FDA Enforcement Discretion for Certain Qualified Health Claims and Cocoa Flavanols

FDA has indicated enforcement discretion for 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.

With “very limited credible scientific evidence” supporting a qualified health claim for cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease, FDA offered four specific allowable statements and stressed that use of the qualified health claim only applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder, not regular cocoa powder, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate.

Allowable qualified health claims for this enforcement discretion include the following:

• “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.”

Qualified health claims are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. To ensure that these claims are not misleading, they must be accompanied by a disclaimer or other qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim.

For assistance with labeling and claims, including qualified health claims for your food and dietary supplement products, contact EAS Consulting Group. Our expert labeling team helps to ensure FDA regulatory compliance and our FSMA experts create systems that support foods safety.