Senators Hatch, Harkin Urge FDA to Rewrite NDI Draft Guidance

In a letter addressed to FDA Commissioner Margaret Hamburg, MD, in late December, Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) asked FDA to withdraw the agency’s new dietary ingredient (NDI) draft guidance, which FDA published in July. The letter also asks FDA to meet with the senators in early January to discuss their concerns.

Hatch and Harkin were the principle authors of the Dietary Supplement Health and Education Act (DSHEA), which passed in 1994 and required FDA to publish the NDI draft guidance. The guidance outlines the agency’s thinking-and its interpretation of DSHEA’s mandates-on when and how NDI notifications should be submitted.

Since its July release, the draft guidance has met much criticism from those in the dietary supplements industry. Many, including Hatch and Harkin, have urged FDA to withdraw the current version of the guidance and start a new version altogether.

“For the reasons outlined below, we urge the FDA to withdraw this guidance and begin work on a new draft that will provide needed clarification on what constitutes a New Dietary Ingredient (NDI), but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.

Like many industry members in their comments submitted to FDA, Hatch and Harkin wrote that the draft guidance is inconsistent with what DSHEA states. For instance:

• On the draft guidance’s requirement that manufacturers submit an NDI notification for every supplement product containing an NDI, Hatch and Harkin wrote, “this is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI.” They added that “FDA’s misinterpretation of this provision is far from harmless,” stating that such a requirement would “impose substantial, additional costs on manufacturers without providing additional safety benefits and would undermine the access to safe, affordable dietary supplement products that DSHEA was designed to ensure.”

• Hatch and Harkin stated that the draft guidance’s position that synthetic botanical ingredients are not considered dietary ingredients is “an assertion that is wholly without statutory basis, and in fact contradicts longstanding FDA policy.” They added: “The draft guidance also unduly limits the types of physical modifications that do not result in ‘chemically altering’ a dietary ingredient by incorrectly construing the list in DSHEA legislative history as an exclusive rather than illustrative list.”

Nutritional Outlook thanks CRN for the tip.

Update: The American Herbal Products Association welcomed the news of the Hatch/Harkin letter:

"AHPA is pleased that Senators Hatch and Harkin have requested that FDA withdraw the draft NDI guidance," said American Herbal Products Association president Michael McGuffin. "This request is in alignment with the position AHPA stated in our comments submitted to the agency in December. We look forward to working with FDA to create new guidance that is consistent with DSHEA and ensures that consumers will continue to have access to safe, affordable dietary supplement products."