FDA Summary: June 10, 2022

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For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • Today, the FDA cleared two new tobacco products for sale through the Premarket Tobacco Product Application (PMTA) pathway. The FDA has issued marketing orders to NJOY LLC for its daily tobacco flavored disposable e-cigarettes, specifically NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%. The FDA has also issued marketing denial orders to NJOY for several other Daily-branded e-cigarette products. Applications for two menthol-flavored Daily products remain under review by the FDA.
  • On Thursday, the FDA warned of the potential dangers of products for treating moles, seborrheic keratoses or skin tags. The agency advises consumers to avoid these products because of their potentially harmful side effects and serious risks. These risks include skin lesions, infections requiring antibiotics, scarring, and delayed diagnosis and treatment of skin cancer. Currently, there are no FDA-approved prescription or over-the-counter medications, or over-the-counter monograph medications marketed legally for the treatment of these lesions.
  • COVID-19 testing updates:
    • To date, 437 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 49 antigen tests and 1 diagnostic breath test. There are 80 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 17 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1000 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


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