On July 21, 2020, the U.S. Food and Drug Administration (FDA) announced 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.  FDA’s letter was in response to a health claim petition submitted on behalf of Ocean Spray Cranberries, Inc.  The petitioner requested that FDA authorize a health claim regarding the relationship between the consumption of cranberry products and the reduced risk of recurrent UTI in healthy women.  By way of background, a health claim characterizes the relationship between a substance and a disease or health-related condition.

FDA 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.

In its response to the petition, FDA noted that it will exercise its enforcement discretion regarding claims for the association between consumption of cranberry juice beverages containing at least 27 percent cranberry juice and cranberry dietary supplements containing at least 500 milligrams (mg) of cranberry fruit powder (100% fruit) and a reduced risk of recurrent UTI.   FDA noted that 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 for cranberry juice beverages are included in the FDA’s letter of enforcement discretion:

“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.”

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

“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.”