Getbig Bodybuilding and Supplement News

The following statement was issued today by Iovate regarding the Hydroxycut recall.

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

Dietary Supplements Linked to One Death; Pose Risk of Liver Injury

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
 
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
 
Hydroxycut products are dietary supplements that 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.  The list of products being recalled by Iovate currently includes:

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

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.