Arizona skincare CEO pleads guilty to selling unapproved medical devices

Bryce Cleveland, president and CEO of Arizona-based skincare company Scalpa Inc., pleaded guilty Monday to three federal charges related to the company’s sale of skincare products that had not been approved by the U.S. Food and Drug Administration, according to the Justice Department.

Cleveland, 42, of Scottsdale, Arizona, pleaded guilty to mail fraud, introducing an adulterated device into interstate commerce and introducing an unapproved new drug into interstate commerce, prosecutors said. He was apprehended late last year in Colombia and brought back to the United States, where the U.S. Marshals Service arrested him on an outstanding federal warrant following his July 2024 indictment, according to the Justice Department.

In 2015, Scalpa was an Arizona corporation that marketed and sold medical devices and drug products intended to affect the structure and function of the human body, court documents state. Between March 2018 and December 2020, Cleveland devised a 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 the Hyaluron Pen — while falsely claiming the devices were not subject to FDA regulation, prosecutors said. He also introduced and delivered, and caused others to introduce and deliver, an unapproved new drug called “Scalpatox” into commerce, according to the Justice Department.

The department said injectable products can pose serious health risks because they are delivered directly into the body — and sometimes directly into the bloodstream — bypassing some of the body’s key defenses against toxins and microorganisms that can cause serious and life-threatening conditions.

Scalpatox was an unapproved and misbranded botulinum toxin product, officials said. The FDA issued a warning on Nov. 5, 2025, to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency said it was aware of adverse events associated with such products, including botulism symptoms.

Cleveland has agreed to a prison sentence of between four and eight years, according to the plea agreement. He has also agreed to pay restitution covering the full scope of his criminal conduct and to forfeit $800,000, prosecutors said.

The FDA’s Office of Criminal Investigations investigated the case with assistance from the U.S. Postal Inspection Service. The Justice Department also credited its Office of International Affairs and the Judicial Attaché Office in Bogotá, Colombia, with providing assistance. The U.S. Marshals Service helped locate Cleveland in Colombia and facilitate his return to the United States.

Assistant U.S. Attorneys Corey Hall and Randy Ramseyer of 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 works with law enforcement agencies to investigate and prosecute violations of federal laws designed to protect public health and safety, focusing on corporations and individuals that make and sell dangerous drugs, food and other consumer products that could cause significant harm.