Exciting news for cocoa lovers! The U.S. Food and Drug Administration has recently announced a qualified health claim for cocoa flavanols in high-flavanol cocoa powder.
In response to a health claim petition submitted on behalf of Barry Callebaut AG Switzerland, requesting 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, FDA determined that there is some limited credible scientific evidence for the health claim.
On Feb. 1, 2023, in a letter of enforcement discretion, FDA announced that it does not object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high-flavanol cocoa powder. Examples of these claims provided within the letter include the following:
- “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4 percent of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
- “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
The letter goes on to specify that foods containing high-flavanol cocoa powder and including the qualified health claim will be expected to meet the definitions for low fat (under 13 grams total), low saturated fat (under 4 grams), and low cholesterol (under 60 milligrams) per Reference Amount Customarily Consumed (RACC). Notably, this claim does not apply to regular cocoa powder or products containing less than 4 percent cocoa flavanols.
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