- For immediate release:
The United States Food and Drug Administration (FDA) continued to act in response to the ongoing response to the COVID-19 pandemic:
- The FDA warned clinical laboratory personnel and health care providers that genetic variants of SARS-CoV-2 could lead to false negative results with molecular testing for SARS-CoV-2. The letter to clinical laboratory personnel and health care providers contains important information about possible false negative molecular test results, including:
- Details about the effect of genetic variants on test performance.
- Recommendations for clinical laboratory personnel and healthcare professionals.
- Actions taken by the FDA.
- Instructions for reporting problems with a test.
- This week, the FDA posted a new web page, Moderna COVID-19 Vaccine Frequently Asked Questions. Questions pertain to specific issues, such as what data the FDA reviewed when deciding whether to approve the vaccine for emergency use, how well the vaccine prevents COVID-19, and more.
- A U.S. District Court in Georgia has issued a consent decree of permanent prohibition to Fusion Health and Vitality LLC, Fusion Ionz LLC, and Matthew Ryncarz for violating federal law through the distribution of products containing vitamin D and hordenine HCl for prevention or treatment of COVID-19. The warrant of permanent injunction issued by the court prohibits the defendants, among other things, from selling or distributing unapproved new drugs or branded drugs with claims that the products can cure, alleviate, treat or prevent diseases in humans, 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, the FDA issued a warning letter to defendants for fraudulently promoting violent products on a number of websites. In the warning letter, the FDA asked for their violations to be corrected immediately, which they failed to do.
- “Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Claims that unproven drugs can cure or prevent disease, including COVID-19, endangers consumer health, ”said FDA Chief Counsel Stacy Amin. “We remain committed to taking swift action against those who seek to undermine the FDA’s regulatory functions by repeatedly ignoring the law and distributing unapproved products.”
- The FDA is particularly concerned that fraudulent products claiming to cure, mitigate, treat, or prevent serious illnesses such as COVID-19 could cause consumers to delay or discontinue appropriate medical treatment, leading to serious and life-threatening damage. The FDA is reminding the public to seek medical attention from their healthcare providers and urges people to talk to their healthcare provider about treatment options.
- To test updates:
- As of today, 311 samples collection tests and 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 self-collected samples. There is one molecular prescription home test, one antigen prescription home test, and one over-the-counter (OTC) home antigen test.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security 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 our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.
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