The Food and Drug Administration (FDA) is warning consumers not to purchase or consume a liquid product called Green Hornet. This product is promoted on the Internet, and sold in stores, as a herbal version of the illegal 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, found in over-the-counter (OTC) drugs.
FDA recently became aware of reports of adverse events experienced by four teenagers after consuming Green Hornet. The teenagers were rushed to a hospital emergency room suffering from seizures; excessive heart rates; severe body rashes and high blood pressure. FDA is investigating whether Green Hornet alone or in combination with other substances caused the severe adverse reactions.
"We are investigating whether the product consumed by the four teenagers caused the seizures and other symptoms. Our advice about so-called "safe" alternatives to street drugs remains the same: They are not safe. Do not buy them, and do not use them," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "FDA will pursue every available enforcement option to remove these products from the marketplace and will seek penalties against those responsible for offering them."
The Green Hornet product involved in this case was sold by Kekio, Inc., Colorado Springs, Colo., doing business as a store called Mind Excursions. The store, which also operates a website, has stopped selling the product.
The product comes in 4 and 16oz. bottles and the label does not bear the name of the manufacturer. The products labeling lists a variety of herbal ingredients, however FDA analysis has identified two drug ingredients in this product: diphenhydramine and dextromethorphan, which are individually found in numerous OTC cough/cold products.
FDA has taken numerous actions against various products that are being manufactured, marketed, or distributed as alternatives to illicit street drugs (street drug alternatives). FDA is concerned that these products are being abused by individuals, including minors, and pose a potential threat to the public health.
FDA considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug marketed in violation of the Federal Food, Drug, and Cosmetic Act. Any product containing undeclared active drug ingredients violates the law. Such violations may result in enforcement action, including seizure and injunction.
06-20-2004, 10:20 AM
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