WASHINGTON — The US Food and Drug Administration does not plan to object to the use of certain qualified health claims about consuming cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. The FDA, however, determined “very limited credible scientific evidence” exists for the reduced risk, which in turn will limit the wording in the qualified health claims.

In a letter dated Feb. 1 the FDA responded to a health claim petition on behalf of Barry Callebaut AG Switzerland that originally was submitted Nov. 21, 2018. The petition stated “supportive but inconclusive scientific evidence” suggests consuming at least 200 mg of cocoa flavanols daily may reduce the risk of cardiovascular disease. In reviewing the petition, the FDA identified no credible studies supporting a relationship between cocoa flavanols in high flavanol semi-sweet/dark chocolate and a reduced risk of cardiovascular disease.

The FDA also ruled foods containing high flavanol cocoa powder and having the qualified health claim will be expected to meet the definitions for low fat, low saturated fat and low cholesterol. The disqualifying nutrient levels for the definitions are 13 grams of total fat, 4 grams of saturated fat and 60 mg of cholesterol per Reference Amount Customarily Consumed (RACC).

The FDA intends to exercise enforcement discretion for the following qualified health claims when used in the labeling of conventional foods:

“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.”