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Safe Are Supplements?Take steps to avoid risks from herbs, vitamins, and minerals What's really in that bottle of vitamins or herbs you just bought at the health food store? The answer may surprise you. Recent independent tests on 23 brands of SAM-e, a supplement touted for relieving joint pain and depression, found that only 11 contained the amount of the active ingredient S-adenosylmethionine claimed on the labels. Four brands had zero to 10% of the amount listed. Among samples of a popular herbal cold remedy, Echinacea, found on store shelves in California, some contained no Echinacea at all. Missing ingredients are bad enough, but some supplements contain elements we definitely don't want. For example, small amounts of lead have been found in some calcium supplements. Herbs and botanicals pose the greatest problem. They're often harvested by collectors in different countries, who are paid to bring back a volume of product. They may not know what they're picking; closely related species may be mixed in, containing botanical and other contaminants. Some companies may not be able to test for these," warns Mary Charlson, M.D., director of the Center for Complementary and Integrative Medicine at the Weill Cornell Medical Center. Then there's the danger of interactions between supplements and prescription drugs (see page 8). For instance, the herb gingko taken by many older people for its purported memory-boosting effects-has blood-thinning properties, and may intensify the effects of other anti-coagulants, including aspirin. Unlike drug manufacturers, supplement makers aren't required to test their products, or provide safety information (but many do). So who's watching out for you? Supplements are big business. In a national survey last year, about 40% of Americans said they had taken at least one vitamin or mineral supplement in the previous month. According to the federal Centers for Disease Control and Prevention, consumers are spending more than $1.7 billion a year on vitamin and mineral supplements. Estimates run as high as $3.8 billion for herbs, although herb sales have slowed as consumers question their efficacy and safety, say industry analysts. Thanks to regulations set by the Food and Drug Administration (FDA), American consumers expect to find aspirin in a bottle marked "Aspirin." But vitamins, minerals, herbs, and other supplements-some of which may have drug-like effects but are not classified as drugs are not subject to the same rules as over-the-counter or prescription drugs (manufacturers mounted an intense lobbying effort against such rules). The Dietary Supplement Health and Education Act (DSHEA) of 1994 made manufacturers responsible for ensuring the safety of their own products. But manufacturers don't need FDA approval before producing or selling dietary supplements. "Unfortunately, DSHEA has no provision for quality assurance," remarks Varro Tyler, PhD., ScD., Dean Emeritus of the Purdue University School of Pharmacy and Pharmaceutical Science.
"This has become a tragic episode in the herbal field today, because we have products ranging from excellent products that are clinically tested to those that are absolute junk. And the consumer has no assurance that what is on the label is in the package." Under current FDA rules, supplement labels only must state the quantity of specific nutrients in vitamin or mineral products, the plant part used in herbal products, and a suggested "serving size" (dietary supplements are actually categorized as food.) While supplement labels can't make health claims, advertisements and health store brochures often do, touting anecdotes from "customers" and alleged "scientific" studies. Since 1999, the Federal Trade Commission (FTC) has taken 23 actions against supplement manufacturers for misleading ads. "The most common problem is a lack of sound science to back up claims about safety or health benefits of a particular product [in ads]," says Michelle Rusk, an FTC staff attorney Whom can you trust? When it comes to vitamins and minerals, manufacturers can opt to have their products tested to qualify for approval by the US Pharmacopeia (USP). Products that meet USP standards for quality, strength, purity, packaging and labeling will say so right on the label. The USP is also launching a new, voluntary pilot program to assess quality of dietary supplement ingredients, including herbals. The program includes checks for compliance with pharmaceutical Good Manufacturing Practices (GMP), random testing of products, and post-marketing surveillance by the USP. (All companies are required to follow general GMPs; pharmaceutical GMPs are stricter.) Starting late in 2001, products meeting all criteria will get a USP certification mark (which companies will pay for). Other testing programs include the National Nutritional Foods Association (NNFA) TruLabel Program. All 500 members of the organization agree to a Code of Ethics; the NNFA