Fruit d’Or Nutraceuticals, a formulator specializing in cranberry ingredients for dietary supplements, discussed a recent FDA decision to allow supplements containing 500 mg or more of whole fruit cranberry to use a qualified health claim on their labels and in marketing materials.
 
To be specific, there are three wording options for the health claim, based on clinical evidence that cranberries can reduce the risk of recurrent urinary tract infection (UTI) in women. One such example would read, “Limited scientific evidence shows that by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
 
The news is expected to trigger new products and formulation types within the already-popular cranberry supplement category, Fruit d’Or reports. In 2019, cranberry ranked fifth in total dollar sales by the American Botanical Council.
 
“Fruit d’Or, a fram-to-finish company, is one of the primary beneficiaries of this great news. More companies are calling us looking to formulate with whole fruit cranberry powder because no one else has our level of expertise,” Jean Leclerc, director of Sales and Business Development for Fruit d’Or, said. “With this ruling, the FDA is raising the bar by recognizing whole fruit powder both for its soluble and insoluble proanthocyanins (PACs). We’ve done all the heavy lifting in this area, and companies are eager to learn how these soluble and insoluble PACs work together.”
 
Formulations Will Have to Be Revisited
 
According to Leclerc, many cranberry supplement brands on the market will need to revisit their formulations if they wish to use the qualified health claim.
 
“The FDA’s qualified health claim is confirmation that not all cranberry is the same,” he said. “It’s not the components of the fruit, it’s not just the juice, it’s the whole fruit. Products must have a 500 mg daily dose of actual cranberry to make this claim. A sprinkle of cranberry does not constitute efficacy. All companies will need to revise their formulations and decide if they want to participate in this claim. We have always believed in the whole spectrum of the cranberry. This is what drove Fruit d’Or to set the industry standards for proper cultivation and handling processes, and to pioneer proper fingerprinting to ensure that formulas contain actual cranberry.”
 
Other Important Strategies
 
Leclerc said that, while it is possible for companies to use the qualified health claim without directly demonstrating efficacy to consumers, there are other strategies to further differentiate products.
 
“Clearly, those who want to differentiate themselves will also want to promote their cranberries’ anti-adhesion activity, standardization, purity, and potency, and quantify the amount of soluble and insoluble PACs. Fruit d’Or is a pioneer and leader in each of these areas,” he said.
 
Assays conducted by Rutgers University demonstrate that the PACs within cranberries are what enable the potential UTI-reducing activity, by inhibiting E. coli’s ability to adhere to epithelial cells in the urinary tract. Work conducted by Complete Phytochemical Solutions, using Fruit d’Or’s product Cran Naturelle, captured electron microscopic images of that ingredient’s PACs bound to pathogenic E. coli, demonstrating that anti-adhesion works.
 
The company is having its branded ingredients, organic Cran Naturelle and conventional Cran d’Or, tested by Amy B. Howell, PhD, and a team of researchers at Rutgers University for this anti-adhesion activity. The company reports that the research will further advance knowledge about the relationship between structure and function of PACs.
 
Fruit d’Or also intends to carry out a marketing campaign regarding the new FDA qualified health claim, and how to identify which cranberry supplements would be efficacious.
 
“In addition to teaching them to look for a minimum of 500 mg on the labels of their cranberry capsules, tablets, or softgels, we will reinforce the truth that a cranberry supplement should have the same color and taste as the fruit,” Stephen Lukawski, Fruit d’Or business manager and lead consultant, said. “We will specifically teach them to look for Cran d’Or or Cran Naturelle on labels, as their assurance of quality, purity, potency, and efficacy.”