FDA Permits Heart-Health Claim for Cocoa Flavanols

The FDA this week announced a letter of enforcement discretion that essentially permits a qualified health claim connecting the consumption of cocoa flavanols in high flavanol cocoa powder with a reduced risk of cardiovascular disease.

The FDA responded to a health claim petition submitted on behalf of Barry Callebaut AG of Switzerland. The cocoa company presented analysis of more than 240 scientific articles and several scientific studies that made the connection between cocoa flavanols and heart health.

Flavanols are antioxidants found in a number of plants.

“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,” the agency wrote in the letter.

“Very limited” evidence, but enough for the “qualified” claim. Food products using the claim must contain at least 4% of naturally conserved cocoa flavanols.

“This qualified health claim only applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder,” the letter continued. “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.”