As you know, Iovate is strongly committed to product safety. In keeping with that mission, Iovate welcomes balanced regulation for the dietary supplement industry, and we feel that these regulations are in the best interest of our customers and our industry.
Millions of consumers purchase Hydroxycut products each year. Iovate carefully considers the ingredients in each of its dietary supplement formulations to make sure that they are safe. Each ingredient in each formulation is investigated for safety by reviewing all of the available medical, scientific, and toxicological information that is publicly available. Iovate works closely with nutritional scientists and other scientists, both within and outside of the company, to develop its products. A world-renowned, independent third-party expert toxicological firm reviews all formulas Iovate launches for safety, before launch. Iovate does not release any product containing any ingredient that it has not evaluated for safety. In addition, once an Iovate product is made available to consumers, Iovate continues to monitor the safety of the product by collecting information on potential adverse experiences with the product.
Iovate initiated a voluntary recall when it became aware that the U.S. Food and Drug Administration’s analysis of 23 reports over the last seven years about consumers having experienced liver-related problems was different than the analysis done by Iovate’s independent, third-party toxicological experts and epidemiologists.
On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.” In 2008, for instance, more than 9 million units of Hydroxycut-branded products were sold, while the FDA only referred to three reports potentially associating the products with liver toxicity.
Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. For instance, the number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the seven years referenced by the FDA. These numbers must be contrasted with the background rate of 1 in 100,000 for hepatitis/liver injury in the general population. Kaplowitz N. 2005, Idiosyncratic Drug Hepatotoxicity, Nature Review Drug Discovery, June 4 (6); 489-99. Moreover, Dr. David Graham of the FDA reviewed data from four epidemiology studies and estimated that the rate of idiopathic (i.e., unexplained) acute liver failure is approximately one per million per year. Graham, D., American Journal of Gastroenterology 2003; 98: 175-179. However, out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products in the United States. Please note that Hydroxycut Hoodia and Cleanse products are not included in this recall; nor are any other Iovate products. We are working with the FDA in this recall process. We will be in contact with you very shortly to effectuate this recall.
This voluntary Class 2 recall applies to the following:
- 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
As you have already heard, the new evolution in the Hydroxycut brand, Hydroxycut Advanced, will be shipping in the near future. You should have received a Hydroxycut Advanced information deck by now, but if you haven’t, please contact your Iovate authorized broker or your Iovate Sales Team member as it is critical that your orders are in place soon. We expect initial demand might exceed our ability to supply the new formulations, at least in the beginning.
Over the last ten years, the Hydroxycut brand has been the top selling weight loss supplement brand in the U.S. During this time, we have continuously reformulated our product offerings. Our new formula, Hydroxycut Advanced, while also based on science, is a completely new and revolutionary formulation.
We thank you for your continued support and we look forward to working closely with you.
Sincerely,
Iovate Health Sciences
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