A man who unlawfully sold unapproved versions of drugs used to treat erectile dysfunction pled guilty on November 1, 2011, in federal court in Sioux City.

            David Kempema, age 50, from Sioux City, Iowa, was convicted of one count of trafficking misbranded drugs with intent to defraud or mislead.

            In a plea agreement, Kempema admitted that, from about October 13, 2009, through about July 9, 2011, he advertised and offered for sale drugs purporting to be Viagra and Cialis. Kempema used the business names Generics Direct, La Costa Direct, and Canned Ads, to market the drugs. When Kempema received an order for Viagra, he supplied the customer with Viprogra-100. When he received an order for Cialis, he supplied the customer with V-Tada 20. Neither the Viprogra-100 nor the V-Tada 20 were approved by the United States Food and Drug Administration (FDA), and neither drug included any directions for use. Kempema obtained the drugs from India and sold them to customers in the United States without any prescription. In order to mislead customers and law enforcement, Kempema shipped the drugs using a fake return address from Costa Rica.

            In the plea agreement, Kempema admitted selling approximately 2505 Viprogra-100 pills and approximately 1263 V-Tada 20 pills. He received approximately $23,723.25 in proceeds from the sales. Kempema agreed to forfeit the money he received from the sales.

            "Americans must have confidence that drugs introduced into and distributed throughout the United States are genuine, FDA-approved products. Further, the public must trust that those who dispense such products are qualified to do so," said Special Agent in Charge Patrick J. Holland of FDA's Office of Criminal Investigations, Kansas City Field Office. "The FDA will aggressively pursue all those who seek to profit from causing the importation and distribution of misbranded foreign drugs."

            Sentencing before United States District Court Judge Mark W. Bennett will be set after a presentence report is prepared. Kempema remains free on bond pending sentencing. Kempema faces a possible maximum sentence of 3 years’ imprisonment, a $250,000 fine, a $100 special assessment, and 1 year of supervised release following any imprisonment.

            The case is being prosecuted by Assistant United States Attorney Peter Deegan and was investigated by the FDA Office of Criminal Investigation.

            Court file information is available at https://ecf.iand.uscourts.gov/cgi-bin/login.pl. The case file number is CR 11-4140 MWB.