Sioux City Man Sentenced For Selling Misbranded Erectile Dysfunction Drugs As ‘All Natural Male’ And ‘Supermale’ Dietary Supplements | USAO-NDIA

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A man who illegally sold unapproved versions of drugs used to treat erectile dysfunction for the second time was sentenced on March 15, 2022 to more than a year in federal prison. David Kempema, 61, of Sioux City, Iowa, was sentenced to prison after pleading guilty on Oct. 26, 2021 to smuggling mislabeled drugs into interstate commerce with intent to defraud.

Information from a plea agreement and sentencing hearing shows that between February 2014 and December 2018, Kempema advertised and offered for sale the pills he had ordered from India or Germany. . The pills contained the same active ingredients as Viagra and Cialis, which were prescription drugs approved by the Food and Drug Administration (“FDA”) to treat erectile dysfunction. To advertise its pills, Kempema placed advertisements in company men’s restrooms along the Interstate 29 corridor. The advertisements referred to the pills as male enhancement “dietary supplements” called “Supermale” and “All Natural Male”. Kempema obtained or attempted to obtain at least 4,059 pills for resale. When questioned by an FDA official, Kempema admitted that he knew the drugs were not the FDA-approved versions and that they contained the same active ingredients as the FDA-approved versions.

Kempema had previously been convicted of introducing mislabeled drugs into interstate commerce in 2011 in USA v David Kempema, case number 11-CR-4140 in the Northern District of Iowa. In a plea agreement in the case, Kempema admitted that between October 2009 and July 2011 he ordered pills from India containing the same active ingredients as Viagra and Cialis. Kempema then sold the non-FDA approved pills as Viagra and Cialis. On February 8, 2012, the accused was sentenced to 60 days in prison and one year of probation.

Kempema was sentenced in Sioux City by Chief United States District Court Judge Leonard T. Strand. Kempema was sentenced to 18 months in prison. He must also serve a one-year probation after the prison sentence. There is no parole in the federal system.

“People who sell mislabeled drugs obtained overseas take advantage of American consumers while exposing those same consumers to the risk of side effects from those drugs,” said Acting U.S. Attorney Timothy Duax. “For the second time, David Kempema has put the lives of others on the line because of his personal greed. This sentence holds him accountable for his actions and demonstrates that this type of crime will not be tolerated.

“Prescription drugs that are smuggled from overseas and are outside the secure supply chain can pose a serious health risk to those who use them. The drugs may contain unknown or dangerous ingredients and are manufactured under unknown or unregulated conditions,” said Special Agent in Charge Charles L. Grinstead, of the FDA’s Kansas City Local Criminal Investigations Office. “We will continue to investigate and bring to justice those who traffic in illegal prescription drugs.”

David Kempema has been released on bail and is due to report to the Bureau of Prisons on a date yet to be determined.

The case was prosecuted by Assistant United States Attorney Kyndra Lundquist and investigated by the FDA’s Office of Criminal Investigations.

Information on the court file at https://ecf.iand.uscourts.gov/cgi-bin/login.pl.

The file number is 21-CR-4081.

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