exercised the majority of its enforcement resources in the pharmaceutical and medical device sectors. "Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements," explains FDA on its website.
FDA sought to update its enforcement of existing authority in July 2011, issuing a draft guidance to establish New Dietary ingredients as any dietary ingredient introduced into interstate commerce after the passage of DSHEA in October 1994, gaining pushback from Hatch, Harkin and the dietary supplement industry, all of whom see it as an overreach of FDA's statutory authority under DSHEA.
Rather than update the current guidance, the agency will likely release a second, new NDI guidance shortly, reports Nutraingredients USA.
NPA - ALERT: Senators Harkin and Hatch Continue Dialogue with FDA on NDI Draft Guidance
Nutraingredients USA - Who says the FDA doesn't listen? Industry welcomes plan to issue revised draft NDI guidance
Natural Products Insider - FDA Reportedly to Revisit NDI Draft Guidance
Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues