Wednesday, February 21, 2018

Nixa residents plead guilty to scheme to market all-natural male enhancement drug that actually contained Viagra ingredient

(From the U. S. Attorney for the Western District of Missouri)

Two Nixa residents have pleaded guilty and a Florida resident has been indicted in a scheme to market an all-natural male enhancement supplement that actually contained the same active ingredient found in Viagra.

John G. Schindele, 41, and Jennifer S. Travis, 45, both of Nixa, waived their right to a grand jury and pleaded guilty in separate appearances before U.S. Magistrate Judge David P. Rush on Tuesday, Feb. 20, 2018.

Michael S. Schindele, 43, of Jacksonville, Florida, was charged in a two-count indictment returned under seal by a federal grand jury in Springfield, Mo., on Tuesday, Feb. 20, 2018. That indictment was unsealed and made public today upon Schindele’s arrest and initial court appearance.

Michael Schindele, the owner and operator of Executive Image International, operated a website that sold dietary supplements and drugs to the general public. The federal indictment alleges that he worked through businesses owned and operated by John Schindele (his brother) and Travis to sell dietary supplements, which claimed to contain only all-natural ingredients.

Michael Schindele marketed Silver Bullet as an “all-natural male performance enhancer,” an “Extreme Male Stimulant,” and a “dietary supplement.” In reality, the indictment says, Silver Bullet contained materially different ingredients than what was listed, including sildenafil, a synthetic pharmaceutical ingredient that was not disclosed to consumers purchasing the product.

Sildenafil is the active pharmaceutical that is commonly used in the erectile dysfunction drug Viagra. The labeling for Silver Bullet failed to provide adequate warnings about the use of a sildenafil-containing product, which is only legally available with a prescription from a doctor.

According to the indictment, Silver Bullet was purchased and shipped from a supplier in the People’s Republic of China, then resold by Michael Schindele and others to consumers throughout the United States.

The indictment charges Michael Schindele with one count of wire fraud and one count of delivering adulterated or misbranded food. It also contains a forfeiture allegation, which would require Michael Schindele to forfeit to the government all property derived from the proceeds of the offense, including a money judgment of $47,930.

John Schindele, who pleaded guilty to one count of mail fraud and one count of delivering adulterated or misbranded food, is the owner of Schindele Enterprises, L.L.C., and Midwest Wholesale. Travis, who also pleaded guilty to one count of mail fraud and one count of delivering adulterated or misbranded food, partially owned and managed a business known as Kinevative. Both businesses sold food and drug products advertised as “dietary supplements” to customers throughout the United States and worldwide. The base of operation for both of these businesses was in Nixa.

By pleading guilty, John Schindele admitted that he marketed Silver Bullet as an “all-natural male performance enhancer,” and a “dietary supplement” and failed to disclose that sildenafil was an ingredient. John Schindele was not authorized or licensed to sell this pharmaceutical.

According to his plea agreement, John Schindele fraudulently received $210,000 for the misrepresented and mislabeled dietary supplements from April 16, 2012, to July 8, 2015.

Travis marketed products known as Boost Ultra and Magic for Men as an “Ultra Sexual Enhancement Formula.” The products were advertised as dietary supplements, and the label listed the contents as “all natural.” Travis admitted that she failed to disclose that Boost Ultra and Magic for Men also contained sildenafil. Travis was not authorized or licensed to sell sildenafil.

Federal agents, acting in an undercover capacity, purchased products, including Boost Ultra and Magic for Men, that were advertised as containing all-natural ingredients. The supplements were purchased from websites that were traced back to Travis. The purchased dietary supplements were then tested by the FDA and found to contain undeclared active pharmaceutical ingredients, including sildenafil.

According to her plea agreement, Travis fraudulently received $152,862 for the misrepresented and mislabeled dietary supplements from June 2, 2014, through Jan. 31, 2017.

Under federal statutes, John Schindele and Travis are each subject to a sentence of up to 21 years in federal prison without parole. The maximum statutory sentence is prescribed by Congress and is provided here for informational purposes, as the sentencing of the defendants will be determined by the court based on the advisory sentencing guidelines and other statutory factors. Sentencing hearings will be scheduled after the completion of presentence investigations by the United States Probation Office.

Garrison cautioned that the charges contained in the indictment are simply accusations, and not evidence of guilt. Evidence supporting the charges must be presented to a federal trial jury, whose duty is to determine guilt or innocence.

These cases are being prosecuted by Assistant U.S. Attorneys Patrick Carney and Nhan D. Nguyen. They were investigated by the U.S. Food and Drug Administration.

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