Feb. 25, 2004 -- The FDA has issued a warning concerning a liqu
Feb. 25, 2004 -- The FDA has issued a warning concerning a liquid product called Green Hornet. This product is promoted on the Internet and sold in stores as an herbal alternative to the illegal street drug ecstasy.
Recently, four teenagers had severe adverse reactions after consuming Green Hornet. They were rushed to a hospital emergency room suffering from seizures, excessive heart rates, severe body rashes, and high blood pressure.
The FDA is investigating whether Green Hornet alone caused the reactions or if other substances were also involved. Green Hornet contains two active ingredients that are not listed on the product label.
"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," says FDA Commissioner Mark B. McClellan, MD, PhD, in a news release.
The FDA is taking action to have this product removed from the marketplace and "will seek penalties against those responsible for offering them," he says.
Green Hornet Is Illegal
Kekio Inc., in Colorado Springs, Colo., produced the Green Hornet herbal ecstasy product involved in this case, the FDA says.
On the Internet and elsewhere, the company sold Green Hornet through a store called Mind Excursions.
The Green Hornet label does not indicate the manufacturer's name. However, Mind Excursions has stopped selling Green Hornet, says the FDA.
The product labeling lists a variety of herbal ingredients. However, FDA analysis has identified two ingredients in this product, diphenhydramine and dextromethorphan, which are not listed on the label. These drugs are individually found in many over-the-counter cough and cold products.
This new advisory is another action the FDA has taken against products that are being manufactured, marketed, or distributed as alternatives to illegal street drugs.
The concern is that minors and others are using these potentially life-threatening products.
Any product like herbal ecstasy that is marketed as a "street drug alternative" is considered to be an unapproved new drug. Products that contain active ingredients that are not listed on the label violate the law. Such violations may result in enforcement action, including seizure and injunction, according to the FDA.
SOURCE: FDA. News release, FDA.
