FDA recently announced it does not 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 (CVD), provided that the qualified claim is appropriately worded so as not to mislead consumers.
This announcement is the latest addition to qualified health claims allowed by FDA for the reduced risk of CVD, in addition to other FDA-permitted qualified health claims for food substances linked to a reduced risk of coronary heart disease, specific cancers, diabetes, and hypertension.
FDA’s Regulation of Health Claims for Food Products
Generally, FDA-authorized health claims are statements on food labels that describe a relationship between a food substance (a food, food component, or dietary supplement ingredient) and the reduced risk of a disease or health-related condition. These claims are supported by significant scientific agreement among qualified experts and are based on the totality of publicly available scientific evidence for a substance/disease relationship. Authorized health claims undergo a thorough review by FDA through a petition process and must meet a high standard of confidence in the validity of the substance/disease relationship.
Conversely, qualified health claims are a type of health claim that have a lower level of scientific evidence supporting the substance/disease relationship. These claims are still reviewed and evaluated by FDA, but the quality and strength of the supporting scientific evidence fall below the requirements for an authorized health claim. Parties, including food industry manufacturers, can petition FDA to consider exercising enforcement discretion for use of a qualified health claim. FDA considers the petition data and information to determine whether the information could support a relationship between the food substance and the disease or health-related condition.
Qualified health claims must be accompanied by a disclaimer or other qualifying language to prevent consumer confusion. FDA will specify claim language that reflects the level of supporting scientific evidence, including additional enforcement discretion factors under which FDA will not object to the use of the qualified health claim.
Qualified Heart-Healthy Claim for Cocoa Flavanols
In FDA’s Letter of Enforcement Discretion in response to a petition submitted by Barry Callebaut AG Switzerland, FDA determined that there is “very limited” credible scientific evidence for a qualified health claim for cocoa flavanols in high flavanol cocoa powder and a reduced risk of CVD.
FDA intends 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.”
In the letter, FDA discusses the factors that it intends to consider in the exercise of its enforcement discretion, including the following:
- The qualified health claim includes a truthful and non-misleading description of the strength of the body of scientific evidence (i.e., “very limited”).
- High flavanol cocoa powder that bears the claim must have at least 4% of naturally conserved cocoa flavanols and contain at least 200 mg cocoa flavanols per Reference Amount Customarily Consumed (RACC).
- If a food containing high flavanol cocoa powder bears the claim, it must have at least one tablespoon (5–6 grams) of the powder that includes 200 mg of cocoa flavanols per RACC.
Implications for Food Industry Stakeholders
FDA has demonstrated a willingness to exercise enforcement discretion for qualified health claims, even when the scientific evidence is “very limited.” Consequently, food manufacturers or interested trade associations may find it beneficial to consider the qualified health claim petition process.
Industry stakeholders should be aware that FDA's recent announcement specifically applies to food manufacturers producing foods containing high flavanol cocoa powder, not those manufacturing regular cocoa powder or other cacao bean products, such as chocolate. Consequently, manufacturers of products that fall outside FDA's enforcement discretion should carefully review their food labels to ensure they are not making heart health claims which could attract enforcement scrutiny.