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.

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Photo of Steve Steinborn Steve Steinborn

Partner, Washington, DC

Steven Steinborn literally wrote the book on food labeling as a principal author of the U.S. Department of Agriculture’s (USDA) labeling guide. On top of that, he offers clients 28 years of experience in guiding informed business decisions, taking into account food laws and other regulations, as well as the environment in which companies operate. Representing food processors, restaurant chains, foodservice operators, ingredient suppliers, and trade associations, Steven focuses on advertising, labeling, and food safety. He is also a strong advocate in enforcement matters brought by the Federal Trade Commission, the Food and Drug Administration, the USDA, and state regulators as well.

From small start-ups to established international brands, Steven understands the dynamics of the food industry. He brings this knowledge to bear on cutting-edge issues ranging from claim substantiation to potential food safety situations. He is also regularly consulted in bringing and defending competitor challenges, and represents companies before the Better Business Bureau’s National Advertising Division. Keenly aware of the current litigation climate, Steven works closely with marketers in exploring all avenues to reach important business objectives.

Beyond the food industry, Steven routinely advises consumer product companies on reporting and potential recall situations arising under the jurisdiction of the Consumer Product Safety Commission. His practice covers a diverse range of industries, including children’s toys, household appliances, infant products, gas grills, furnaces, consumer electronics, computers, printers, handheld devices, and child-resistant packaging.

Steven is a frequent speaker on innovation and legal compliance and has authored numerous articles on a range of subjects, from the latest developments in the regulation of genetically engineered foods to important developments that impact food advertising.