Yes. Published studies report the safety and efficacy of plant stanol ester intake in children on diet therapy for the management of high cholesterol.

In clinical studies, side effects with plant stanol esters were comparable to placebo. Plant stanol esters have an excellent safety profile. This safety record is further supported by ten years of experience with plant stanol esters consumed as BENECOL? Spread.

Phytosterolemia is an extremely rare inherited disease caused by a high rate of absorption of plant sterols in the intestine and reduced biliary removal of plant sterols from the liver. Plant stanols, like those found in BENECOL? Spreads, are virtually unabsorbed by humans.

In clinical trials there was no evidence of weight gain with the use of BENECOL? Spreads. BENECOL? Spreads should be used in place of the regular spreads your patients are currently using, such as their usual spreads, butter, or margarine, and as part of a healthy diet with proper exercise.

There is no evidence to indicate that BENECOL? Spreads will interfere with any medications. We have evaluated for possible drug interaction in clinical studies but found no evidence of such interactions. No interactions have been reported in the literature.

The safety of BENECOL? Spreads is supported by more than 25 published clinical studies. Plant stanol esters, the beneficial dietary ingredient in BENECOL? Spreads, have an excellent safety profile. BENECOL? Spreads have been consumed by millions of people since their 1995 launch in Finland.

There is no clinical evidence to indicate that BENECOL? Spreads will interfere with any medications. In clinical studies using BENECOL? Spreads, a number of subjects were using medications, but no drug interactions were reported. Additionally, no drug interactions have been reported in the medical literature.

The National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Guidelines recommend 2 grams of plant stanols (3.4 grams of plant stanol esters) as part of a daily diet low in saturated fat and cholesterol to help reduce the risk of heart disease. This amount can be obtained by enjoying 4 servings of BENECOL? Spread. If you recommend more than 2 servings of BENECOL? Spread per day, we suggest your patients use BENECOL? Light Spread.

No. BENECOL? Spreads are not drugs. They contain plant stanol esters, are available without a prescription, and may be found in your local grocery store.

Yes. Studies have demonstrated the effectiveness of plant stanol esters in blocking the absorption of cholesterol in individuals with diabetes. Individuals with diabetes should refer to the package for nutritional information related to BENECOL? Spreads, or speak with a healthcare professional about how to incorporate BENECOL? Spreads into their individualized dietary regimen.

BENECOL? Spreads are appropriate for all people who are concerned about their cholesterol levels. People with elevated cholesterol levels need to consult a doctor to find out if cholesterol-lowering medication is appropriate for them.

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The FDA has authorized use of a health claim stating that "Products containing 0.7 grams or more of Plant Stanol Esters per serving taken twice a day with meals for a daily intake of at least 1.4 grams may reduce the risk of heart disease as part of a diet low in saturated fat and cholesterol." Four servings of BENECOL? Spreads per day can deliver a total of 2 grams of plant stanols (3.4 grams of plant stanol esters) daily, the level of plant stanols recommended by the NCEP Guidelines.

Yes, BENECOL® Spreads can be used in conjunction with a low fat diet to provide additional cholesterol lowering benefit versus diet alone. Plant Stanol Esters affect biliary as well as dietary cholesterol absorption. A clinical study published in the American Journal of Clinical Nutrition, 1999; 69:403-410, examined the use of plant stanol ester spread in subjects who were on a low-fat, low-cholesterol diet similar in fat content to a Step II diet.

BENECOL? Spreads are certified kosher. They bear the Circle U P (Parve) symbol. They are not certified kosher for Passover.

BENECOL? Spreads are foods and not drugs. They are used as part of a dietary approach and have been proven to reduce cholesterol. Two to four servings of BENECOL® Spreads per day with meals, added to a diet low in saturated fat and cholesterol may reduce the risk of heart disease.

BENECOL? Spreads do not have a clinically significant effect on fat soluble vitamin status (A,D,E,K). Some studies indicate that plant stanol esters have a variable effect on beta-carotene levels. The only known biological function of beta-carotene is as a precursor of vitamin A and vitamin A levels have not been shown to be affected by plant stanol esters. It is recommended that carotenoid - containing fruits and vegetables be consumed daily for good health.

BENECOL? Spreads have an excellent safety profile. We would not expect there to be any ill effects if one were to occasionally eat more than four servings of BENECOL? Spreads per day. For optimum results, we recommend that patients eat at least 2 servings per day of BENECOL? Spreads with meals and snacks. If you recommend more than 2 servings of BENECOL? Spread per day, we suggest your patients use BENECOL? Light Spread. BENECOL? Regular Spread should continue to be used for cooking and baking.

In a clinical study in which plant stanol esters (3 grams of plant stanols/day) were added to the diets of individuals on stable statin regimens, an additional 17% reduction in LDL (compared to 7% in the controls) was achieved. 2

Over 25 published clinical studies have proven the benefits of taking plant stanol esters for reducing total and LDL cholesterol levels.