Green Hornet Herbal “Ecstasy” Drink Subject Of FDA Consumer Alert
This article was originally published in The Tan Sheet
Executive Summary
Liquid product Green Hornet, marketed by Kekio Inc. as an herbal equivalent to the illegal street drug "ecstasy," was the subject of an 1FDA consumer alert Feb. 25 designating the product an unapproved drug
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Liquid product Green Hornet , marketed by Kekio Inc. as an herbal equivalent to the illegal street drug "ecstasy," was the subject of an 1 FDA consumer alert Feb. 25 designating the product an unapproved drug. The product, sold in 4 and 16 oz. bottles, contains undeclared active ingredients diphenhydramine and dextromethorphan. The two ingredients are found in numerous over-the-counter drug products. FDA became aware of Green Hornet after four teenagers in Colorado Springs suffered seizures, excessive heart rates, severe body rashes and high blood pressure believed to be associated with the drink. "We are investigating whether the product consumed by the four teenagers caused the seizures and other symptoms," FDA Commissioner Mark McClellan, MD/PhD, said. The commissioner added that the agency "will pursue every available enforcement option to remove these products from the marketplace, and will seek penalties against those responsible for offering them." FDA also is conducting an ongoing investigation of Kekio, the agency says. Specific enforcement measures have not yet been outlined, but the agency says it "will take whatever actions are necessary" to prevent the promotion of Green Hornet. Kekio marketed the product through a 2 website as well as a Colorado Springs-based retail store. FDA reports the company has taken Green Hornet off its site, and the state of Colorado has embargoed the product. The firm's site advertises several products with contro-versial ingredients. Liquid Invigorate II , a "strong sleep aid," is touted as an alternative to "date rape" drug gamma hydroxybutyrate (GHB). An ephedra-free pill combination, Trip2Night , contains Citrus aurantium (bitter orange). FDA has expressed an interest in exploring the safety of the popular ephedra replacement ingredient (3 (Also see "Chattem Optimistic On 2004 Line Extensions, Litigation Settlement" - Pink Sheet, 26 Jan, 2004.), p. 10). FDA previously has targeted makers of "street drug alternatives." The agency issued several warning letters last year to ephedra marketers calling their products "potentially risky" (4 (Also see "Supplements Sold As “Street Drug Alternatives” Draw FDA Warning Letters" - Pink Sheet, 7 Apr, 2003.), p. 6). |