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Good Morning All, This item ran in the NYT in Jan. 2002 but is good reading now with the coQ10 stuff... cheers ...... murray * * * The New York Times - January 2, 2002, Wednesday EATING WELL; It's on the Label, But in the Tablet? By Marian Burros THE dietary supplement industry has always been the Wild West of health, unregulated and risky. There has been no way to know whether a bottle contained what the label said it did and no way to know whether the supplement was effective. Now, in the absence of government oversight, several private companies are getting into the business of analysis and certification. While some critics of the supplement industry are pleased to see any effort at all, others shake their heads in dismay, certain that consumers will be more confused than enlightened. Unlike prescription and over-the-counter drugs, for which the Food and Drug Administration has stringent regulations, there is barely any government oversight of the safety and efficacy of vitamins, minerals and herbal and nonherbal supplements. Not even the venerable USP seal from United States Pharmacopeia, the organization that sets standards for vitamins and minerals recognized by the government, means that products have been certified by an independent source. Compliance to the standards is voluntary, and the use of the USP seal is infrequently monitored. Only the manufacturer knows if the label information accurately reflects the actual contents and their strength. The three companies that will certify supplements -- United States Pharmacopeia, ConsumerLab.com and NSF International -- will test to see if the contents and potency listed on the label of a product are accurate. But these tests will not provide the answers the public really needs: Are these products safe and effective? What's more, none will reveal which supplements failed tests, and there are many unsettled issues about consistent testing methods. Such partial certification may have unintended consequences, leading consumers to believe that a seal on the label of a supplement is also proof that it is safe and that it works. Even the certifiers acknowledge the problem. ''In terms of efficacy, I'm sure there are going to be consumers who will not look carefully at verbiage around the seal and aren't going to look at the Web site and may perhaps interpret the seal as covering more than it actually does,'' said Ray Jaglowski, the vice president for business development at NSF, a nonprofit organization in Michigan known for its certification of drinking water. Certification of supplements is a new endeavor for NSF. ''We are doing the best we can to provide accurate information,'' he said, ''but we recognize it's not going to be 100 percent.'' Bonnie Liebman, the director of nutrition for the Center for Science in the Public Interest, said such programs have more pluses than minuses. ''Clearly some people may mistakenly believe that this stamp of approval guarantees safety and effectiveness,'' she said. ''But it is still better to have the testing than have consumers buy these products blind, because we know there are some products that give you less than what they claim.'' According to ConsumerLab.com, of the 20 top-selling dietary supplements -- 500 products in all -- it has evaluated, 15 percent of vitamins and minerals and 40 percent of herbals failed their tests, principally because they contained less of the active ingredient than the label claimed. A few had too much of certain vitamins, and some failed because they contained pesticides or heavy metals, such as lead in calcium. The company would not reveal the brand names of the supplements tested, only the general category: calcium, coenzyme Q10, creatine, echinacea, ginkgo biloba, ginseng, glucosamine, chondroitin, iron, MSM, multivitamins, omega-3 fatty acids, SAMe, saw palmetto, St. John's wort, valerian, isoflavones like soy and red clover, and C, E and B vitamins. The push to certify has its roots in the 1994 Dietary Supplement Health and Education Act, essentially treating supplements like food, which does not require premarket approval. The law effectively barred the F.D.A. from regulating supplements the way it regulates drugs. Problems with safety and questions about efficacy have contributed to a decline in supplement sales that began in 1998 and has not let up. ''Consumers are interested and concerned about the quality of products they are hearing negative things about, and some type of seal would be helpful,'' said J. B. Cordaro, president of the Council for Responsible Nutrition, a trade association for dietary supplement manufacturers. United States Pharmacopeia is joining ConsumerLab.com and NSF in offering certification for a fee, which troubles Jeff Asher, technical director of Consumer Reports. ''I think money changing hands makes it impossible to be unbiased,'' he said. Fees at ConsumerLab range from $2,000 to $7,000. At NSF, fees range from $5,000 to $75,000. United States Pharmacopeia refused to reveal its fees. Consumer Reports and the Good Housekeeping Institute are the only organizations that undertake the more costly testing for safety and efficacy. But they have investigated only a small fraction of the supplements on the market. Consumer Reports take no money. Good Housekeeping offers its seal only to those who agree to purchase an advertisement in its magazine. Unlike NSF and United States Pharmacopeia, ConsumerLab.com, a for- profit business, chooses the products it wants to test and buys the supplements off the shelves. If a product passes the test, it may appear on the approved list on the company's Web site, http://www.consumerlab.com . Companies are not charged for this, but can ask to be included for a fee. Web site subscribers are entitled to a more comprehensive list of supplements for an annual fee of $15.95. Supplements that failed the test are not revealed. United States Pharmacopeia and NSF do not disclose the names of supplements that failed tests, either. ''Originally we did include those that did not pass,'' said Dr. Tod Cooperman, president of ConsumerLab, ''but we got so bombarded by lawyers we could not do anything else and had to stop.'' Products that appear on its Web site list are tested every three years, but products that carry the company's seal, for which a fee must be paid, are retested every year. The company does not test supplements which are known to be hazardous, like comfrey. In addition to testing for the principal ingredients, the company also tests for the presence of heavy metals and pesticides. NSF, which began its program in July, is hired by manufacturers to test supplements provided by the company. It has already tested a few products and expects to certify between 25 and 50 shortly after the first of the year. Working with the companies, NSF evaluates the formula for the supplement and the conditions under which it is manufactured. Accredited products will be audited once or twice a year. Like ConsumerLab, it will not evaluate a supplement known to be hazardous. Unlike ConsumerLab, it does not test for the amount of time it takes a supplement to dissolve and disintegrate, important considerations that determine whether the consumer will actually get the full benefit of a mineral like calcium. United States Pharmacopeia is the best known of the three certifiers, setting standards recognized by the Food and Drug Administration for 180 years. Some vitamins and minerals carry the letters USP on their labels, indicating they meet those standards. What many consumers don't realize, though, is that the use of the USP letters is based on self-certification. Neither United States Pharmacopeia nor the F.D.A. tests the products to see if they are in compliance. Now United States Pharmacopeia is going into the certification business. It plans to launch a program similar to the one at NSF. There are some differences: United States Pharmacopeia, for example, will test mineral supplements for dissolution and disintegration. The question that comes immediately to mind is how consumers will be able to distinguish the differences between the USP now on labels and the certification mark that will begin to appear sometime next year. Dr. Forouz Ertl, vice president for United States Pharmacopeia's dietary verification program, said the USP certification mark will be quite different from the letters now in use. ''There will be a very elaborate campaign to educate people about what the USP mark will mean,'' Dr. Ertl said. Despite the caveats, Mr. Asher of Consumer Reports says third-party certification is a step in the right direction. ''If there is a seal from a reputable organization, on balance it's a good thing because purity and potency would be known even if people think it covers more.'' But he likened it to the Underwriters Laboratory's UL seal on the electric cords attached to appliances. Most people assume the seal is a mark of quality assurance for the entire appliance, when actually it applies only to the cord. On the Web: The United States Pharmacopeial Convention http://www.usp.org/ http://www.usp-dsvp.org/home.htm NSF International http://www.nsf.org/ ConsumerLab http://www.consumerlab.com SOURCE: The New York Times - January 2, 2002 http://query.nytimes.com/search/article- page.html?res=9C01E0D81430F931A35752C0A9649C8B63 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn