FDA Warns Consumers about Herbal Product

COLORADO SPRINGS, Colo.--The Food and Drug Administration (FDA) posted an alert Feb. 25 warning consumers not to purchase or consume Green Hornet, a product marketed on the Internet and in stores as an herbal version of the street drug ecstasy. FDA considers this product to be an unapproved new drug since it contains, among other ingredients, the undeclared active ingredients diphenhydramine and dextromethorphan, which are found in over-the-counter (OTC) drugs.

This action comes after FDA became aware of four Colorado teenagers who were rushed to a hospital emergency room Feb. 13 for seizures, excessive heart rates, severe body rashes and high blood pressure after consuming Green Hornet. FDA is now investigating whether Green Hornet alone or in combination with other substances caused the severe adverse reactions.

Green Hornet is sold by Colorado Springs, Colo.-based Kekio Inc. dba Mind Excursions (www.mindexcursions.com). The store, which also operates a Web site, has stopped selling the product, according to FDA.

"Our advice about so-called safe alternatives to street drugs remains the same, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. They are not safe. Do not buy them, and do not use them."

In a Feb. 18 editorial appearing in the Denver Post, the regulatory structure of the dietary supplement industry was once again lambasted. The newspaper wrote, The laughably weak federal law on herbal supplements has again put people at risk. The law [the Dietary Supplement Health and Education Act] has so hamstrung the FDA that it can't really protect consumers in the expanding market for supplements.

In 1995, four industry associations denounced the marketing of natural street drug alternatives and asked FDA to use the power DSHEA gave the agency to take enforcement actions against these types of products. In their joint statement, the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), National Nutritional Foods Association (NNFA) and Utah Natural Products Alliance (UNPA) also reported such alternatives are illegal and are subject to controlled substance regulations.

In its alert, FDA reported any product containing undeclared active drug ingredients violates the law. Such violations may result in enforcement actions that include seizure and injunction. More information on the can be found at www.fda.gov/bbs/topics/NEWS/2004/NEW01026.html.