Are your supplements safe?

Nutrition Action Healthletter, Nov, 2003 by David Schardt

In 2002, 28-year-old Jennifer Rosenthal of Long Beach, California, a truck dispatcher and mother of a four-year-old, purchased some dietary supplements on the Internet to help her lose weight quickly.

She had no idea that she was buying them from a tee-shirt salesman who was importing Chinese herbs as a sideline. Three weeks into taking only half the recommended (dose, Rosenthal slipped into a coma, her liver apparently destroyed by usnic acid, an ingredient in the supplement.

Doctors were able to save Rosenthal's life with an emergency liver transplant. She now has to take 47 pills a day to keep her body from rejecting her new liver.

Seven out of every ten adults in the U.S. take vitamins, minerals, herbs, or other supplements, according to a 2002 Harris Poll. Some--calcium, folic acid, glucosamine, and saw palmetto, fro example--are beneficial. Others--soy isoflavones, ginseng, ginkgo may or may not be. And still others--ephedra, usnic acid, kava--can be dangerous.

And any supplement can do damage if you take too much or take it in the wrong combinations.

"How many supplement takers suffer adverse reactions, no one really knows," says Christine Hailer, a medical toxicologist at the University of California at San Francisco who has analyzed reports on the toxicity of ephedra for the Food and Drug Administration (FDA). (Ephedra, which has been called an "herbal fat burner," was linked to the death of Baltimore Orioles pitcher Steve Bechler last spring.)

"We really can't tell how serious the safety questions are for dietary supplements until we look at these products more carefully," says Mary Palmer, an emergency room physician and toxicologist in Alexandria, Virginia.

Palmer, Haller, and their colleagues recently analyzed nearly 500 calls about bad reactions to supplements that had been phoned in to 11 poison control centers in the U.S. in 1998. (1)

"When I started the study I thought that maybe the safety problems with supplements really were mild and that my worries were unfounded," says Palmer. "I was very surprised to see how serious the adverse reactions really were." A third of them included heart attacks, liver failure, bleeding, seizures, and death.

Prescription medications cause an estimated 100,000 deaths and 2.2 million adverse reactions each year. While the toll from supplements is nowhere near as great, it's far from trivial. For example, more than 20,000 complaints about weight-loss products containing ephedra, including scores of deaths, have been registered during the past decade.

Supplements are regulated so much more loosely than drugs that it's impossible to know how much harm they cause.

"Drugs can be sold only if companies have enough evidence to convince the FDA and panels of independent experts that they're safe and effective and that their benefits justify their risks," says Bruce Silverglade, director of legal affairs at the Center for Science in the Public Interest (publisher of Nutrition Action Heathletter).

In contrast, "The dietary supplement market is the Wild West," says Congressman Henry Waxman, a California Democrat and longtime champion of measures to protect consumers' health.

"There are no requirements that a company prove anything about either the safety or the effectiveness of its products before they go to market."

Most people don't realize that.

"About 60 percent of U.S. consumers believe that dietary supplements must be approved by a government agency like the Food and Drug Administration before they can be sold to the public," says Nancy Wong of the Harris Poll.

Not so. Congress made sure of that when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. "DSHEA put manufacturers in the driver's seat when it comes to which supplements are sold and what claims can be made for them," notes Palmer.

Before DSHEA, if the FDA questioned a supplement's safety, the manufacturer had to prove that it was safe. "DSHEA shifted the burden of proof," says Silverglade. "With drugs, food additives, and pesticides, it's always up to the manufacturer to prove safety. But thanks to DSHEA, the FDA has to prove that supplements are dangerous.

"Because of DSHEA," says Silverglade, "the FDA has been reduced to regulating by press release."

When the agency considers a supplement unsafe, it typically issues a consumer advisory and then discourages--but doesn't prohibit--companies from continuing to sell the product. How many consumers hear about these FDA advisories? "We don't know," concedes FDA spokesperson Sebastian Cianci. "To find that out would require research we don't have the resources to do."

Bottom line: The FDA can only bark, not bite.

In late 2001, for example, the agency received reports of young adults who developed liver damage or failure soon after starting to use a weight-loss product called LipoKinetix. (It contained usnic acid, the same substance thought to have destroyed Jennifer Rosenthal's liver a year later.) hr response, the agency put out a press release advising consumers to "immediately stop use of LipoKinetix."