Many point to Congress’ intent in the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a reason why FDA’s NDI Draft Guidance steps over the line.  In fact, attorney Marc Ullman, Ullman, Shapiro and Ullman, said FDA itself said DSHEA calls for ingredient, not supplement, notifications. However, the Draft Guidance says notifications are necessary for each new supplement with an NDI.

In comments he submitted to FDA, he noted FDA itself estimated the number of NDIs that would be required each year would be 12 or fewer, not the thousands that would be necessary if notifications would be required for every single new supplement with a NDI or new combination of ingredients. Ullman said FDA issued a Final Rule in 1997 that included a cost benefit analysis of the NDI notification process. FDA said the economic impact would not be significant because so few notifications would be submitted each year.

Thus, FDA’s own analysis showed the notifications would be required for ingredients, not supplements. If FDA thought DSHEA called for supplement notifications, it would have reported the economic effect to be much greater because clearly, more than 12 new supplements with NDIs are launched each year.

Ullman noted the Draft Guidance changes the law, which is not the purpose of a guidance. He said if FDA wanted to make NDI notifications required for supplements rather than ingredients—which was not what DSHEA outlined—the agency would need to propose changes to the federal registrar, which offers more scrutiny and review than a draft guidance. He calls for FDA to withdraw the draft guidance completely.

Jon Benninger, vice president of business development for the Health & Nutrition Network at VIRGO, outlined Ullman’s point in his blog.

What to others think? Did Ullman just undercut FDA’s whole argument that notification s are required for each supplement? Or, can FDA explain away its 1997 Final Rule?