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FDA Coronavirus (COVID-19) Update: August 11th, 2020

 

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

As part of the FDA’s effort to protect consumers, the agency issued a warning letter to one firm for selling unapproved products with fraudulent COVID-19 Coronavirus claims.

Coronavirus

Coronavirus

The company, H-Lab Life, sells “Multi-Use Spray” products, with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.

There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus.

FDA requested that H-Lab Life immediately cease selling these unapproved products. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

FDA has taken additional action to help ensure that hand sanitizers produced under the agency’s temporary guidances do not contain unsafe levels of methanol. FDA has updated its guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol, if the ethanol or IPA is obtained from another source.

FDA has also included an additional denaturant formula in the temporary guidances. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Consumer and health care personnel safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to facilitate an increase in the supply of hand sanitizer.

FDA issued an Emergency Use Authorization to George Washington University Public Health Laboratory for its GWU SARS-CoV-2 RT-PCR Test. This molecular test is for use by health care providers for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (e.g., nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs) from individuals suspected of having contracted COVID-19 Coronavirus.

Administration of this test is limited to the George Washington University Public Health Laboratory.

Testing updates:

To date, the FDA has currently authorized 208 tests under EUAs; these include 169 molecular tests, 37 antibody tests, and 2 antigen tests.

 


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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