Dangerous supplements: still at large.(CR Investigates)(Cover Story)

If you can buy it at a clean, well-lighted store, if it's "all natural," it's not going to do you serious harm, right? That's what many Americans assume about dietary supplements. But while most supplements are probably fairly benign, CONSUMER REPORTS has identified a dozen that according to government warnings, adverse-event reports, and top experts are too dangerous to be on the market. Yet they are. We easily purchased all 12 in Feburary in a few days of shopping online and in retail stores.

These unsafe supplements include Aristolochia, an herb conclusively linked to kidney failure and cancer in China, Europe, Japan, and the U.S.: yohimbe, a sexual stimulant linked to heart and respiratory problems; bitter orange, whose ingredients have effects similar to those of the banned weight-loss stimulant ephedra; and chaparral, comfrey, germander, and kava, all known or likely causes of liver failure. (For a complete list of the "dirty dozen," see the table on page 15.)

U.S. consumers shelled out some $76 million in 2002 for just three of these supplements: androstenedione, kava, and yohimbe, the only ones for which sales figures were available, according to the Nutrition Business Journal, which tracks the supplement industry.

The potentially dangerous effects of most of these products have been known for more than a decade, and at least five of them are banned in Asia, Europe, or Canada. Yet until very recently, the U.S. Food and Drug Administration had not managed to remove a single dietary supplement from the market for safety reasons.

After seven years of trying, the agency announced a ban on the weight-loss aid ephedra in December 2003. And in March 2004 it warned 23 companies to stop marketing the body-building supplement androstenedione (andro).

Despite these actions against high prone supplements, whose dangers were so well known that even industry trade groups had stopped defending them, the agency continues to be hamstrung by the 1994 Dietary Supplement Health and Education Act (DSHEA, pronounced de-shay). While drug manufacturers are required to prove that their products are safe before being marketed. DSHEA makes the FDA prove that supplements on the market are unsafe and denies the agency all but the sketchiest information about the safety record of most of them.

"The standards for demonstrating a supplement is hazardous are so high that it can take the FDA years to build a case," said Bruce Silverglade, legal director of the Center for Science in the Public Interest, a Washington, D.C., consumer-advocacy group.

At the same time, the FDA's supplement division is understaffed and under-funded, with about 60 people and a budget of only $10 million to police a $19.4 billion-a-year industry. To regulate drugs, annual sales of which are 12 times the amount of supplement sales, the FDA has almost 43 times as much money and almost 48 times as many people.

"The law has never been fully funded," said William Hubbard, FDA associate commissioner for policy and planning. "There's never been the resources to do all the things the law would command us to do."

The agency has learned that it must tread carefully when regulating supplements. The first time it tried to regulate the dangerous stimulant ephedra, in 1997, overwhelming opposition from Congress and industry forced it to back down.

As a result, the FDA is sometimes left practicing what Silverglade calls "regulation by press release"--issuing warnings about dangerous supplements and hoping that consumers and health practitioners read them.

There are signs of hope. The FDA has said that if the ban on ephedra holds up against likely legal challenges, it plans to go after other harmful supplements. Legislation has been introduced to strengthen the FDA's authority under DSHEA and give the agency more money to enforce the act.

But the supplement marketplace still holds hidden hazards for consumers, especially among products that aren't in the headlines. "Consumers are provided with more information about the composition and nutritional value of a loaf of bread than about the ingredients and potential hazards of botanical medicines." said Arthur Grollman, M.D., professor of pharmacological sciences at the State University of New York, Stony Brook, and a critic of DSHEA.

A QUESTION OF SAFETY

Supplement-industry advocates say the ephedra ban demonstrates that DSHEA gives the FDA enough power to protect consumers from unsafe products. "I don't think there's anything wrong except that FDA has only recently begun vigorous and active enforcement of the law," said Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition, a major trade association for the supplement industry.

But critics of DSI-IEA think the ban illustrates the extremes to which the FDA must go to outlaw a hazardous product.

When the agency initially tried to rein in ephedra use in 1997, alter receiving hundreds of reports of adverse …