May 1 (Bloomberg) -- U.S. regulators warned consumers against using Hydroxycut dietary supplements, saying 23 people reported serious liver injuries and one died.

Iovate Health Sciences Inc., a closely held Canadian company, has agreed to recall 14 of its Hydroxycut products because of the liver risks, according to a notice posted today on the Food and Drug Administration’s Web site.

The recalled products were marketed for weight loss, as fat burners and energy enhancers as well as low-carbohydrate diet aids, with more than 9 million units sold in 2008, said Vasilios Frankos, director of the FDA’s division of dietary supplement programs. A 2007 law requiring companies to report adverse events led the agency, which can’t demand a recall, to ask Iovate to pull the products off shelves, said Linda Katz, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

“We looked at the totality of the evidence in the medical literature and had discussions with our hepatologist, now is the time we felt we could go to the company and request a mandatory recall,” Katz said today.

Iovate, based in Oakville, Ontario, didn’t return calls for comment.

Consumers who suffered adverse reactions to the product reported seizures, liver damage requiring transplants, cardiovascular disorders, abdominal pain, vomiting and excessive fatigue, the FDA said in its statement. The death linked to Iovate products was of a 19-year-old male who lived in the southwest U.S., Katz said. He died in 2007 though the company wasn’t required at the time to report adverse events to the FDA. The agency learned about the death this year, she said.

Katz said that Iovate products initially contained Ephedra, a weight-loss aid that was linked to heart problems and strokes and banned in 2006. Iovate stopped using Ephedra in 2004 and “continually reformulated” its products after that, Katz said.

The agency said it hadn’t isolated the specific ingredients causing damage to consumers. Two of the company’s products remain on the market, as they don’t contain the suspected ingredients.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Nicole Gaouette in Washington at ngaouette@bloomberg.net;

Last Updated: May 1, 2009 13:45 EDT