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 consumption of certain cranberry products and a 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. Under the law, FDA may authorize health claims provided that there is significant scientific agreement (SSA) that the claim is supported. In 2017, a Petition submitted on behalf of Ocean Spray Cranberries, Inc. requested that FDA authorize a health claim regarding the relationship between the consumption of cranberry products and a reduced risk of recurrent UTI in healthy women. FDA determined that the evidence supporting the claim did not meet the SSA standard for an authorized health claim, and, early in 2018, the Petitioner agreed to have the Petition treated as a qualified health claim petition.
As described in FDA’s letter of enforcement discretion, FDA will not object to claims regarding the consumption of cranberry juice beverages containing at least 27 percent cranberry juice, provided that claims include a qualifier that there is limited in inconsistent evidence showing that daily consumption of 8 fl ounce of a cranberry juice beverage reduces the risk of recurrent UTI in healthy women.
For cranberry dietary supplements, FDA will also exercise enforcement discretion for a claim about the relationship between the consumption of cranberry dietary supplements containing at least 500 milligrams (mg) of cranberry fruit powder (100% fruit) and the reduced risk of recurrent UTIs in healthy women provided the claim specifies that the claim is supported by limited scientific evidence.
The letter of enforcement discretion is effective immediately, i.e., the qualified health claims may be used immediately in the labeling of eligible products.