The FDA recently expanded the opportunity for phytosterol-containing beverages and foods through its “no objection” to a GRAS notification letter. This decision that plant sterols and sterol esters may be considered GRAS in a larger spectrum of products means that additional heart-healthy food applications now will be made with these ingredients.

Plant sterols are fat-like substances that occur naturally in many vegetables and fruits. They have been found to have the ability to lower LDL, or “bad” cholesterol, while not affecting the levels of the HDL or “good” cholesterol in the body. When plant sterols are changed into plant sterol esters, they become more lipid-soluble and, therefore, are better distributed in the digestive tract. During digestion, plant sterol esters break apart and reduce cholesterol levels by competing with cholesterol for incorporation in micelles, by which cholesterol is normally absorbed into the bloodstream.

Cognis, the world’s largest producer of plant sterols and sterol esters, has built a new $25 million esterification facility. The plant operates using proprietary technology, Cognis’ own food GMPs and meets the criteria for ISO 22000. The company’s portfolio of eight phytosterol ingredients is called Heart Choice® and includes plant sterol esters as oils and water-dispersible powders, and free plant sterol ground powders and water-dispersible powders. Four are non-genetically modified, identity-preserved sterol and sterol ester ingredients. The Heart Choice line also is kosher and halal-certified, appropriate for a range of applications, such as margarine and vegetable oil spreads, salad dressings, bars, yogurts, beverages, cereals, pastas, sauces, salty snacks, confections and ground roasted coffee.

A large body of clinical research supports the use of plant sterols for various health benefits, including seven studies conducted with Cognis’ phytosterols for heart health. On average, a reduction of up to 15% of LDL cholesterol levels has been found. For instance, in a recent meta-analysis of the clinical research published investigating the effects of phytosterols and stanols on lipid concentrations in familial hypercholesterolemia (FH) subjects, the authors concluded phytosterols/stanols to be an effective adjunct treatment strategy for lowering cholesterol in FH patients (Moruisi, et al., 2006. J Am Coll Nutr. 25:41-8).

Sales of cholesterol treatment products are estimated at $30 billion, and Cognis can help its customers position products that target this marketplace. As an example, Cognis has created an ingredient brand to be used at the consumer level, “Heart Choice™.” The website,, is part of Cognis’ co-branding program and supports consumer education on the benefits of phytosterols.

Laura Troha, a Cognis marketing manager, points out that most Americans do not get enough sterols in their diets. Even though sterols are naturally found in vegetables, fruits, oils, legumes, nuts and grains, few eat enough of these foods on a daily basis. “Because the highest concentrations of phytosterols are often naturally occurring in high-fat foods, some of the most health-conscious consumers intentionally omit these foods. As a result, they miss a significant source of sterols, creating a need for supplementation from functional foods and dietary supplements,” she says.

For more information:
Cognis Nutrition & Health • LaGrange, Ill.
Laura Troha • 708-579-6173

Sidebar: Sterols and Sterol Esters Health Claim

The FDA has approved the following food health claim:

Foods containing at least 0.65g per serving of plant sterol esters or 0.4g of plant sterols, eaten twice a day with meals for a daily intake of at least 1.3g of plant sterols or 0.8g of sterols as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.

Laura Troha, Cognis, says the company helps manufacturers leverage the FDA's authorized health claim in product formulation, product packaging and consumer marketing. “This powerful claim, combined with compelling clinical research, allows us to help our customers create products that command a real competitive advantage. Surveys show that consumers want natural cholesterol-lowering products, if they're effective. Cognis' phytosterols are safe, natural and clinically-proven- they're everything consumers want in a heart-health product.”