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d5-i99e 13 41 FROM SAN FRgNCISCO PAS TO 913089445252 P.04 ....FDA Consumer, October 1994 Investigators' Reports Paqe ....FDA Consumer, October 1994 Investigators' Reports Georgia Man Arrested In GHB Seizure Charcoal dust covered the teenager's Pace when she awoke in the hospital intensive care unit. Her throat felt like it was on fire. She had lost consciousness several hours earlier after an overdose of en unapproved drug called gamma hydroxybutyrate (GHB). The charcoal on her fece came from the mixture used to pump her stomach, and her throat pain from emergency workers' efforts to help her breathe. This is one of many serious reactions to GHB that FDA iiscovered during a year-long investigation in 1993 that eventually led to a 21-month prison sentence and a $30,000 fine for the man who sold the unap:~roved drug to the teenager and many others. On April 14, Joseph Saffar, Morrow, Ga., was sentenced in the U.S. Distric Court for the Northern District of Georgia. Saffar, 55, pleaded guilty last Dec. 9 to one felony count of introducing a misbranded drag into interstate commerce. GHB is promoted illegally for strength training, muscly building, weight loss, and as a replacement for L-tryptophan, a food supplelaent that FDA order removed from the market in 1989 after reports associated its use with a rare blood disorder. GHB is also sold and used as a hallucinogen and a sleep inducer. FDA has_not approved the drug ~ marketing in t:zis country for any use. However, chnaca ria s currently are testing its ssfety any ~~ctiveness as a treatment for narcolepsy, a rare disorder characterized by uncontrollable periods of sleep. Although Saffar was sentenced based on his activities in 1993, his involvement with GHB first came to FDA's attention in January 1991, when his _ name appeared on a customer list belonging to Amino Disco inters Ltd., a Tucso Ariz., firm the agency was investigating for manufacturing and distributing GHB. On Jan. 2, 1991, Atlanta district FDA investigator Eris Weiiage visited Saffar at his Morrow, Ga., health food store,-Naturally Good. Weilaqe warned him that it was illegal to sell GHB. Saffar replied that Ze no longer sold it but that he believed GHB was a legitimate product and felt FDA was harassing Amino Discounters for no reason. At some time during the next two years, Saffar began selling GHB again, an in November 1992, the Morrow Police Department relayed to FDA's Atlanta offic a citizen`s complaint about the sale of GHB at Naturally ;ood. In January, a member of the Fayette County, Ga., Narcotics Task Force raported to FDA an overdose associated with the use of GHB purchased from Naturally Good. On Jan. 14, FDA investigator Marie Mathews interviewed the woman who had complained to the police. The woman`s daughter told Mathe•ds that fellow high school students were buying GHB at Naturally Good. That same day, Mathews went to Naturally Good undercov:r and purchased a bottle of GHB. A week later, she bought five more bottles. Saffar told her GHi could be used to "bulk up" and to "get high." On April 8, an Atlanta Constitution reporter told FDA .he Fayette County Department of Emergency Services had responded to 11 cases of GHB overdoses