Be Still, My Beating Heart: FDA Announces Qualified Health Claims for Cocoa Flavanols and Reduced Risk of Cardiovascular Disease

Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease.

Though not quite a love letter, FDA’s letter to Petition, Barry Callebaut AG Switzerland, arrived just before Valentine’s Day and announces the Agency’s intention to exercise enforcement discretion for the following qualified health claims:

• “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.”

FDA’s favorable determination for the petitioner was far from love at first sight.  For all qualified health claims, FDA considers the data and information provided in the petition and available to the Agency, including individual reports of human studies, meta-analyses, review articles, and animal and in vitro studies.  This qualified health petition was submitted in 2018, and after four supplements to the petition (see, e.g., here and here), a public comment period, and a years-long extension to FDA’s response deadline, FDA determined that the current evidence supports the use of the qualified health claims above, provided that the labeling is consistent with its letter of enforcement discretion.  FDA intends to exercise enforcement discretion when the following factors are met:

• The qualified health claim includes a truthful and non-misleading description of the strength of the body of scientific evidence (i.e., “very limited”);
• If high flavanol cocoa powder bears the claim, it has at least 4% of naturally conserved cocoa flavanols and contains at least 200 mg cocoa flavanols per Reference Amount Customarily Consumed (RACC);
• If a food containing high flavanol cocoa powder bears the claim, it includes at least one tablespoon (5-6 grams) of HFCP that includes 200 mg of cocoa flavanols per RACC;
• The high flavanol cocoa powder or food containing high flavanol cocoa powder meets the regulatory definitions for “low fat,” “low saturated fat,” and “low cholesterol” in 21 C.F.R. § 101.62;
• The high flavanol cocoa powder or food containing high flavanol cocoa powder does not exceed disqualifying nutrient levels for total fat, saturated fat, cholesterol, or sodium content under 21 C.F.R. § 101.14; and
• The food containing high flavanol cocoa powder contains at least 10 percent of the Daily Value establishment for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per RACC.

But before you dig into any heart-shaped boxes of chocolate this Valentine’s Day, note that FDA’s enforcement discretion for these qualified health claims only applies to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder—not regular cocoa power, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate.  Although the science might not be there, a piece of chocolate on Valentine’s Day may still do you some good.