The Dietary Supplement and Health Education Act of 1994 (DSHEA) was intended to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products, including dietary supplements, remain available to those who want to use them. The assumption behind the Act is that there may be a “positive relationship between sound dietary practice and good health.”
In my view, the dietary industry has gone well beyond any reasonable definition of dietary practice in the promotion of products. I don't think many Americans have a diet that includes St. Johns wort, ginseng, guarana, saw palmetto, blue-green algae, bee pollen or horny goat weed. The reality is that dietary supplements have not lived up to the promise of the DSHEA. There is no evidence to support this well intended but, in my view, misguided legislation. Now may well be the time for the Act to be modified or rescinded.
Although ephedra has finally been removed from the market by the U.S. Food and Drug Administration, it is not the only supplement that you should be concerned about. Here are the reasons why I believe the DSHEA is a bad piece of legislation:
It took the FDA over seven years to obtain sufficient evidence to allow the removal of ephedra-containing products from the shelves. During those seven years, the FDA received 16,000 reports of injuries, 62,000 consumer complaints, and at least 155 deaths related to ephedra-containing products.
So, the next time you are thinking about purchasing a dietary supplement, remember that you are not very well protected. Consumers are at the mercy of the manufacturers and marketers of these products. Many manufacturers can be trusted, but some cannot. At the moment there is no way to tell one from another.
Harold J. DeMonaco, M.S. is senior clinical associate in the Decision Support and Quality Management Unit at the Massachusetts General Hospital and is currently a Visiting Scholar at the MIT Sloan School of Management. He is author of over 20 publications in the pharmacy and medical literature and routinely reviews manuscript submissions for eight medical journals.