According to a recent Department of Justice (DOJ) News Release, Johnny T. Stine, a self-claimed biotech expert and Founder and President of North Coast Biologics was arrested on a federal warrant for marketing an untested, unapproved COVID-19 vaccine online, offering vaccine injections to customers across the country for $400 to $1000 each. The conduct is now under investigation.
Social media posts alerted the Food and Drug Administration's Office of Criminal Investigation (FDA-OCI) to Stine's marketing efforts. According to the criminal complaint, an undercover investigator contacted Stine, who conveyed that he had COVID-19 vaccines for sale. Stine claimed that he created the COVID-19 vaccine using a method similar to one he had been using to bout cancer tumors.
During the investigation in March 2020, FDA-OCI also received complaints indicating that Stine was injecting people with the vaccine. In early April, Stine told these undercover investigators that he traveled across the U.S. giving his vaccine. In late April, based upon public complaints, the Washington State Attorney General issued a cease and desist letter to Stine, aiming to stop Stine from making claims and offering his “vaccine” for COVID-19. Stine continued his efforts, calling the vaccines "immunogen" instead. Stine eventually signed a Consent Decree in June where he agreed to not continue promotion or selling of such vaccine, but continued to sell the vaccine. Additionally, in late May, FDA and the Federal Trade Commission (FTC) sent a warning letter to Mr. Stine for unapproved and misbranded products related to COVID-19 for similar practices claiming that it was an "unlicensed biological product".
Law enforcement contacted Stine in Idaho and seized the vaccine in August. The investigation also revealed that Stine sold untested "vaccines" to target malignant tumors to cancer patients.
U.S. Attorney Brian T. Moran states in the news release, “Untested, untried and potentially unsafe – this defendant was injecting people with an unknown substance claiming it was a vaccine for COVID-19. Preying on our fears in the midst of this pandemic is unconscionable. DOJ continues to investigate and prosecute these fraud cases.”
Among other comments made by agencies in the news release, Special Agent in Charge Robert Hammer, of Homeland Security Investigations (HSI) states, “The very idea that someone would prey upon fearful people seeking a COVID vaccine in the midst of a global pandemic is not only despicable, but potentially deadly behavior. Equally appalling is the exploitation of vulnerable cancer patients and their families, desperate for treatment. Snake oil salesmen, such as this, who endanger consumers should take this arrest as a stern warning."
A copy of the DOJ News Release is available here.
For more information regarding DOJ enforcement, please see the Government Prosecutions section of the Enforcement Actions Database.