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FDA Roundup: July 5, 2022

For Immediate Release:

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

  • Today, the FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System, opened registration for the 2022 Public Meeting of NARMS. The meeting will take place virtually on Wednesday, September 21 and Thursday, September 22, 2022, and is open to all stakeholders at no cost
  • On Thursday, June 30, as part of the FDA’s efforts to protect consumers, the agency issued warning letters, jointly with the Federal Trade Commission, to four companies selling unapproved kratom products and one company selling essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms. The FDA has not approved kratom or essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms. In addition, the agency has received concerning reports about the safety of kratom. The FDA is actively evaluating all available scientific information on this issue and advises consumers not to use kratom or essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms. The companies that received warning letters are: 
  • Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science to its regulatory activities. The agency invites you to attend the next presentation on July 14, 2022, from 12:00 to 1:00 p.m. EDT, on the topic, “One Health at FDA: From Concept to Application.”
  • COVID-19 testing updates:
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1016 revisions to EUA authorizations

Related Information

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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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