The Honorable (Congressional Representative's First/Last Name)

Dear Representative (Last Name):

I am writing in opposition to H.R. 6168, the Adverse Event Reporting bill . This bill would regulate supplements like drugs instead of like foods as is intended under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The bill would mandate dietary supplement manufacturers, distributors, and retailers to submit to the FDA reports of serious adverse health reactions relating to supplement use. The FDA already has a voluntary reporting system. In testimony before the House Committee on Government Reform on March 9, 2006, Robert Brackett, Ph.D., Director, Center for Food Safety and Applied Nutrition (CFSAN) stated that since becoming operational in June of 2003, the FDA had received 1,145 voluntary adverse event reports. The FDA is already receiving this information. In Congressional testimony, the FDA has also said it does not need, nor want, mandatory AER reporting for supplements.

As one of the 60 million consumers of dietary supplements, I am not convinced that this legislation is needed. I do not support needless federal regulation.  Regulating supplements like prescription or over-the-counter drugs is not something I support. The real issue is holding government bureaucrats at the FDA accountable for their performance under the existing law. The FDA seems to think that they are doing this. So, why is this bill needed?

This is a bad bill and does not deserve your support. I appreciate your consideration and look forward to knowing what your position is on this legislation.

Sincerely,