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Dame Cacao: A Response to the FDA Conditionally Approving Claims of Cocoa Powder’s Health Benefits

By Max Gandy

To start, these claims can only be applied to cocoa powders, but only powders with a high proportion of cocoa flavanols. More specifically, cocoa powders so labeled must contain 4 percent or more of ‘naturally conserved’ flavanols, which are a specific type of antioxidant found in high concentrations in cacao.

The FDA’s announcement also states that such claims must be ‘appropriately worded so as not to mislead consumers and that other factors for the use of the claim are met.’ The exact wording allowed to be used on packaging remains quite restrictive. This is because it’s based on only two small studies which looked specifically at the relationship between consuming high flavanol cocoa powder and incidence of cardiovascular disease (CVD). 

Additionally, these health claims can only be made on the packaging of products which contain at least 200mg of flavanols per serving. They also cannot otherwise exceed certain levels of fat, sodium, and cholesterol per serving. This is combined with the requirement that such products provide at least 10% of your recommended daily allowance for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber. The only explicit exception to this is pure cocoa powder, as it’s generally consumed in amounts so small that it couldn’t reasonably fulfill those requirements. 

These conditional approvals come only in response to a 2018 petition submitted on behalf of the Barry Callebaut group, which claims on their website to process approximately 20 percent of the annual global cacao crop. 

In the 27-page official response to that petition, the FDA ‘concludes that there is very limited credible scientific evidence for a qualified health claim for cocoa flavanols in high flavanol cocoa powder and risk reduction of CVD.’ This incredibly limited approval followed nearly five years of internal discussion regarding the validity of such claims.

After reviewing all the evidence submitted with Callebaut’s petition and all information available online, the FDA found just two studies whose results seem to support this claim. However, by their own admission, even these two studies had “moderate methodological quality… [as well as a] small number of subjects and short duration.”

The official response conditionally allows cocoa powder-containing products to be labeled with one of these four claims:

1) “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.” [sic]

2) “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”

3) “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4 percent of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”

4) “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4 percent of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4 percent of naturally conserved cocoa flavanols. See nutrition information for X and other nutrients.” 

So, what does all this mean for chocolate makers?

Well, if you’re a chocolate maker with the access and scale to be able to test every batch of your cacao beans for their average flavanol content, you might be able to make good use of this opportunity. But very few makers would have such an ability, and Callebaut and the FDA know this.

By giving their conditional approval to chocolate companies to be able to use ‘heart-healthy’ claims on certain products, it opens the door to manufacturers like Callebaut to take just enough flavanol-rich cocoa powder and put it in all kinds of other things. They could create lines of cocoa powders, coatings, sugar-free confections, and other products without regard to the sourcing or the flavor. 

It wouldn’t surprise me if in the next few years, Callebaut came out with a pill-like ‘conventional food product’ whose serving size meets the requirements for this health claim and is meant to supplement the diets of Americans who wouldn’t have otherwise swallowed such a bitter pill. 

Only time will tell if using such a conditional label on a product will increase sales, though my instincts say it will.

About Max Gandy: Max Gandy is the writer & podcaster at damecacao.com, where she’s been covering the global identity of craft chocolate since 2015. Her site is dedicated to connecting readers to quality chocolate and the people who produce it by changing the way we eat and understand chocolate.