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FDA Roundup: October 25, 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 issued a Safety Communications warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC (doing business as Perch) due to the risks of injury, including electric shocks, skin burns, rashes or irritation. Yesterday, Whele LLC, announced a recall of over 500,000 Mighty Bliss electric heating pads that were distributed between July 2021 and July 2022. These products were sold through Amazon.com and Walmart.com and have the following descriptions and model numbers: 
    • Blue Electric Heating Pad: Extra-Large (12” x 24”), Model Number: MB-002 (NA-H21C) 
    • Grey Electric Heating Pad: Large (12” x 24”), Model Number: PE-MtyBls-HeatPad-12×24-Gry-V2(NA-H1121B) 
    • Blue Electric Heating Pad: Large (12” x 24”), Model Number: MB-001 (NA-H1121B 

To date, the FDA is not aware of any deaths associated with the use of these products. The company has received reports of user injuries and device malfunctions. 
 

  • Today, the FDA issued a warning letter jointly with the Federal Trade Commission to Lakpura LLC for selling unapproved and misbranded products as drugs for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • On Friday, the FDA along with the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) announced a public meeting of the National Advisory Committee on Microbiological Criteria for Foods. The meeting will be held virtually and will discuss adding a work charge being advanced by FDA on Cronobacter spp. in powdered infant formula. The Committee will also discuss updates under the Cyclospora cayetanensis subcommittee and vote on adopting the following report: “Enhancing Salmonella Control in Poultry Products.” Additional information about the meeting can be found here.  
  • COVID-19 testing updates: 
    • As of today, 435 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 77 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests. 
    • The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1136 revisions to EUA authorizations 

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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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