North Carolina Man Ran Lucrative Fraud Scheme Selling Unapproved Substances that Mimic the Health Benefits of Legal Drugs
FOR IMMEDIATE RELEASE
Tuesday, August 31, 2021
PITTSBURGH, PA - A resident of North Carolina pleaded guilty in federal court to a charge of conspiracy to defraud the United States, Acting United States Attorney Stephen R. Kaufman announced today.
Joshua Fulton, 41, Bolivia, North Carolina, pleaded guilty to one count before United States District Judge Christy C. Wiegand.
In connection with the guilty plea, the court was advised that Fulton owned or operated several businesses that sold substances designed to mimic the effects of steroids, a Southeast Asian plant called kratom, and products labeled as nootropics. In connection with the sale of these products, Fulton’s businesses made claims about the health effects that would result from their consumption, and Fulton was aware that most of his customers consumed his products as drugs—in other words, to obtain those purported effects. To evade regulation by the Food and Drug Administration, which regulates the sale of drugs in interstate commerce, Fulton and his co-conspirators included disclaimers on their websites and the parcels shipped to consumers, falsely indicating that the products were not for human consumption. They also failed to register the facility where these substances were produced and distributed with the Secretary of Health and Human Services, as required by law. In connection with his plea, Fulton agreed to forfeit approximately $10.7 million in funds traceable to his businesses.
“Joshua Fulton sold SARMs (Selective Androgen Receptor Modulators) over the internet, a substance which mimics the effects of anabolic steroids, and other substances by misbranding the products in a scheme to avoid regulations by the FDA,” said Acting U.S. Attorney Kaufman. “As this case demonstrates, we are committed to prosecuting anyone who uses deceitful practices to defraud the United States.”
“The requirement that FDA approve new drugs before they are marketed is designed to ensure the health and safety of consumers,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “The FDA will continue to aggressively pursue those who place the public health at risk and compromise the integrity of the regulatory system by purposely evading scrutiny.”
“For generations, humans have looked for quick fix, and still, that 'all-natural' remedy could cause serious health effects. What Fulton admitted to selling were unapproved substances that mimicked steroids, which he purported would have certain effects on the buyer,” said Assistant Special Agent in Charge for HSI in Pittsburgh, J. David Abbate. “HSI worked closely with Federal Drug Administration's Office of Criminal Investigations on this case to ensure that Fulton can no longer risk the health of others to fill his pockets.”
Judge Wiegand scheduled sentencing for January 6, 2022, at 9 a.m. The law provides for a total sentence of five years in prison, a fine of $250,000, or both. Under the Federal Sentencing Guidelines, the actual sentence imposed is based upon the seriousness of the offense and the prior criminal history, if any, of the defendant.
Source: https://www.fda.gov/inspections-com...g-unapproved-substances-mimic-health-benefits
FOR IMMEDIATE RELEASE
Tuesday, August 31, 2021
PITTSBURGH, PA - A resident of North Carolina pleaded guilty in federal court to a charge of conspiracy to defraud the United States, Acting United States Attorney Stephen R. Kaufman announced today.
Joshua Fulton, 41, Bolivia, North Carolina, pleaded guilty to one count before United States District Judge Christy C. Wiegand.
In connection with the guilty plea, the court was advised that Fulton owned or operated several businesses that sold substances designed to mimic the effects of steroids, a Southeast Asian plant called kratom, and products labeled as nootropics. In connection with the sale of these products, Fulton’s businesses made claims about the health effects that would result from their consumption, and Fulton was aware that most of his customers consumed his products as drugs—in other words, to obtain those purported effects. To evade regulation by the Food and Drug Administration, which regulates the sale of drugs in interstate commerce, Fulton and his co-conspirators included disclaimers on their websites and the parcels shipped to consumers, falsely indicating that the products were not for human consumption. They also failed to register the facility where these substances were produced and distributed with the Secretary of Health and Human Services, as required by law. In connection with his plea, Fulton agreed to forfeit approximately $10.7 million in funds traceable to his businesses.
“Joshua Fulton sold SARMs (Selective Androgen Receptor Modulators) over the internet, a substance which mimics the effects of anabolic steroids, and other substances by misbranding the products in a scheme to avoid regulations by the FDA,” said Acting U.S. Attorney Kaufman. “As this case demonstrates, we are committed to prosecuting anyone who uses deceitful practices to defraud the United States.”
“The requirement that FDA approve new drugs before they are marketed is designed to ensure the health and safety of consumers,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “The FDA will continue to aggressively pursue those who place the public health at risk and compromise the integrity of the regulatory system by purposely evading scrutiny.”
“For generations, humans have looked for quick fix, and still, that 'all-natural' remedy could cause serious health effects. What Fulton admitted to selling were unapproved substances that mimicked steroids, which he purported would have certain effects on the buyer,” said Assistant Special Agent in Charge for HSI in Pittsburgh, J. David Abbate. “HSI worked closely with Federal Drug Administration's Office of Criminal Investigations on this case to ensure that Fulton can no longer risk the health of others to fill his pockets.”
Judge Wiegand scheduled sentencing for January 6, 2022, at 9 a.m. The law provides for a total sentence of five years in prison, a fine of $250,000, or both. Under the Federal Sentencing Guidelines, the actual sentence imposed is based upon the seriousness of the offense and the prior criminal history, if any, of the defendant.
Source: https://www.fda.gov/inspections-com...g-unapproved-substances-mimic-health-benefits