- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA’s Office of Criminal Investigations recently investigated a case that has led to an arrest and the filing of a criminal complaint by the U.S. Department of Justice for introducing misbranded drugs into interstate commerce. The criminal investigation found that in a variety of online postings from as early as March 2020, the defendant, Johnny T. Stine, claimed to have a COVID-19 vaccine that he offered to inject in customers for $400-$1000 each. Stine’s company, North Coast Biologics, had previously received a warning letter from the agency for promoting an unapproved COVID-19 vaccine product.
“Unproven injectable vaccines purported to prevent or treat COVID-19, made from unknown substances under unknown conditions, present significant health risks in and of themselves. They also can lead consumers to make lifestyle choices that increase their actual risk of infection with COVID-19, or to delay or stop appropriate medical treatment,” said Special Agent in Charge Lisa L. Malinowski, FDA Office of Criminal Investigations Los Angeles Field Office. “The FDA will continue to investigate fraudulent COVID-19 treatments and bring to justice those who try to profit from the pandemic by offering unproven and illegally marketed coronavirus products.”
- The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times.
Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simulated and real-world use, the FDA has determined that it is appropriate to protect the public health or safety to revise certain decontamination system EUAs to limit the number of decontamination cycles and respirator reuses permitted under each authorization.
- Today, the FDA also added two new devices to the device discontinuance list on our web page that lists medical device shortages during the COVID-19 public health emergency. There are no updates to the device shortage list at this time. The FDA will continue to update the device shortage and device discontinuance lists as the COVID-19 public health emergency evolves. Specifically, the FDA added the following devices to the device discontinuance list:
- 3M Company's 3M Triple Layer Molded Face Mask (2042F) and 3M Triple Layer Molded Face Mask, Petite (2042FP)
- BioFire Diagnostics, LLC's FilmArray Instrument (FLM1-ASY-0001)
- Testing updates:
- As of today, 319 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 237 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 33 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Abby Capobianco