US FDA Approves Limited Health Claims of Cocoa Flavanols and Cardiovascular Diseases

The use of certain qualified health claims regarding the association between the consumption of high flavanol cocoa powder and a lower risk of cardiovascular disease is not anticipated to be objected by the US FDA. However, the US FDA determined that there is very little credible scientific evidence for the reduced risk, which will restrict the qualified health claims’ language.

The US FDA responded to Barry Callebaut AG Switzerland’s health claim petition on February 1, 2023, in a letter that was originally submitted on November 21, 2018. According to the petition, consuming at least 200 mg of cocoa flavanols daily may lower the risk of cardiovascular disease, based on supportive but inconclusive scientific evidence. The FDA looked over the petition and found that there were no reliable studies that showed a link between the cocoa flavanols in high flavanol semi-sweet/dark chocolate and a lower risk of heart disease.

The FDA also said that foods with a qualified health claim and a lot of flavanol cocoa powder should be expected to be low in fat, saturated fat, and cholesterol. 13 grams of total fat, 4 grams of saturated fat, and 60 mg of cholesterol per Reference Amount Customarily Consumed (RACC) are the nutrients that are excluded from the definitions.

When qualified health claims are used on conventional food labels, the FDA intends to have enforcement discretion. The FDA has concluded that there is very little scientific evidence to support the claim that the cocoa flavanols in high flavanol cocoa powder lower the risk of cardiovascular disease.

The high flavanol content cocoa powder’s cocoa flavanols may lower the risk of cardiovascular disease. The FDA has concluded that this claim is supported by very little scientific evidence. According to scant scientific evidence, consuming high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. The claim does not apply to chocolate, regular cocoa powder, foods that contain regular cocoa powder, or other chocolate-based foods.