The U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods, provided the qualified claim is appropriately worded so as not to mislead consumers and that other factors for the use of the claim are met.
The FDA responded to a health claim petition submitted on behalf of Barry Callebaut AG Switzerland. The petition requested that the FDA review a qualified health claim about the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. A health claim characterizes the relationship between a substance and a disease or health-related condition.
After reviewing the petition and other evidence related to the proposed health claim, the FDA determined that there is very limited credible scientific evidence for a qualified health claim for cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. This letter also discusses the factors that the FDA intends to consider in the exercise of its enforcement discretion for the use of a qualified health claim in conventional foods and the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease.
The FDA intends to exercise enforcement discretion for the following qualified health claims regarding cocoa flavanols in high flavanol cocoa powder when used in the labeling of conventional foods consistent with the letter of enforcement discretion:
- “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although the FDA has concluded that there is very limited scientific evidence for this claim.”
- “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. The FDA has concluded that there is very limited scientific evidence for this claim.”
- “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
- “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”
This qualified health claim only applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder. The claim does not apply to regular cocoa powder, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate.
