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Greg Webb
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“Herbal Hepatotoxicity”, Dietary Supplements, and the NIH

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In the past two weeks, there has been some negative press about dietary supplements, especially about weight loss supplements. One young woman who wanted to lose weight and used the product, SlimQuick™ – which contains Green tea extract – “suffered marked inflammation of the liver with necrosis suggestive of toxic injury,”[1] according to a paper by Douglas H. Weinstein et al. of the University of Maryland, published online April 27, 2012, in the World Journal of Hepatology, (study of liver and its diseases). Thankfully, the woman improved and survived with corticosteroid therapy. The report sent some shock waves into the dietary supplement industry—and, hopefully, it will make consumers sit up and take notice also.

SlimQuick™ isn’t the first dietary supplement to raise this type of health concern. It is only one in a series, but it raises questions about which ingredient in the product may have caused the toxicity…the green tea? the caffeine?… and who is doing anything about it now? In 2009, the FDA announced a voluntary recall of 14 diet products sold under the brand name, Hydroxycut. At that time, there were also reports of liver damage associated with people having taken the Hydroxycut dietary supplements. The FDA acted after it received 23 reports of serious health issues associated with Hydroxycut products, including a death in 2007 and a consumer who required a liver transplant. [2]

The FDA does not regulate dietary supplements like it regulates conventional medications (e.g., prescription medications).[3] The Dietary Supplement Health and Education Act (DSHEA) of 1994 actually provides for an Office of Dietary Supplements within the National Institutes of Health (NIH). The Act states that the purpose of that Office is “to explore the role of dietary supplements as a significant part of the efforts of the United States to improve health care; and to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other related conditions.”[4] Has the NIH ever generated any research, or explored the role of dietary supplements in causing herbal hepatotoxicity?

In addition, one of the Office’s primary duties, according to the Act, is to serve as the principal advisor to the Secretary [of Health and Human Services] and to the Assistant Secretary for Health with regard to the safety of dietary supplements. While that duty is ranked third in priority, we hope it would still be considered an important priority and that time, attention, and research would be devoted to it. So, just what and how much research is NIH devoting to identify and recommend that “bad” dietary supplements which appear to be dangerous to human health be withdrawn from the marketplace? It continues to confound that the manufacturer is the responsible party for making sure that dietary supplements are safe for consumption (the government does not review a dietary supplement manufacturer’s claims) —whether they are to lose weight, burn fat, grow hair or make you taller—before the products arrive in the marketplace. As my father told me many times, if it seems too good to be true, it probably is not true. There was another one he told me as well: quick fixes rarely stand the test of time. Beware of buying “snake oil”.

[1] SlimQuickTM-associated hepatotoxicity in a woman with alpha-1 antitrypsin heterozygosity”, Weinstein, Douglas H. et al, World Journal of Hepatology, April 27, 2012. http://www.wjgnet.com/1948-5182/pdf/v4/i4/154.pdf

[2] “The Bad News About Products Too Good to Be True”, Tufts University Health & Nutrition Letter, The Friedman School of Nutrition, Science and Policy, September 2009. www.tuftshealthletter.com

[3] Op. Cit.

[4] Dietary Supplement Health and Education Act (DSHEA) of 1994, National Institutes of Health, U.S. Department of Health and Human Services, Washington, D.C., http://ods.od.nih.gov/about/dshea_wording.aspx