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3 Key Findings Explained |
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Highlights & Findings The story begins. A booming industry and its key products. Most surprising findings in brief. How we got into this mess. A quality control nightmare. Herbal folk myths are exposed. Dangerous botanical products. Hormones top the list of risks. Inside the FDA's enforcement program. Still,are they safer than drugs? |
A Fatally Flawed System
--The safety of dietary supplements is not assured. Of more than 20,000 products on the market, only 46 have received even a cursory independent safety review at the FDA. Assuming so-called "natural products" and human hormones are safe is a mistake, experts and FDA officials say. --No quality standards are in place to insure the products don't have dangerous pesticide residues, chemical contaminants, or heavy metals such as lead and mercury. Also, independent tests showed some tablets contained none of the active ingredient; others would not break down in the body, or provided a 50 percent overdose. --Regulating dietary supplements is pitifully low priority at the FDA. The FDA has three times as many people assigned to monitor drugs for pets and farm animals as it does for dietary supplements. Just three people review and investigate adverse reaction reports for dietary supplements, compared to 10 for veterinary drugs and 71 for prescription and over-the-counter drugs. Overall, the meager regulatory presence is a combination of congressionally mandated deregulation combined with a history of neglect at the FDA. --These products need not have any benefit s proven or imagined. Instead, consumers are provided with an official hypocrisy mandated by law. Every bottle has this statement: "This product is not intended to diagnose, treat, cure or prevent any disease." Yet an avalanche of advertising, books and uncritical media reporting has convinced of millions of people otherwise. A recent poll showed more than 1 of 3 Americans thought dietary supplements could help stop cancer, and a majority believed they could help treat arthritis and the common cold. Meanwhile, the FDA is apparently satisfied with the current situation-or afraid to challenge the powerful forces in Congress that curbed the agency's authority over these drug products. For example, FDA Commissioner Jane Henney recently told a Congressional hearing on dietary supplements, "The FDA is committed to developing a positive relationship with industry." The FDA has "the necessary legal authority to protect the public health," she said. An industry spokesman was also positive. "Dietary supplements have an excellent safety record compared to virtually any food category," said Annette Dickinson, vice president for scientific and regulatory affairs for the Council for Responsible Nutrition. "The core products of the industry provide a marvelous opportunity to do so much good for so many people." However, Dickinson said the FDA needed to strengthen enforcement within existing law, in particular to enact a system to insure better quality control. The law is also popular among advocacy groups for alternative medicine. "Our agenda is to ensure that the gains made are both properly implemented and not chipped away," said Susan Haeger, president of Citizens for Health. Her group fights government controls on alternative treatments such as dietary supplements, chellation therapy, and homeopathy. The real issue is not whether these products are useful-or should be available. The question is whether it makes sense to exempt them from safety testing, and strict quality controls--and to leave consumers to sort through a sea of conflicting and often misleading claims about what these drug products will do. One fact is abundantly clear: Never have so many people consumed so many medical products about which we know so little. |
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