CEO of Scalpa, Inc. Pleads Guilty to FDCA Charges and Mail Fraud

ABINGDON, Va. – Bryce Cleveland, the President and CEO of Scalpa, Inc., pleaded guilty today to three charges related to Scalpa’s selling of skincare products that had not been approved by the U.S. Food and Drug Administration (FDA). Cleveland, 42, of Scottsdale, Arizona, pleaded guilty to mail fraud, introduction of an adulterated device into interstate commerce, and introduction of an unapproved new drug into interstate commerce. Cleveland was apprehended late last year in Colombia and arrested on an outstanding federal warrant by the United States Marshals Service after an Indictment against Cleveland was returned in July 2024. Scalpa was a for-profit corporation incorporated in Arizona in 2015 that marketed and sold medical devices and drug products intended to affect the structure and function of the human body. Between 2018 and December 2020, Cleveland devised a fraudulent scheme to unlawfully enrich himself by marketing and delivering, and causing others to market and deliver, unapproved devices to consumers, including ScalpaJECT Hyaluronic Acid and Hyaluron Pen, while making false representations that the devices were not subject to FDA regulation. Similarly, Cleveland introduced and delivered, and caused others to introduce and deliver, the unapproved drug “Scalpatox” into commerce. ScalpaJECT Hyaluronic Acid, Hylaron Pen, and similar unapproved and misbranded devices are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions. Scalpatox was an unapproved and misbranded botulinum toxin product. The FDA has issued numerous warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox, and has noted adverse events associated with these products, including botulism symptoms. Cleveland has agreed to be sentenced to a term of imprisonment between four and eight years. He has further agreed to pay restitution for the entire scope of his criminal conduct. In addition, he has agreed to forfeit $800,000. Finally, Cleveland has agreed that he committed all 34 crimes charged in the Indictment. The U.S. Food and Drug Administration—Office of Criminal Investigations and United States Postal Inspection Service investigated the case. Valuable assistance was provided by the United States Marshals Service and the Department of Justice’s Offices of International Affairs and the Judicial Attaché in Bogotá. First Assistant United States Attorney Robert N. Tracci made the announcement. Assistant U.S. Attorneys Corey Hall and Randy Ramseyer and Trial Attorney Taylor Broadbent from the Criminal Division’s Health and Safety Unit are prosecuting the case. The Health and Safety Unit within the Department of Justice’s Criminal Division works with law enforcement partners to investigate and prosecute violations of federal laws designed to protect public health and safety. The unit focuses on corporations and individuals who make and sell dangerous drugs, food, and other consumer products that could cause significant harm to Americans. For more information, see https://www.justice.gov/criminal/criminal-fraud/health-safety-unit .