Three Individuals and One Company Indicted for Introducing Adulterated and Misbranded Devices into Interstate Commerce and Mail Fraud Conspiracy
The defendants are facing a forfeiture allegation of $327,047.56
SAN JUAN, Puerto Rico – A federal grand jury in the District of Puerto Rico returned an indictment on February 1, 2023 charging Elberto Berdut-Teruel, Wanda L. Carballo-Cabrera, María Santos-Carballo, and Magnetic Healer of PR Inc. with conspiracy and introduction of adulterated and misbranded devices with intent to defraud and mislead, conspiracy to commit mail fraud, and alteration of a device after shipment in interstate commerce.
According to court documents, the defendants unlawfully enriched themselves and operated the company Magnetic Healer of PR Inc. to sell devices containing magnets (“healing magnets”) which were advertised as being effective in the cure, mitigation, treatment, and prevention of diseases in humans, which included COVID-19, migraines, depression, insomnia, Parkinson’s disease, Alzheimer’s disease, autism, and cancer, among others. The indictment alleges that the defendants generated proceeds from the unlawful sale of the devices, which were adulterated and misbranded for purposes of the Federal Food, Drug, and Cosmetic Act (the FDCA) and seeks the forfeiture of a money judgment totaling $327,047.56.
One purpose of the FDCA is to ensure that devices and drugs sold to prevent, cure, or treat diseases are safe and effective for their intended uses and bear labeling that contain true and accurate information and have adequate directions for use. The FDCA prohibits, among other things, the knowing introduction and delivery in interstate commerce of a device that is misbranded or adulterated.
The devices that the defendants sold were misbranded under the FDCA because the defendants marketed and sold devices without notifying and obtaining the necessary approval from the United States Food and Drug Administration (FDA). The lack of approval from the FDA also made the devices adulterated for purposes of the FDCA. Furthermore, the devices were misbranded because their the labeling was false and misleading; the labeling failed to bear adequate directions for use; and the labeling lacked adequate warnings.
The defendants obtained parts for the devices via the mail from vendors outside of Puerto Rico and assembled the devices in Puerto Rico. They promoted the devices on social media and websites, including www.elbertoberdut.com and www.magneticbiotherapy.com. The defendants falsely claimed that the devices did not require FDA approval, had been submitted for FDA approval, and were FDA Authorized, using an official “FDA authorized” logo. The defendants sold the devices via the same websites and at the company’s physical address in San Juan, Puerto Rico.
Elberto Berdut-Teruel was the president, secretary, treasurer, and resident agent of Magnetic Healer of PR Inc. Wanda L. Carballo-Cabrera and María Santos-Carballo were employees of the company.
“Companies that sell medical products put their customers at risk when they misrepresent the quality, safety, or effectiveness of those products,” said W. Stephen Muldrow, United States Attorney for the District of Puerto Rico. “Working with the FDA and other law enforcement partners, we are committed to holding individuals and companies accountable for violating the integrity of the FDA approval process, which directly impacts public health and safety.”
“The FDA continues to actively monitor the marketplace for fraudulent products related to our battle against COVID-19 as well as other diseases and conditions,” said Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations Miami Field Office. “We will continue to take appropriate action against those who choose to mislead consumers and attempt to subvert the legitimate device regulatory regime.”
The defendants are scheduled for their initial court appearance today before U.S. Magistrate Judge Bruce McGiverin of the U.S. District Court for the District of Puerto Rico. If convicted, the defendants face a maximum penalty of 20 years in prison. A federal district court judge would determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The FDA – Office of Criminal Investigations is investigating the case. Assistant U.S. Attorney Victor O. Acevedo-Hernández is prosecuting the case.
For more information about the FDA, the products it regulates, and public safety notices, please visit www.FDA.gov or www.FDA.gov/about-fda/fda-en-espanol.
To report an adverse event or serious problem to the FDA, please visit https://www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda or https://www.fda.gov/safety/reporting-serious-problems-fda/como-los-consumidores-pueden-reportar-eventos-adversos-o-problemas-serios-la-fda.
An indictment is merely an allegation, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.