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of the Food & Drug Administration (FDA), 14 Republican members of the Committee expressed their concern that the draft guidance “appears to undermine” the Dietary Supplement Health and Education Act (DSHEA) of 1994 “in a number of critical respects”.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.
Workload
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.”
Importance
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The letter follows similar calls from leading politicians for FDA to go back to the drawing board on the draft guidance.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of 17 house members led by Jason Chaffetz (R, UT) and Dan Burton (R, IN) was filed calling for the withdrawal of the draft guidance.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.
Signatories
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.