High-flavanol cocoa powder linked with reduced cardiovascular disease risk, says the FDA

06 Feb 2023 --- The US Food and Drug Administration (FDA) will not object to a qualified health claim on reducing the risk of cardiovascular disease for conventional foods. The claim will only apply to cocoa flavanols in high-flavanol powder, a powder that contains at least four percent of naturally conserved cocoa flavanols, or food with high-flavanol cocoa powder.

However, manufacturers need to make clear to consumers that there is limited scientific evidence for the claim. 

The company Barry Callebaut AG Switzerland petitioned the FDA to review the health claim about the relationship between high-flavanol cocoa powder and reduced risk of cardiovascular disease. 

The FDA proposes four versions of the health claim it will not object to, which clarify to consumers there is limited scientific evidence. 

The health claims
The qualified health claims are that “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,” or that “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.”

The FDA further states that companies may also use the claim that “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.” 

FDA announces qualified health claim for cocoa flavanols in high cocoa flavanol powder and reduced risk of cardiovascular disease. Conversely, companies could also state that “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.”

A health claim characterizes the relationship between a substance and a disease or health-related condition. Qualified health claims do not meet rigorous significant scientific proof for an authorized health claim. 

To ensure they are not misleading to consumers, the FDA requires companies to include a disclaimer that clarifies the level of scientific evidence that supports the claim. 

Previously, the FDA allowed a qualified health claim that magnesium consumption might reduce the risk of high blood pressure, following a petition from the Dietary Supplement Trade association, the Council for Responsible Nutrition, and other organizations on behalf of the Center for Magnesium Education and Research. 

Additional requirements 
To use the claim, foods containing cocoa powder as an ingredient need to include at least one tablespoon of high-flavanol cocoa powder (5-6 g), which contains 200 mg of cocoa flavanols as a reference amount customarily consumed. 

Manufacturers cannot use the claim on regular cocoa powder, foods that contain regular cocoa powder, or other products made from cocoa beans, such as chocolate, as studies on these products still need to be conducted.

The FDA also expects foods using the claim to meet definitions for low in fat, saturated fat and cholesterol. However, due to a lack of scientific evidence, the agency has yet to determine if cocoa powder in foods high in fat and cholesterol could be beneficial to reduce cardiovascular disease risk.  

Foods may not exceed certain total fat, saturated fat, cholesterol, or sodium content levels, as specified in general requirements for health claims. These include 13 g of total fat, 4 g of saturated fat, 60 mg of cholesterol and 480 mg of sodium per serving. 

The FDA also says that for foods to be  considered eligible for the claim, they need to contain at least 10% of the recommended daily intake of vitamin A and C, iron, calcium, protein or dietary fibers.

Edited by Jolanda van Hal 

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