randomly tests their products (purchased in retail stores); and members may also pay for an independent inspection of their plant. NSF International, a nonprofit public health and safety organization, also has a certification seal. The certification program offers testing, GMP surveillance and ongoing monitoring, says the NSF's Kathy Pompliano. Paid for by manufacturers, the product-specific tests will usually be done by independent labs at NSF's Ann Arbor, Michigan, headquarters. The program will test for contaminants and verify labeled ingredients. The FDA will be working through 2002 with the Institute of Medicine to develop a review process for the safety of dietary supplements. How to avoid problems Look for major brands. Without rules requiring standardization of active ingredients and guarantees against impurities, many experts advise sticking with national brands, such as Nature Made, Centrum, Sundown, and General Nutrition Corporation (GNC), or generics sold by major drugstore chains like CVS. With major manufacturers' brands you'll have more assurance of quality control-that contents will not vary from bottle to bottle. Check the expiration date; many supplements and herbs lose potency over time (especially in hot and humid weather). Check for additives, preservatives and dyes; they can cause allergic reactions. Look for products that meet USP standards. The label may say "Calcium Citrate Tablets, USP" (for example), or state that the product "Conforms to USP <209 1 > for weight. Meets USP <2040> for disintegration" (or specify the amount of time it takes for a supplement to dissolve). You may not see the letters USP on every product; some labels display the initials "NF" for National Formulary, or USP-NF to show that they adhere to the USP standards. Other products carry a GMP seal. Before you buy herbals, check out a product with a reliable source, such as the American Botanical Council (www.herbalgram.org) or www.NaturalDataBase.com, advises Dr. Tyler. Be especially alert for potential interactions with medications you may be taking (see chart, page 8). Make certain the herb is properly identified with both its common name and botanical or chemical name (eg: St. John's wort, Hypericum perforatum). Herbal preparations vary (for example, dried extract in capsules or a liquid tincture) along with the way they're taken. Potency will also vary, so note whether a product contains a "standardized dose" and specifies how much to take, advises Dr. Tyler. Be cautious in health food stores. Don't believe all the claims being made for herbs and other supplements. Do a little research on your own to see which supplements have been studied scientifically. Good starting places include web sites maintained by the FDA (www.fda.gov) and the National Institutes of Health Office of Dietary Supplements site (http://dietarysupplernents.info.nih.gov), Stay away from web sites that are pushing supplements or other products. The good news is that consumers are demanding more information about supplements, observes Shawn Talbott, PhD, an assistant professor of nutrition at the University of Utah and a consultant to SupplementWatch.com. He summarizes the new attitude as: "'before I put that pill in my body, I want you, the manufacturer, to show me that it works and what it does."' Carol Milano WHERE TO FIND SUPPLEMENT TEST RESULTS: NSF International posts daily listings at www.nsf.org, adding a product as soon as it's certified. Click on Certified Products, then Dietary Supplements. Their toll-free number for consumers-800-NSF-MARK-offers help in finding certified products. You won't learn about those that failed the test, however, for legal reasons. The National Nutritional Foods Association is now posting results of its tests on its website, www.nnfa.org. From the Home Page, click on TruLabel results. Consumerlab.com, a private testing/publishing firm, chooses a category to review and tests 15 to 20 products within it through a network of independent labs. Recent reviews feature echinacea, St. Johns wort, MSM and valerian. "Each test requires different labs; we use over a dozen established independent labs," notes Tod Cooperman, M.D., president. The free portion of www.consumerlab.com gives a category's general results and examples of products that passed the tests. Subscribers ($15.95/year) see a list of every product that passed. (Failures are not listed for legal reasons.) SupplementWatch.com takes no money from manufacturers and sells no products. "Most of our information comes from thousands of peer-reviewed journals, and from some analytical testing," says Dr. Talbott. Visitors can ask about a specific product's safety and effectiveness. Special bonus for readers of the "Food & Fitness Advisor:" a free one-month trial. Call (801) 572-1905 to request it. FDA WARNING LIST The U.S. Food and Drug Administration recently issued alerts on these supplements:
OTHER SUPPLEMENTS TO AVOID:
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