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:
The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.”
The guidance provides a mechanism for FDA-regulated establishments (human food facilities and farms) to voluntarily notify the agency of temporary closures and significant reductions in operations and to request assistance from FDA on issues that might affect continuity of their operations during the pandemic.
The FDA issued a guidance document entitled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications” to provide answers to frequently asked questions. The agency is providing answers concerning certain aspects of sponsor requests for formal meetings with industry, user fee applications goals and timelines, and prioritization of drug and biological application reviews during the public health emergency.
The FDA and Federal Trade Commission (FTC) issued warning letters to four companies for promoting and participating in the sale of 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. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.
The first company warned, CBD Gaze, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of CBD productswith misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people.
The second company warned, Alternavita, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of grapefruit seed extract, colostrum, and cod liver oil products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people.
The third company warned, Musthavemom.com, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of products including colloidal silver, vitamins, minerals, herb oils and a homeopathic drug product with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people.
The fourth company warned, Careful Cents, LLC, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of essential oil products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people.
Today, a judge in the U.S. District Court for the Eastern District of Oklahoma entered a preliminary injunction against Xephyr LLC, doing business as N-Ergetics, and individual defendants Brad Brand, Derill J. Fussell and Linda Fussell. The injunction requires Xephyr and the associated individuals to, among other things, immediately stop distributing colloidal silver products. It was issued on the same basis as a temporary restraining order entered by the court on May 14th, 2020.
As noted then, defendants offered their colloidal silver products for sale to treat coronavirus, which includes COVID-19 and many other diseases, and, which FDA alleges violates the Federal Food, Drug, and Cosmetic Act (FD&C) because the products are unapproved new drugs and misbranded drugs. The preliminary injunction governs throughout the course of the legal proceeding, thereby disrupting the supply chain for defendants’ fraudulent colloidal silver products until the court rules on permanent relief.
The complaint was filed by the U.S. Department of Justice at FDA’s request. The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction.
The FDA issued a letter to health care providers to remind reprocessing staff in health care facilities to use the correct sterilization cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 Coronavirus pandemic.
These sterilization systems help increase the availability of respirators by allowing decontaminated compatible respirators to be reused so health care workers on the front lines can be better protected when providing care to patients with COVID-19 Coronavirus.
Yesterday, the FDA issued two guidance documents (one new guidance and one revised guidance) for industry to help address potential shortages of face masks, surgical masks, respirators, and face shields for use during the COVID-19 public health emergency: Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).
These guidances help to address potential shortages by facilitating the safe reuse and conservation of surgical masks and respirators for medical purposes through the use of decontamination and bioburden reduction systems and providing recommendations of alternatives and updated options for when FDA-cleared or NIOSH-approved N95 respirators are not available.
Yesterday, the FDA issued an Emergency Use Authorization (EUA) for emergency use of the CLEWICU System of CLEW Medical Ltd for use by healthcare providers in the intensive care unit (ICU) as a diagnostic aid to assist with the early identification of adult patients who are likely to be diagnosed with respiratory failure or hemodynamic instability which are common complications associated with COVID-19 Coronavirus.
The CLEWICU system utilizes the full range of available patient data to provide continuous predictions based on data driven algorithms and machine learning models. The CLEWICU system delivers workflow improvements and dynamic worklist prioritization, enabling healthcare providers to spend less time on administration and more time on patient treatment. In this way, CLEWICU may reduce the contact between ICU personnel and patients by providing the ICU clinician the ability to view the patient risk status from a remote location.
Testing updates:
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.
Additional Resources:
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)
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.
