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 Now may well be the time for the Act to be modified or rescinded.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:
- Supplements such as ephedra, St. Johns wort, saw palmetto, ginseng, guarana extract and many of the products covered by the DSHEA are drugs, regardless of their regulatory status. These products affect the way the body works in the same way that prescription drugs do. Doesn't it make sense to use the same set of rules and regulations governing prescription drugs to approve the marketing of dietary supplements? Ephedrine (the active ingredient in ephedra) is regulated as a drug. Why shouldn't ephedra have been as well? And if ephedra should have be regulated, why not all of these products?
- Have you ever wondered about the wording used in the claims made for dietary supplements? Unlike all other drugs, the manufacturers of these products don't have to show that there is evidence that their products actually work. Manufacturers are required to put this warning on their labels: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." If the product is not intended to treat, cure or prevent any disease, what is it to be used for?
- If supplements actually worked (and many do not, according to scientific studies), they must have risks as well as benefits. No medicinal product is without side effects. No drug is entirely safe even if taken as directed. Yet, supplement manufacturers don't have to show that their products, which they call supplements instead of drugs, are safe or effective. Unlike the drugs regulated by the FDA, it is up to the regulators to show the product is unsafe. That may not sound bad, except for the fact that, unlike producers of drugs, the manufacturers of supplements don't have to tell the FDA about problems they discover with their products.
- The FDA tightly regulates the manufacturing of all drugs except those covered by the DSHEA. The FDA sets strict manufacturing requirements for all drugs that receive or hope to receive approval for sale. This is not required for products covered by the DSHEA. As things stand, supplement manufacturers have virtually free rein to market anything they wish.
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.