FDA Okays Cargill Health & Food Technologies Request on Phytosterol Heart-Health Claim FDA announcement is good news for CoroWise phytosterols line

MINNEAPOLIS - February 20, 2003 - Cargill Health & Food Technologies helped trigger a U.S. Food and Drug Administration action Feb. 14th that will expand the use of the phytosterol heart-health claim to a broader range of foods and beverages.

The FDA's action provides a unique and immediate opportunity for the food industry to incorporate Cargill's newly branded CoroWise™ phytosterols into new heart healthy commercial products. Based on a letter FDA sent to Cargill, the agency will allow a broader range of food products and dietary supplements to bear the heart health claim in labeling when formulated with 0.65 grams of phytosterol esters or 0.4 grams free phytosterols per serving. The letter was sent by FDA's Office of Nutritional Products, Labeling and Dietary Supplements within the Center for Food Safety and Applied Nutrition. “We appreciate the FDA's work on this matter given the other pressing issues it faces. This is a significant step toward propelling science-based functional foods and beverages into the mainstream,” said Fred Shinnick, Cargill Health & Food Technologies' (H&FT) manager of regulatory and scientific affairs.

Cargill H&FT worked with FDA for nearly two years on this issue. “The FDA's action gives our customers more latitude in the types of products developed with phytosterols so that consumers can enjoy the benefits in applications that fit their lifestyle and expectations,” said Cargill H&FT President, Ted Ziemann. “We are excited about the prospect of helping our customers meet the pressing consumer demand for convenient, good-tasting heart healthy product solutions,” he said. Elevated blood cholesterol is a major risk factor for heart disease, which is responsible for 1/3 of all deaths worldwide. Plant sterols have been found effective in lowering elevated cholesterol when incorporated into a variety of low fat foods, demonstrating an eight to 15 percent reduction in LDL cholesterol with no reported adverse health effects. The scientific substantiation supporting the health benefits of phytosterols has been well established and public health authorities, such as the National Institutes of Health coordinated U.S. National Cholesterol Education Program (NCEP), are beginning to include phytosterols as part of their dietary recommendations (NCEP, 2001). “Consuming phytosterols as part of a healthy diet that is also low in saturated fat and cholesterol provides an important option in the promotion of cardiovascular health,” added Ziemann.

Cargill's H&FT business is part of a larger Cargill initiative called Food System Design. As such, Health & Food Technologies works in concert with customers to produce ingredient breakthroughs and other food system solutions that result in appetizing, nutritious, and convenient consumer products. Cargill Health & Food Technologies, based in Minneapolis, is a leading developer, processor and marketer of science-based, healthy ingredients for food and dietary supplements worldwide. It is a business unit of Cargill, Incorporated, an international marketer, processor and distributor of agricultural, food, financial and industrial products and services with 97,000 employees in 59 countries. Cargill provides distinctive customer solutions in supply chain management, food applications, and health and nutrition.

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