FDA Talk Paper Plant Sterol

FDA TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
5600 Fishers Lane Rockville, MD 20857

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September 5, 2000                      

FDA AUTHORIZES NEW CORONARY HEART DISEASE HEALTH CLAIM FOR PLANT STEROL AND PLANT STANOL ESTERS

The FDA has authorized use of labeling health claims about the role of plant sterol or plant stanol esters in reducing the risk of coronary heart disease (CHD) for foods or supplements containing these substances. This interim final rule is based on FDA's conclusion that plant sterol esters and plant stanol esters may reduce the risk of CHD by lowering blood cholesterol levels.

Plant sterols are present in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, and other plant sources.

Foods that carry the claim must also meet the requirements for low saturated fat and low cholesterol, and must also contain no more than 13 grams of total fat per serving .  In addition, except for dietary supplements, the food must contain at least 10% of the RDI for vitamin A, vitamin C, iron, calcium, protein, or fiber.

Scientific studies show that 1.3 grams (1300 mg) per day of plant sterol in the diet are needed to show a significant cholesterol lowering effect.

In order to qualify for this health claim, a food must contain at least 0.65 grams (650 mg) of plant sterol esters per serving.. . . The FDA is issuing this rule as an interim final rule. It is effective immediately. . ..