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 Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-ContactCFSAN Constituent Updates FDA Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintConstituent Update

May 16, 2023

The U.S. Food and Drug Administration (FDA) has released a draft Compliance Policy Guide to provide guidance for FDA staff on the FDA’s enforcement policy regarding major food allergen labeling and cross-contact.  The draft CPG more accurately reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, it will replace the existing CPG 555.250 for FDA staff.

Among the updates, the draft CPG describes the labeling requirements for major food allergens and the proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. Further, the draft CPG describes additional allergen labeling violations. It also directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations. The updated CPG reflects the FDA’s risk-based and science-based approach for the evaluation of potential allergen violations.

The FDA is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address the issue of industry adding sesame to products that did not previously contain it, the draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. The FDA is engaged with various stakeholders on this issue. The FDA recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume-an outcome that the FDA does not support.

To ensure that comments are received before work begins on the final version of the guidance, submit electronic or written comments within 60 days of publication in the Federal Register.  Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number FDA-2023-D-1103. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

**For More Information:**

*Federal Register* notice
	Compliance Policy Guide Sec. 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact
	Food Allergies

                                                                                  Content current as of:
      05/16/2023
              
              
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  Allergens
				  				     				  				  
				  
				   
				  
				  				  LabelingCFSAN 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