What You Should Know About Drugs vs. Herbs
(Page 2 of 5)
December 2006/January 2007
By Lynn Keiley & Stephanie Bloyd
Regulation of Dietary Supplements
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Alternatively, herbal supplements are regulated as foods in the United States, rather than drugs, under the 1994 Dietary Supplement and Health Education Act (DSHEA). Supplement manufacturers are responsible for ensuring their products are safe before marketing them, but the manufacturers generally aren’t required to register their products with the FDA, unless the ingredients are new to the U.S. market. The law allows supplement manufacturers to claim their products help “maintain the structure or function of the body” without FDA preapproval or regulation, but they must include an FDA disclaimer and notify the FDA within 30 days of marketing the product. By law, manufacturers may print health claims on the packaging to describe a supplement’s “effect on reducing the risk of or preventing disease” only if the FDA approves use of the claim. The FDA is also responsible for taking action against supplements after they reach the market and problems are reported.
Once a problematic herb appears on the market, it can take years before it’s pulled off the shelves, since the burden of proof lies on the FDA to determine that it’s unsafe. For years, the agency received reports of people suffering heart attacks, strokes and seizures after using the popular weight-loss herb ephedra, and several people died. It wasn’t until the death of Baltimore Orioles pitcher Steve Belcher, who used ephedra, that there was enough of a spotlight on the herb’s safety to spur the FDA into action. “Consumers are provided with more information about the composition and nutritional value of a loaf of bread than about the ingredients and potential hazards of botanical medicines,” according to Donald M. Marcus, M.D., and Arthur P. Grollman, M.D., authors of a recent article in The New England Journal of Medicine.
And yet, consumers are somewhat justified in their comfort with botanicals and other supplements. Far fewer people suffer adverse reactions to herbs than to pharmaceutical drugs. There’s currently no mandatory adverse event reporting system for supplements or nonprescription drugs, so monitoring the number of harmful effects is challenging. However, a study published in The Lancet found that there were only a few hundred calls in one year to U.S. poison control centers involving probable adverse events of dietary supplements. In contrast, another study published in the Journal of the American Medical Association, found that there were more than 200,000 adverse reactions to pharmaceutical drugs reported by hospitals in one year, and half of the reactions were fatal. Although these results were hotly debated in the medical community, a recent report in the United Kingdom also found that nearly a quarter of a million people there were admitted to hospitals in a single year because of adverse drug reactions.
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