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WASHINGTON, Sep 29, 2003 (United Press International via COMTEX) -- A new survey has found half of all Internet marketers of herbal products have violated federal law by making false claims or omitting legally required disclaimers and medical warnings. The findings suggest many consumers are vulnerable to purchasing substandard or potentially dangerous products by patronizing the illegal sites.
The rapid growth in the herbal supplements market over the past five or so years coincided with the explosive growth of the Internet over the same period. The twin booms led to the popular practice of consumers purchasing herbal products online requiring nothing more than a credit card number and a shipping address, but the herbal product manufacturers do not always keep consumers fully informed about the supplements' limitations.
"The (herbal) industry is primarily regulated at the post-marketing level," Dr. Charles Morris, an internist at Brigham and Women's Hospital's division of pharmacoepidemiology and pharmacoeconomics in Boston, told United Press International. That means the government does not have the authority to step in unless an herbal product has been found faulty or dangerous, if advertising information on the product makes unauthorized health claims to directly cure disease, or if the product labeling states unsubstantiated claims.
"It's up to federal agencies to police the Internet," Morris commented.
Morris and colleagues analyzed 443 Web sites by using online search engines to find information on the eight top-selling herbs: St. John's wort, echinacea, ginseng, garlic, saw palmetto, ginkgo biloba, kava kava, and valerian root. Of the 338 sites examined that sold herbal products, 81 percent made one or more health claims. Among this group of sites, 55 percent claimed to treat, prevent, diagnose or cure a specific illness. At the same time, they frequently failed to mention risks. Morris said several sites failed to disclose, for example, recent research linking kava kava use to liver toxicity -- although those findings remain controversial.
Under the 1994 Dietary Supplement Health Education Act, federal law prohibits dietary supplement manufacturers from making specific claims that their products treat or cure particular diseases. For example, an herbal product label can state "garlic may help promote healthy circulation," but it cannot state "garlic prevents heart attacks."
Unlike prescription and over-the-counter drug manufacturers, however, makers of herbal products are not required to submit their health claims to the Food and Drug Administration in advance of marketing their product. Morris said this legal framework sets up the federal government to play catch-up with the herbal industry.
"DSHEA has certainly changed or impaired the federal government's ability to regulate this industry," Morris said. "A lot of what consumers can now find and read on the Internet is somehow indirectly or directly related to the legislation in 1994. We would strongly call for the consideration of pre-marketing regulations, just like (for) prescription or over-the-counter drugs."
The alternative therapy craze is not fading. Morris said 2001 data show half of the U.S. adult population spent about $18 billion on herbal remedies. This is consistent with a 2002 survey, conducted by the Pew Charitable Trusts, which found 62 percent of online users that year searched the Web for health information, with more than half reporting they were looking for information on alternative medicine.
"We've always been concerned about consumers who don't have the ability to determine what's reasonable and credible information on the Web," Mark Blumenthal, executive director of the American Botanical Council in Austin, Texas, told UPI. "We don't think (manufacturers) should be making claims beyond what the law allows. There are definitely products that have been reported to be misleading. Some of the stuff on government, "dot-gov" Web sites aren't necessarily all that reliable."
However, he added, "just because a claim on the Internet might be illegal because it doesn't fit technical requirements of the regulatory system doesn't mean that it's not true."
Blumenthal suggested more regulations might not be the answer. "I don't think there's any legislation needed," he said. "It's an issue of needing more active self-regulation by companies making their claims."
Michael McGuffin, president of the American Herbal Product Association in Washington, a trade group representing about 200 companies, said he "would love to see more active enforcement" by the Federal Trade Commission, the agency overseeing advertising regulations, to prevent misleading herbal information from being distributed online.
"It's important to our trade that the regulators do their job because if they don't do their job, it's bad business for all of us," McGuffin told UPI. "The Internet is just such a rampant business opportunity. If you're in business today in the U.S.A., you have a Web site. It behooves (every company) to make sure the information on (its) Web site is accurate and legal."
McGuffin said he thinks most herbal manufacturers obey federal law. "The majority of companies marketing their goods in the United States are doing the right thing." But physicians like Dr. Bishmal Ashar, an assistant professor of medicine at Johns Hopkins University in Baltimore, who see patients experimenting with herbal products online, question whether that statement is true.
The Internet is such a fluid medium that companies can change their Web sites within a few minutes, Ashar said. He recently conducted his own research investigating ephedra, the popular Chinese herb used for weight loss, and found Internet claims on the product were not always truthful. "When you run across an ad that sounds so good and you want lose weight and nothing's worked before, it's very enticing to want try these products," he told UPI.
"It's very difficult to track and follow and keep up with companies who just want to change Web sites," Ashar added. "It's a very difficult enforcement problem. Patients should just be wary of anything that sounds too good to be true."
Copyright 2003 by United Press International.
