FDA Summary: April 26, 2022

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 four new tobacco products for sale through the Premarket Tobacco Product Application (PMTA) pathway. The FDA has issued marketing orders granted to NJOY LLC for its Ace closed electronic cigarette device and the three accompanying tobacco flavored e-liquid pods, specifically, NJOY Ace Device, NJOY Ace Pod Classic Tobacco 2 ,4%, NJOY Ace Pod Classic Tobacco 5%, and NJOY Ace Pod Rich Tobacco 5%. The FDA has also issued marketing denial orders to NJOY for several other Ace e-cigarette products. Applications for two menthol flavored Ace e-liquid pods remain under review by the FDA.
  • The FDA has announced May and June dates for the series of virtual town halls for coronavirus (COVID-19) test developers. The new time for events will be 12:05 p.m. to 1 p.m. ET
  • COVID-19 testing updates:
    • To date, 431 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 296 molecular tests and sample collection devices, 84 antibody tests and other immune response tests, 50 antigen tests and 1 diagnostic breath test. There are 77 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 28 antigen tests and 9 molecular tests for serial screening programs. The FDA also authorized 945 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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