Introduction of the “Dietary Supplement and Nonprescription Drug Consumer Act”

June 21, 2006
The Honorable Orrin Hatch
The Honorable Richard Durbin
United States Senate
Washington, DC 20510
Dear Senators:
We deeply appreciate your efforts to address a long-standing problem regarding dietary supplements and the lack of information on dangerous side effects, and we are grateful for your introduction of the “Dietary Supplement and Nonprescription Drug Consumer Protection Act.”
Consumers Union, the independent, non-profit publisher of Consumer Reports, strongly supports legislation to detect better possible problems with the widespread use of dietary supplements, which are often marketed without scientific proof of their short or long-term safety or effectiveness and at dosages often far in excess of the daily recommended allowance for vitamins and minerals.
In May, we had the opportunity to serve as the consumer representative on the National Institutes of Health “State of the Science” Consensus Panel on the advantages and disadvantages of the use of dietary supplements (multivitamins and mineral supplements) on chronic illness prevention. The expert panel found

    The current level of public assurance of the safety and quality of multivitamins and minerals is inadequate, given the fact that manufacturers of these products are not required to report adverse events, and the FDA has no regulatory authority to require labeling changes or to help inform the public of these issues and concerns. It is important that the FDA’s purview over these products be authorized and implemented.

This Consensus Panel was the fourth report in recent years to recommend stronger dietary supplement adverse event reporting requirements. In its deliberations, the panel noted the surprising number of cases of adverse and even fatal events reported to the Centers for Disease Control’s Poison Center. While a few adverse events are currently reported to the FDA, the general lack of knowledge of this reporting venue and the failure to require serious adverse event reports has severely limited the usefulness of the current FDA system—and thus justifies your legislation.
In May, 2004 Consumer Reports included a major article entitled, “Dangerous Supplements Still At Large,” where we listed a ‘dirty dozen’ that consumers should avoid, many of which could cause death or severe organ failure. Consumers Union believes that more needs to be done to protect consumers from untested and exaggerated claims of dietary supplements. And adverse event reporting is a key to beginning to understand the most dangerous products in the marketplace. By helping us focus on actions against deadly and dangerous products, adverse event reporting can help increase consumer confidence in the dietary supplement sector.
We hope that industry and consumers can work together to ensure early passage of this bipartisan legislation. Again, thank you for your work in the development of this legislation.
William Vaughan
Senior Policy Analyst (Health)
Washington Office