This bizarre operation was summed up in a recent federal court ruling allowing a class-action suit against the company to proceed. The case stems from the FDA's decision to remove Hydroxycut from the market in 2009, after it received 23 reports of liver damage from the drug and at least one death.
The case seeks money back for anyone who bought Hydroxycut, in addition to damages for the people who suffered liver damage. The defendants include retailers who continue to sell Hydroxycut such as Walmart, Walgreens, CVS and GNC.
Although Iovate had marketed Hydroxycut as "clinically proven" to help consumers "lose weight fast," "without any unwanted side effects," and that the products are "backed by science," there was no clinical proof of Hydroxycut's safety or efficacy. The ruling notes that in one study commissioned by Iovate, subjects using Hydroxycut lost less weight than the placebo group.
Iovate's former director of research told Canada's National Post that the product was garbage:
It still lacks regulation by the FDA and Health Canada and the bottom line is the majority of products they put on their shelves don't have pure clinical research to support them ... They use over-exaggerated claims -- Muscletech [Iovate's former name] does it and so does everybody else -- to sell their products.... Unfortunately, it's a lot of B.S.Hydroxycut used to contain ephedra until it was banned by the FDA for triggering heart attacks and at least one death specifically linked to Hydroxycut. Iovate replaced that active ingredient with garcinia cambogia, a fruit native to Asia and Africa and used by very poor people to make meals more filling. It has never been proven to help with weight loss, according to the ruling.
Now the company makes the same dubious claims for its new product, that it's "clinically proven" in "clinical trials" to help with weight loss. Iovate describes two trials on its site that it claims favored Hydroxcut, but in neither case does it give the number of subjects in the trial or the journal in which the results were published. In other words, the results probably don't withstand scrutiny.
Hydroxycut's active ingredient is now caffeine mixed with a bunch of herbs. It's literally a cup of tea in a pill. Yet the company makes the same claims for the "caffeine free" version of its product.
The reason Iovate can get away with all this and not be shut down by the feds can be found in the legal disclaimer at the bottom of Hydroxycut's web page:
These statements have not been evaluated by the Food and Drug Administration.That means they're not reliable. It's also a signal that the company is seeking cover under the Dietary Supplement Health and Education Act of 1994, which specifically removes FDA authority over diet supplements, unless they kill people.