Articles Posted in Hydroxycut

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U.S. Court of Appeals for the 9th Circuit has reversed a district court’s dismissal of an action alleging consumer claims against MusclePharm Corp., a manufacturer of nutritional supplements, for making false or misleading statements about the protein in one of its products. The case was sent back to the trial court for further proceedings.

The district court dismissed the action as preempted by the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. ¶¶ 301-399(i), reasoning that any declarations of protein content anywhere on a product label could not be false or misleading if the listed amount of protein reflected measurements made in accordance with federal regulations concerning the federally mandated nutrition panel. The court of appeals held that, as relevant here, the FDCA and its implementing regulations concerned only the calculation and the disclosure of protein amounts. Specifically, the panel held that the FDCA preempted the state-law misbranding theory premised on the supplement’s use of nitrogen-spiking agents to inflate the measurement of protein for the nutrition panel.

The court of appeals held that the FDCA did not, however, preempt a state-law misbranding state-law theory premised on the label’s allegedly false or misleading implication that the supplement’s protein came entirely from two specifically named, genuine protein sources.

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Since this May, when the U.S. Food and Drug Administration (FDA) reported that Hydroxycut product users could suffer from adverse liver disease, numerous lawsuits have been filed around the country, including several in the Chicago area.

On May 1, 2009, the FDA announced that it had been made aware of 23 reports of adverse liver effects that occurred in the course of normal Hydroxycut usage. The reports included injuries that ranged from general liver damage, the need for a liver transplant, and to death. At that time the FDA warned consumers to immediately cease using Hydroxycut products.

Signs and symptoms of liver damage from Hydroxycut usage can include fatigue, malaise/ tiredness, loss of appetite, nausea, jaundice, blurry vision, abdominal itching, abdominal pain, and/or dark colored urine. Hydroxycut has also been known to cause drug-induced hepatitis and liver failure.

In response to the FDA’s warning, Iovate, the owner and distributor of Hydroxycut products, agreed to recall its remaining product from store shelves. Hydroxycut was generally sold throughout the United States and Illinois at stores such as Wal-Mart, Walgreens, and CVS Pharmacy, among others.

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Increased reports of medical problems associated with certain nutritional supplements has prompted The Food and Drug Administration (FDA) to issue a public health advisory on body building supplements. These supplements may contain steroids or steroid-like substances and may be associated with kidney failure and liver failure in men.

While the FDA has not specified exactly how many products fall into this category, it advised that consumers not to purchase and use products labeled with words such as “anabolic” or “tren” or phrases like “blocks estrogen” and “minimizes gyno”. In addition, the FDA cautions consumers to be wary of body-building products claiming to enhance or diminish the effects of hormones like testosterone, estrogen or progestin.

Of those products that the FDA did specifically name, those included MASS Xtreme, TREN-Xtreme, ESTRO Xtreme, HMG Xtreme, AH-89-Xtreme, MMA-3 Xtreme, TT-40-Xtreme, and VNS-9 Xtreme, all of which contained hidden and potentially dangerous steroids. The FDA has taken action in the form of sending a warning letter to these drugs’ manufacturer, Americell-Labs, stating that the company should produce products that are in compliance with federal regulations.

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The U.S. Food and Drug Administration (FDA) advised consumers that products sold under the Hydroxycut branded name could cause liver and heart problems. The FDA Hydroxycut advisory stated that “although liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risks.” The results were that its products were recalled.

Chicago and Illinois residents have reported symptoms of adverse affects from taking Hydroxycut, which range from stomach and abdominal pain, excessive fatigue, recurring headaches, excessive weakness, vomiting, loss of appetite, to kidney failure and liver damage severe enough to require a liver transplant.

Hydroxycut products are dietary supplements that were marketed for weight loss as fat burners, energy-enhancers, low carbohydrate diet aides, and for water loss. The brand names are marketed by Iovate Health Sciences, Inc., Iovate Health Sciences USA, Inc., Muscle Tech, among other brand names.

The FDA has asked that healthcare professionals and consumers report any serious adverse or side effects from the taking of these products.

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The Food and Drug Administration (FDA) has reported that it has received 23 reports of adverse health effects in persons who have used the weight-loss product, Hydroxycut. Reported complications from using Hydroxycut include heart problems and a kind of muscle damage that could lead to kidney failure. One person suffering from severe side effects of Hydroxycut even required a liver transplant.

On May 1, 2009 the FDA issued a warning to consumers to stop using Hydroxycut. According to the FDA warning the manufacturer, Iovate Health Scientists of Oakville, Ontario, Canada and its American distributor, are recalling Hydroxycut. All in all, lovate is recalling 14 of its product line. This recall will not affect its products Hydroxycut Cleanse and Hoodia, which have different ingredients than the other products.

The Hydroxycut brand has been widely sold at national stores including Vitamin Shoppe and GNC. The product is sold in a form of pills, drinks and powders which is designed to increase energy, burn calories and fat, and control appetite. According to the FDA about nine millions units of the product were sold in 2008. Vitamin Shoppe and GNC reportedly are removing Hydroxycut products from their websites and stores.

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