Coronavirus (COVID-19) Update: Daily Roundup August 10, 2020 – FDA.gov

For Immediate Release:

August 10, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its continuous response effort to the COVID-19 pandemic:

As part of the FDAs effort to protect customers, the company issued a caution letter to one company for offering unapproved products with deceptive COVID-19 claims. The business, H-Lab Life, offers “Multi-Use Spray” items, with misleading claims that the products can mitigate, avoid, treat, identify, or cure COVID-19 in people. There are presently no FDA-approved products to deal with or avoid COVID-19. FDA requested that H-Lab Life right away stop selling these unapproved products. Consumers concerned about COVID-19 needs to seek advice from their healthcare service provider.
FDA has upgraded its assistances to supply explanation that companies test each lot of the active component (ethanol or isopropyl alcohol (IPA)) for methanol, if the ethanol or IPA is acquired from another source. Consumer and health care personnel safety is a leading priority for FDA, and an important part of FDAs mission is to safeguard the public from harm, specifically as we look for to assist in 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 usage by health care service providers for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (e.g., nasal, mid-turbinate, oropharyngeal and nasopharyngeal swabs) from people suspected of having contracted COVID-19. Administration of this test is restricted to the George Washington University Public Health Laboratory.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by guaranteeing the security, efficiency, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical gadgets. The firm also is accountable for the security and security of our nations food supply, cosmetics, dietary supplements, products that release electronic radiation, and for regulating tobacco products.

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

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Content present since:

08/10/2020

Managed Product( s).

As part of the FDAs effort to secure customers, the company released a warning letter to one firm for offering unapproved products with deceitful COVID-19 claims. FDA has upgraded its guidances to supply information that companies test each lot of the active component (ethanol or isopropyl alcohol (IPA)) for methanol, if the ethanol or IPA is acquired from another source. Consumer and health care workers security is a leading priority for FDA, and a crucial part of FDAs objective is to protect the public from harm, particularly as we look for to assist in a boost 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.

Health Topic( s).