Senators Hatch and Harkin Express Support for Impending NDI Guidance

A letter sent by Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) to FDA Commissioner Margaret Hamburg last week expresses support for FDA’s upcoming publication of new dietary ingredient (NDI) guidance, which the agency is due to deliver in July.

In particular, the letter expresses the senators’ expectations that the NDI guidance will be in line with the policies enacted by the Dietary Supplement Health and Education Act of 1994 (DHSEA).

“While the guidance should clarify when manufacturers must submit New Dietary Ingredient Notices, it should also refrain from erecting barriers that will inhibit or needlessly delay consumer access to safe products that were in fact marketed in the U.S. prior to October 15, 1994,” the letter states. “The intent of the law was to give FDA the tools necessary to help ensure the safety of dietary supplements and the accuracy of the limited claims allowed for them, but also to minimize regulatory burdens that might inhibit consumer access to lawfully manufactured and labeled supplement products.”