Coronavirus Disease 2019 (COVID-19) | FDA

Coronavirus Disease 2019 (COVID-19) | FDA

Coronavirus (COVID-19) Update: Daily Roundup May 8, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic: The U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously authorized under the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline. Today, FDA issued two documents designed to assist retail food establishments that might have been closed or partially closed during the COVID-19 pandemic in preparing to reopen. The checklist and infographic documents are designed to help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars and carry-outs, protect employee and public health as they reopen for business.

Today, the FDA issued an updated At-A-Glance that provides a quick look at facts, figures and highlights of agency’s response efforts. The FDA and Federal Trade Commission (FTC) issued warning letters to four companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. The first seller warned, Sanit Technologies LLC dba Durisan, offers non-alcohol based hand sanitizer products for sale in the U.S. with false or misleading claims including that the products maintain their effectiveness for up to 24 hours. Such time-specific extended efficacy claims may give users the false impression that they need not rigorously adhere to interventions such as social distancing and exercising good hygienic practices that have been demonstrated to curb the spread of COVID-19. The second seller warned, AgroTerra, Ltd. Dba Patriot Hemp Company, offers CBD products for sale U.S. with misleading claims that the products are safe and/or effective for the prevention of COVID-19. In addition, FDA observed that the company participates in the Amazon Associates program. In the program, the company earns commissions by promoting the sale of multiple products on the company’s website with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The third seller warned, WashingtonsLastFrontier.Com, participates in the Amazon Associates program.  As an Amazon associate, the company earns commissions by promoting the sale of products, including essential oils and dietary supplements, on the company’s website with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The fourth seller warned, Chronic Lyme Treatments, offers herbal products for sale in the U.S. that misleadingly represent the products as safe and/or effective for the prevention and/or treatment of COVID-19.

Yesterday, the FDA issued an EUA for the Duke Decontamination System for use in decontaminating compatible N95 or N95-equivalent respirators for reuse by health care personnel when there are insufficient supplies of these respirators resulting from the COVID-19 pandemic. This is the sixth respirator decontamination system FDA has authorized for emergency use during this pandemic and the second based on public health emergency preparedness research funded by FDA. Yesterday, FDA approved an Abbreviated New Drug Application for lidocaine hydrochloride injection USP, 1%, which is indicated for production of local or regional anesthesia and a drug listed in the FDA Drug Shortage Database. FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.

Diagnostics update to date: During the COVID-19 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 65 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 testing 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.

Coronavirus Disease 2019 (COVID-19)