The approval of a cardiovascular disease (CVD)-reduction claim for cocoa flavanols is a sign that the research on these ingredients is increasingly robust, an expert with long experience in the field asserted.

In response to a petition filed by Barry Callebaut AG Switzerland, FDA announced new qualified health claims on Feb. 1, 2023. Technically speaking, FDA does not “approve” such claims, but rather announces them via a letter of enforcement discretion.

“The petition requested that the agency review the use of a qualified health claim regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder or high flavanol semi-sweet/dark chocolate and a reduced risk of cardiovascular disease,” FDA wrote.

After reviewing Barry Callebaut’s submission—which was revised three times, with the final submission coming in November 2021—FDA concurred with the company’s assertion of a reduction in the risk of CVD when regularly consuming chocolate product that contains a sufficient concentration (200 mg) of naturally occurring cocoa flavanols per serving.

 Four specific claims approved

As a result, the agency approved the following four qualified health claims:

When making use of such claims for marketing purposes, companies must use the claims exactly as FDA has specified. Thus, they may be of limited use for marketing purposes because of the lukewarm tone of the language.

Nevertheless, the claims say something very powerful about the underlying science, said Risa Schulman, Ph.D., who heads the scientific and regulatory consulting agency Tap-Root.

History of cocoa flavanols

Schulman was working at Mars more than a decade ago when the company’s research in cocoa flavanols was kicking into high gear. Mars has indicated this was first motivated by the role those compounds play in the flavor of chocolate, but Schulman said the story quickly expanded from there.

“Even at that time, which was around 2010, there was 20 years of research that was strongly suggestive of the benefits of cocoa flavanols. It wasn’t just Mars’ research, though they had done a lot of it,” Schulman told Natural Products Insider.

Schulman was part of a team that translated that research into what eventually became the CocoaVia line of cocoa flavanol supplements.

“Our mission was to take it from the idea to the shelf. We operated like a startup with a large company,” she said.

CocoaVia is based on a high flavanol extract of cocoa that delivers 500 mg of cocoa flavanols in a serving. The marketing message has long been directed at increased blood vessel flexibility and resiliency and thus increased blood flow, which translates into a performance benefit when the circulatory system is under load, as during strenuous exercise.

In the letter to Barry Callebaut, FDA narrowed the consideration of the research and the language of the health claims to cocoa flavanols within a whole chocolate matrix—whether that is cocoa powder or whole dark chocolate.

Even with that narrowed focus (which saw FDA discard 17 studies that had focused on extracts as the test material), the agency still found more than 30 studies to evaluate to make the decision about the qualified health claims.

COSMOS and Flaviola studies

Schulman said that new research on extracts lends further credence to the power of the data backing the health effects of cocoa flavanols, even if FDA didn’t consider them as part of Barry Callebaut’s petition.

“There has been more research even since 2018, like the COSMOS study. And we have had positive results from the Flaviola study,” Schulman said.

COSMOS (COcoa Supplement and Multivitamin Outcomes Study) is a large trial organized through Brigham and Women’s Hospital in Boston. The study enrolled more than 20,000 subjects over a three-year term and continues to yield follow-on results as the researchers comb through this rich data set.

From the main study, the researchers found 500 mg of cocoa flavanols daily reduced total cardiovascular events by 15% and deaths from CVD by 27%.

The Flaviola study, which was published in 2015, used a drink containing 450 mg of cocoa flavanols as its test material. That study found a reduction in CVD risk and postulated the following preventive health benefit: “In healthy individuals, regular CF [cocoa flavanol] intake improved accredited cardiovascular surrogates of cardiovascular risk, demonstrating that dietary flavanols have the potential to maintain cardiovascular health even in low-risk subjects.

Schulman said that even though the qualified health claims apply to cocoa powder and whole chocolate, the official recognition of the underlying science is essentially good news for the whole category.

“This doesn’t really help anyone directly besides Barry Callebaut,” she said. “The qualified health claims have the stricture that you have to use them exactly as they are. They are of very limited use as a result. But the idea is that with any approved health claim, it’s going to raise all ships.”

Having a big war chest helps

When assembling this science and going through the lengthy and rigorous process of obtaining a qualified health claim (Barry Callebaut first submitted its dossier in 2018), it helps to have the underpinning of a thriving category to help fund the research.

Research firm Grandview Research puts the current size of the global chocolate market at $133 billion. While growth in the category is forecast to be a relatively sedate 3% over the coming decade, the popularity of chocolate as a flavor remains durable.

In 2019, per an article in Beverage Industry, an expert with the French flavor and extraction technology firm Prova claimed chocolate and vanilla remain at the top of consumers’ flavor preferences.

Barry Callebaut, which is based in Zürich, Switzerland, reported $8.8 billion annual revenue in its fiscal 2022. MacLean, Virginia-based competitor Mars, which has also funded significant cocoa flavanol research, is privately held but reportedly brought in between $40 and $45 billion during the same period.

Omega-3 qualified health claim

Years ago, the omega-3s industry took on a similar challenge, and funded the effort out of a smaller market sector. The market for omega-3s—one the largest, oldest and among the best researched subsets of the dietary supplement sphere—was sized at $47 billion in 2021 by the Global Organization for EPA and DHA Omega-3s (GOED).

The $47 billion figure includes all applications, such as foods, beverages and pharmaceuticals. The dietary supplement slice of that pie was sized at about $5 billion, with $1.35 billion of those sales coming in the United States.

Even with this smaller economic underpinning, GOED was able to lead a charge that resulted in qualified health claims relating to the omega-3 fatty acids EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). That came to a successful conclusion, though the organization had hoped for more, said Harry Rice, Ph.D., GOED’s VP of scientific and regulatory affairs.

“When GOED submitted its petition to the FDA in November 2013, we were requesting an authorized—not qualified—health claim,” Rice said. “In August 2014, when the agency came back with its preliminary opinion that our health claim petition unlikely met the standard of significant scientific agreement, we were given the option to agree to a qualified health claim (QHC) review. At that point, we decided qualified recognition was better than no recognition, so we agreed to the QHC review.

“Importantly, as part of its review of GOED’s petition, the agency updated its safety review to examine more recent evidence regarding the effects of consuming EPA and DHA at levels above 3 grams/day on risk of excessive bleeding,” Rice added. “The FDA concluded ‘… that dietary supplements that provide no more than 5 g/day EPA and DHA when used as recommended or suggested in their labeling are safe and lawful under 21 CFR 101.14(b)(3)(ii).’ When all is said and done, we consider the outcome to be a win for the omega-3 industry.”