ADM Receives FDA Letter For Cardioaid™ Plant Sterols
ADM announced today that the Food and Drug Administration has issued it a letter which greatly expands the GRAS (Generally Recognized As Safe) categories of its cholesterol-reducing CardioAid™ plant sterols. As a result, food companies now have a newly expanded range of food products which can be fortified with CardioAid™ plant sterols.
“Until today, the range of food products which could be fortified under GRAS status with plant sterols was very narrow,” said Steven J. Furcich, President ADM Natural Health & Nutrition. “However, ADM’s letter from the FDA now allows food companies to incorporate CardioAid brand sterols into many of their other consumer products. No other sterol ingredient available today has been evaluated for so many new GRAS food categories.”
Food companies can now look at incorporating CardioAid ™ plant sterols into mayonnaise; dressings for salad; pasta and noodles; healthy beverages; sauces; healthy bars; salty snacks; milktype products, including processed soups; puddings; soy milk, ice cream and cream substitutes; adult confections; yogurt; vegetarian meat analogs; cheese and cream; edible vegetable oil (home use); adult ready-to-eat breakfast cereals; and fruit/vegetable juices.
Presently, the NIH (National Institute of Health) through the National Cholesterol Education Program suggests that Americans consider plant sterols as a therapeutic lifestyle change for reducing cholesterol. And a 2003 review published in Mayo Clinic Proceedings states that eating foods low in saturated fat and cholesterol and high in sterols can reduce LDL cholesterol by 20 percent. ADM’s CardioAid plant sterols provide an effective, dietary method for countering elevated cholesterol, a crisis facing 105 million Americans.
In 2000, FDA authorized a coronary heart disease (CHD) health claim for plant sterol and plant stanol esters. This interim rule reflected the agency’s conclusion that sterol and stanol esters may reduce CHD risk by decreasing blood cholesterol levels as part of a diet low in saturated fat and cholesterol. CHD kills more Americans than any other disease, according to the Center for Disease Control. Foods that carry the claim also must meet requirements for low saturated fat and low cholesterol. In addition, these foods also must contain no more than 13 grams of total fat per serving and per 50 grams.
Consequently, food companies can now take advantage of the FDA’s permitted health claim on product labels and in their marketing materials for a newly expanded range of food products. For customers around the world, ADM draws on its resources – its people, products and market perspective – to help customers meet today’s consumer demands and envision tomorrow’s needs.
ADM Media Relations