- For immediate release:
The U.S. Food and Drug Administration today announced the following actions 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 one company for selling unapproved products containing fraudulent COVID-19 claims. The company, H-Lab Life, sells “Multi-Use Spray” products, with misleading claims that the products COVID-19 can reduce, prevent, treat, diagnose or cure. There are currently no FDA-approved products to prevent or treat COVID-19. The FDA asked H-Lab Life to stop selling these unapproved products immediately. Consumers who are concerned about COVID-19 should consult their healthcare provider.
- The FDA has taken additional measures to ensure that hand sanitizers produced under the agency’s temporary leads do not contain unsafe levels of methanol. The FDA has updated its guidelines to clarify 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 extra denaturant formula in the temporary leads. Denaturing alcohol in hand sanitizers is critical to prevent children from unintentional ingestion. Safety of consumer and health care personnel is a top priority for FDA, and an important part of the FDA’s mission is to protect the public from harm, especially as we seek to facilitate an increase in the supply of hand sanitizers.
- FDA has 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 healthcare providers for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (eg nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs) of persons suspected of COVID -19. Administration of this test is limited to the George Washington University Public Health Laboratory.
- Test updates:
- To date, the FDA has currently authorized 208 tests under EUAs; these include 169 molecular tests, 37 antibody tests, and 2 antigen tests.
The FDA, an agency in the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food ban, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.
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