HERBAL SUPPLEMENTS: Industry Boom Sparks Safety Concerns
While the herbal supplement industry continues to expand, hundreds of adults and children are falling seriously ill and the FDA has little control over the regulation and testing of the dietary aids, according to the Washington Post. Since no comprehensive evaluation of illnesses and deaths resulting from dietary supplements has been made, the Post conducted a nationwide survey of health officials, researchers and advocates. Among the findings: tests on some supplements continue to reveal "dangerous contaminants and poor quality control;" a growing number of children are having adverse reactions to supplements; and many state poison control centers are reporting adverse reactions from a "broad range" of the dietary aids. Health officials blame the regulatory loopholes on the 1994 Dietary Supplement Health and Education Act, which exempts supplement manufacturers from "almost all federal regulation, including any requirement that they file reports when the use of one of their products goes wrong." Supplements do not have to be pre-screened by the FDA, nor do they go through the peer-review trials that most prescription drugs face. And once supplements hit the market, the FDA that has the burden of showing that a product is dangerous enough to warrant being taken off the market. With projected sales of supplements expected to reach $15.7 billion this year, health officials are concerned that supplement companies are rushing to take advantage of the lax rules. Prosy Abarquez-Delacruz, regional administrator for the California Health Services Department Food and Drug Branch, said, "It's like the John Wayne industry, like the wild, wild West, and the practices of a few have tainted the many."
To battle the problem, a growing number of states have passed their own restrictions and are beginning to collect safety data. However, the underreporting of adverse events remains a problem. The Post found that between 1993 and 1998, the FDA's monitoring system reported 2,621 adverse events associated with dietary aids, compared to 6,914 reports of supplemental side effects received by the American Association of Poison Control Centers in 1998 alone. Even supplement companies and health food advocates concede that tougher regulations are necessary. But they contend that those regulations will come about as the "field evolve[s]" (Gugliotta, 3/19).