May 1, 2009 – The U.S. Food and Drug Administration today issued a consumer warning regarding the use of one of the most popular diet and weight–loss supplements sold in the United States. The product has been associated with numerous incidences of liver injury and one death:
Quote from the FDA release:
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.
The product manufacturer/marketer is in the process of issuing a recall for this, and many similar products sold under the same brand name.
The scientific literature also contains case reports of liver toxicity associated with the use of the above-mentioned dietary supplement:
(Report begins on page 477 of the document)
Quotes from the above report:
Patient 1, a 27–year–old man, presented with 8 days of fatigue and jaundice. He had been taking Hydroxycut for 5 weeks, 3 tablets 3 times per day.
Patient 2, a 30–year–old man, presented with 10 days of jaundice, fever, vomiting, and fatigue. For 5 days, between the 16th and 11th days before presentation, he had been taking 9 tablets of Hydroxycut per day.
In the April 2009 edition of the Integrated Supplements Newsletter, we discussed the danger of liver toxicity associated with the use of potent herbal extracts currently being included in dietary supplements – including the above–mentioned product. Isoflavones from soy, polyphenols from green tea, and many other plant chemicals currently being promoted as “antioxidants,” are often found in highly concentrated amounts in dietary supplements. Broadly, these chemicals can be classified as phytoestrogens, or, plant chemicals which are similar to estrogen in structure and in many biological functions.
As hormonally active chemicals, these herbal extracts often place a far more significant burden on the liver than many people realize. The liver is called upon to detoxify food–based and herbal hormones such as these, and the doses often found in supplements appear to sometimes damage liver function significantly.
As a company dedicated to producing only safe and effective dietary supplements, we at Integrated Supplements have gone on record warning against the use of many common products sold as dietary supplements, including potent phytoestrogenic herbal extracts.
We’ve also warned against the use of other common supplement staples such as:
• Whey Protein Concentrate
• Soy Protein
• Caseinate Powders
• Nitric Oxide “Boosters”
• Concentrated Fish Oils (in the doses often recommended)
• Flaxseeds and Flax Oil
Although the diet product mentioned above is one of the most recognizable products in the nutritional supplement industry, its formula is not unique. Scores of similar products line the shelves at supplement stores, drugstores, and supermarkets throughout the country. As supplement use becomes more mainstream, the number of adverse events related to dietary supplement usage is sure to increase, unless we find a way to create educated and impassioned dietary supplement consumers.
Those of us who value our access to dietary supplements will be well served to take the above warning seriously. In the United States, we currently have the freedom to choose a nearly countless array of nutritional substances. But a corollary of the freedom to choose is the responsibility of educating ourselves – and of honestly assessing the risks involved in consuming any given product.
We implore supplement users, retailers, medical professionals, and public health authorities to examine the research–backed articles on our website, www.IntegratedSupplements.com. As a result of shoddy manufacturing practices, inferior raw material selection, and overall biological ignorance with regard to product formulation, many nutritional supplements now possess a greater risk profile than ever before. Similarly, with the advent of increasingly potent herbal extracts (many of which are often combined haphazardly in single formulations), supplement use has strayed ever–so–slowly away from its roots in nutrition, and towards the realm of wanton and inadvertent self–medication.
In the midst of a nutritional landscape marred by short–range thinking, dietary supplements should rightfully offer us the ability to compensate for an increasingly nutritionally–degraded food supply. But far too often, in actual practice, dietary supplements merely serve to create more health problems than they solve.
This is a trend we at Integrated Supplements are intent on combating head–on.
We’ll have more research coming your way soon.




