- For immediate release:
Today, the US Food and Drug Administration announced the following actions to be taken in its ongoing response to the COVID-19 pandemic:
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to a company for selling unapproved products with COVID-19 fraud claims. The company, H-Lab Life, sells its product “Multi-Use Sprays”, with a misleading claim that it can reduce, prevent, treat, diagnose or cure COVID-19 in humans. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requires H-Lab Life to stop selling these unapproved products immediately. Consumers concerned about COVID-19 should consult with their healthcare provider.
- The FDA has taken additional action to help ensure that hand sanitizers made according to its interim guidelines are free from unsafe methanol levels. The FDA has updated its guidelines to clarify that companies test each batch 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 denatured formulation in interim guidelines. The denaturation of alcohol in hand sanitizer is very important to prevent inadvertent ingestion by children. Safety for consumers and healthcare workers is an FDA’s top priority and an important part of FDA’s mission is to protect the public from harm, especially as we seek to facilitate harm. to increase hand sanitizer supplies.
- FDA has issued an Emergency Use License to the George Washington University Public Health Laboratory to perform the GWU SARS-CoV-2 RT-PCR Test. This molecular test is used by health care providers to qualitatively detect nucleic acids from SARS-CoV-2 in upper respiratory tract samples (e.g., nasal swab samples middle, nasopharyngeal, and oropharynx) from people with suspected COVID-19 infection. Administering this test is limited to the George Washington University Public Health Laboratory.
- Checking for updates:
- So far, the FDA has currently allowed 208 tests under the EUA; these include 169 molecular tests, 37 antibody tests and 2 antigen tests.
FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of medicines for humans and veterinary drugs, vaccines, and products. bio-products for human use and for medical devices. It is also responsible for the safety and security of food supplies, cosmetics, dietary supplements, and products that emit electronic radiation and regulates tobacco products in their respective countries. me.