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."
FDA approvals thin
With 2 in 3 American adults overweight and 1 in 3 obese, such controversies are likely to continue.
In the last year alone, pharmaceutical companies in the U.S. abandoned two promising drugs -- rimonabant (known commercially as Acomplia) and taranabant -- after regulators raised concerns about their safety and questioned their effectiveness for long-term weight loss. Aside from a wide range of amphetamines, only two drugs on the market have been approved for weight loss by the FDA: Meridia, which increases a user's feeling of fullness, and the over-the-counter fat-blocker orlistat, marketed as Alli.
That dearth of FDA-approved options has been a bonanza for the dietary supplements industry, which is not required by law to provide proof of a product's safety or effectiveness before putting it on the market.
Americans spent $1.67 billion in 2007 on dietary supplements pitched as appetite suppressants, fat burners, satiety aids and meal replacements to help with weight loss, according to the Nutrition Business Journal. Of the hundreds of weight-loss aids on the dietary supplements market, Hydroxycut had established itself among the most visible and bestselling. In 2008, the company sold 19 million units of its various pills and powders.
Regulators said the adverse events that sparked Hydroxycut's recall are "rare, but they exist." In a statement posted to its website, the company sought to cast these reports in a broader context and more favorable light.
Iovate called the adverse events cited by the FDA "a small number . . . relative to the many millions of people who have used Hydroxycut products over the years." A spokeswoman for Iovate, Jamie Moss, stressed that the company voluntarily recalled its products. Iovate may return them to the market after reformulation, she added.
So far, the FDA has not identified which of the many ingredients in Hydroxycut products, or its dosage, may have caused dangerous side effects. Nor has it singled out which patients may be more vulnerable to ill effects from Hydroxycut products. Since many of the ingredients in the Hydroxycut formulations are found widely in other dietary supplements, the culprit -- if there is one -- may still be on the market.
So the search is on for the common thread that links those who have reported a sudden change in health while taking a dietary supplement marketed for weight loss, according to FDA spokeswoman Susan Cruzan. And more patients will probably step forward to blur -- or clarify -- the picture: In the wake of a product warning, the FDA typically sees a rise in adverse-event reports, as doctors and patients make a connection between a product and a subsequent illness or injury.