HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent

On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011.  We have a keen interest in the draft guidance and have previously posted on it here, here, here, and here. 

The current draft guidance ignores the balance struck by the Dietary Supplement Health and Education Act of 1994 (“DSHEA”) between ensuring safety and minimizing unnecessary and unreasonable regulatory requirements for dietary ingredients and supplements.  Implementation of this draft guidance would severely disrupt the market for dietary supplements and impose extraordinary burdens on industry and FDA.  Therefore, the comments request that FDA withdraw the draft NDI guidance and reissue a guidance that reflects the intent behind DSHEA and that can be implemented in a practicable manner within FDA’s limited resources.  In addition, they encourage FDA to articulate its rationale for its interpretation of the various NDI provisions in the law.

Although differing from some trade association comments in significant ways, HP&M’s comments request that the draft NDI guidance be withdrawn, consistent with the comments of the Alliance for Natural Health, the American Herbal Products Association, the Consumer Healthcare Products Association, the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 here and here.