The recent recall of a popular weight-loss supplement comes at a time when Americans are more desperate than ever to lose weight.
The pharmaceutical industry has come up virtually empty in a multibillion-dollar race to find a safe and effective weight-loss pill, and consumers, to many health experts' chagrin, are often turning to dietary supplements instead.
Now proponents and critics of these products have snapped to attention.
This month, the Food and Drug Administration warned consumers to stop using Hydroxycut, a line of herbal dietary supplements marketed as an aid to weight loss, body sculpting and athletic performance.
The warning prompted Hydroxycut's maker, Iovate Health Sciences Inc. of Ontario, Canada, to recall 14 of its products. The FDA has linked these products to 23 known cases of liver damage (including one death), four reports of seizures and 46 reports of cardiovascular events -- from palpitations to heart attack -- since 2002.
In the aftermath, both sides are asking whether recent regulatory changes have succeeded in making dietary supplements safer for U.S. consumers.
Is Hydroxycut a repeat of the blockbuster weight-loss supplement ephedra, which the FDA banned in 2004 after linking it to more than 100 deaths and thousands of illnesses? Or have new federal rules and a 2007 law given government regulators the power to intervene before another dietary supplement can become a public health disaster?
Defenders of the supplements industry say that the recall of Hydroxycut demonstrates the agency already has the power to protect consumers.
"The law's working. This is the way it's supposed to happen," says Loren Israelsen, executive director of the United Natural Products Alliance, a trade association for supplement makers. "People should anticipate that these things will happen, and that there's now a system in place to recognize and investigate them."
Critics cite the Hydroxycut case as evidence that the FDA's powers over dietary supplements need to be expanded.
New York University biochemist Dr. Gerald Weissmann says little has changed since the Dietary Supplement Health and Education Act (DSHEA) of 1994 exempted a wide range of plants, oils, enzymes and vitamins from the kind of government oversight applied to drugs.
"These aren't dietary supplements, they are drugs," Weissmann says. Unless these often potent substances are brought under stricter controls, he adds, "people can get hurt."
