The news spread like wildfire of the voluntary recall by Iovate of Hydroxycut due to reported cases of serious illness, death, or liver failure . The confusing part for consumers is that Iovate voluntarily recalled a number of their products and that the FDA did not institute a ban as they did with Ephedra in 2004. Many questions have been asked and unanswered. Why did Iovate voluntarily recall Hydroxycut and several other of its other products? They are all viable questions with no definitive answers.
In December, 2007, the new final rule on good manufacturing process (CGMP) began to roll out for larger companies and will completely roll out over the dietary supplement industry at the end of 2010. Part of the new rule for the FDA is now tracking through MedWatch serious injury, illness and death associated with dietary supplement products in attempts to relate safety and efficacy of dietary supplement products with 150 million Americans who use dietary supplements.
According to the Nutrition Business Journal, “the dietary supplement industry is growing and total sales were about $23.7 billion in 2007. Top selling supplements in 2007 included multivitamins, sports nutrition powders and formulas and calcium. In addition, one of the areas of greatest growth and supplements within the United States in 2007 was among weight loss products. Projections through 2011 show that growth in the industry is expected to continue.” According to the January 2009 GAO report “since mandatory reporting went into effect, FDA has received 596 mandatory reports of adverse events including cardiac, respiratory, gastrointestinal disorders as of October 21, 2008. Among other results, these events included nine deaths, 64 life-threatening illnesses and 234 patient hospitalizations.” In spite of adverse report events skyrocketing, the FDA and the GAO have admitted that the reporting as one of the areas of concern and limitations in the Agency’s ability to remove products from the market.
As with the herbal supplement Kava, which contained warnings as to liver failure, the FDA never banned Kava.
Although reports of liver failure were a small number, they still account for 10% of drug-induced liver failure in the United States. It must have come on someone’s radar because shortly thereafter liability insurance carriers began excluding Kava, along with other supplements such as Ephedra under liability insurance policies Some large chain supplement stores voluntarily took some of these products off their shelves due to insurability issues, as well as consumer confidence. One thing is for sure is that the actions are late and voluntary.
Ironically, a lot of the products that we are seeing now that are being voluntarily recalled by their manufacturers have had a dark history. A lot of the weight loss supplements contained the prior FDA-banned ingredient Ephedra and reformulated. Hydroxycut was one of them. The current formulation of Hydroxycut includes no banned substances. The FDA Health Hazard Evaluation Board acknowledged in its report “it does not know what ingredients of Hydroxycut are responsible for producing liver toxicity. In addition, there is sufficient information to determine whether there is a dose response effect between Hydroxycut ingestion and liver disease and whether its effects are cumulative over time.” The Board concluded, “three lines of evidence derived from multiple disparate sources suggested is very likely that exposure to Hydroxycut can cause idiosyncratic hepatoxicity.” The study published by Nature Review’s Drug Discovery, May 2005, “Idiosyncractic hepatoxicities are currently the main cause for Food and Drug Administration mandated warnings, restrictions of use or even withdrawals of drugs from the market.” Although the intentions of the Obama Administration is to clean up the supplement industry, skepticism among consumers should remain high and due diligence performed.