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The manufacturers of dietary supplements will soon be required to tell federal drug regulators of any reported severe reactions to their products, as part of new legislation that is cracking down on this lightly monitored industry.

The new measure, which was approved last weekend, will make it easier for the U.S. Food and Drug Administration to pull a diet drug from the market if it poses “significant” risks to consumers. Until now, the diet drug industry was never required to report any bad reactions to the agency.

“With this bill, the FDA will have the tools to monitor supplements that cause dangerous health problems like heart attack, stroke, seizures, and liver failure,” said Illinois Sen. Richard Durbin, who pushed for the bill after the 2002 death of a high-school athlete who took an ephedra-containing supplement.

Ephedra, an herbal stimulant that was widely used in many dietary supplements, was a cause for concern among FDA officials for several years before the product was banned in 2003. One diet drug maker continues to fight the ban in court.

Legislation Requirements

It took a number of years for the new bill to move from the proposal stage to its passage, as a group of lawmakers addressed the concerns of all parties involved and fine-tuned the provisions.

The legislation, which also covers over-the-counter supplements, requires that all makers of dietary supplements marketed nationwide must give the FDA—within 15 business days—any information or consumer reports of “serious” reactions and adverse events associated with the use of the drugs. Serious events include hospitalization, birth defects, persistent disability, and death.

President Bush must sign the bill and the companies will be given one year to prepare before the requirements are enacted.

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