Heart-healthy Formulation How-To: Free sterols or sterol esters?
Senior food scientist
On Feb. 21, 2012, the U.S. Food and Drug Administration (FDA) announced that it would allow continued use of the health claim linking consumption of free plant sterols as well as sterol esters to a reduced risk of coronary heart disease until a final rule is issued. It was good news in that food and dietary supplement manufacturers can keep using free sterols in applications such as beverages and tablets, but the lack of a final decision on health claim requirements may spell continued uncertainty for some of these manufacturers.
FDA’s recent review of the sterols health claim also spurred interesting discussions of the relative merits of and differences between sterol esters and free sterols. At Cargill, we stay on top of regulatory issues so we can inform our customers on FDA’s actions like the proposed amendment of the sterol/heart disease risk reduction health claim. We extend our expertise to our customers to identify which version of sterol ingredient is best for their particular application now and, if the FDA issues a final decision on the health claim at some point in the future, what it might mean for them.
Cargill's CoroWise® Naturally Sourced Cholesterol Reducer™ brand of plant sterols comes in two versions: free sterols and sterol esters. Plant sterols block the absorption of cholesterol and may reduce low-density lipoprotein (LDL) cholesterol by 8% to 15%. CoroWise® plant sterols are used in a wide range of products that includes orange juice, dietary supplements, milk, snacks and spreads.
Free sterols are in the form of a fine waxy powder that can be used in milk, orange juice, bread and yogurt. When we add a fatty acid to a free sterol molecule to make the sterol ester, the physical properties change. It becomes thicker in consistency and is now fat-soluble with a lower-melting point.
This is a better ingredient for muffins, cakes, spreads and oils. However, because the fatty acid takes up 40% of the molecule, you need more of the sterol esters by weight to achieve the cholesterol-reducing equivalency of a free sterol. Because the amount of plant sterols needed to meet the health claim minimum inclusion level is fairly low – currently 400 mg on a free sterol basis per serving (though FDA has proposed an increase to at least 500 mg per serving) – formulation changes are rarely needed and taste, texture and flavor are unaffected.
Based on our customers' needs, we make recommendations and can customize sterol ingredients with specific fatty acid profiles or make specific sterol ingredient forms for food and dietary supplement products. If you're curious about adding heart-healthy plant sterols to your product and want to discuss all your options, call the experts at Cargill. Whether you choose CoroWise with sterol esters or free sterols, you'll have made a decision you can live with.
Carol Lowry, a senior food scientist, has been with Cargill for the last 10 of her 28 years in the industry.