U.S. Food and Drug Administration
FDA Consumer magazine
November-December 2000
Table of Contents
By Carol Lewis
Planning a healthier diet that helps reduce the risk of heart disease just got easier. And a little tastier. Foods containing certain plant extracts, which have been shown to reduce blood cholesterol levels, have received the go-ahead to tout their ability to lower the risk of heart disease.
In September, the Food and Drug Administration gave food manufacturers permission to put labels on foods containing plant sterol esters and plant stanol esters to indicate that they may reduce the risk of coronary heart disease (CHD). As in authorizing similar health claims for soy, oat bran, and other foods, FDA based this action on a review of the scientific evidence that shows the benefits of these plant extracts in a healthy diet. FDA-authorized health claims are intended to help otherwise healthy consumers make informed choices about products that may help promote health and prevent disease.
The proven ability of plant sterol and stanol esters to lower cholesterol is supported by more than 20 scientific studies, both in the United States and in Europe. High blood cholesterol levels are a major risk factor for developing CHD or other heart problems. CHD is the most common and serious form of cardiovascular disease, and according to the American Heart Association, accounts for more deaths in the United States than any other disease or group of diseases.
Although cholesterol seems to be widely condemned as the cause of heart disease, the body actually needs a certain amount of this substance to function properly. Produced in the liver and absorbed from the diet, cholesterol helps build structures like cell membranes and some hormones. It circulates in the body in several complex forms, including low-density lipoprotein (LDL) cholesterol--sometimes called "bad" cholesterol, and high-density lipoprotein (HDL) cholesterol--often referred to as "good" cholesterol.
However, excess cholesterol in the blood can contribute to fatty buildup in the arteries. The buildup forms plaque deposits that narrow the arteries and make the heart work harder to force the blood through. If the plaques accumulate in the coronary arteries that supply blood to the heart muscle, then blood flow is impeded and the heart itself becomes starved for oxygen, causing chest pain. If a blood clot forms and completely obstructs the artery, a heart attack can occur.
Plant sterol and stanol esters work by blocking the absorption of cholesterol from the diet. Plant sterols have been known for some time to reduce the blood cholesterol levels that are responsible for most heart attacks. Plant sterol esters can be found in soybean oil as well as in many fruits, vegetables, nuts, cereals and other plant sources. Plant stanols occur naturally in even smaller quantities from some of the same sources. For example, both plant sterols and stanols are found in vegetable oils.
Research on the cholesterol-lowering benefits of the plant sterol and stanol esters led food manufacturers to consider adding these compounds to products that could substitute for high-saturated fat, high-cholesterol products, such as butter.
Following a heart attack in 1996, with the recommendation of his physician to follow a heart-healthy diet, 51-year-old "health nut" Phillip Terry reluctantly decided to switch to one of the two cholesterol-busting spreads currently being marketed as butter alternatives to reduce LDL cholesterol. He hoped it would lower his risk of future heart disease.
"It tastes just like margarine," says the Dallas, Tex., resident, although he admits he was initially skeptical about using a food product containing fat to aid in controlling his cholesterol levels. Skeptical or not, Terry's cholesterol levels told the tale.
"His is the most impressive case," says Terry's physician, Nilo Cater, M.D., assistant professor of medicine at the University of Texas Southwestern Medical Center at Dallas. Cater says that Terry "has had a significant, consistent response that has reduced his LDL cholesterol from 102 milligrams (mg/dL) per deciliter of blood, to 66 mg/dL. While the ideal LDL-cholesterol level for most people is less than 130 mg/dL, the desirable level for prior heart attack patients, like Terry, is less than 100."
For manufacturers to make a heart-healthy claim on any product containing these plant esters, the product must meet certain conditions. For example, the claim must specify that the daily dietary intake of plant sterol esters or plant stanol esters should be consumed in two servings eaten at different times of the day with other foods. Consistent with other health claims to reduce the risk of CHD, FDA is also requiring that health claims about plant sterol and plant stanol esters state that they should be consumed as part of a diet low in saturated fat and cholesterol.
Under this interim final rule, manufacturers are able to use the claim immediately while FDA accepts public comments for 75 days. FDA will consider all comments it receives and will publish a final rule next summer. If the comments convince FDA to make changes in the rule, manufacturers may have to revise their labeling.
Doctors believe that, by reducing LDL cholesterol through exercise and diet, many Americans may be able to avoid drug therapy to reduce their risk of heart disease. And incorporating plant sterol and stanol esters into the diet is one option for Americans who are trying to lower their cholesterol levels to benefit their hearts.
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