The U.S. Food and Drug Administration (FDA) said in February that it will exercise enforcement discretion for 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.

FDA was responding to a qualified health claim petition submitted in 2018 by Barry Callebaut AG.

Based on FDA’s review of the strength of the total body of scientific evidence for the proposed claims, the agency has determined that qualifying language should be included to convey the limits on the strength of the scientific evidence supporting the relationship.

The qualified health claim only applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder. The claim does not apply to regular cocoa powder, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate.

Recommendation for Flavan-3-ols

FDA’s statement came just a few months after the Academy of Nutrition and Dietetics issued a first-of-its-kind dietary recommendation for daily intake of 400-600 mg of flavan-3-ols to support cardiometabolic health. The advice represents the first time the group has made a dietary recommendation for a non-essential bioactive food compound.

“Increasing consumption of dietary flavan-3-ols may help improve blood pressure, cholesterol levels, and blood sugar,” according to authors writing in the Advances in Nutrition. “A continuously growing body of research demonstrates higher consumption may reduce the risk of certain cardiometabolic disease and related mortality.”

Typically, dietary recommendations focus on deficiencies of essential nutrients, like vitamin C, as opposed to improvement of health outcomes from plant bioactives.

AND suggested the general adult population—including healthy individuals as well as those with overweight or obesity and those who are at risk of chronic disease—increase consumption of nutrient-dense foods rich in flavan-3-ols and low (or absent) in added sugars, such as tea, apples, berries, and cocoa.

Flavan-3-ols are the most highly consumed flavonoid subclass, according to National Health and Nutrition Examination Survey data.

Dietary flavonoids include a range of polyphenolic compounds that occur naturally in plant foods. According to Raman et al., “their structural complexity has led to their sub-classification as flavonols, flavones, flavanones, flavan-3-ols (and their oligomers, pro(antho)cyanidins), isoflavones, and anthocyanins.”

Dialog Through Research and Innovation

With flavonoids in the news, consumers may be ready for a more nuanced discussion about “antioxidants,” a term used so broadly that many people have become confused or dismissive.

“I believe consumers are willing to learn more about antioxidants if there is new research to be shown,” said Rob Brewster, president of Ingredients by Nature, which supplies its proprietary lemon flavonoid blend, Eriomin—composed primarily of eriocitrin. Human clinical trials have demonstrated IBN’s formula can help control blood glucose and manage prediabetes.

“Our industry may always have nay-sayers,” said Brewster, “but if companies continue to rigorously study their product(s) in various doses, formats, and combinations with other natural ingredients and even prescription drugs, through gold-standard human clinical research, we should feel confident about our findings and work together to promote the research and industry as a whole.”

The antioxidant category is wide-ranging, he added, noting there is more work to do in terms of educating consumers about the quality of ingredients and how supplements should be incorporated into everyday lifestyles to optimize wellbeing.

“Branded ingredients do not dominate in this space yet because many of the most commonly used antioxidants, such as vitamin C, are easily sourced and formulated into products,” Brewster said. “That being said, the natural products industry has experienced a surge in consumer awareness over the past few years and many consumers are beginning to recognize that there are better options than generic ingredient offerings.”

Consumers are doing more research, he noted. “I can see branded ingredients making more headway in this space as consumers and formulators recognize the added value clinically tested ingredients bring, including strong, comprehensive research and improved safety and efficacy.”