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.”
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