The US Food and Drug Administration (FDA) recently announced in a letter of enforcement direction, 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, as long as the claim is not worded to mislead consumers and that other requirements for the claim are met.

According to the FDA’s response to a health claim petition submitted on behalf of Barry Callebaut AG, Switzerland, it determined that there is very limited credible scientific evidence for a qualified health claim for the relationship between cocoa flavanols in high-flavanol cocoa powder and a reduced risk for cardiovascular disease. The letter also discusses the FDA’s intent to consider the health claim in the exercise of its enforcement discretion.

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.”

These listed qualified health claims only apply specifically to cocoa flavanols in high-flavanol cocoa powder and foods that contain high-flavanol cocoa powder. It does not apply to regular cocoa powder, foods containing regular cocoa powder or other food products made from cacao beans.