More on FDA's NDI Being Redirected

From Natural Solutions Foundation in Panama -- January 5, 2012 - 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"Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) urged FDA to withdraw its New Dietary Ingredient (NDI) Draft Guidance in a letter to FDA Commissioner Margaret Hamburg, MD - Senators Hatch and Harkin, the principal authors of the Dietary Supplement Health and Education Act  of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 "The Senators said the draft guidance undermines DSHEA in a number of ways.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.'"

http://www.naturalproductsinsider.com/news/2012/01/senators-hatch-harkin-call-for-ndi-guidance-redo.aspx