Pallone, Guthrie Nudge FDA on NDI Guidance

WASHINGTONReps. Frank Pallone (D-NJ) and Brett Guthrie (R-KY), joined by 27 other House members, sent a letter to FDA Commissioner Margaret Hamburg urging the agency to expedite its efforts to release the draft guidance for new dietary ingredient (NDI) notifications.

This comes on the heels of a strong nudge from the House Appropriations Committee, which recently noted the agency has been tight-lipped on the NDI guidance despite prior requests from the committee to address concerns.

FDA initially released a draft guidance on NDI notifications in July 2011, but agreed to rework the draft guidance in June 2012 after much criticism from industry and other stakeholders over key parts of the document, including the agency's consideration of chemically altered dietary ingredients and a focus on notifications for finished products, not just ingredients. Overall, critics felt the guidance did not reflect the scope of the industry's landmark law, the Dietary Supplement Health and Education Act of 1994 (DSHEA), the law that mandated NDI notifications. Comments on the draft closed in December 2011, but there has been no further definitive update from FDA on the status of the reworked version.

"We appreciate the industry's willingness to engage with industry on this important issue and work toward a revised guidance that reflects fair and workable NDI notification system, based on the principles outlined in the Dietary Supplement Health and Education Act (DSHEA)," the Congressmen wrote. "However, we remain concerned about the speed of progress on these discussions and when we can expect the agency to release a revised guidance."

The letter further urged FDA to try harder to bring clarity on NDIs, "as it is critical to ensure consumers have access to safe and affordable dietary supplement products." The letter closed by saying, "We hope that you will work toward completion in a timely manner. ... We look forward to an update on these efforts."

Other members of Congress signing the letter included Reps. Marsha Blackburn (R-TN), Jared Polis (D-CO), Jason Chaffetz (R-UT), Jim Matheson (D-UT), and Bill Johnson (R-OH).

Mike Greene, vice president, government relations, the Council for Responsible Nutrition (CRN), said the letter is "a cautionary reminder to FDA and industry that Congress is still interested in resolving concerns with the draft NDI notification guidance. I see it as a request for a progress report or a status update. "

Greene added the supplement industry needs this guidance and should continue to work with FDA toward resolving concerns with NDIs.  "Industry and FDA have had three meetings (four, if you include next week's industry/FDA meeting on NDIs) with the agency.  Last year, many members of Congress were interested in this issue, so I see the Pallone Guthrie bipartisan letter (27 signers) as a reminder from Congress that this issue continues to be of importance."     

Greene applauded the efforts of both Pallone and Guthrie, calling them more than just industry allies. "One is a champion and the other is a good friend," he said. "Congressman Pallone is an industry champion in the House of Representatives. He supported passage of DSHEA in 1994, he worked closely with the dietary supplement industry on key issues over the last 20 years, he was a proponent of the Dietary Supplement and Nonprescription Drug Consumer Protection Act in the House and has been a leader in the Dietary Supplement Caucus.  Congressman Guthrie is a good friend and has been interested in the NDI issue. He was the lead author of an NDI letter to FDA, last year, by Energy and Commerce Republicans."