- For immediate release:
The U.S. Food and Drug Administration (FDA) continued to act on the ongoing response to the COVID-19 pandemic:
- The FDA has warned the team of clinical laboratories and healthcare professionals that genetic variants of SARS-CoV-2 can lead to false-negative results with molecular tests for SARS-CoV-2. The Letter to the Clinical Laboratory Team and Health Service 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 teams and health professionals.
- Actions the FDA has taken.
- Instructions for reporting problems with a test.
- This week, the FDA published a new web page, Moderna COVID-19 Vaccine Frequently Asked Questions. The questions cover specific aspects, such as what data the FDA reviewed 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 issued a permanent injunction consent decree 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 a prevention or treatment for COVID- 19. The permanent injunction order that the Court issued prohibits defendants from, among other things, selling or distributing new unapproved drugs or drugs with false marks 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, the FDA issued a letter of warning to defendants for fraudulently promoting infringing products on various websites. In the warning letter, the FDA requested that they immediately correct their violations, which was not done.
- “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 disease, including COVID-19, puts consumers’ health at risk, ”said Stacy Amin, FDA Chief Counsel. “We remain committed to seeking and acting quickly against those who attempt to subvert the FDA’s regulatory functions, repeatedly breaking the law and distributing unapproved products.”
- The FDA is particularly concerned that fraudulent products that claim to cure, mitigate, treat or prevent serious illnesses like COVID-19 can cause consumers to postpone or interrupt appropriate medical treatment, leading to serious and fatal damage. The FDA reminds the public to seek medical help from their health care providers and urges people to speak 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 authorization (EUAs). This includes 235 molecular tests and sample collection devices, 64 antibody tests and 12 antigen tests. There are 32 molecular permits that can be used with samples collected at home. There is a home test with molecular prescription, a home test with antigen prescription and a home antigen test without prescription (OTC).
The FDA, an agency of the United States 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 security and protection of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products.
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