Hydroxycut® Recall Underscores the Dangers of Unregulated Diet Pills & Supplements
The Recall
On May 1, 2009, the Food & Drug Administration warned dieters and body builders to immediately stop using Hydroxycut, a widely sold supplement linked to cases of serious liver damage and at least one death. In a special health alert the FDA said Iovate Health Sciences , the distributor of the dietary supplement has, agreed to immediately recall a total of 14 products distributed under the Hydroxycut brand.
Sold in grocery stores and pharmacies without the need for a doctor’s prescription, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, according to the FDA. Dr. Linda Katz of the FDA’s Food and Nutrition Division reportedly said that the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March. According to FDA, other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver.
US Military Doctor Told Iraq Troops to Discard Hydroxycut in 2006
Adverse reactions by two soldiers in Iraq who took the weight-loss supplement Hydroxycut caused a military doctor to “strongly discourage” use of the product. http://www.stripes.com/article.asp?section=104&article=34766&archive=true In 2006, a 20-year-old soldier was reportedly brought to the emergency department by friends. The soldier had collapsed lost consciousness and lost bladder control. On arrival, the soldier was confused and did not recall the event, according to a Feb. 9 letter from Col. Frederick C. Good, an emergency physician at Ramadi with the 228th Support Battalion.
Also, a 19-year-old soldier came in with complaints of palpitations and chest pain. The soldier was found to be experiencing an abnormal heart rhythm, which could have led to a fatal rhythm, the letter read.
“Hydroxycut … should not be used in a combat zone with the inherent problems encountered in regard to hydrating adequately and eating regularly,” according to a letter from Col. Good. The letter noted that the use of Hydroxycut “is strongly discouraged, and any remaining product should be discarded. This product and any similar products are not a shortcut to fitness, and no substitute for a regular Physical Training program.”
Supplements Largely Unregulated
Prescription drugs are highly regulated by the Food & Drug Administration. Before such products can be marketed in the United States, manufacturers must convince FDA scientists that they are both reasonably safe and that they actually work as intendedFDA will not accept just any type of proof. Prescription drug manufacturers must submit controlled studies which examine the effects of proposed new drugs on animal and human subjects in comparison to subjects given a placebo (sugar pill). These so-called “double-blinded placebo controlled” studies are the only valid way it can be scientifically demonstrated that a health-related product actually works. Not so in the case of most dietary supplements.
Unfortunately, Americans are largely unaware of the way in which most dietary supplements are developed and regulated. Most people readily assume that these products are subject to the same testing and regulations that govern over-the-counter drugs. Nothing could be further from the truth. Instead, the recent proliferation of
these products has occurred not because they have been scientifically proven safe or effective, but because a federal law implemented in 1994 largely eliminated FDA oversight of dietary supplements.
More important, unlike prescription drugs, the manufacturers of diet supplements such as Hydroxycut are not required to report adverse reactions they are made aware of by doctors and consumers. According to FDA’s Dr. Katz, evidence of the dangers inherent in the use of Hydroxycut was difficult to isolate by regulators because the cases of liver damage were rare and the FDA has no authority to review supplements before they are marketed. “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” Katz reportedly noted.
The Dietary Supplement Health and Education Act
In 1994, the powerful diet supplement and vitamin industries lobbies successfully convinced Congress to pass the Dietary Supplement Health and Education Act (DSHEA). This cleverly but deceptively-named statute significantly reduced FDA oversight of supplement products. The law allowed supplement manufacturers to market their products without having to submit evidence that they work or that they are safe. FDA can take action against a manufacturer when the Agency discovers that a supplement on the market poses “a significant or unreasonable risk of injury.” Unfortunately, this usually doesn’t occur until some number of consumers have been injured or killed, as was the case with ephedra-containing diet pills in the 1990’s, and now, apparently, as is the case with Hydroxycut.
DSHEA does prohibit supplement manufacturers from making unsubstantiated advertising claims that their products are effective in the treatment or prevention of specific diseases or medical conditions. However, a huge loophole in the statute allows supplement companies to make so-called “structure and function claims” without FDA approval as long as the product label carries the language: “This statement has not been evaluated by the FDA.” This means while a company cannot legally claim that a supplement cures a specific illness, it can, for example, nevertheless advertise that the product “helps support a healthy immune system.” Unfortunately, consumers are often misled by such advertising claims, and reasonably assume that supplements are “safe” can treat or cure any number of medical conditions.
Do I Have a Hydroxycut Lawsuit?
Moore Labriola, LLP is currently accepting new Hydroxycut induced side effect claims. If you or a loved one have used any Hydroxycut products and subsequently developed a serious side effect, including liver injury or liver damage we urge you to contact us immediately. You may be entitled to compensation for your injuries and we can help.


