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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-41
April 9, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Expands Warning About "Green Hornet" To Include All Other Products By Cytotec Solutions, Inc.

The Food and Drug Administration (FDA) is warning consumers not to purchase or consume products that claim to provide "safe legal highs" or that are marketed as "street drug alternatives" by Cytotec Solutions, Inc., of Tampa, Fla. Today's warning expands on the February 2004 warning concerning a product called Green Hornet, also marketed by Cytotec Solutions. Products by this company have been promoted and sold on the Internet and in stores as legal versions of illicit street drugs.

FDA issued a warning in February 2004, about adverse events experienced by four teenagers after they consumed Green Hornet Liquid that contained high levels of the over-the-counter drugs diphenhydramine and dextromethorphan.

FDA analyses of additional products, manufactured or distributed by Cytotec Solutions Inc., has not only found the drugs, diphenhydramine HCl and dextromethorphan, but ephedrine and the controlled substances GBL and GHB as well. Although this firm is no longer producing these products, they remain under investigation and FDA is working to identify and address additional distributors of the products. The agency is issuing this warning because consumers may still have these products in their possession or may be able to buy them commercially.

"FDA has taken numerous actions against various products that are being manufactured, marketed, or distributed as street drug alternatives," said Lester M. Crawford, D.V.M., Ph.D., Acting FDA Commissioner. "There is no doubt that these products pose a potential public health concern, and FDA is concerned that these products may be misused or abused by individuals, especially minors and young adults."

The products included in this warning, which consumers should not use, are Trip2Night, Invigorate II, Snuffadelic, Liquid Speed, Solar Water, Orange Butterfly, Schoomz and Green Hornet Liquid. The labeling for these products lists a variety of herbal and other ingredients but does not provide either the name of the manufacturer or the presence of these drug ingredients.

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. Also any product containing undeclared active drug ingredients violates the law. Such violations may result in enforcement action, including seizure and injunction.

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