FDA extends phytosterol health claim

The US Food and Drug Administration is to expand use of the phytosterol heart-health claim to a broader range of foods and beverages. The move was triggered by requests from Cargill Health & Food Technologies, the company said last week.

The US Food and Drug Administration is to expand use of the phytosterol heart-health claim to a broader range of foods and beverages.

The move was triggered by requests from Cargill Health & Food Technologies, the company said last week.

Cargill reported that a FDA letter to the company said it 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."This is a significant step toward propelling science-based functional foods and beverages into the mainstream," said Fred Shinnick, manager of regulatory and scientific affairs at the Minneapolis-based company.

The FDA's action, announced on February 14, boosts the marketing potential of Cargill's newly branded CoroWise phytosterols for use in health foods.

Cargill H&FT president Ted Ziemann said the action would give Cargill customers more scope in the types of products developed with phytosterols. The company is reported to have worked on the issue with the FDA for nearly two years.

Plant sterols have been found effective in lowering elevated cholesterol when incorporated into a variety of low fat foods and have no reported adverse health effects. Elevated blood cholesterol is a major risk factor for heart disease, which is responsible for a third of all deaths worldwide.