A health claim petition submitted on behalf of Ocean Spray Cranberries, Inc, requested that the FDA authorize a health claim regarding the relationship between the consumption of cranberry products and the reduced risk of recurrent UTI in healthy women.
However, 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.
In FDA’s letter of enforcement discretion, the Agency stated it would exercise its enforcement discretion regarding claims for the association between consumption of cranberry juice beverages containing at least 27% 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, added the Agency.
The following qualified health claims are included:
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.”