Senators Hatch and Harkin Request that FDA Withdraw Draft NDI Guidance

By Riëtte van Laack –

In a strongly worded letter to FDA Commissioner Hamburg dated December 22, 2011, the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), requested that FDA immediately withdraw the Draft New Dietary Ingredient Guidance ("Draft NDI Guidance") because it undermines DSHEA in unacceptable ways.

The Senators’ letter is consistent with industry’s concerns over the Draft NDI Guidance.  As examples of FDA’s misinterpretation the Senators included FDA’s view that a manufacturer must submit an NDI notification for every dietary supplement containing an NDI, FDA’s assertion that synthetic copies of botanical ingredients can never be a dietary ingredient, FDA’s unduly broad interpretation of what constitutes chemical alteration, and the Agency’s narrow definition of “old dietary ingredient.” 

The Senators request that, as part of the process of withdrawing and rewriting the guidance, Commissioner Hamburg direct her staff to meet with the Senators’ staff to further discuss concerns with the guidance in more detail.

On December 2, 2011, Hyman, Phelps, & McNamara filed comments to the controversial Draft NDI Guidance requesting that it be withdrawn, consistent with the comments of the Alliance for Natural Health, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance – see our previous post here.