FDA responds to petition on cocoa flavanols

February 13, 2023

The US Food and Drug Administration (FDA) announced recently in a letter of enforcement that it does not intend to object to the use of certain health claims regarding the consumption of cocoa flavanols in high flavanol cooca powder and a reduced risk of cardiovascular disease, provided the claim is “appropriately worded” so as not to mislead consumers.

The announcement comes as a response to a health claim petition submitted on behalf of Barry Callebaut. 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 characterises 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 there is limited scientific evidence for a qualified health claim for cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease.

The 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 consumption of cocoa flavanols.

The FDA has said it intends to exercise enforcement discretion of the qualified health claims when used in the labelling of convetional 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.”
“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.”

The claim only applies specifically to cocoa flavanols in high flavanol cooca powder and foods that contain high flavanol cocoa powder, but not regular cocoa powder, foods containing, or other food products made from cacao beans.

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