DIETARY SUPPLEMENTS: Debate Over Regulation Heats Up
A study in today's New England Journal of Medicine detailing how a Chinese herb used for weight loss damaged the kidneys of 105 patients in Belgium and caused 18 cases of cancer among them is raising more questions about the unregulated dietary supplement industry, the AP/Arizona Daily Star reports. The study, according to lead author Dr. Joelle Nortier of the Hospital Erasme in Belgium, "reinforce[s] the idea that the use of natural herbal medicine may not be without risk." Former FDA administrator Dr. David Kessler, who is now dean of Yale's medical school, wrote an accompanying NEJM editorial arguing that the "report shows how dangerous dietary supplements can be, and should help convince Congress that they should be regulated." As a result of the study, the FDA has announced a halt to the importation of the specific group of Chinese herbs (6/7).
A Successful Supplement Industry
"Dietary supplements don't meet the level of standards that my hair dryer has to meet," Thomas Moore, a health policy analyst at the George Washington University, said. A Salon.com expose of the supplement ephedra, an herb which speeds the heart rate and curbs the appetite, uncovered "the weird, sometimes dangerous, world of dietary supplements" and the "few controls over what's in a product." Salon.com recounts the regulation history of how the $14 billion-a-year industry, starting in 1993 when the FDA threatened to tighten restrictions on dietary supplements. After 30 people died from 1-tryptophan, a "natural" sleeping aid, the industry mounted a vigorous, $2.5 million publicity campaign, urging consumers to "[w]rite to Congress today, or kiss your supplements goodbye!" An industry-sponsored television ad featured Mel Gibson being handcufffed by FDA agents for carrying vitamins. A year later, Congress passed the Dietary Supplement Health and Education Act, which gave the FDA power to respond quickly if a supplement "posed a clear health threat," but laid the burden of proof of the supplement's relative danger with the government rather than with the industry. In the case of the diet aid ephedra, which has been linked to cases of irregular heartbeats, heart attacks and strokes, the FDA received roughly 400 complaints of "adverse reactions" to products containing the herb, including 15 deaths. The agency released a consumer alert on ephedra products, and Kessler, then FDA director, called them "street drugs masquerading as dietary supplements." In 1998, the FDA proposed regulations for ephedra, requiring labels recommending a daily limit of 25 milligrams of ephedrine for no more than a week. When Congress received the proposals, the industry again launched a lobbying effort, delivering mail "by the pound to the FDA and Capitol Hill." Manufacturers of ephedra products, such as Metabolife, donated to lawmakers' campaigns. Rep. Brian Bilbray (R-Calif.), who received over $32,000 from ephedra companies, successfully requested a commissioned study of the FDA's proposed regulations, which concluded that the agency had based the rules on inadequate data. The supplement industry continues its financial contributions to congressional supporters. The FDA, with Jane Henney at the helm, "has been thoroughly demoralized," Moore said. Earlier this year, it withdrew its proposed regulations. However, new rules may be forthcoming, as public hearings to discuss a new report of adverse effects are scheduled for this summer. "This time we want everybody to see the data first," FDA spokesperson Brad Stone said (Brownlee, 6/7).