Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:
Thursday, the FDA provided an update on the Agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 Coronavirus pandemic.
In response to scammers on the internet selling unproven medical products, the FDA has taken – and continues to take – a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus.
The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 Coronavirus products, as part of the agency’s effort to protect consumers.
There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.
- The first seller warned, Alive By Nature, Inc., offers “NAD+” and “NMN” sublingual gel products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19 Coronavirus.
- The second seller warned, GlutaGenic, offers Viral Protection Kits for sale U.S. with misleading claims that the products in the kits are safe and/or effective for the prevention of COVID-19 Coronavirus.
Yesterday, the FDA shared the first test report and detailed data from the independent validation study performed at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center sponsored by the National Institutes of Health’s (NIH) National Cancer Institute (NCI), which data were used to support an EUA request.
The results come from a collaborative effort by the FDA, NIH, U.S. Centers for Disease Control and Prevention (CDC), and Biomedical Advanced Research and Development Authority (BARDA) to evaluate certain serological tests. While the EUA request was not granted solely based on the validation data, the data were leveraged to inform FDA’s decision making.
The NCI FNLCR test report provides new details on the testing that is being performed by NCI. Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases, the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.
Yesterday, the FDA issued an Emergency Use Authorization (EUA) to Sherlock BioSciences, Inc.’s Sherlock CRISPR SARS-CoV-2 Kit.
This test is the first authorized use of CRISPR technology for an infectious disease test. The Sherlock CRISPR SARS-CoV-2 Kit is a CRISPR-based SHERLOCK (Specific High sensitivity Enzymatic Reporter unLOCKing) diagnostic test that looks for the specific target RNA or DNA sequences of the SARS-CoV-2 virus in upper respiratory specimens, such as nasal swabs, and bronchoalveolar lavage specimens, such as from fluid in the lungs, from individuals suspected of COVID-19 Coronavirus by their healthcare provider. Use of the test is limited to laboratories certified under CLIA to perform high-complexity tests.
Today, the FDA reissued the EUA for non-NIOSH-approved respirators manufactured in China. The FDA updated the eligibility criteria by making a few main changes, including revising one of the criteria that required an accredited and independent lab test to now require that certain respirators previously listed in Appendix A must pass CDC/NIOSH testing, as further explained in the EUA.
As part of the government’s continuous quality assessment of these respirators, CDC, working with FDA, conducted additional assessments and found that some of the respirators authorized under the April 3rd, 2020 EUA did not meet the expected performance standards. As a result, the FDA revised and reissued the EUA to remove all firms that were authorized based on the independent lab test criterion.
Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China – all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC NIOSH to determine whether the respirator meets acceptable particulate filtration standard. The FDA is committed to helping health care providers navigate this dynamic situation, and we issued a Letter to Healthcare Providers with considerations for all health care facilities that have respirators in their inventory.
Today, the FDA issued a Letter to Health Care Providers on Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization. The FDA has become aware of the potential for health care facility staff that reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of medical devices because there is no standard indicator color to indicate a sterilized device.
The Agency recommends that health care facility staff review the manufacturer’s instructions for their indicators. Each manufacturer has developed its own color scheme to validate the sterilization process, and the colors vary among manufacturers even though many are validated for the same cycle conditions. There have been no injuries reported to the FDA associated with the use of these indicators.
Today, the FDA issued an immediately in effect guidance, “Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency” to assist animal drug sponsors in submitting timely and informative drug shortage notifications to the FDA. This guidance explains how and why to notify the FDA, and the details to provide about the discontinuance or interruption of manufacturing and other factors that may impact availability of animal drug products.
The guidance also includes examples of steps FDA’s Center for Veterinary Medicine may take to prevent or mitigate animal drug shortages, and information sponsors can provide proactively to help avoid shortages.
The FDA released informational materials for food industry in Spanish, Somali and other languages. This assistance provides food safety best practices for retail food stores, restaurants and food pick-up/delivery services during the COVID-19 Coronavirus pandemic.
- Spanish resource: What to Do if You Have COVID-19 Confirmed Positive or Exposed Workers in Your Food Production, Storage, or Distribution Operations Regulated by FDA
- Spanish resource: Use of Respirators, Face masks, and Cloth Face Coverings in the Food and Agriculture Sector During Coronavirus Disease (COVID-19) Pandemic
- Somali, Af Soomaali resource: Best Practices for Retail Food Stores, Restaurants, and Food Pick-Up/Delivery Services During the COVID-19 Coronavirus Pandemic
- Hmong, Hmoob resource: Best Practices for Retail Food Stores, Restaurants, and Food Pick-Up/Delivery Services During the COVID-19 Coronavirus Pandemic
Diagnostics update to date:
- During the COVID-19 Coronavirus pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
- To date, the FDA has issued 63 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 245 laboratories have begun using their own tests under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
Additional Resources:
Consumer Inquiries: 888.INFO.FDA
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.
