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FDA Takes Initial Action on Ocean Spray Cranberries, Inc. Health Claim Petition for Cranberry Product and UTIs in Women

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On September 8, 2017, Ocean Spray Cranberries, Inc. (Ocean Spray) originally submitted a health claim petition to the Food and Drug Administration (FDA) for approval of a health claim tying together the consumption of cranberry products and the reduced risk of urinary tract infections (UTIs) in healthy women. More recently, on February 20, 2018, the FDA sent a letter to Ocean Spray stating that it is proceeding to review the petition as one for a qualified health claim. All of this information has now been posted in the agency docket. Comments on this qualified health claim petition will be accepted until May 7, 2018, and the FDA expects to issue a final decision on the claim by October 5, 2018.

This post summarizes Ocean Spray’s petition, the studies cited in support of Ocean Spray’s claim, the discussion concerning cranberry as an eligible “substance,” and the FDA’s response.

Click here to read more.

 

Authored by Steve Steinborn.

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