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 removed back to the United States where he was arrested on an outstanding federal warrant by the U.S. Marshals Service after an indictment against him was returned in July 2024. 

In 2015, Scalpa was a for-profit corporation incorporated in Arizona that marketed and sold medical devices and drug products intended to affect the structure and function of the human body. Between March 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 the 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 new drug “Scalpatox” into commerce.  

The ScalpaJECT Hyaluronic Pen, Hylaron Pen, and similar unapproved and misbranded devices and drugs 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. On Nov. 5, 2025, the FDA issued a warning to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware of adverse events associated with unapproved and misbranded botulinum toxin products, including botulism symptoms.

Cleveland has agreed to be sentenced to a prison term of between four and eight years. He has also agreed to pay restitution for the entire scope of his criminal conduct, and to forfeit $800,000. 

The FDA Office of Criminal Investigations investigated the case with assistance from the U.S. Postal Inspection Service.

Valuable assistance was provided by the Department of Justice’s Office of International Affairs and the Judicial Attaché Office in Bogotá. The U.S. Marshals Service provided exceptional assistance in locating the defendant in Colombia and facilitating his return to the United States.

Assistant U.S. Attorneys Corey Hall and Randy Ramseyer for the Western District of Virginia and Trial Attorney Taylor Broadbent of the Criminal Division’s Health and Safety Unit are prosecuting the case.

The Health and Safety Unit within the Department’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.