Are your supplements safe?

Nutrition Action Healthletter, Nov, 2003 by David Schardt

Not so. Unlike drug labels, supplement labels don't have to disclose who shouldn't take the product, what drugs if shouldn't be taken with, or other warnings.

So, for example, beta-carotene supplements are unlikely to warn smokers that high doses (at least 25 mg, or 42.000 IU) may increase their risk of lung cancer. And zinc supplement labels are unlikely to disclose that too much zinc can compromise the immune system.

* Unreported problems. "The FDA maintains surveillance of prescription drugs by requiring prompt reports from manufacturers of all adverse events brought to their attention," says Arthur Grollman, chair of pharmacology at the State University of New York at Stony Brook.

"But there is no mandatory requirement for manufacturers of supplements to record, investigate, or forward to the FDA reports of adverse effects they might receive," he adds. "Under current regulations, there is no penalty for withholding these reports." Grollman wants Congress to require companies to report safety problems.

For years, Metabolife, the leading manufacturer of weight-loss pills that contain ephedra, denied that it knew of any serious complaints about its products. Then last year, lawyers who were suing the company all behalf of injured consumers learned that Metabolife had, in fact, received more than 13,000 complaints from users.

Among them were more than 1,000 reports of significant adverse reactions, including 18 heart attacks, 26 strokes, 43 seizures, and five deaths)

An angry FDA has asked the Department of Justice to pursue filing criminal charges against Metabolife officials for lying to the agency.

* Unavailable adverse reaction reports. For years, the Food and Drug Administration has been collecting reports of adverse reactions to dietary supplements. But last year the agency pulled the database from its Web site, saying that the information was confusing.

Last June, the FDA installed a new system (the Center for Food Safety and Applied Nutrition Adverse Events Reporting System, or CAERS) to track complaints by consumers and physicians to its MedWatch hotline (800-FDA-1088 or www.fda.gov/medwatch/report/consumer/consumer.htm).

But health professionals and the public can't view the complaints that have been submitted to CAERS.

"We're working on a way to give the public access to this information, but that's at least a year away," says FDA spokesperson Sebastian Cianci. "Until then, you need to file a Freedom of Information Act [FOIA] request to see the information."

That can take months, which is tar too king to help people track down what's causing a reaction. And it certainly would have been too long for people like Jennifer Rosenthal, the California mother who paid a steep price for her lesson in supplement safety.