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:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Issues Updated Compliance Program for Infant FormulaCFSAN Constituent Updates FDA Issues Updated Compliance Program for Infant Formula
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintConstituent Update

The U.S. Food and Drug Administration has updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious. This effort is part of the FDA’s ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry.

In September 2022, the FDA released its internal evaluation of the infant formula response which recommended that the agency review and update its infant formula compliance program to ensure that it reflected the latest science on *Cronobacter*and offered consistency and clarity on our inspection and compliance activities. In November 2022, as part of the *Cronobacter* prevention strategy the agency committed to completing this review and update.

The FDA has now published its updated compliance program, which builds on lessons learned over the last several years to elaborate on our approaches for inspections, sampling, laboratory analysis, and imported infant formula products. For example, updates include instructions for annual environmental sampling of*Cronobacter* and *Salmonella*at powdered infant formula facilities. The compliance program provides instruction for FDA notification should a sample test positive for *Cronobacter*or *Salmonella*, or if a sample is found to have nutrients that are above or below required levels per the FDA’s infant formula regulation.

The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.

More generally, additional background on the risks associated with *Salmonella*and *Cronobacter* in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.

All updates related to the FDA’s oversight of infant formula can be found on the FDA's Infant Formula webpage.

Additional Information:

Food Compliance Programs
	Infant Formula

                                                                                  Content current as of:
      10/06/2023
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 Subscribe to CFSAN Constituent Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 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