The FDA’s new qualified health claim for whole fruit cranberry supplements causes tremendous excitement

Fruit d’Or says the FDA’s acknowledgment of the need for soluble and insoluble PACs could push cranberry ingredients over $100 million in sales.

Cranberry industry giant Fruit d’Or Nutraceuticals was already having its best year ever, when news of a Food & Drug Administration (FDA) qualified health claim made business even sweeter. For the first time ever, 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 including, “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.”

This news is expected to trigger even more products and innovations within the already popular cranberry supplement industry. In 2019, cranberry ranked #5 in U.S. sales by the American Botanical Council.

Demand increases for Fruit d’Or Nutraceuticals’ Cran Naturelle and Cran d’Or
“Fruit d’Or, a farm-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,” acknowledges Jean Leclerc, director of Sales and Business Development for Fruit d’Or, which is the world’s largest grower of certified organic cranberries.

“With this ruling, the FDA is raising the bar by recognizing whole fruit powder for both 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.”

Some companies will need to revisit their formulations
“The FDA’s qualified health claim is confirmation that not all cranberry is the same. It’s not the components of the fruit … it’s not just the juice … it’s the whole fruit. And products must have a 500 mg daily dose of actual cranberry to make this claim,” explains Leclerc.

He adds, “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.”

How to reach the top even faster
Leclerc acknowledges that it is possible to use the qualified health claim without demonstrating efficacy. “We still have to fight that battle. Clearly, those who want to differentiate themselves will also want to promote their cranberries’ anti-adhesion activity, standardization, purity, potency and quantifying the amount of soluble and insoluble PACs. Fruit d’Or is a pioneer and leader in each of those areas.”

Anti-adhesion assays by Rutgers University have shown that cranberry PACs may inhibit pathogenic E. coli’s ability to adhere to epithelial cells in the urinary tract. Additionally, work conducted by Complete Phytochemical Solutions using Fruit d’Or Cran Naturelle, captured electron microscopic images of that specific cranberry ingredient’s PACs bound to pathogenic E. coli that showed how the anti-adhesion works.

Fruit d’Or is having its premium branded ingredients, organic Cran Naturelle and conventional Cran d’Or, tested by Amy B. Howell, Ph.D. and her team at Rutgers University for this anti-adhesion activity. This testing is more than the current gold standard for confirming efficacy. It will also help further advance cranberry research and science by relating structure to function.

Leclerc explains that the FDA qualified health claim will also open the door for companies that want to create cranberry capsules with no fillers or lubricating agents. “So far, Fruit d’Or is the only company that can provide this level of seed-to-table purity.”

Fruit d’Or will be doing more consumer education
In conjunction with the FDA’s qualified health claim, Fruit d’Or will educate consumers on how to identify real, whole fruit cranberry supplements with demonstrated efficacy. “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,” comments Fruit d’Or Business Manager and Lead Consultant Stephen Lukawski. “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.”

Additional labeling options
In addition to the labeling option mentioned above, supplement manufacturers may use either of these qualified health statements:
1. “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”

2. “Consuming 500 mg [X capsules/tablets/soft gels] each day of [this identified cranberry dietary supplement] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”

Visit for additional information about the advances Fruit d’Or is making within the cranberry industry.

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