FDA has published a letter of enforcement discretion, which it sent to legal counsel for Ocean Spray Cranberries, Inc., that authorizes a qualified health claim (QHC) for specific cranberry products when consumed in specific amounts by specific people. The substantiation for the diet-disease relationship warranted a “limited and inconsistent” or “limited” scientific evidence qualifier.
Based on the scientific evidence submitted as part of the health claim petition, the QHC may be used in labeling only the following cranberry products:
- A cranberry juice beverage (e.g., cranberry juice cocktail, cranberry juice drink/beverage); or
- A cranberry dietary supplement (i.e., containing whole cranberry powder as a dietary ingredient.
To be eligible for the QHC, the cranberry juice beverage must contain at least 27% cranberry juice, and the cranberry dietary supplement must contain at least 500 milligrams (mg) of cranberry fruit powder.
Additionally:
- Neither product may exceed the disqualifying levels for total fat, saturated fat, cholesterol, and sodium in 21 C.F.R. § 14(a)(4); and
- The cranberry juice beverage must meet the 10% minimum nutrient content requirement of 21 C.F.R. § 101.14(e)(6).
These additional eligibility requirements typically should not be problematic.
The disease targeted by the QHC is risk of recurrent urinary tract infection (UTI) in healthy women with a history of UTI.
The authorized QHCs are:
For a Cranberry Juice Beverage
- “Limited and inconsistent scientific evidence shows that by consuming one serving (8 [fl] 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 [fl] 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 [fl] 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.”
For a Cranberry Dietary Supplement
- “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.”
These authorized QHCs may be used immediately in labeling eligible products.
