FDA Approves Lipton's Anti-Cholesterol Spread

A new plant sterol containing spread—formulated to help promote healthy blood serum cholesterol levels—is now hitting grocery stores following the completion of an FDA review of research showing the product's key ingredient is safe. The FDA made the announcement following an evaluation of materials submitted by Lipton, the Englewood, NJ-based manufacturer of the spread.

"The agency has no questions at this time regarding Lipton's conclusion that vegetable oil sterol esters are generally recognized as safe under the intended conditions of use," the FDA wrote in a letter to Lipton.

Lipton also worked with the FDA to come up with appropriate language to describe the product's claim it helps promote healthy cholesterol levels, said David Blanchard, VP of research and development for Lipton.

Within hours of the FDA news, the spread, under the brand name "Take Control," appeared on the shelves of one Cub Food store in Chicago, the city which also is the site of the annual Food Marketing Institute Convention where supermarket retailers have had the opportunity to sample the spread. The product will begin appearing on supermarket shelves nationwide in a few weeks.

The product is Lipton's first entry into the functional food category. The company adds that Take Control is the first of its kind to meet the regulatory requirements for food products that offer advantages beyond traditional nutrition.

The product's functional properties are attributed to plant sterols, a natural soybean extract that promotes healthy cholesterol levels. In recent studies, including one published in the European Journal of Clinical Nutrition (April, 1999), plant sterols, helped promote healthy cholesterol levels. Lipton recommends eating one to two servings of Take Control a day, as part of a diet low in saturated fat and cholesterol.

"Plant Sterols are naturally occurring plant extracts that work as part of the normal digestive process to help block the absorption of cholesterol," said Dr. Ernest Schaefer, chief, Lipid Metabolism Laboratory, USDA Human Nutrition Research Center on Aging at Tufts University, "So they can help people to promote healthy cholesterol levels, as part of diet low in saturated fat and cholesterol."

Take Control will be available in two forms: a 10-oz tub and a unit of 16 portion packages. The product is low in saturated fat, free of trans fatty acids and contains 6-g of fat and 1.1-g soybean extract per tablespoon serving.

Lipton is an operating unit of Unilever, a worldwide manufacturer of margarines and spreads. Unilever first started studying soybean extract as an ingredient for improving the properties of foods in the late 1980s. U.S. food regulations require that new food ingredients must either win FDA approval or be certified by qualified experts as a generally safe substance. The safety of the ingredient was confirmed based on its natural origin, stringent Unilever testing, the advice of a panel of independent experts and the completion of the FDA review. In addition, the company has conducted numerous studies over the years on benefits of the ingredient and further research continues.