02.07.24
Following FDA’s approval of a qualified health claim for cranberry dietary supplements for the prevention of recurrent urinary tract infections, demand for cranberry ingredients began to surge.
Further boosting the demand was a 2023 review published in Cochrane Database of Systematic Reviews.
Supplements that contain a daily serving of 500 mg of whole-fruit cranberry may now use a qualified health claim on their labels and in their marketing materials. The FDA authorized three wording options, such as “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.”
For the Cochrane review, the authors carefully reviewed 50 randomized studies involving 8,857 participants. The authors concluded that cranberry products reduce the risk of culture-verified UTIs in women with recurrent UTIs, in children, and in people susceptible to UTIs.
Raising the Bar
“Fruit d’Or, a farm-to-finish company, is one of the primary beneficiaries of this great news. More companies are calling who are looking to formulate with whole fruit cranberry powder because no one else has our level of expertise,” said Stephen Lukawski, lead sales and business development consultant at Fruit d’Or.
“With this ruling, the FDA is raising the bar by recognizing whole fruit powder for both its soluble and insoluble proanthocyanins (PACs),” said Lukawski. “We’ve done all the heavy lifting in this area, and companies are eager to learn how these soluble and insoluble PACs work together.”
Lukawski noted that not all cranberry ingredients can meet specifications to make the FDA qualified health claim. Per dose, a supplement must contain 500 mg of whole fruit cranberry powder, not just juice.
“A sprinkle of cranberry does not constitute efficacy,” Lukawski said. “All companies will need to revise their formulations and decide if they want to use 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.”
Finished product manufacturers can still use qualified health claims without directly demonstrating the efficacy of their products, Lukawski said. “We still have to fight that battle. Those who want to differentiate themselves will also want to promote their cranberries’ anti-adhesion activity, standardization, purity, authenticity, potency and quantifying the amount of soluble and insoluble PACs. Fruit d’Or is a pioneer and leader in each of those areas.”
“In addition to teaching consumers 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,” Lukawski continued. “We will specifically encourage consumers to look for Cran d’Or on labels, as their assurance of quality, purity, potency and efficacy.”
Rutgers University research demonstrated that PACs may inhibit E. coli’s ability to adhere to epithelial cells in the urinary tract. Work conducted by the contract research laboratory Complete Phytochemical Solutions using Fruit d’Or captured electron microscopic images of that specific cranberry ingredient’s PACs bound to pathogenic E. coli that showed how the anti-adhesion effect works.
For more on this, Lukawski and several other subject matter experts on cranberry ingredients spoke with Nutraceuticals World about FDA’s qualified health claim, best practices for quality testing, and the Cochrane review in July last year.
Fruit d’Or is having its organic and conventional cranberry ingredients tested by Amy B. Howell, PhD, and her team at Rutgers University for anti-adhesion activity. The testing will also advance cranberry research by relating structure to function.
The FDA qualified health claim also opens the door for companies that want to create cranberry capsules with no fillers or lubricating agents, Lukawski said. “So far, Fruit d’Or is the only company that can provide this level of seed-to-table purity.”
Further boosting the demand was a 2023 review published in Cochrane Database of Systematic Reviews.
Supplements that contain a daily serving of 500 mg of whole-fruit cranberry may now use a qualified health claim on their labels and in their marketing materials. The FDA authorized three wording options, such as “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.”
For the Cochrane review, the authors carefully reviewed 50 randomized studies involving 8,857 participants. The authors concluded that cranberry products reduce the risk of culture-verified UTIs in women with recurrent UTIs, in children, and in people susceptible to UTIs.
Raising the Bar
“Fruit d’Or, a farm-to-finish company, is one of the primary beneficiaries of this great news. More companies are calling who are looking to formulate with whole fruit cranberry powder because no one else has our level of expertise,” said Stephen Lukawski, lead sales and business development consultant at Fruit d’Or.
“With this ruling, the FDA is raising the bar by recognizing whole fruit powder for both its soluble and insoluble proanthocyanins (PACs),” said Lukawski. “We’ve done all the heavy lifting in this area, and companies are eager to learn how these soluble and insoluble PACs work together.”
Lukawski noted that not all cranberry ingredients can meet specifications to make the FDA qualified health claim. Per dose, a supplement must contain 500 mg of whole fruit cranberry powder, not just juice.
“A sprinkle of cranberry does not constitute efficacy,” Lukawski said. “All companies will need to revise their formulations and decide if they want to use 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.”
Finished product manufacturers can still use qualified health claims without directly demonstrating the efficacy of their products, Lukawski said. “We still have to fight that battle. Those who want to differentiate themselves will also want to promote their cranberries’ anti-adhesion activity, standardization, purity, authenticity, potency and quantifying the amount of soluble and insoluble PACs. Fruit d’Or is a pioneer and leader in each of those areas.”
“In addition to teaching consumers 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,” Lukawski continued. “We will specifically encourage consumers to look for Cran d’Or on labels, as their assurance of quality, purity, potency and efficacy.”
Rutgers University research demonstrated that PACs may inhibit E. coli’s ability to adhere to epithelial cells in the urinary tract. Work conducted by the contract research laboratory Complete Phytochemical Solutions using Fruit d’Or captured electron microscopic images of that specific cranberry ingredient’s PACs bound to pathogenic E. coli that showed how the anti-adhesion effect works.
For more on this, Lukawski and several other subject matter experts on cranberry ingredients spoke with Nutraceuticals World about FDA’s qualified health claim, best practices for quality testing, and the Cochrane review in July last year.
Fruit d’Or is having its organic and conventional cranberry ingredients tested by Amy B. Howell, PhD, and her team at Rutgers University for anti-adhesion activity. The testing will also advance cranberry research by relating structure to function.
The FDA qualified health claim also opens the door for companies that want to create cranberry capsules with no fillers or lubricating agents, Lukawski said. “So far, Fruit d’Or is the only company that can provide this level of seed-to-table purity.”
