Death by Dietary Supplement

IN HIS NEW BOOK Dr. Atkins' Age-Defying Diet Revolution, best-selling author Robert Atkins urges readers to take various dietary supplements -- vitamins, herbs, and minerals -- that he says will prevent or alleviate a host of ailments. Most of these concoctions are harmless enough, even if their purported health benefits are unproven. But he is imprudent in encouraging the use of ginkgo biloba, advocating large doses and setting no upper limit on the amount readers should take. He never warns about this herb's anticoagulant, or blood-thinning, properties, a matter of concern to people who might require emergency surgery or who are being treated with blood thinners. Atkins is not alone in promoting dietary supplements. They are advertised everywhere, for all manner of ailments, and about one-third of Americans buy herbal products like echinacea, ginseng, and St. John's wort. They spend about $5 billion annually at retail outlets, and sales are rising about 18 percent a year. Thousands of products cram the shelves of health food stores, grocery markets, and pharmacies nationwide. They are also widely available through catalogs and the Internet. Even major pharmaceutical companies are adding dietary supplements to their lines. But what assurances do consumers have about exactly what they are getting, and about the safety of the products? A regulatory vacuum REGULATION OF DIETARY supplements varies considerably among developed countries, even among member states of the European Union, which has yet to adopt any transnational standards for these products. Under the most extensive legal framework, Germany has tested more than 300 herbal remedies since 1980, finding about two-thirds of these products to be safe and at least minimally effective (under a very liberal standard). It controls these substances as drugs. But consumers in other Western societies receive little protection. Last year, Canada allotted $7 million (Canadian) to establish an Office of Natural Health Products over a three-year period. Although this new agency will govern the premarket assessment, labeling, licensing, and monitoring of herbal supplements, the precise scope of its mandate has yet to be determined. In the meantime, these products are blooming and booming in a regulatory vacuum. In Britain, the majority of herbal remedies are classified as food supplements and are thus unlicensed. Others, sold by herbalists, are specifically exempt from licensing under a 1968 law. Only a small number of herbs that are regulated as drugs by the Medicines Control Agency carry any real assurance that they are safe and effective. But few places in the industrialized world, if any, have a more permissive environment than the United States. The U.S. Congress has virtually exempted herbal remedies from government oversight. When the Food and Drug Administration considered regulating these products in the early 1990s, manufacturers and health food stores orchestrated a massive lobbying campaign against stricter controls. The industry produced television commercials that depicted movie star Mel Gibson handcuffed by FDA agents for possessing vitamins. The result was the Dietary Supplement and Health Act of 1994. Pushed heavily by Sen. Orrin Hatch of Utah, the home base of many supplements makers, and passed over the objections of the FDA, the law created a new product class, the dietary supplement, which was not subject to regulations applied to drugs. Now any substance that can be found in foods, regardless of amount or action and including chemicals that act as hormones or toxins, can be produced and sold without any premarket testing or approval. The FDA can restrict the sale of an herbal product only if the agency receives well-documented reports of health problems associated with it. The FDA formed its Special Nutritionals Adverse Event Monitoring System in 1993 as an important component of its MEDWatch program, which is designed to track problems arising from the range of drugs and medical devices the FDA is charged with regulating. …

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