The FDA Responds to Heath Claim Petition for High-Flavanol Cocoa Powder and Reduced Risk of Cardiovascular Disease
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement direction, that it does not intend to object to the use of 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, as long as the claim is not worded to mislead consumers and that other requirements for the claim are met.
According to the FDA’s response to a health claim petition submitted on behalf of Barry Callebaut AG, Switzerland, it determined that there is very limited credible scientific evidence for a qualified health claim for the relationship between cocoa flavanols in high-flavanol cocoa powder and a reduced risk for cardiovascular disease. The letter also discusses the FDA’s intent to consider the health claim in the exercise of its enforcement discretion.