- 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:
- The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
- The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home use with a self-collected nasal swab sample by people age 14 years and older or people age 8 years and older, when the nasal swab sample is collected by an adult, within the first six days of the onset of COVID-19 symptoms.
- A new FDA Voices entitled National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams, by Judy McMeekin, Pharm. D., explains that the FDA is on the lookout for charlatans seeking to profit from the pandemic. Vaccine distribution is underway throughout the country and schemes to mislead and scam the American public are prevalent. Public health protection for consumers is the hallmark of our mission and the FDA remains vigilant to ensure that consumers are shielded from seedy efforts and can have confidence in COVID-19 vaccines.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Ageless Global, LLC for selling unapproved products with fraudulent COVID-19 claims. The company sells products, including “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray,” and misleadingly represents the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested Ageless Global, LLC take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to KDunn and Associates, P.A. dba HealthQuilt and Kimberly Dunn, M.D., Ph.D., for not complying with federal laws and regulations, including laws and regulations to protect people participating in clinical trials, during the clinical investigation of an investigational drug to treat, cure and prevent COVID-19. Sponsors seeking to develop new drugs to treat or prevent any disease, including COVID-19, must comply with the FDA’s laws and regulations governing the drug approval process.
- Testing updates:
- As of today, 335 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 249 molecular tests and sample collection devices, 71 antibody tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test and one over-the-counter (OTC) at-home antigen test.
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.
- Alison Hunt