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FDA Coronavirus (COVID-19) Update: April 10th, 2021

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued a letter to health care personnel and facilities recommending transition from use of decontaminated disposable respirators.

COVID-19 Coronavirus

COVID-19 Coronavirus

The FDA is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse.

Based on the increased domestic supply of new respirators approved by the U.S. Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is an adequate supply of respirators to transition away from the use of decontamination and bioburden reduction systems.

As part of the FDA’s effort to protect consumers and animals, the agency issued warning letters jointly with the Federal Trade Commission (FTC) to two companies for selling unapproved products with fraudulent COVID-19 Coronavirus claims. The FDA requested the companies take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

The first company, Allure Imports, sells products, including “Silver Soul Immune Support”, “Silver Soul Body Spray” and “Vitality C60,” and misleadingly represents that the products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people and animals.

The second company, About Mineral, sells “Puriton” topical skin products, and misleadingly represents that the products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people.

Testing updates:

As of today, 354 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 258 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 21 antigen tests. There are 43 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, four over-the-counter (OTC) at-home antigen test, and one OTC molecular test.

The FDA has authorized 6 antigen tests and 1 molecular test for serial screening programs.

 


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.


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