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- ~r199b 1340 FROM SAhI FRANCISCO PAS TO 91'~3089445~_~ r.u~ ....FDA Consumer, SeptembCr 1995 investigators' .ports Page for sleep plus for its growth hormone properties." In January 1992, an undercover FDA investigator cal Led Omniopathy's toll-free number and talked to a person who identified himself as Frank Richards. They discussed the company's "Oxy-Sleep." According to the investigator, Richards said the product's active ingredie:~t was gamma hydroxybutyrate, which he acknowledged was "off the market." The investigator ordered and received various dosaga forms of Oxy-Slee FDA analyses showed the product contained GHB. In other undercover telephone calls, FDA ordered, received and tested additional supplies of Oxy-Sleep, which also tested positive for GHB. In February 1992, investigators, armed with a warrant, searched the premises in Santa Ana. Among items seized were: * numerous computers containing invoices for drug products dated from 1: through 1992 * promotional materials for Omniopathy products * letters and documents on adverse reactions people had to Omniopathy products * numerous drug injectables, powders and capsules worth an estimated • $500,000, according to Omniopathy's price list. FDA analysis showed th drugs were GHB. During the search, investigators extracted £rom com;~uter data informat about the Villa Park site, which led FDA to obtain a seco:zd search warrant f that site. There, investigators found 645 kilograms of GH3 and various other illegal drugs. In interviews with Omniopathy employees and business associates, FDA learned that Griffin bought GHB and placed it in unlabeled bottles and jars stored at Zenker's Villa Park residence_ Griffin then had labels made and ha an unindicted co-conspirator of his and Zenker's put the Labels on the bottl and jars. The labels identified the product as Oxy-Sleep snd Falsely stated that the active ingredient was the illegal drug glutathio:ze. Also, the label did not give adequate directions for use and warnings. From his home, Zenker helped fill and ship GHB orders via the U.S. Pos Service and from assorted private mail drops. In June 1992, a grand jury for the U.S. District Co']rt for the Centra] District of California handed down a six-count indictment against Zenker anc Griffin. Because of health problems, Zenker was tried separately from Graff: in June 1994, at which time the jury found Zenker guilty ~f all counts. In addition to prison, Zenker was sentenced to two gears' probation. F is eligible for parole in 1996.Paula Kurtzweil is a member of FDA's public affairs staff.