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 Infant Formula Update: August 10, 2022Press Announcements FDA News Release
  FDA Infant Formula Update: August 10, 2022

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  August 10, 2022
 

  
      
       

  Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities.

**Company:** Reckitt Nutrition/Mead Johnson Nutrition (Mexico)

**Product(s):** Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron)

**Type of Formula:** Base powder for Specialty Formula (amino acid-based formula)

**Estimated Quantity:** an initial shipment of 331K pounds of base powder which will be used to produce (about 469,000 cans or about 6 million full-size, 8-ounce bottles)

**Availability:** The PurAmino base will be produced in August, to then be blended and packaged in the U.S. and is expected to be distributed immediately following.

**More Information and Where to Find the Products:** PurAmino is a hypoallergenic, iron fortified, amino acid-based infant formula used for infants and toddlers with severe cow’s milk protein allergy and other food allergies. The product will be distributed primarily through hospitals and other healthcare settings and select retail stores.

The FDA is exercising enforcement discretion for the importation of the infant formula products listed above following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history.

The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition. The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there's adequate infant formula available wherever and whenever parents and caregivers need it.

The FDA issued guidance on May 16 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries. This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to further increase the quantity of domestically-produced product for the U.S. market. The agency has posted a webpage that will be updated with information about additional products headed to the U.S.

**Ongoing FDA Steps to Increase Availability of Safe, Nutritious Infant Formula**

The agency's around-the-clock work as part of the all-of-government efforts has already begun to improve supply and availability. The agency expects that the measures and steps it is taking, and the resumption of production at the Abbott Nutrition's Sturgis, Mich., facility, will mean more and more supply is on the way or on store shelves moving forward.

The FDA continues to advise against making infant formulas at home or diluting formula. Parents and caregivers are encouraged to work with their child's health care provider for recommendations on changing feeding practices, if needed. The U.S. Department of Health and Human Services also has additional information available at HHS.gov/formula, including information to help families find infant formula.

The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. The FDA also monitors and follows up on various external signals such as consumer complaints about potential counterfeit and fraudulent products.

The FDA will continue to dedicate all available resources to help ensure that safe and nutritious infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.

  Related Information
  
  Related Information
              Infant Formula Information and Ongoing FDA Efforts to Increase Supply
	Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
	HHS.gov/formula
	HHS.gov/news
	FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
	Powdered Infant Formula Recall: What to Know
	CDC Information on Cronobacter Infection and Infants

###
  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
           
           
                      301-796-4540
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      08/10/2022
               
               
Regulated Product(s)
		 Food & Beverages   

        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