'All-Natural' Male Enhancement Supplement Contained Active Ingredient Found in Viagra
SPRINGFIELD, Mo. – A former Springfield, Mo., business owner was sentenced in federal court today for his role in leading a scheme with two Nixa, Mo., residents to market an all-natural male enhancement supplement that actually contained the same active ingredient found in Viagra.
“This criminal scheme involved thousands of individual acts of fraud over several years, and distributed misbranded and dangerous products throughout the United States,” said Tim Garrison, U.S. Attorney for the Western District of Missouri. “This placed the health of an untold number of individuals at risk, because the product actually contained dangerous levels of sildenafil – the active ingredient found in Viagra – more potent than what a person could obtain through a doctor’s prescription.”
“American consumers are put at risk when the true nature of ingredients for dietary supplements is hidden,” said Charles L. Grinstead, Special Agent in Charge, FDA Office of Criminal Investigations’ Kansas City Field Office. “We will continue to pursue and bring to justice those who jeopardize the public health.”
Michael S. Schindele, 44, of Jacksonville, Fla., was sentenced by U.S. Chief District Judge Beth Phillips to three years and one month in federal prison without parole. The court also ordered Schindele to forfeit $47,930, which represents his profit from the scheme.
On Aug. 15, 2018, Schindele pleaded guilty to one count of wire fraud and one count of delivering adulterated or misbranded food. Schindele, the owner and operator of Executive Image International, operated a website that sold dietary supplements and drugs to the general public. He worked through businesses owned and operated by co-defendants John G. Schindele, 42 (his brother), and Jennifer S. Travis, 46, both of Nixa, to sell dietary supplements, which they claimed contained only all-natural ingredients. John Schindele and Travis both pleaded guilty, in separate but related cases, and were each sentenced to five years of probation.
Among the many supplements sold by Michael Schindele was Silver Bullet, marketed as an “all-natural male performance enhancer,” an “Extreme Male Stimulant,” and a “dietary supplement.” In reality, 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. Michael Schindele was not authorized or licensed to sell this pharmaceutical.
Michael Schindele’s misrepresentations resulted in him, Executive Image International, Schindele Enterprises, and Midwest Wholesale obtaining at least $150,000 from consumers. Michael Schindele, personally, received at least $47,930, which must be forfeited to the government.
Michael Schindele directed the purchase of sildenafil from a supplier in the People’s Republic of China. He directed hundreds, if not thousands, of mass mailings of misleading and fraudulent advertisements claiming the product was “all natural,” which included samples of the tainted products. He coordinated the sale of the tainted products through his brother, John Schindele, and Travis over several years. Michael Schindele also directed his brother to use the proceeds from these fraudulent sales to pay for his personal expenses and transfer the cash in order to conceal his involvement in the fraud.
After he moved to Jacksonville, according to court documents, Michael Schindele started another business to perpetrate the same criminal fraud. He hired another person in the state of Georgia to handle the mailings and distribution of the illegal product. The new operation fraudulently sold dangerous misbranded food products that contained sildenafil and tadalafil at higher than normal levels that a reasonable physician would initially prescribe. In fact, there is not a combination pill currently approved by the FDA that contains both drugs, as they are created by different manufacturers.
During the time of the fraud scheme, which operated from Oct. 11, 2011, through Jan. 6, 2014, Michael Schindele also pleaded guilty in a separate and unrelated case to the misdemeanor offense of introducing an unapproved animal drug. Schindele admitted that he sold heartworm tablets that were produced in Australia and had not been approved for sale in the United States, and which required a veterinarian’s prescription. Federal agents seized 1,368 doses of the heartworm tablets from Michael Schindele’s EZBody store in Springfield. Michael Schindele was sentenced for that offense on July 17, 2012, to one year of unsupervised probation.
According to court documents, Michael Schindele recruited his brother and Travis to become the face of the operation after he became aware of the government’s investigation into this earlier criminal enterprise.
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. 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.
These cases were prosecuted by Assistant U.S. Attorneys Nhan D. Nguyen and Patrick Carney. They were investigated by the U.S. Food and Drug Administration’s Office of Criminal Investigations (OCI).