The Boston Globe reportage gave a fair and balanced portrayal. Globe staff reporter Christopher Rowland also presented the point of view of the American Herbal Products Association (AHPA), a trade organization representing herbal supplement manufacturers, and was reasonably accurate in describing the regulatory framework for supplementssomething often lacking from recent media coverage of dietary supplements.
Patient safety is the primary concern of Doctors Morris and Avorn: "We want to make sure consumers are not misled with the properties of these products and how they are marketed." The JAMA article concludes, "More effective regulation is required to put this class of therapeutics on the same evidence-based footing as other medicinal products," which implies that consumers would be better protected if all health claims had to be approved by the FDA before the product could be marketed, as is the case for drugs.
However, AHPA disagrees that preapproval of marketing claims would benefit the consumer. According to Suzanne Shelton, an AHPA spokesperson, "It's a fallacy that the FDA-approval model is a guarantee of anything, other than that the companies had enough money to go through the FDA approval process" (which can often run as high as $500 million dollars). Michael McGuffin, president of AHPA, thinks stricter enforcement is a better approach than stricter regulation, and says, "Why would we want the FDA to enforce a different law when they aren't enforcing this one?"
"False claims for supplements should be prosecuted under existing law just as vigorously as false claims for any other product or service," says Peter Everett, vice president and cofounder of the Dietary Supplement Quality Initiative.
The crux of the matter is what constitutes a "false claim." Historically, the FDA has called any claim that they haven't specifically approved as "false."
For example, in 1989 the FDA threatened a manufacturer of aspirin for making the "false claim" that low-dose aspirin can prevent heart attacks. It was known then, as it is now, that daily low-dose aspirin can prevent about one-third of all heart attacks. Until recently the FDA was threatening legal action against the scientifically well-established claim that fish oil, specifically omega-3 fatty acids, can be used to reduce the risk of heart attacks and stroke.
The explosion of new scientific information about the benefits of supplements, and risks for that matter, is too big to squeeze through the bottleneck of a single bureaucratic arbiter of "truth."
The medical and scientific communities have known this for a long time. Their solution was to set up the process of peer review, and create specialized committees for the purpose of issuing guidelines and consensus statements.
Practitioners of traditional herbal medicine have also amassed a valuable body of empirical knowledge about the safety, efficacy, and interactions of herbal supplements.
Consumers need to have available the full range of information to make informed choices, including summaries of the latest findings in the medical community. Neither the FDA's conclusions nor the findings of medical studies are always reliable. For example the FDA has approved many drugs that turn out to be unsafe or ineffective, and doctors have recently reversed themselves on the benefits of hormone-replacement therapy.
The quality of dietary supplements cannot be higher than the quality of information about them. By the admission of former FDA Commissioner Jane Henney, existing regulations under the Dietary Supplement Health and Education Act contain all the tools the FDA and FTC need to root out fraudulent claims. They also allow truthful claims that aren't yet blessed by the FDA to be made. This is exactly the kind of information and protection that consumers want and need.
Christopher Rowland. "Study cautions buyers of online herbal products." The Boston Globe, 17 September 2003.
Dr. Charles A. Morris (of Brigham and Women's Hospital's Division of Pharmacoepidemiology and Pharmacoeconomics) and Dr. Jerry Avorn (of Brigham and Women's and Harvard Medical School). Abstract of "Internet Marketing of Herbal Products." Journal of the American Medical Association, 17 September 2003. (JAMA. 2003;290:1505-1509.)
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