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On top of that, questionable health claims made by some less-than-reputable companies serve to raise concerns--from consumers as well as industry officials and government regulators. As more products made of more new ingredients and formulas find their way to store shelves, consumers who rely on supplements need to learn about the products they're taking. Oregon's Wild Harvest is a good example of a company that cares. When the company started in 1990, it purchased all of its stock from secondary growers and suppliers. But in 1994, quality concerns led the company to start producing its own ingredients. Now, Oregon's Wild Harvest grows 85 percent of its own herbs and purchases only from other farmers who abide by strict production rules. "We can't completely rely on suppliers," said Pam Martin, who owns the company with her husband, Randy. "A lot of raw materials come from Third World countries. When they come in powdered form, it's tough to identify exactly what's in there." Various manufacturers' and consumer groups have reported finding pesticides, herbicides, heavy metals and other contaminants in imported products. One men's virility supplement was found to be spiked with the drug Viagra; another product claiming to be a "natural steroid" was laced with pharmaceutical steroids. independent testing Leaders in the supplement industry take the notion of product safety and purity seriously. During the past decade, supplement makers have worked cooperatively to develop standards known as Good Manufacturing Practices (GMPs), which control how products are made and tested (see sidebar). This year, for the first time, supplement companies will also be able to obtain manufacturing quality and standards certification from private auditing organizations that specialize in foods and pharmaceuticals. But even though the certification process brings more credibility to the industry, it doesn't guarantee total product integrity. Tod Cooperman, MD, began his interest in supplements in the mid-'90s. When he couldn't find an independent evaluation service, he decided to start one of his own. In 1999, Cooperman founded ; ever since, the company has been a boon to consumers and a thorn in the side of some manufacturers. Cooperman hired a former US Food and Drug Administration (FDA) chemist to test the quality and amount of ingredients present in different supplement products. Consumerlab also tests the pills and capsules themselves to make sure they break down properly to allow absorption by the body. Products for testing are picked at random from store shelves. Test results are neither complimentary to the industry nor encouraging for consumers. "What we've found is that, across the board, a quarter of the products we test cannot pass," Cooperman says. Products that fail are found to contain too little or too much of the ingredients promised or are contaminated. Here's a sampling of popular supplement products that flunked basic integrity tests: * Valerian, 47 percent failure rate; * Ginseng, 59 percent; * Echinacea, 44 percent; * Saw palmetto, 37 percent; * St. John's wort, 33 percent. If those results aren't bad enough, consider this about nutrition bars: Sixty percent of those tested did not contain the amount of nutrients claimed. Other products fared better, though the results can't exactly be considered stellar: * Vitamin and mineral products, 15 percent failure rate; * Specialized supplements such as creatine and fish oils, 21 percent failure rate; * Protein powders, 8 percent failure rate. "This is definitely alarming. If it was five percent that failed, that would be much more understandable," Cooperman says. also examines product claims. By studying generally available scientific and pharmacological information, testers determine if supplement ingredients could deliver the results stated. "We bend over backward to make sure we're being fair," Cooperman says. "We do blind tests, and if a product doesn't pass, we send it to a second independent lab for more tests. Our science is well regarded in the industry." The company's information is also well regarded by consumers. Some 20,000 people pay $ a year to subscribe to its Web site, making Consumerlab one of the few dot-coms that can use black ink in its ledger. To avoid the potential threat of lawsuits, posts only the names of products that have passed its tests. And now, supplement makers who initially greeted the testing outfit with scorn are paying the company to test their products. More independent testing can only help the industry, Cooperman says. "There was such a rush to supplements in the '90s because of the appeal of the claims that were made to consumers. Then people realized that many of the products weren't doing what the labels said. That's why the industry has gone through a real downturn." A problem for many manufacturers, Cooperman says, is that they make dozens of products, and testing all of them can be expensive--something that's difficult in a highly competitive business. Unlike pharmaceutical companies, supplement makers can't claim exclusive--and profitable--patent rights on vitamins, herbs or special formulations of natural products. The publicity surrounding GMPs and other certifications helps the industry, Cooperman believes, but even GMPs can't offer consumers complete assurance. The raw materials manufacturers buy from numerous suppliers are cause for concern, as well--Cooperman's not convinced all such materials are tested for contaminants and assayed for quality. Says Cooperman: "A company can use good GMPs to make a bad product." supply & demand Industry officials point out that most manufacturers pay close attention to what suppliers deliver. For leading companies, analyzing and testing raw materials is a critical part of the manufacturing process. Diamond-Herpanacine, based near Philadelphia, uses a contract manufacturer to make skin care products that are blends of vitamins, herbs, minerals and antioxidants. The company receives a certificate of analysis on every batch of raw materials used in its products. "We interviewed a lot of companies before we picked a manufacturer for our products," says Lesli Diamond, CEO of Diamond-Herpanacine. "The facility we use is FDA-approved. I'm on the phone with them constantly, and they're always available to answer questions." To promote quality assurance, the National Nutritional Foods Association (NNFA), one of the most prestigious trade associations in the supplement industry, operates the TruLabel Program. Any supplement maker who is a member must put ingredient labels on all products, and the labels must be registered with the NNFA. The organization maintains a database of 23,000 labels, which allows it to track ingredients if problems are reported. As a further check, the NNFA routinely buys its members' products and submits them for testing to third-party independent laboratories. If the ingredients don't match what the label says, the companies are notified and required to fix the problem. If they fail to do so, they lose their NNFA membership. Ingredient testing, however, can pose significant challenges because there are so many products in so many different forms. While generally accepted standards to determine the content of vitamin or mineral tablets have been around for years, that's not the case for all herbs or specialized supplements. If content can't be accurately proven, safety is a concern, and that worries Phil