WASHINGTON, May 1 — The maker of Hydroxycut supplements, a line of diet aids that sold more than 9 million units last year, has recalled 14 products after reports of severe liver damage, including the death of a 19-year-old man and at least one transplant, the FDA said today.

The agency said the supplement makers — Iovate Health Sciences USA of Blasdell, N.Y., and Iovate Health Sciences of Oakville, Ontario, in Canada — are voluntarily recalling products suspected of hepatotoxicity.

Linda Katz, M.D., M.P.H., interim chief medical officer, at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), told news media that the agency had received 23 reports of serious health problems, ranging from asymptomatic elevated liver enzymes to liver failure and death.

The death occurred in 2007, but the FDA only learned of it in March 2009. Dr. Katz said the delay was not unusual because supplement manufacturers are subject to voluntary rather than mandatory reporting requirements.

Unlike drug manufacturers, who are strictly regulated, the makers of diet supplements are not required to provide precise ingredient formulae to the FDA — a longstanding issue for regulators seeking to identify the toxicity of specific ingredients.

Supplement makers only provide the FDA with “propriety blend” information, said Vasilios Frankos, Ph.D., director of the FDA’s Division of Dietary Supplement Programs.

So at this point, the FDA does not know if the toxicity was caused by a single ingredient or a mix of ingredients.

Dr. Katz said, however, that the toxic reaction does not appear to be a dose response, nor does it appear related to “long- versus short-term use.”

The recalled products, which are marketed under both Iovate and MuscleTech brands are:

• Hydroxycut Regular Rapid Release Caplets
• ?Hydroxycut Caffeine-Free Rapid Release Caplets ?
• Hydroxycut Hardcore Liquid Caplets ?
• Hydroxycut Max Liquid Caplets
• ?Hydroxycut Regular Drink Packets ?
• Hydroxycut Caffeine-Free Drink Packets ?
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• ?Hydroxycut Max Drink Packets
• ?Hydroxycut Liquid Shots
• ?Hydroxycut Hardcore RTDs (Ready-to-Drink)
• ?Hydroxycut Max Aqua Shed
• ?Hydroxycut 24 ?
• Hydroxycut Carb Control
• ?Hydroxycut Natural

Two other products marketed under the Iovate or MuscleTech brands, Hydroxycut Cleanse and Hoodia, are not affected by the recall.

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