The FDA announced supplements that contain a daily serving of 500mg of whole-fruit cranberry are now allowed to use a qualified health claim on their labels and in their marketing materials. FDA authorized and allowed three wording options for qualified health claims for dietary supplements. The following qualified health claims 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.”
FDA also authorized qualified health claims for cranberry juice beverages, including:
- “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 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.
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