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FDA OKs Limited Health Claims About Cranberries and UTIs

Juice, dietary supplements may reduce the risk of urinary tract infections in women

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The jury remains out on the benefits of cranberry products on urinary tract infections, but a major producer has for now been given the right to make limited claims about the possible link.

The Food and Drug Administration (FDA) will allow Ocean Spray Cranberries Inc. to make a “qualified health claim” that certain cranberry juices and dietary supplements reduce the risk of recurrent urinary tract infection (UTI) in healthy women. While the FDA's decision does not constitute outright approval of the claims, it will allow the company to market the claims with stipulations that the evidence so far is lacking.

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In a news release accompanying its official Letter of Enforcement Discretion, the FDA said it had determined that the scientific evidence behind the claims for both juices and supplements is inadequate for a number of reasons.

The FDA would accept the following wording for the qualified claim for juices: “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.” For dietary supplements: “Limited scientific evidence shows that by consuming 500mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI."

Ocean Spray had petitioned for a stronger “authorized health claim” from the FDA, but the agency found that the results of a number of studies do not support such a conclusion.

"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,” the agency wrote.

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