By Heather VanBlarcom
General Counsel & Senior Regulatory Specialist for Dietary Supplements
We can breathe a sigh of relief thanks to Senate supplement-industry champions Tom Harkin (D-IA) and Orrin Hatch (R-UT). After a meeting they had on Tuesday, June 19, 2012, with the top three FDA officials, Commissioner Margaret Hamburg, Assistant Commissioner for Legislation Jeanne Ireland and Deputy Commissioner for Foods Michael Taylor, the FDA agreed to issue a revised NDI draft guidance. As currently written, the NDI draft guidance is contrary to both the letter and Congressional intent of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). Senators Harkin and Hatch, the principal authors of DSHEA, had criticized the draft guidance, stating that it strays too far from the legislation they wrote. For now, it appears Senators Harkin and Hatch have been successful in their attempt to convince the FDA not to undermine the balance Congress struck in enacting DSHEA, which allows consumers access to safe and affordable dietary supplement products.
It is expected that the FDA will revisit five specific issues that had been highlighted as particularly problematic for the industry. These include how to establish grandfathered ingredient status, the definition of “chemically altered”, the permissibility of using synthetic versions of botanical components, the necessity of NDI submissions for ingredients versus finished products, and the level of safety required for a NDI submission.
The revised NDI draft guidance will be re- issued with a renewed comment period. However, the FDA has not confirmed a timeline for when it will be released. Speculation is that no action will be taken until after the November elections. It is important to note that while the draft guidance is being rewritten, it continues to be necessary to submit notifications for new dietary ingredients.
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The following email was sent from FDA’s Dr. Daniel Fabricant to the dietary supplement industry:
“Today Commissioner Hamburg, accompanied by Deputy Commissioner Mike Taylor and Assistant Commissioner Jeanne Ireland met with Sens. Harkin and Hatch to discuss the NDI draft guidance. One item that you may hear from their personal and/or committee staffs in the near future and I wanted to confirm is that we are planning on promulgating a revised draft NDI guidance to address points that may need further clarity to avoid misinterpretation, and possibly being taken out of statutory context. While we are working diligently on the matter, the timeline is unknown at present, yet, we will keep all parties posted on progress to the extent we can. Please assure your members that the comments received in December are still being administratively reviewed and vetted accordingly. We will likely be in contact in the near future on the issue, maybe for a possible meeting. Thank you for your time.”
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