After receiving 23 reports of serious health problems—indicating a possible link to liver damage—FDA initiated a recall of 14 Hydroxycut products from Iovate Health Sciences Inc., Oakville, Ontario, Canada, in early May. The company agreed to remove products from the market after FDA received reports of health problems that ranged from jaundice to liver damage severe enough to require a transplant. One death due to liver failure has been reported to FDA. Other health problems include seizures, cardiovascular disorders and rhabdomyolysis, a type of muscle damage that can lead to kidney failure. The agency is investigating which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products, which contain a variety of ingredients and herbal extracts. More than 9 million units of the Hydroxycut brand were sold in 2008. These dietary supplements are marketed for weight loss, as fat burners, as energy enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., commended FDA for its actions. “The potential safety problem was discovered by an adverse event reporting (AER) system that gives FDA the ability to monitor for signals or patterns of adverse events that could identify potential safety problems,” he said. “CRN believes FDA took appropriate action to protect consumers, while not drawing speculative conclusions until further investigation is completed.” (More information on the potential impact of this recall on dietary supplement manufacturers can be found in this issue’s “Capitol Comments” column on page 24.)