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 Announces Qualified Health Claim for Certain Cranberry Products and Urinary Tract InfectionsCFSAN Constituent Updates FDA Announces Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintConstituent Update

July 21, 2020

The U.S. Food and Drug Administration announced today in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.

The FDA responded to a health claim petition submitted on behalf of Ocean Spray Cranberries, Inc.  The petition requested that the FDA authorize a health claim regarding the relationship between the consumption of cranberry products and the reduced risk of recurrent urinary tract infection (UTI) in healthy women.  A health claim characterizes the relationship between a substance and a disease or health-related condition.

After reviewing the petition and other evidence related to the proposed health claim, the FDA determined that the scientific evidence supporting the claim did not meet the “significant scientific agreement” standard required for an authorized health claim, and the petitioner agreed to have the petition evaluated as a qualified health claim petition.

Based on the FDA’s review, the agency concluded that there is limited and inconsistent credible scientific evidence to support a qualified health claim for the consumption of cranberry juice beverages and limited credible scientific evidence to support a qualified health claim for the consumption of cranberry dietary supplements and a reduced risk of recurrent UTI in healthy women.  Specifically, the FDA intends to exercise its enforcement discretion regarding claims for the association between  consumption of cranberry juice beverages containing at least 27 percent cranberry juice (most commercially available cranberry cocktails contain this amount) and cranberry dietary supplements containing at least 500 milligrams (mg) of cranberry fruit powder (100% fruit) and a reduced risk of recurrent UTI.  The claims do not include other conventional foods or food products made from or containing cranberries, such as dried cranberries or cranberry sauce.

The following qualified health claims are included in the FDA’s letter of enforcement discretion:

For cranberry juice beverages

“Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
	“Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
	“Consuming one serving (8 oz) each day of [this identified cranberry juice beverage] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”For cranberry dietary supplements

“Limited scientific evidence shows that by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
	“Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”
	“Consuming 500 mg [X capsules/tablets/soft gels] each day of [this identified cranberry dietary supplement] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”**For More Information**

Qualified Health Claims

                                                                                  Content current as of:
      07/21/2020
              
              
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