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Hydroxycut Recall: best-selling weight loss gimmick takes a fall

Friday, May 08, 2009 Posted by Peter Janiszewski, PhD

Last week, the US Food and Drug Administration (FDA) released a consumer warning regarding the dangers of Hydroxycut use, urging all consumers to stop using the products immediately. The FDA’s warning motivated the subsequent recall of all Hydroroxycut products sold in the US and Canada by the manufacturer.

Hydroxycut is a top selling over the counter weight loss supplement in North America, with approximately 1 million items sold every year in the US alone. Open any health and fitness magazine, like the one I just purchased (Maximum Fitness) and there is a good chance the very first page you see is an ad for some version of Hydroxycut (see picture below advertising Hydroxycut Hardcore). Prior to the recent recall, the Hydroxycut television ad campaign was no less pervasive, and whole sections of drug store shelves were crammed with various concoctions of the same product. Their advertising was so successful that I even found a bottle of Hydroxycut at my parent’s house during a recent visit – rest assured, I discussed the potential dangers of such products with my folks, and removed it from their medicine cabinet.

Thankfully, as instigated by the FDA warnings, the recent recall has resulted in empty sections of drug store shelves where the Hydroxycut products once were (as I noticed at the local Shoppers Drug Mart). I can only imagine how much shelf space has just become available at supplement stores like GNC.

Our Canadian readers may be interested to know that Hydroxycut products are produced by Iovate Health Sciences Inc. of Oakville, Ontario.

Hydroxycut products are nutritional supplements marketed as fat burners, appetite suppressants, energy enhancers – all with the purpose of producing weight loss. Since the first appearance of Hydroxycut products, there have been numerous changes in the composition of ingredients. Initially, Hydroxycut consisted of a blend of ephedrine and caffeine along with other random, and largely useless ingredients. The combination of caffeine and ephedrine is known to result in a significant stimulatory effect – alertness, thermogenesis, elevations in heart rate, etc. – changes which would transiently increase energy expenditure, and may result in some weight loss.

Unfortunately, the same stimulatory effect can result in anxiety, sleep disturbance, GI problems, and most notably death due to cardiovascular complications. Subsequent to numerous reports of health risk associated with using ephedrine, this ingredient was banned from use in all supplements. Thus, in 2004 Hydroxycut was reformulated without one of its key ingredients.

Since then, even caffeine free versions of Hydroxycut have been produced. In other words, the same ingredients that might be expected to have some effects on energy metabolism , appetite, and weight loss (caffeine and ephedrine) have progressively been removed from the concoction, leading one to wonder how the product might work at all in these diluted versions. In the end, since the withdrawal of the products from the market, a discussion of whether any evidence for the efficacy of the product in producing any of the touted effects exists seems unnecessary (like beating a dead horse).

The FDA warning and the voluntary product recall by Iovate stemmed from a growing number of reports suggesting Hydroxycut use may lead to various health problems, most commonly liver toxicity.

The FDA website states the following:

“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.”

Indeed, a recent letter to the editor at the World Journal of Gastroenterology points to a number of published case reports of liver injury associated with the use of Hydroxycut.

According to a Health Canada spokesperson, 17 adverse reaction reports associated with Hydroxycut products have also been filed north of the border. These adverse reactions involved the cardiovascular, respiratory, gastrointestinal, and neurological systems, although no liver problems have been reported.

While you should not be able to find these products on any store shelf any longer, the FDA’s advisory further recommends that, “consumers who have these products are urged to stop using them.”

To download an MP3 of the FDA media briefing regarding the hazards of Hydroxycut please click here.

Interestingly, despite the pervasive presence on store shelves throughout the country prior to last week, Hydroxycut products have never been officially authorized for sale in Canada. This, of course, did not interfere from the products being sold across the country. You see, with “nutritional supplements,” Health Canada, and from my understanding, the US FDA, do not impose the same rigor with regards to product efficacy or safety as they do with prescription medication. Instead, the product safety of any given supplement is only evaluated after the product is already on the market. Thus, you, the consumer, are the guinea pig. If you and others using a given product complain enough about adverse events, only then will Health Canada or the FDA step in and pull the plug on the company peddling the product – all supplements are thought to be safe until problems occur (innocent until proven guilty). These notions are well addressed in this article.

The FDA website has a great question and answer section regarding the Hydroxycut consumer warning, which you can read here.One of the best questions, which I have heard many times, along with the perfect response is included below:

Question: I thought Hydroxycut contains natural ingredients. Doesn’t that make it safe?
Answer: No. “Natural” ingredients don’t necessarily mean that a product is safe. Many substances that come from nature can be toxic.

In a letter sent to Iovate Health Sciences Inc. (read in full here), the FDA is “advising consumers to consult their health care provider if they are experiencing symptoms possibly associated with this product, particularly nausea, weakness or fatigue, fever, abdominal pain, or any change in skin color."

Responding the FDA letter, in the official product recall announcement by Iovate Health Sciences Inc. (read in full here), the company states that “…out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products.”

The recalled Hydroxycut products include all of 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

For product refunds, consumers are encouraged to return their product directly to the location where it was purchased or they can contact the Iovate Health Science Inc. directly by phone (1-877-468-2835).

So if you’ve recently been thinking about buying some Hydroxycut, thankfully, you no longer have that option – the FDA just saved you some cash, not to mention some serious health complications. If you have already purchased a Hydroxycut product and are currently using it, discontinue and return to the place of purchase.

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Have a great weekend.


Related Posts:

Lobb, A. (2009). Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance World Journal of Gastroenterology, 15 (14) DOI: 10.3748/wjg.15.1786

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We are PhD students in the School of Kinesiology and Health Studies at Queen's University in Kingston, Ontario. Our research focuses on the relationships between obesity, physical activity, and health risk. This blog is our attempt to consider the many "cures" for obesity that we read about on a daily basis. Enjoy.


The opinions expressed here belong only to Peter and Travis and do not reflect the views of any organization. Any medical discussion on this page is intended to be of a general nature only. This page is not designed to give specific medical advice. If you have a medical problem you should consult your own physician for advice specific to your own situation.

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