Ocean Spray seeks FDA approval for health claim

Workers harvest Ocean Spray cranberries on the Long Beach Peninsula in Washington. Ocean Spray has petitioned the Food and Drug Administration to make claims that cranberries prevent urinary tract infections in women.

Ocean Spray is asking the Food and Drug Administration to let it claim that cranberries may help prevent reoccurring episodes of urinary tract infections in women.

Cranberries have long been a folk remedy for such afflictions. The Massachusetts-based grower cooperative hopes to move the claim from “old wives’ tale” to one that the government recognizes has a scientific basis, Ocean Spray spokeswoman Kellyanne Dignan said Tuesday.

“We really want to have a clear message to consumers,” she said.

Ocean Spray petitioned the FDA in September to use the claim in its advertising. The FDA has indicated it will make a decision by Oct. 5 and recently put the request out for public review. As of Tuesday, the FDA had not received any comments. The comment period ends May 7.

Ocean Spray, whose members include growers in Washington and Oregon, seeks to make a “qualified health claim.” Scientific evidence must support the statement, though it doesn’t have to meet a more rigorous standard to make an “authorized health claim.”

The cranberry industry has been searching for ways to reduce a huge surplus that’s suppressing farmer income. The USDA is considering a petition by the Cranberry Marketing Committee to order that 5 percent of the 2017 crop be diverted from the market. The industry also has tried to brand itself as “America’s original superfruit.”

Dignan declined to say how much Ocean Spray spent preparing the petition to the FDA. Ocean Spray last fall announced it will spend $10 million over the next five years on researching the antibacterial properties of cranberries.

“Both Ocean Spray and the cranberry industry have talked about the health benefits for decades,” Dignan said. “This really is a continuation of that.”

The FDA does not have the authority to review claims by dietary supplements. Numerous products are marketed as containing cranberry concentrate and able to cleanse urinary tracts.

Ocean Spray is asking the FDA to use its authority under the Federal Food, Drug and Cosmetic Act to permit a narrow claim. The claim is that the daily consumption of cranberries, cranberry juice, dried cranberries and powdered cranberry may help prevent ­— though not treat — recurring urinary tract infections in healthy women.

To back the claim, Ocean Spray stresses three studies that concluded women who received a daily dose of cranberry juice or capsules were 20 percent to 58 percent less likely to suffer a new infection than women who took a placebo.

Ocean Spray funded the most recent and largest of the three studies. Some 185 women with a history of recent infections drank cranberry juice, while 188 women were served a placebo. After 24 weeks, 39 of the women who drank cranberry juice suffered new infections, compared to 67 women who drank the placebo, according to an abstract of an article published in 2016 in the American Society for Nutrition.

The study’s authors were associated with Ocean Spray, Boston University School of Medicine and Biofortis Clinical Research, a research organization based in Illinois. They concluded that drinking cranberry juice lowered the number of new infections in healthy women.

Ocean Spray’s petition acknowledged two studies that failed to find that connection.

In one of the studies, conducted at the University of Michigan, Ocean Spray served the cranberry juice. It also formulated the placebo that had the flavor and color of cranberry juice but no cranberry content, according to a 2011 article in the journal Clinical Infectious Diseases.

The other study that failed to find that cranberries prevented infections was led by a University of Washington researcher and was published in 2012 in the journal Mayo Clinic Proceedings.

Recommended for you