New Rules From FDA
Offer Little Supplement-Safety Aid
[This article may as well have a flashing sign at the top that says “Buy Pharmanex!” In our briefings we’ve been saying exactly what it’s saying below. Not only does it give great coverage & credibility to http://www.reiddds.com/techdr/consumerlab/ (which has only Pharmanex products listed as passing their “Athletic Banned Substances Screening” program), but it also mentions U.S. Pharmacopeia, whose USP rating is right on the LifePak box. Our clinical studies on LifePak and subsequent glowing reviews from http://www.reiddds.com/techdr/supplementwatch/ also become paramount after a consumer reads an article like this. And how about these questions: Is a supplement safe? Does it work? Is it backed by scientific study? This is where the scanner enters the equation. Don’t miss my followup comments/questions at the bottom of the article. And definitely don’t miss the last section of the article subtitled “How do I know if I'm buying a reputable brand?” Red highlights are mine. – JC] New Rules From FDA
Offer Little Supplement-Safety Aid
Wall Street Journal - HEALTH JOURNAL By TARA PARKER-POPE March 11, 2003 - After years of sitting on its hands, the Food and Drug Administration last week finally moved to impose some quality control on the dietary-supplement industry. But the truth is, none of it is going to do much to help consumers sort through the marketing hype of the $19 billion industry. The new rules will force supplement makers to deliver the actual ingredients they promise on the label, without contaminants. But they still won't provide the answers to such basic questions as, is a supplement safe? Does it work? Is it backed by scientific study? Will it interfere with prescription medicines or other treatments? For now, the 40% to 60% of the population that takes a vitamin or supplement will still have to get those answers on their own. Health experts say consumers are surprisingly lax in educating themselves about herbal supplements, often turning to the very Web sites that sell the products, making whatever information they find highly suspect. But with a little effort, consumers can find resources for objective and credible answers to their questions: Is it safe? Unlike with drugs, supplement makers don't have to prove a product is safe before putting it on store shelves. A new Web site from Memorial Sloan-Kettering offers consumers a fast, free way to find out about supplement safety. The Web site contains information about 140 products and is updated regularly. Click on the FAQs button to find which products pose a health risk, and you'll quickly get the lowdown on the well-publicized safety concerns posed by the antianxiety supplement kava, which can cause serious liver damage. But you may also be surprised to learn that a cancer therapy derived from aloe vera was linked to several deaths, or that rhubarb and sassafras can cause severe health problems. The site also includes information on whether a supplement can interact with other treatments or prescription drugs -- and many do. The National Institutes of Health's Office of Dietary Supplements also posts recent safety warnings on its Web site, as does the National Center for Complementary and Alternative Medicine. Does it work? Often, the answer is no, but it's worth doing some research to find those few products that really do offer some benefit. Numerous studies, for instance, show that garlic can promote heart health, but the supplement can interfere with some medical treatments. Other trendy new supplements -- such as coral calcium, touted to prevent cancer -- simply aren't backed up by science. "If you look at the scientific data supporting these products, it's pretty sparse in most cases," says Donald Hensrud, associate professor of preventive medicine and nutrition at the Mayo Clinic in Rochester, Minn. "Some supplements have shown benefit, some have done definite harm, and there's a whole lot that don't do a lot of good." BUYER BEWARE Here are some tips to help you choose the best herbal-supplement brands: Buy only single-herb products that show how
much each dose has. Some products are mixtures of several herbs with
inadequate doses of each.
Source: Mayoclinic.com The Sloan-Kettering site gives a detailed listing of the scientific research behind a given supplement. Medline, the database for the National Library of Medicine, offers a way to research the science behind herbal supplements on its Web site: Click on Health Topics and find Herbal Supplements. The site includes a link to www.herbmed.org, which provides a comprehensive look at the scientific data on most herbal supplements. The Office of Dietary Supplements site also contains useful fact sheets containing information about scientific research, but the site, unfortunately, includes less than two dozen products. Finally, the USDA Food and Nutrition Center Web site, offers a "dietary supplements resource list" of books, magazines and Web sites about the science behind supplements. For people who don't want to use the Web, the American Dietetic Association has published "The Health Professional's Guide to Dietary Supplements." The book provides a listing of supplements, a look at marketing claims and a detailed summary of the scientific evidence. How do I know if I'm buying a reputable brand? You don't. Numerous studies show supplements often don't contain the ingredients they promise, and some are adulterated with lead or other contaminants. The independent testing firm ConsumerLab.com, whose work was cited during last week's FDA announcement, has consistently found that a large percentage of products don't contain the promised amount of ingredient or have been contaminated due to poor manufacturing standards. Although the FDA proposal should help the problem, it will be months before it takes effect. Until then, there are ways to improve the odds of finding a reliable supplement. The U.S. Pharmacopeia, a nonprofit, offers a USP seal for products that pass its testing program. Products that passed ConsumerLab's testing may carry the CL seal. For detailed information about brands reviewed by ConsumerLab, consumers must pay a fee of up to $17.95. Experts say the care with which a product is bottled can be important, and consumers should look for bottles that contain safety seals. Also, while manufacturers are required to adhere to the government's food-processing standards, some voluntarily adhere to the higher manufacturing standards imposed on drugs, and the label may reflect that. "The only way to get information is to look on label and see if it talks about quality control in any respect," says Barrie R. Cassileth, chief, integrative medicine service at Memorial-Sloan Kettering. "Anyone can put anything in a bottle and put it on the shelf." Updated March 11, 2003 11:05 a.m. [A couple things to remember:
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