Report: Herbal Supplements May Pose Health Risk

(May 26) -- Natural supplements, now taken by at least a quarter of adult Americans, often contain trace amounts of lead, mercury, arsenic and potentially dangerous levels of pesticides.

That's the conclusion of a new federal report, released today by the Government Accountability Office. It's just in time for a key Senate hearing, set to begin in two weeks, that will decide whether to approve a food safety bill that could clamp down on regulation of such products.

Investigators tested 40 herbal supplements. Of those, 37 contained trace amounts of heavy metals, especially lead, mercury, cadmium and arsenic. The content wasn't enough to exceed safety limits, but it does raise questions about the sterility of the supplement ingredients and the plants where they're produced.

"Consuming high levels of the contaminants for which we tested the 40 products can lead to severe health consequences, such as increased risk of cancer," the report reads, adding that the toxicity depends largely on one's dosage and individual health.

Sixteen of the supplements contained elevated levels of pesticides. Most of those chemicals aren't capped by legal restrictions because of insufficient scientific evidence about their risk to humans.

The products aren't identified by name, but investigators opted for those often used by the elderly, including "chamomile, echinacea, garlic, ginkgo biloba, ginseng, peppermint, saw palmetto and St. John's wort," according to the report.

In addition to unexpected ingredients, nine of the products also advertised using deceptive and illegal health claims. Any product that markets itself in terms of treatment, prevention or curing needs Food and Drug Administration regulation, because it qualifies as a drug rather than a food product. Herbal supplements, provided they don't make such claims, go largely unregulated.

At least for now.

The proposed food safety bill could give the FDA license to enforce recalls of supplements and mandate that manufacturers use only FDA-approved ingredients.

That's if the act is as tough as possible. More realistically, insiders say, it'll simply force companies to register annually with the agency, helping it keep tabs on manufacturers.

"The FDA needs the authority and tools to ensure that dietary supplements are as safe and effective as is widely perceived by the Americans who take them," said Sen. Herb Kohl, the Wisconsin Democrat who chaired the hearing where the report was released.

In 2007, the agency mandated that supplement manufacturers needed to report all adverse effects and use clear labeling and contaminant-free manufacturing facilities. But critics say the agency isn't adequately enforcing the rules.

Representatives of the supplement industry, however, say there's little cause for concern. Products contain trace metals because ingredients are sourced from soil and water, according to Steve Mister, president of the Council for Responsible Nutrition, a supplement trade group.

"I don't think this should be of concern to consumers," he told The New York Times.

Mister speculates that while the Senate hearing is unlikely to tighten down on supplements, it'll spur more funding for FDA inspections of manufacturing plants. Most products are now produced overseas and are rarely examined by the agency.

No matter the conclusions that result from the Senate debate, there's no question that supplement companies have a huge financial stake in continuing to sell their products without intervention. In the U.S. alone, vitamins and supplements are a $25 billion industry.

The new act also won't do much to address problems in how the supplements are sold by retailers. The report includes results of an undercover operation where investigators disguised as elderly shoppers were given "potentially dangerous advice" by salespeople.

"In making these claims, sellers put the health of consumers at risk," Greg Kurtz, head of the Government Accountability Office Forensic Audits and Special Investigations, said in a statement obtained by ABC News.

The supplement industry, for its part, is announcing support for the toned-down version of the food safety act -- especially a bill proposed by Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, that would give the FDA more money to oversee herbal products.

"While some have called for additional regulations on supplements, Sens. Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law," John Gay, executive director of the Natural Products Association, said in a statement.

"The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple," he said.