- 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:
- As part of the FDA’s effort to protect consumers, the FDA and the Federal Trade Commission issued warning letters to two companies for selling fraudulent COVID-19-related products. There are currently no FDA-approved products to prevent COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- The first company, Spartan Enterprises Inc. dba Watershed Wellness Center, sells “Dissolve BioActive Silicate” and products labeled to contain silver with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. FDA requested that Watershed Wellness Center immediately stop selling these unapproved and unauthorized products.
- The second company, NovaBay Pharmaceuticals, Inc., sells “AVENOVA® ANTIMICROBIAL LID & LASH SOLUTION, PURE HYPOCHLOROUS ACID, 0.01%, 20 ml” (also referred to as Antimicrobial Avenova Direct 20 ml Spray Solution and Antimicrobial All-Natural Facial Spray) with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. FDA requested that NovaBay Pharmaceuticals, Inc. immediately stop selling these unapproved and unauthorized products.
- A U.S. District Court in Oklahoma granted a motion for default judgment and permanent injunction against Xephyr LLC dba N-Ergetics, Derrill Jinks Fussell, and Linda Sue Fussell for violating federal law by distributing their colloidal silver products 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 March, FDA issued a warning letter to defendants and requested that they immediately correct their violations, which they did not do.
- Today, the FDA alerted clinical laboratory staff and health care providers that false positive results can occur with antigen tests for the rapid detection of SARS-CoV-2. The FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings, and continues to monitor and evaluate these reports and other available information about device safety and performance. The FDA reminds clinical laboratory staff and health care providers about the risk of false positive results with all laboratory tests. Clinical laboratory staff and health care providers can help ensure accurate reporting of test results by following the authorized instructions for use of a test and key steps in the testing process as recommended by the Centers for Disease Control and Prevention.
- Testing updates:
- As of today, 287 tests are authorized by FDA under EUAs; these include 223 molecular tests, 57 antibody tests, and 7 antigen tests.
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.
- Jane Hubbard