Senators Hatch, Harkin Call for NDI Guidance Redo

SILVER SPRING, Md.Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) urged FDA to withdraw its New Dietary Ingredient (NDI) Draft Guidance in a letter to FDA Commissioner Margaret Hamburg, M.D. Senators Hatch and Harkin, the principal authors of the Dietary Supplement Health and Education Act  of 1994 (DSHEA), asked Dr. Hamburg to issue a new draft that, "will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products."

The Senators said the draft guidance undermines DSHEA in a number of ways. For example, they wrote FDA's belief that notifications are required for each supplement containing an NDI is contrary to the language of DSHEA, which they said requires one notification per new ingredient. "The FDA's misinterpretation of this provision is far from harmless," they wrote. "Indeed, this burdensome requirement would impose substantial, additional costs on manufacturers without providing additional safety benefits and would undermine the access to safe, affordable dietary supplements that DSHEA was designed to ensure."

Senators Hatch and Harkin also took issue with the Draft Guidance's claim that synthetic botanicals are not dietary supplements. They said this assertion is without statutory basis and contradicts long-standing FDA policy.

Further, the senators said the Draft Guidance overreaches in its definition of "chemically altered." The senators wrote the list of processing methods that do not trigger an NDI provided by Congress at the time DSHEA passed was illustrative, not exhaustive. They added the limit on physical modifications described in the Draft Guidance diverges from Congressional intent by, "including only ingredients that were marketed before enactment of DSHEA in the form of dietary supplements as 'old dietary ingredients.' The term dietary supplement wasn't even defined prior to DSHEA."

The concerns brought up by the senators were reflected in many comments submitted by industry members.

As part of the process of creating a new Draft Guidance, the senators urged FDA to collaborate with their staffs in January to discuss the concerns they listed in the letter.

"AHPA is pleased that Senators Hatch and Harkin have requested FDA withdraw the draft NDI guidance," said Michael McGuffin, president, American Herbal Products Association (AHPA). "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 consumers will continue to have access to safe, affordable dietary supplement products."