Harvey, chief science officer and director of quality assurance for the NNFA. "There's definitely a need in the industry for a collaborative effort to develop validated test methods. For some products, testing is still an art. For some of these products, there's no gold standard where everyone gets the same measure," Harvey says. Some companies and organizations are working to develop valid test methods, but the sheer number of ingredients makes the task daunting. A special program started last year by NNFA should help with this issue. The association has set up a GMP third-party certification program in conjunction with the National Sanitation Foundation (NSF), a testing and standards development organization that has evaluated products and manufacturing processes since 1944. NSF's work in the food area is recognized by the FDA, the World Health Organization and Health Canada. NSF inspectors conduct rigorous audits of supplement manufacturers' ingredients, facilities and manufacturing processes. Those that pass are allowed to display the NSF certification mark on their products; they're also required to submit to semiannual plant audits. "We test to make sure the consumer gets what he or she pays for," says Kathy Pampliano, manager of new business development for the Ann Arbor, Michigan-based organization. "If a company isn't in compliance, we don't allow them to use the NSF mark." The NSF certification mark will start showing up on supplement product labels this year. Another testing and standards organization, United States Pharmacopoeia (USP), also started offering a GMP certification program to supplement makers last year. USP, which caters to large manufacturers, has provided standards and testing services for the pharmaceutical industry for more than 100 years. consumer benefits For consumers, the growing emphasis on quality control is good news. And it's likely that supplement makers will start doing more to inform consumers about product quality in the future. Retailers, too, after getting burned by bad products and the accompanying negative publicity, are paying more attention to consumer concerns. Tom Sokoloff owns two retail stores in Florida--Paradise Health and Nutrition--and is on the board of the NNFA. When buying products to stock his shelves, he seeks out established companies that have solid histories and reputations for quality. He also prefers to work with manufacturers who are members of the NNFA. "I view myself as a gatekeeper, and I personally scrutinize every product I carry," he says. "Our consumers have developed a trust in their local health food stores. When questions arise, I want to assure them that they're buying quality goods." If you have any concerns about the supplements you buy, your favorite natural products retailer should be able to answer your questions. If anyone asks Kemper Isley, owner of 15 Vitamin Cottage stores in Colorado, for instance, they'll learn that he routinely takes products from his shelves and sends them to independent labs for testing. He says most come back with positive scores. Isley's advice to consumers is basic: "Shop in a reputable health food store and you'll be assured of getting high-quality products." RELATED ARTICLE: What are GMPs? In 1995, the National Nutritional Foods Association (NNFA) began working with manufacturers, suppliers and government officials to establish a set of Good Manufacturing Processes (GMPs) for the supplement industry. NNFA members adopted the standards in 1999, and manufacturers wishing to belong to the prestigious trade group must comply with these guidelines. The rules are under review by the US Food and Drug Administration (FDA), and will carry regulatory authority when adopted. FDA approval is expected sometime this year. Essentially a testing and audit trail, GMPs establish procedures and standards for every step of the supplement-manufacturing process. Twinlab, a major manufacturer based in New Jersey, makes extensive use of the NNFA guidelines, and strict quality controls govern the company's manufacturing process to ensure its end products match master formula recipes. Twinlab is typical of leading companies in the industry, says Phil Harvey, chief science officer and director of quality assurance for the NNFA. "Manufacturers know they have to do these things," Harvey says. "We're also seeing more pressure for GMPs from retailers because they're hearing the concerns of their customers." RELATED ARTICLE: Consumer tips. It's easy to feel overwhelmed when walking through the supplements aisle of your natural products store. Hundreds of items beg for your attention, all making claims that they'll provide the tonic for a better life. So what's a consumer to do? Here's what nutritionists and supplement experts say. * First, understand that responsibility for the efficacy and safety of supplement products lies squarely with the manufacturer. The US Food and Drug Administration (FDA) has rules that govern the supplement industry, but it doesn't test products. The FDA only steps in when problems arise. So buy products from companies you trust. * Manufacturers aren't allowed to make specific health claims in advertising or on packaging. But clever copywriters know how to get around that rule in subtle ways. Load up on a healthy supply of skepticism before reading promotional claims. Outrageous claims can be reported to the Federal Trade Commission--but don't expect a quick response from the government agency. * The basis for good health is a sound diet and exercise. Pills, powders, caplets, tablets, tinctures, oils and herb formulas can aid good health, but only if they're supplemental to a good diet. * If you're looking for a specific result or want help with a specific problem, resist the urge to self diagnose. Talk to a naturopath, a nutritionist or your healthcare practitioner, any of whom should be able to provide sound advice backed up by solid information. * Read, read, read. Plenty of books and Web sites are dedicated to nutrition and supplements. Here's a short list: --Vitamins, Minerals, Herbs and Supplements: The Complete Guide, by H. Winter Griffith. --Physician's Desk Reference for Nutritional Supplements, published by Medical Economics/Thompson Health Care. --The Botanical Safety Handbook, published by the American Herbal Products Association and available on the association's Web site at /. --The ABC Clinical Guide to Herbs, being published by the American Botanical Council in September, available at . --The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines, published by Commission E of the German government. : The Web site publishes results of independent tests of supplement products. --The Council on Responsible Nutrition, . CRN published a book in June 2002, Benefits of Nutritional Supplements, which summarizes and explains significant research. The book is available via the Web site. --The National Nutritional Foods Association, , is the major trade association in the natural products industry. It also publishes consumer information. A monthly pamphlet on nutrition topics is available on its Web site under the publications link. --The FDA Center for Food Safety and Applied Nutrition, .gov/~dms/. --National Center for Complementary and Alternative Medicine--an office of the National Institutes of Health, .gov. --Office of Dietary Supplements--an office of the National Institutes of Health, .. --Dietary Supplement Education Alliance, .
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