House Energy & Commerce Committee members call on FDA to ‘re-examine’ NDI draft guidance

By Stephen Daniells

- Last updated on GMT

Related tags New dietary ingredient Dietary supplement

House Energy & Commerce Committee members call on FDA to ‘re-examine’ NDI draft guidance
Select members of the highly influential House Energy & Commerce Committee have written to FDA calling for a 'significant reworking' of the controversial new dietary ingredient (NDI) draft guidance.

In a letter dated March 29 and addressed to Margaret Hamburg, commissioner of the Food & Drug Administration (FDA), 14 Republican members of the Committee expressed their concern that the draft guidance “appears to undermine”​ the Dietary Supplement Health and Education Act (DSHEA) of 1994 “in a number of critical respects”.

“Therefore, we respectfully request FDA to reexamine and significant rework this guidance so it does not undermine consumer access to safe, affordable dietary supplement products,”​ they added.


The Members of Congress wrote: “We understand that with this guidance, FDA may in effect be establishing a pre-market review process for dietary supplements and impose standards that were deemed suitable for food additives. Furthermore, it appears that this guidance will require multiple filings on the same ingredient in certain situations which is at odds with the statute, past rulemaking and longstanding practice.

“Given FDA’s current workload, it does not seem prudent to follow this course of action.

“Imposing these regulatory requirements on products that have a long history of safe use will increase costs on manufacturers at a time when we should be encouraging, rather than hindering their efforts.

“It is our hope that FDA will engage in meaningful dialogue with the relevant stakeholders in industry to bring forward a useful guidance on New Dietary Ingredient submissions that is consistent with the DSHEA.”


The letter was described as “important”​ by Mike Greene, VP of government relations for the Council for Responsible Nutrition (CRN).

“The House Energy & Commerce Committee is very important because it has jurisdiction over FDA,”​ he told NutraIngredients-USA. “And it’s important that select members have written to FDA.”

The letter follows similar calls from leading politicians for FDA to go back to the drawing board on the draft guidance. On February 29, 2012, a bi-partisan group of 17 house members led by Jason Chaffetz (R, UT) and Dan Burton (R, IN) was filed calling for the withdrawal of the draft guidance.

This letter was preceded by a letter from industry champions Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) for FDA to again withdraw the document.

CRN’s Greene said he did not know if there would be more joint letters, but he does expect some individual letters.


The 14 members of the House Energy & Commerce Committee to sign the March 29 letter are: Brett Guthrie, Joe Barton, John Shimkus, Ed Whitfield, Mary Bono Mack, Lee Terry, Mike Rogers, Marsha Blackburn, Sue Myrick, Brian Bilbray, Charles Bass, Bob Latta, Gregg Harper, Adam Kinzinger.

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

Related topics Regulation NDI draft guidance

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1 comment

Champions on BOTH sides of the aisle? Missing in Action!

Posted by Michael R,

Historically, defending the natural health industry from an overreaching FDA has been a bi-partisan effort. Senator Reid was one of the first supporters of DSHEA in '93. I'm sorely disappointed not to see more Democrats in our corner. The FDA's NDI Guidance is contrary to Congressional intent of DSHEA AND contrary to President Obama's Jan 2011 Executive Order. So why are Democrats running from this issue? I can think of a number of reasons, and all of them lead down a bad path. LET THIS BE THE SIGNIFICANT BI-PARTISAN EFFORT THAT IS SORELY LACKING IN CONGRESS!

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