According to FDA estimates there are roughly 55,000 dietary supplements sold in the United States yet only 0.3 percent of those drugs have been studied to assess potential side effects. Reportedly, seventy percent (70%) of the dietary supplement companies are not following quality control standards. In December 2013, I wrote about OxyElite Pro, a weight loss supplement that has been linked to liver damage. We are seeing a continuing trend of dangerous dietary supplements leading to liver injuries. Today, dietary supplements account for nearly 20 percent of drug-related liver injuries that show up in hospitals, up from 7 percent a decade ago, according to an analysis by a national network of liver specialists, as reported in the New York Times.
The most recent research found that many of the products implicated in liver injuries were bodybuilding supplements spiked with unlisted steroids, and herbal pills and powders promising to increase energy, build muscle, and help consumers lose weight. Those most likely to show up at the doctor or hospital with liver damage were young men taking supplements as part of a bodybuilding or fitness regime. More alarming is the rising trend among middle-aged women. Researchers studied “85 patients with liver injuries linked to herbal pills and powders. Two-thirds were middle-aged women, on average 48 years old, who often used the supplements to lose weight or increase energy. Nearly a dozen of those patients required liver transplants, and three died.” (New York Times, 12/21/13)
One of the products linked to liver damage is green tea extract. Green tea is often touted as good for increasing metabolism and being a ‘fat burner’. If one cup of tea is good for you, the reasoning goes that green tea extract works even better. But the amount of extract in these pills is not regulated. Catechin, the potent antioxidant found in green tea, can be quite dangerous when taken in larger does, leading to toxicity of the liver.
According to Dr. Victor Navarro, the chairman of the hepatology division at Einstein Healthcare Network in Philadelphia, liver injuries attributed to herbal supplements tend to be more severe and result in the need for liver transplants. They often contain ingredients not listed on the label, some of which may be harmless while others, like steroids, can be harmful to one’s health.
The FDA has no authority to regulate the supplement manufacturers before the product is marketed, which leaves the consumer to pick and choose without the benefits of scientific research or regulation to weed out the dangerous products. By the time the FDA is notified and issues a warning about a specific dangerous supplement the damage likely has been done. It’s what happened with OxyElite Pro and Jack3d, both dietary supplements linked to severe injury and in some cases, death.
“Americans spend an estimated $32 billion on dietary supplements every year, attracted by unproven claims that various pills and powders will help them lose weight, build muscle and fight off everything from colds to chronic illnesses. About half of Americans use dietary supplements, and most of them take more than one product at a time.” (New York Times, 12/21/13)
We should know by now that there is no miracle weight loss product. There is no magic pill, and claiming herbal or ‘all natural’ ingredients is no guarantee that a dietary supplement is safe. Federal regulation during the manufacturing process of supplement industry is necessary, because the status quo is such that the supplement industry is a little like the Wild West. (Incidentally, one of the primary checks and balances on that industry is the American tort system – civil lawsuits.) The consumer should understand that the dietary supplement market is mostly unsupervised and unregulated – unless one trusts self-monitoring. What I mean by this is that, during the critical design, development and/or manufacturing phase, “a firm is responsible for determining that the dietary supplements in manufactures are safe and that any representations of claims made about them are substantiated by adequate evidence to show that they are not false or misleading.” The FDA can step in after marketing, perhaps after it is too late, to take action against the manufacturer. Without a rule maker and enforcer – like the FDA, during the critical development and manufacturing phase – the tension between profits and safety becomes increasingly highlighted. Until then, the old Latin term caveat emptor seems to be the rule.