FDA Expands Warning on 'Herbal' Products

WASHINGTON--The Food and Drug Administration (FDA) posted a consumer alert April 9 warning consumers not to purchase or consume eight additional products manufactured by Cytotec Solutions. FDA posted an alert about the company's Green Hornet product in mid-February, after it found the product contained two pharmaceutical ingredients. (For more on this story, see /sitecore/content/repository/nutrition/articles/2004/03/fda-warns-consumers-about-herbal-product.aspx.) The action came after FDA became aware of four Colorado teenagers treated at a hospital after ingesting Green Hornet.

In its expanded warning, FDA noted it analyzed additional products manufactured or distributed by Cytotec, and found several over-the-counter pharmaceuticals, including diphenhydramine and dextromethorphan, as well as the controlled substances GHB (known as the "date rape" drug) and GBL. The products included in FDA's warning are: Trip2Night, Invigorate II, Snuffadelic, Liquid Speed, Solar Water, Orange Butterfly, Schoomz and Green Hornet Liquid.

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

According to reports by Reuters and the Associated Press, Cytotec Solutions, based in Tampa, Fla., has gone out of business, but the products are still being sold in stores and on the Internet as alternatives to street drugs.

Industry associations remain supportive of FDA's move to remove street drug alternatives from the market. In a 1995 joint statement, the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), National Nutritional Foods Association (NNFA) and Utah Natural Products Alliance (UNPA) asked FDA to take enforcement actions against these types of clearly illegal products that are subject to controlled substance regulations.