Federal drug regulators warned consumers to stop using the popular Hydroxycut line of weight-loss products, citing reports of a death due to liver failure and other instances of serious health problems.
In all, the Food and Drug Administration said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said.
The Hydroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the F.D.A.
That company, Iovate Health Sciences of Oakville, Ontario, and its American distributor are voluntarily recalling 14 of the products. Two other products, Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall.
Unlike drugs, whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products.
According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale.
The agency has been on a campaign to identify and warn consumers about tainted weight-loss pills that illegally contain prescription drug ingredients. Since December, the F.D.A. has issued a list of 70 brands that contained hidden and potential hazardous drugs including an antiseizure medication.
The F.D.A. said that a new law that requires manufacturers to notify the agency of any reports of serious health problems helped officials identify a pattern of adverse events linked to Hydroxycut users. In addition, the agency cited reports in medical journals of serious liver disease being diagnosed in six people who had taken Hydroxycut.
The agency said the consumers were healthy before using Hydroxycut and took the recommended dose. Because the formula for Hydroxycut has changed over time and because the product contains different amounts of a proprietary blend of ingredients, the agency said it had not yet determined which of the product’s ingredients might constitute a health hazard.
Vitamin Shoppe and GNC said they were removing Hydroxycut products from their Web sites and stores. Several months ago, the companies stopped selling another well-known weight-loss brand, StarCaps, that was found to contain a powerful prescription diuretic.
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