Little is known about the young man whose liver failure death likely pushed the U.S. Food and Drug Administration to crack down on Hydroxycut, a popular diet aid pulled off the market early this month. But the few details available are horrifying.
He was just a 20-year-old guy living in the southwestern United States who decided at some point to pop a pill to lose weight. He went to the emergency room on Jan. 19, 2007, and was given a grim diagnosis: He had such severe liver damage that he became a transplant candidate. Three weeks later he was dead.
The FDA first learned of his death in March, more than two years after the fact. While there are still many unanswered questions about the dangers posed by Hydroxycut's blends of ingredients, the two-year lag time is deeply disturbing and raises the question: Who else and what else doesn't the FDA know about?
The good news is that the FDA has a welcome new tool to help it evaluate supplement safety. It's a new law called the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Since December 2007, it has required supplement manufacturers to document and tell the FDA about so-called "adverse events," health problems reported by doctors and consumers. It's also given the agency authority to inspect the firms' documentation. If Hydroxycut's manufacturer learned of the young man's death in February 2007, it wouldn't have been mandated to tell federal officials. But because it claims to have learned of the death in March 2009, after the act was in effect, it was legally bound to inform the agency.
Why it took so long for this information to reach the FDA is unclear, but the recent Hydroxycut recall shows why timely reporting of this information by manufacturers is crucial for consumer safety and shouldn't be voluntary. This is an industry with many conscientious manufacturers, but still too many fly-by-night firms. Keep in mind that Hydroxycut's founder and original pill formulator has only a high school education.
The FDA needs to wield this new law more effectively than it has, particularly in the wake of the Hydroxycut recall. It needs to take a more proactive role in evaluating the quality of firms' adverse events reporting systems. Some may not be set up to collect this data from consumers or have the medical expertise on staff to analyze it for troubling trends, allowing critical information to slip through the cracks. And while the FDA is chronically understaffed, the agency could make smarter use of its available resources by targeting the records of firms whose products contain ingredients suspected of causing problems.
Right now, the FDA should concentrate on companies whose products contain one or more of the three Hydroxycut ingredients that a medical journal article said are "likely implicated in liver toxicity": chromium, green tea root extract (Camellia Sinensis) and garcinia cambogia, a botanical extract sometimes marketed as Super CitriMax. Consumers may want to check labels and consult with their doctors. The FDA still hasn't said which of Hydroxycut's ingredients are linked to liver problems, but a thorough review of the manufacters' records, and cooperation with these firms to identify commonalities, could help answer that question sooner.
