FDA silent on calls from Sen Hatch and Harkin to withdraw NDI draft guidance

06-Jan-2012 - Last updated on 10-Oct-2023 at 14:30 GMT

Senator Orrin Hatch: Guidance contradicts longstanding FDA policy

Staff for Senators Harkin and Hatch are still waiting for a response from the Food and Drug Administration (FDA) following calls from the Senators for FDA to withdraw its NDI draft guidance and for January meetings to discuss concerns.

In a letter dated December 22, 2011, Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) call for FDA Commissioner Margaret Hamburg to withdraw the draft guidance for new dietary ingredients (NDIs) and to start work on a new document.

“As part of that process, we would ask that you direct your staff to sit down with our staff early in January to discuss these concerns in more detail,” wrote the senators.

However, a spokesperson for Sen Hatch told NutraIngredients-USA: “We have not yet heard back from the FDA”.

Undermining DSHEA

The NDI draft guidance is the hottest issue in the US dietary supplements industry, with the industry seemingly united in its calls for a withdrawal, or a substantial revision at least.

In the letter to Commissioner Hamburg, Senators Harkin and Hatch – principle authors of the Dietary Supplements Health and Education Act of 1994 (DSHEA) – wrote that the “draft guidance serves to undermine DSHEA in a number of important respects”.

Echoing many of the comments from industry, the Senators note that requiring a manufacturer to submit an NDI notification for every supplement containing an NDI is “directly contrary to the language of DSHEA”.

Assertions by the agency that synthetic copies of botanicals can never be dietary ingredients also “contradict longstanding FDA policy”.

“It [the draft guidance] diverges from our intent by including only ingredients that were marketed before enactment of DSHEA in the form of dietary supplements as ‘old dietary supplements’. The term dietary supplement wasn’t even defined prior to DSHEA,” they added.

Please click here to read the full letter.

Please click here to view our video round-up of comments to the draft guidance.