EU monacolin restrictions expose ‘flaw in heart health model’ and accelerate shift toward systems-based approaches, says ACI Group

Ingredient distributor ACI Group has said planned EU restrictions on monacolins are exposing a fundamental flaw in the way cardiovascular health has been approached for decades, arguing the sector must move away from single-active cholesterol reduction and toward systems-based metabolic solutions.

With restrictions expected by 2026 due to safety concerns around muscle toxicity and liver effects, ACI Group says the issue is not simply reformulation, but category design.

“Monacolins have anchored the category around LDL cholesterol, but that model reduces a complex metabolic system to a single endpoint,” said Sam Lubbock Smith, Business Development Manager at ACI Group. “Cardiovascular health is not a single-pathway issue. It reflects interconnected systems including liver function, lipid transport, inflammation and vascular integrity.”

Lubbock Smith said the regulatory shift is exposing structural limitations in the category rather than creating a short-term ingredient gap.

“We are not dealing with a substitution problem,” he said. “We are dealing with a systems problem that the category has never properly addressed.”

ACI Group said attention is now shifting toward multi-pathway botanical systems, including polyphenol-rich citrus extracts such as bergamot, alongside a growing recognition of the liver as a central regulator of cardiometabolic health.

This systems-based approach is already reflected in clinically studied combination technologies such as Bergacyn®FF, which combines bergamot citrus fruit with Cynara cardunculus (artichoke) leaf extract.

Human studies on the combination have shown reductions in liver fat, improvements in body weight, and improvements in key liver enzymes including ALT, AST, ALP and GGT over 12–16 weeks, alongside improvements in endothelial function and uric acid levels at 600mg dosing.

“Cholesterol regulation is downstream of liver function,” said Lubbock Smith. “If you ignore that, you are only intervening halfway in the system.”

ACI Group said this reflects a wider shift away from single “hero ingredient” positioning toward integrated metabolic systems designed to reflect how the body regulates lipid metabolism, inflammation and vascular health in parallel.

“The next phase of heart health innovation is not about finding a replacement for monacolins,” Lubbock Smith concluded. “It is about redesigning the model around how the body actually works.”

For more information on Bergacyn® FF, including clinical data and partnership opportunities, contact ACI Group to speak with the business development team.