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FDA takes action against bodybuilding supplement
January 21, 1999 WASHINGTON (CNN) -- The Food and Drug Administration has asked manufacturers to voluntarily recall a type of dietary supplement that the agency says can pose serious and potentially life-threatening health problems. The supplements contain the ingredient gamma butyrolactone and are marketed under various brand names, including Blue Nitro, Renewtrient, Revivariant, GH Revitalizer, Gamma and Remforce. They have been linked to 55 reports of adverse health effects, including one death and 19 other people left unconscious or comatose, the FDA said. Symptoms include vomiting, seizures and slowed breathing or heart rates. While the recall is voluntary, the FDA said it would consider regulatory measures if manufacturers did not comply. Marketed as muscle-building supplements and sold over the Internet and in health food stores and fitness centers, gamma butyrolactone products have also been touted as everything from a fat burner to a sleep aid to an aphrodisiac. While gamma butyrolactone itself isn't illegal, once consumed it metabolizes in the body to create gamma hydroxybutyric acid, or GHB, which is illegal to produce or sell. GHB can be especially dangerous if taken with alcohol or drugs. Last week, the state of California notified retailers that selling gamma butyrolactone products violated the state's Controlled Substances Act. The makers of Blue Nitro defend their product, saying that their Web site and the bottle's label include warnings about the dangers of mixing it with alcohol. "If our product is taken the way we recommend, there's no problem. It's completely metabolized and out of their system within three hours," said manufacturer Barry Hartman. "It's very beneficial for people that have insomnia and it's very pro-sexual." | |||||||||||||||||||||||||||||
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