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FDA Coronavirus (COVID-19) Update: July 8th, 2020

 

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:

Yesterday, the FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers alerting them of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.

Coronavirus

Coronavirus

In one study, the manufacturer found approximately three percent (3%) of results were false positive results.

The FDA is working with Becton, Dickinson and Company (BD) to resolve this issue and will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed for new or additional information.

The FDA updated the Molecular Diagnostic templates on FDA.gov to provide more detailed recommendations for the validation of assays intended to be used for pooling patient samples. Laboratories and commercial manufacturers may choose to use the Molecular Diagnostic templates to simplify the preparation and submission of an Emergency Use Authorization request for molecular SARS-CoV-2 assays intended for pooling patient samples.

FDA is warning consumers and health care professionals that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin as well as life-threatening when ingested. Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects.

FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. When doing so, they should provide the agency with as much information as possible to identify the product.

As part of the FDA’s effort to protect consumers, the agency issued warning letters to five companies for selling fraudulent COVID-19 Coronavirus products. There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

The five companies that received warning letters include:

  • SinoTradition.com, which offers traditional Chinese medicine products, including “Lianhua Qingwen Capsules” and “Qing Fei Pai Du Tang,” for sale in the United States with false or misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.
  • Butterfly Expressions, LLC, which offers blessed waters, essential oils, hand sanitizers, homeopathic products, and tinctures for sale in the United States with false or misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.
  • Lotus Herbal Supplements, which offers traditional Chinese medicine products, including “Lianhua Qingwen Capsules,” for sale in the United States with false or misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.
  • Lianhuaqingwencaps.com, offers traditional Chinese medicine products, including “Lianhua Qingwen,” for sale in the United States with false or misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.
  • Shen Clinic, LLC, which offers traditional Chinese medicine products, including “SHUANG HUANG LIAN,” for sale in the United States with false or misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.

 


 

Testing updates:

To date, the FDA has currently authorized 166 tests under EUAs; these include 138 molecular tests, 26 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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