Dietary Supplements Can Cause Liver Damage (cont.)
But that's not all! Numerous instances have been reported in the medical literature of dietary supplements, especially herbal products, causing liver damage. These supplements include kava (which has received much recent coverage in the press), Jin Bu Huan, germander, chaparral, shark cartilage, and mistletoe, to name a few. Dietary supplements can cause liver injury in a number of different ways. In some instances, for example with kava, liver injury is dose-related. That is, the higher the dose, the more often liver damage occurs. In many instances, however, liver injury is an unpredictable peculiarity in an individual (an idiosyncratic reaction).
It is well known that people often take combinations of herbal and/or other dietary supplements. In this circumstance, if a person develops severe liver injury, identifying which supplement is the specific culprit is very difficult. What's more, as the dietary supplement market becomes more competitive, the manufacturers of supplements are mixing and matching their products and doing so in proportions that have never before been tried. A case in point is the above-mentioned Lipokinetix, which contains among its ingredients an ephedrine-like stimulant, a type of thyroid hormone, and the tea extract.
The main problem is that the Food and Drug Administration (FDA) does not regulate the manufacturing process for dietary supplements, as it does for conventional drugs. You see, the FDA cannot consider a dietary supplement to be a food or a drug. Thus, the purity of dietary supplements is determined and reported to the public by the manufacturer only. Moreover, the dosage of these supplements is determined by the manufacturer and is often without scientific support or data that is published in peer reviewed scientific journals. Furthermore, the FDA requires no pre-marketing animal or clinical testing of dietary supplements, as it does for conventional drugs. Additionally, physicians report adverse events only voluntarily when they happen to encounter them.
Therefore, as long as the manufacturer does not make an outrageous claim about their product, and does not market the product as a food or a drug, these supplements end up on the store shelves without much, if any, scrutiny by the FDA. It turns out that designating a health product as a dietary supplement is a loophole created by the 1994 Dietary Supplements Health and Education Act. (The term "dietary supplement" implies an addition to the diet of something that is already present in the food we eat.) This loophole enables the producers of dietary supplements to avoid FDA regulation of the manufacturing of these products. Well, this situation regarding the rather loose regulation of dietary supplements makes me nervous. I am concerned, especially when considering that conventional drugs (medications) are subjected to a fairly rigorous review process.