On Tuesday, August 2, 2011, Emord & Associates filed comments with the FDA and Office of Management and Budget (OMB) concerning the FDA’s proposed collection of information through 75-day New Dietary Ingredient notifications.  We previously reported on the FDA’s proposed New Dietary Ingredient (NDI) guidance here and here.

Federal agencies frequently collect information from private entities, often through compulsory reporting requirements like 75-day NDI notifications.  A “proposed collection of information” must be approved by the OMB before regulatees are obligated to comply with the agency’s request.  ANH’s August 2nd comment asks the FDA and OMB to reconsider the economic burdens imposed by the FDA’s new guidance document.

ANH’s comment presents an economic impact analysis by a top regulatory economist, Dr. Joanna Shepherd-Bailey.  Shepherd-Bailey confirmed that enforcement of the NDI proposed guidance will cause up to 50 percent of existing supplements to be unlawfully marketed, cause a loss in the billions of dollars for the industry, and may cause as many as 100,000 people to lose their jobs.

Dr. Shepherd-Bailey’s economic assessment confirms the obvious.  The FDA’s draft NDI guidance substantially broadens the class of dietary ingredients subject to NDI notifications, while making more difficult the task of proving grandfathered status for older ingredients.  The guidance would require multiple submissions for the same ingredient.  Each company must furnish safety data at considerable expense.

The cost of this approach is significant.  ANH’s comment shows that FDA’s assessment was grossly understated.  In its June 3, 2011 Federal Register notice, the FDA sought comments on “the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.”  See 76 Fed. Reg. 32214.  FDA estimated that just 55 companies would be required to submit 75-day notifications per year with each submission requiring 20 hours to prepare.  Dr. Shepherd-Bailey concluded, by contrast, that the FDA’s new guidance will require between 22,240 and 125,000 NDI submissions, each requiring between 100 and 350 hours of employee time (not including professional time and fees).

The full copy of ANH’s comment is available here.  Check back for updates on FDA’s NDI Guidance.



– Peter Arhangelsky is a Senior Associate with Emord & Associates and can be reached at (202) 466-6937 or parhangelsky@emord.com.

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