Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          FDA Roundup: January 11, 2022Press Announcements FDA News Release
  FDA Roundup: January 11, 2022

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  January 11, 2022
 

  
      
       

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

On Jan. 10, the FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension), provided that the claims are appropriately worded to avoid misleading consumers and other factors for the use of the claim are met.
	Today, Acting FDA Commissioner Janet Woodcock, M.D., testified before the U.S. Senate Committee on Health, Education, Labor and Pensions in a hearing titled, Addressing New Variants: A Federal Perspective on the COVID-19 Response. Her congressional testimony can be found here.
	Today, the FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers. These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine. Specifically, the Fact Sheet for Health Care Providers includes information about reports of adverse events following use of the vaccine which suggest an increased risk of ITP during the 42 days following vaccination, and that individuals with a history of ITP should discuss the risk and the potential need for platelet monitoring following vaccination with their healthcare provider.  The Fact Sheet for Recipients and Caregivers includes additional information under the questions, “What should you mention to your vaccination provider before you get the Janssen COVID-19 Vaccine?” and “What are the risks of the Janssen COVID-19 Vaccine?” regarding ITP, as well as what to look for and when to seek medical attention. The FDA and CDC continue to monitor the level of potential excess risk. Individuals should speak to their health care provider to determine which COVID-19 vaccine is most appropriate for their own situation.
	COVID-19 testing updates:
	As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 43 antigen tests. There are 69 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
		The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 756 revisions to EUA authorizations.Related Information
  
  Related Information
              FDA Newsroom

###
  Boilerplate
      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.
Inquiries
  
    
        
         Media:
                 
      
                            FDA Office of Media Affairs
           
           
                      888-INFO-FDA
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      01/11/2022
               
               
Health Topic(s)
			  Infectious Disease
			    			       			    			       Coronavirus   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop