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> September 25, 1998: Hour One: Dietary Supplements
| When you go to the health food store, what's in all those pill bottles? Are they drugs? Not exactly. Though they can affect your health, for either good or ill, they're classified as "dietary supplements," and are regulated more like foods than like drugs. Supplements are big business - consumers spent over $6.5 billion on them in 1996, according to one study. But are they safe?
| Supplement safety and efficacy has been in the news lately. Last week, the New England Journal of Medicine published several articles about health risks from different dietary supplements. Some of the supplements were contaminated, while others were pure but had unexpected effects on patients. In North Carolina this week, a government-sponsored conference met to discuss the state of research into the safety and efficacy of medicinal herbs, a large part of the supplement industry.
Almost any product intended as a supplement to the diet, including vitamins, herbs, amino acids, and concentrates or extracts of those products, falls under a 1994 law called the Dietary Supplement Health and Education Act, which created a special niche for supplements in the U.S.. While pharmaceutical companies must prove to the FDA that new products are safe and effective before they are brought to market, supplement manufacturers must only provide information that supports their conclusion that new ingredients may be reasonably expected to be safe. The FDA must show that a product on the market is unsafe before it can take steps to restrict use of the product.
Supplements cannot claim to treat any specific disease. Only drugs may do that. However, supplement manufacturers can make "structure/fuction" claims, which allege that the product affects the structure or function of part of the body. "Treats arthritis" or "cures cancer" are illegal claims under DSHEA, while claims like "promotes prostate health" or "improves brain function" are permitted.
Just how safe and effective are dietary supplements? Should they be more closely regulated? We'll talk about it, on this hour of Science Friday.
Guests: John Cardellina Director of Botanical Science and Regulatory Affairs Council for Responsible Nutrition Washington, DC
Barrie Cassileth Adjunct Professor of Medicine University of North Carolina Author "The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies" Truro, MA
Bernadette Marriott Director Office of Dietary Supplements National Institutes of Health Bethesda, MD
Books/Articles Discussed:
"The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies" by Barrie R. Cassileth. W.W. Norton, 1998.
Related Links: NIH Office of Dietary Supplements Council for Responsible Nutrition - industry group FDA Guide to Dietary Supplements FDA Summary of the Dietary Supplement Health and Education Act of 1994 New England Journal of Medicine editorial - critical of supplement industry CRN Response to NEJM Editorial
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