The U.S. Food and Drug Administration (FDA) said it will exercise enforcement discretion for 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.

FDA was responding to a qualified health claim petition submitted by Barry Callebaut AG in November of 2018, which had also asked the agency to consider evidence supporting high flavanol semi-sweet/dark chocolate and a reduced risk of CVD.

The agency reviewed and considered scientific evidence submitted with the petition and other pertinent scientific evidence to form its conclusion.

FDA said in its letter of enforcement discretion—signed by Claudine Kavanaugh, PhD, MPH, RD, director of the Office of Nutrition and Food Labeling at the Center for Food Safety and Applied Nutrition (CFSAN)—“there is very limited credible scientific evidence for a qualified health claim for cocoa flavanols in high flavanol cocoa powder and risk reduction of CVD.”

Based on FDA’s review of the strength of the total body of scientific evidence for the proposed claims, the agency has determined that qualifying language should be included to convey the limits on the strength of the scientific evidence supporting the relationship.

The letter also discussed the factors FDA intends to consider in the exercise of its enforcement discretion.

The 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.

Qualified Language

FDA said it will exercise enforcement discretion for the following qualified health claims:

• “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.”