- For immediate release:
The US Food and Drug Administration (FDA) has continued to act in response to the ongoing COVID-19 pandemic:
- The FDA has warned clinical laboratory staff and healthcare providers that genetic variants of SARS-CoV-2 could lead to false negative results with molecular tests for SARS-CoV-2. The letter to clinical laboratory staff and healthcare providers contains important information about possible false negative results with molecular tests, including:
- Details on the effect of genetic variants on test performance.
- Recommendations for clinical laboratory staff and healthcare providers.
- Steps taken by the FDA.
- Instructions for reporting problems with a test.
- This week, the FDA launched a new website, Modern COVID-19 Vaccine Frequently Asked Questions. Questions cover details, such as what data the FDA reviewed when deciding to authorize the vaccine for emergency use, how well the vaccine COVID-19 appears, and more.
- A U.S. district court in Georgia has granted a permanent restraining order 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 prevention or treatment for COVID-19. The Permanent Order issued by the court permanently prohibits the accused from selling or distributing, among other things, unapproved new drugs or trademarks with allegations that the products may cure, alleviate, treat or prevent diseases in humans, including COVID -19. In addition, the order permanently prohibits defendants from selling or distributing nutritional supplements containing hordenine HCl because hordenine HCl is an unsafe additive. In May, the FDA issued a warning letter to the accused for fraudulently promoting the offending products on a number of websites. In the warning letter, the FDA requested that they rectify their violations immediately, which they did not do.
- ‘Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. “Evidence that unproven drugs can cure or prevent diseases, including COVID-19, is endangering the health of consumers,” said Stacy Amin, FDA chief executive. “We remain committed to taking swift action against those who seek to undermine the FDA’s regulatory functions by repeatedly disregarding the law and distributing unapproved products.”
- The FDA is particularly concerned that fraudulent products that claim to cure, alleviate, treat or prevent serious diseases such as COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening damage. The FDA reminds the public to seek medical help from their healthcare providers and asks people to talk to their healthcare provider about treatment options.
- Test updates:
- As of today, 311 tests and sample collection devices are approved by the FDA under emergency use permits (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 samples collected at home. There is one home test with molecular prescription, one home test for antigen prescription and one home antigen test without prescription.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products.
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