SILVER SPRING, Md.,
July 7, 2020 /PRNewswire/ -- The U.S.
Food and Drug Administration (FDA) today continued to take action
in the ongoing response to the COVID-19 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. 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 products. There are currently no FDA-approved products to
prevent or treat COVID-19. Consumers concerned about COVID-19
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 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 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 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
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 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.
Additional Resources:
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public
Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)
Media Contact: Lee.Herring@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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.
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SOURCE U.S. Food and Drug Administration