For Immediate Release:
January 08, 2021

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
    • Details on the effect of genetic variants on test performance.
    • Recommendations for clinical laboratory staff and health care providers.
    • Actions the FDA has taken.  
    • Instructions for reporting problems with a test. 
  • This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA review when deciding whether to authorize the vaccine for emergency use, how well the vaccine prevents COVID-19, and more.
  • A U.S. District Court in Georgia granted a consent decree of permanent injunction against Fusion Health and Vitality LLC, Fusion Ionz LLC and Matthew Ryncarz for violating federal law by distributing products containing vitamin D and hordenine HCl, as preventions or treatments for COVID-19. The order of permanent injunction that the Court issued permanently prohibits the defendants from, among other things, selling or distributing unapproved new drugs or misbranded drugs with claims that the products can cure, mitigate, treat or prevent diseases in people, including COVID-19.  In addition, the injunction permanently prohibits defendants from selling or distributing dietary supplements containing hordenine HCl because hordenine HCl is an unsafe food additive. In May, FDA issued a warning letter to the defendants for fraudulently promoting violative products on a number of websites. In the warning letter, the FDA requested that they immediately correct their violations, which they did not do.  
    • “Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases, including COVID-19, places consumers’ health at risk,” said FDA Chief Counsel Stacy Amin. “We remain committed to pursuing and taking swift action against those who attempt to subvert the regulatory functions of the FDA by repeatedly disregarding the law and distributing unapproved products.” 
    • The FDA is particularly concerned that fraudulent products that claim to cure, mitigate, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. The FDA reminds the public to seek medical help from their health care providers and urges people to talk to their health care provider about treatment options.
  • Testing updates:
    • As of today, 311 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 235 molecular tests and sample collection devices, 64 antibody tests, and 12 antigen tests. There are 32 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.

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