On Feb. 3 the U.S. Food and Drug Administration (FDA) announced their approval for a qualified health claim regarding the relationship between high-flavanol cocoa powder and reduced risk of cardiovascular disease.
The qualified health claim covers products that contain at least 200 milligrams (mg) of cocoa flavanols per serving and at least 4 percent of naturally conserved cocoa flavanols.
The approved health claim is based on a 2018 filing stating that 200 mg of cocoa flavanols can support heart health. The FDA approved the claim but noted that scientific evidence is still very limited.
The 200 mg level in the FDA approved claim is low compared to cocoa flavanol levels administered in successful clinical trials of brain, heart, and metabolic health which seem to range between 500 mg and 1000 mg.
This is consistent with the new flavanol consumption guidelines from the Academy of Nutrition and Dietetics, recommending 400 mg to 600 mg daily to achieve improved cardio-metabolic outcomes.
Harvard’s five-year, 21,400-person placebo-controlled COSMOS study published in March 2022 in The American Journal of Clinical Nutrition, found that consuming 500 mg of cocoa flavanols per day significantly reduced deaths from cardiovascular disease by 27 percent compared to placebo. The researchers also found a meaningful reduction in major cardiovascular events.
Ground Breaking Dietary Guidelines
The new dietary guideline for daily consumption of flavanols was the first guideline ever recommended that was not based on deficiencies but rather an improvement in health outcomes.
157 randomized controlled studies and 15 cohort studies on flavanols were reviewed by the expert guideline panel to inform these new guidelines.
The panel found that daily consumption of flavanols can reduce the risk associated with cardiovascular disease and diabetes and may help improve blood pressure, cholesterol concentrations, and blood sugar.
The suggested daily flavanol intake for the general adult population is 400–600 mg/d.
The authors recommend people achieve target flavanol levels by increasing consumption of nutrient-dense, high-flavanol foods, including cocoa, tea, apples, and berries, and clarify that this is a “food-based guideline” not a recommendation for flavanol supplements.
