Hydroxycut Recall a Sign of Wanting Regulation

Washington, DCThe voluntary recall of Hydroxycut supplements last month points to more than a problem with Hydroxycut diet supplements. There appears to be a far larger issue with regard to the regulatory process involved for dietary supplements, a process which—were it more rigid and thorough—might prevent things like Hydroxycut liver damage.

At least two Canadian distributors of Hydroxycut participated in the voluntary recall last month: Iovate Health Sciences Inc., which is based on the Canadian west coast, and supplement juggernaut MuscleTech based on Oakville, near Toronto. Iovate is identified as the manufacturer of Hydroxycut. The recall was triggered after the US Food and Drug Administration (FDA) linked the weight-loss and workout supplement to 23 cases of liver damage, including the death of a 19-year-old boy.

On its web site, Iovate references the recall and notes that the identified Hydroxycut products are no longer available from Iovate in the US and "SVNCanada has immediately ceased sales of these products until further notice." The disclaimer appears in red text on the Iovate home page.

For its part, MuscleTech links to a website that carries a disclaimer, together with an educational piece about the Hydroxycut recall whenever anyone clicks on any of the hydroxycut buttons on the firm's website. MuscleTech, too is no longer vending the product at this time.

Critics of Hydroxycut, while applauding the voluntary recall, point to a much larger problem concerning the regulatory environment under which dietary and food supplements currently exist.

According to an exhaustive investigative report in a recent edition of Sports Illustrated, FDA scrutiny was once required of the dietary supplement industry. Supplements such as concentrated milk, egg and soy powders were once considered with equal scrutiny to that of any type of food or drug, all of which must carry the FDA seal of approval.

That all changed for dietary supplements in 1994 with the passage of the Dietary Supplement Health and Education Act by Congress. The new Act allowed supplements broadly defined as vitamins, minerals, herbs, amino acids and various other products that do not contain approved pharmaceutical drugs and are not meant to treat diseases—to be sold with no requirement for proof of effectiveness or safety and without requirement of approval of the FDA.

That legislative change is said to have created the modern supplement industry, as we know it. Various franchises have appeared, and a host of manufacturers churn out dozens of new formulas and either sell directly to stores and under their own retail banners, or manufacture to order for handfuls of independents.

Almost anyone can open a storefront and arrange to have the manufacturing of product outsourced to contract manufacturers that will delver product under an independent retailers custom label.

Among the 23 FDA reports on Hydroxycut were adverse liver effects including jaundice, liver damage and liver transplant. One person—a 19-year-old—died of liver damage. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms of liver disease might include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, or loss of appetite.

The FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis and cardiovascular disorders ranging in severity from palpitations to a heart attack.

Hydroxycut products 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. Unlike with prescription medicines, FDA does not test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety.

As an aside, a 2007 study of supplements by Informed-Choice, a screening company, found that 25 percent of the 58 supplement samples it tested contained steroids or stimulants banned by the World Anti-Doping Agency.

Not that all supplements contained banned, or harmful substances. Indeed, some dietary supplements are good for you and are rigorously tested via proven scientific methods before they are brought to market.

However an unregulated industry allows for the possibility that similar recalls to that which has befallen Hydroxycut supplements could happen again. Hydroxycut diet supplements and the possibility of associated Hydroxycut liver damage suggest not just a problem with the supplement, but also of the regulatory environment that allowed Hydroxycut onto the market in the first place. A qualified Hydroxycut lawyer would drive that point home, especially for clients harmed by Hydroxycut.