Dietary Supplement and Nonprescription Drug Consumer Protection Act

DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT -- (Senate - December 06, 2006)

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Mr. DURBIN. Mr. President, today, the Senate adopted a bipartisan bill that provides the Food and Drug Administration with the tools it needs to help monitor the safety of dietary supplements.

Dietary supplements are safely consumed by millions of Americans every day. I myself take a multivitamin every morning. The vast majority of these supplements do not result in harm to the consumer.

Unfortunately, this is not the case for all supplements. Some cause dangerous health problems: increased blood pressure, heart attack, stroke, seizures and liver failure. Ephedra is the most well-known among these.

Under the Dietary Supplement Heath and Education Act, DSHEA, which passed in 1994, supplement manufacturers are not required to prove their products are safe or effective before they are marketed: supplements are assumed safe until proven unsafe.

The bill we passed today will help the FDA identify products that may be causing harm to consumers.

In 2000, the FDA contracted with the Institute of Medicine at the National Academies of Science to develop a scientific framework for the evaluation of dietary supplements under DSHEA.

IOM's proposals flowed from their first and essential recommendation to Congress: Make adverse event reporting mandatory. They asserted that ``adverse event reports have considerable strength as potential warning signals of problems requiring attention, making monitoring by the FDA worthwhile.''

Unfortunately, under current law, reporting is voluntary and it is not working. The Office of the Inspector General at the Department of Health and Human Services, HHS, estimated in 2001 that less than 1 percent of all adverse events associated with dietary supplements are reported to the FDA.

My own experience reinforces the need for a mandatory system of reporting. Metabolife told the FDA in February of 1999 that, ``Metabolife has never been made aware of any adverse health events by consumers of its products. Metabolife has never received a notice from a consumer that any serious adverse health event has occurred because of ingestion of Metabolife 356.''

The Justice Department began investigating the truthfulness of that statement and found that Metabolife was holding 16,500 adverse event reports, including almost 2,000 significant cardiac, neurological and psychiatric reports.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act will prevent this scenario from ever happening again. Manufacturers of over-the-counter drugs and dietary supplements will be required to send these reports to the FDA.

I would like to thank Senators Hatch, Harkin, Enzi and Kennedy, who have worked with me for the last 3 years on this important issue.

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