Raisio Group licenses the Benecol brand and sells the ingredient stanol ester to food companies around the world.
[1] The European Commission approved the following statement regarding Benecol products: "Plant stanol esters have been shown to lower/reduce blood cholesterol.
Blood cholesterol lowering may reduce the risk of coronary heart disease" but noted that "there are no studies demonstrating that plant stanol esters have an impact on population-based CHD morbidity and mortality rates".
The following is the FDA model health claim, to which certain designated optional modifications may be made: “Foods containing at least 0.5g per serving of plant stanols eaten with meals or snacks for a daily total intake of 2g as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.
"[6] Consuming more than 3g of plant stanol per day is not recommended and Benecol foods may not be appropriate for pregnant or breast feeding women, and children under 5 years old.