- Following a petition from Ocean Spray Cranberries, the FDA said it would not object to the use of qualified health claims that show a relationship between consumption of certain cranberry products and a reduced risk of recurrent urinary tract infections (UTI) in healthy women.
- Qualified health claims will be enforced at the FDA's discretion and can only be made for beverages containing at least 27% cranberry juice, which the agency said accounts for most commercially available options. They can also be made on cranberry dietary supplements containing at least 500 milligrams of fruit powder.
- The original request from Ocean Spray asked for an authorized claim, which would more definitively allow the manufacturer to tout a link between cranberries and UTIs. The FDA determined that evidence from the scientific community establishing a link between cranberry consumption and UTI reduction was "limited and inconsistent," and not sufficient to support such a claim.
This ruling from the FDA comes more than two years after the cranberry cooperative first petitioned the U.S. regulatory agency to allow the health claim. Although Ocean Spray may now use health claims related to cranberries, the qualified claim permission the FDA granted is limited.
In the FDA’s announcement, it offered examples of qualified health claims that Ocean Spray can employ, 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."
Even with the limited qualifier claim, consumers may still respond positively. Health claims are important to people, and they are becoming even more so as the pandemic continues to prompt consumers to seek out healthy options that boost their immune systems.
Cranberries are positioned to benefit from an FDA-approved seal of health because they have long been considered a functional food. The tart berries have been associated with mitigating gut problems from animal-based diets, delivering powerful antioxidants, reducing bacteria that can cause cavities and potentially lowering the incidence of ulcers and cancer. However, as the FDA pointed out, these studies may not be all that rigorous. The study showing that cranberry powder can help gut health was conducted on only 11 adults and was funded in part by the Cranberry Institute. The largest study that Ocean Spray cited as evidence in its petition to the FDA was funded by the company itself.
Still, it was prudent of the cranberry cooperative to gain the FDA’s approval. Companies that feature unfounded claims can find themselves in hot water. Recently, Ocean Spray found itself in the hot seat and agreed to pay $5.4 million to settle a class-action lawsuit filed in 2017 alleging it labeled some juice products as containing no artificial flavors when they actually did. Having the FDA’s authorization for a limited UTI health claim will at least protect the company.
Ocean Spray is not the only juice brand that will be able to benefit from the FDA’s authorization to use these claims. J.M. Smucker Company’s Santa Cruz Organic, Coca-Cola’s Simply line and PepsiCo’s Minute Maid brand all feature cranberry juices that meet the FDA’s threshold of containing 27% cranberry juice to use this claim. However, featuring a claim that announces the limitations to cranberries’ health halo may end up being more of a liability than a benefit for companies looking to entice consumers through healthy claims on packaging.