Tests Show Many Supplements Have Quality Problems

"We called it 'the body rule,'" said William Obermeyer, a chemist who left the FDA to found ConsumerLab.com with Cooperman. If a supplement was harmful, "we had to have so many adverse events before we could make a move on it. It was really like closing the barn door after all the animals left."

The law said the FDA could write quality control rules for products sold in the U.S. It took the FDA 13 years to adopt these, and they are just now taking effect. But the rules do not say what tests companies must do to prove what is in their products, and some tests can be fooled by subbing other ingredients. The rules also set no limits on toxins such as lead; nor do they change the fundamental way these products are sold to the public.

"It leaves the level of quality up to the manufacturer," Cooperman said.

In a written statement, FDA spokeswoman Susan Cruzan said the new rules contain what is "needed to ensure quality," and that products that contain contaminants or whose labels do not honestly describe their contents, are considered adulterated and subject to further action by the agency. But she conceded that the agency is spread thin.

"In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness," she wrote.

Millions of Americans take vitamin, herbal or other dietary supplements. Annual sales exceed $23 billion, and more than 40,000 products are on the market. Tens of thousands of supplement-related health problems are handled by U.S. poison control centers each year, according to a report in the New England Journal of Medicine in 2002.

Until last year, supplement makers were not required to report problems to the FDA, and even now they must report only serious ones. The agency estimates that more than 50,000 safety problems a year are related to supplement use.

The Institute of Medicine, an independent science panel that advises the government, studied the situation in 2005.

"The committee is concerned about the quality of dietary supplements in the United States. Product reliability is low," says its report, which urged amending the 1994 law to tighten consumer protections.

Trade associations say the FDA's new rules do that.

"We are FDA-regulated products," though not in the same way as prescription or over-the-counter drugs, said Steven Mister, president of the Council for Responsible Nutrition.

The FDA can ask law enforcement to act against any company selling an adulterated product, said McGuffin of the herbal products association. "You can go to jail, you can have your company seized," he said.

"We represent companies that we consider the responsible center of the industry," who are working to comply with the new rules, he said.