FDA allows qualified health claim for cranberry products

October 1, 2020

FDA announced 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.

FDA announced 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. FDA authorized three wording options for qualified health claims for dietary supplements, 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.”
  • “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.”
  • “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.”

FDA also authorized qualified health claims for cranberry juice beverages, 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.”
  • “Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
  • “Consuming one serving (8 oz) each day of [this identified cranberry juice beverage] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”

“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,” said Jean Leclerc, director of sales and business development for Fruit d’Or (Villeroy, QC, Canada), in a press release. “With this ruling, 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.”

Anti-adhesion assays by Rutgers University have shown cranberry PACs may inhibit pathogenic E. coli’s ability to adhere to epithelial cells in the urinary tract. To build on this body of research, Fruit d’Or's organic Cran Naturelle and conventional Cran d’Or, will also be tested by Amy B. Howell, Ph.D. at Rutgers for this anti-adhesion activity. This testing is not only the gold standard for confirming efficacy, but it will help advance cranberry research and science by relating structure to function.

“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,” said Stephen Lukawski, Fruit d’Or business manager and lead consultant, in a press release “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.”