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T00-40                                 Print Media: Ruth Welch, 202-205-4144                                                           
September 5, 2000                      
                                       Consumer Inquiries  888-INFOFDA

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 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.

Coronary heart disease, one of the most common and serious forms of cardiovascular disease, causes more deaths in the U.S. than any other disease. Risk factors for CHD include high total cholesterol levels and high levels of low density lipoprotein (LDL) cholesterol.

This new health claim is based on evidence that plant sterol or plant stanol esters may help to reduce the risk of CHD. Plant sterols are present in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, 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.

Foods that may qualify for the health claim based on plant sterol ester content include spreads and salad dressings. Among the foods that may qualify for claims based on plant stanol ester content are spreads, salad dressings, snack bars, and dietary supplements in softgel form.

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 and per 50 grams. However, spreads and salad dressings are not required to meet the limit for total fat per 50 grams if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section of the label for information about fat content. In addition, except for salad dressing and dietary supplements, the food must contain at least 10% of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, or fiber. FDA is also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of a diet low in saturated fat and cholesterol.

Scientific studies show that 1.3 grams per day of plant sterol esters or 3.4 grams per day of plant stanol esters 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 of plant sterol esters per serving or at least 1.7 grams of plant stanol esters per serving. 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.

An example of a health claim about the relationship between plant sterol esters and reduced risk of heart disease is:

Foods containing at least 0.65 grams per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ____ grams of plant sterol esters.

An example of a health claim about the relationship between plant stanol esters and reduced risk of heart disease is:

Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___ grams of plant stanol esters.

This new health claim interim final rule responds to petitions submitted to the FDA by Lipton (plant sterol esters) and McNeil Consumer Healthcare (plant stanol esters). The FDA is issuing this rule as an interim final rule. It is effective immediately with an opportunity for the public to comment. The final rule on this health claim may differ from this interim rule, and manufacturers would be required to revise their labeling to conform to any changes adopted in the final rule.

Written comments will be received until 75 days after date of publication in the Federal Register and may be addressed to: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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