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FREQUENTLY ASKED QUESTIONS AND ANSWERS ABOUT BENECOLŪ SPREADS

BENECOLŪ BASICS

Q. What is the recommended daily intake of BENECOLŪ Spreads?

A. 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 BENECOLŪ Spread. If you recommend more than 2 servings of BENECOLŪ Spread per day, we suggest your patients use BENECOLŪ Light Spread. BENECOLŪ Regular Spread should continue to be used for cooking and baking.

Q. Do I need to write a prescription for BENECOLŪ Spreads?
A. No. BENECOLŪ Spreads are not drugs. They contain plant stanol esters, are available without a prescription, and may be found in your local grocery store.


Q. Do BENECOLŪ Spreads need FDA approval or review?

A. 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 BENECOLŪ 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.*

* If you recommend more than 2 servings of BENECOLŪ Spread per day, we suggest your patients use BENECOLŪ Light Spread. BENECOLŪ Regular Spread should continue to be used for cooking and baking.

Q. Can BENECOLŪ Spreads be incorporated into a low-fat diet?

A. 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. Control subjects on the Step II diet lowered their total cholesterol by 7.7% and LDL cholesterol by 9.9% with diet alone. Subjects who were on the Step II diet and also consumed 5.1 grams of plant stanol esters daily lowered their cholesterol up to 18.3% and LDL cholesterol up to 23.6%. The addition of plant stanol ester spread to the diet resulted in an additional reduction of 10.6% for total cholesterol and 13.7% for LDL cholesterol in addition to the reduction achieved by diet alone. The investigators concluded that the use of plant stanol ester containing spread is effective when used as part of a low-fat, low-cholesterol diet.

Two recent meta-analyses encompassing 41 clinical studies found that 2 grams of plant stanols (3.4 grams of plant stanol esters) daily achieved cholesterol-lowering. The recommendation for BENECOLŪ Spreads is at least 2 servings per day with meals and snacks. Four servings per day of BENECOLŪ Spreads 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. If you recommend more than 2 servings of BENECOLŪ Spread per day, we suggest your patients use BENECOLŪ Light Spread. BENECOLŪ Regular Spread should continue to be used for cooking and baking.

We recommend that BENECOLŪ Spread be substituted in the diet for foods with similar fat content so patients do not increase their total daily fat calories. In clinical trials when plant stanol esters spread was substituted for foods with similar fat content, subjects maintained their weight.


Q. Can I recommend BENECOLŪ Spreads to my patients following a kosher diet?

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

PLANT STANOL ESTERS


Q. What are plant stanol esters?

A. Plant stanol esters are the unique dietary ingredient in BENECOLŪ Spreads. They are proven to lower cholesterol levels. The plant stanol esters in BENECOLŪ Spreads are made from naturally occurring oils found in plants such as soy and even in pine trees.

Q. How do plant stanol esters work in the body?

A. Plant stanol esters reduce the absorption (inhibit the uptake) of cholesterol in the digestive tract resulting in lower serum low-density lipoprotein (LDL) and total cholesterol levels. Plant stanol esters do not affect high-density lipoprotein or triglyceride levels.


Q. How much plant stanol ester is needed daily for significant cholesterol lowering?

A. 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. One serving (one tablespoon) of BENECOLŪ Spread contains 0.85 grams of plant stanol ester (0.5 grams of plant stanol). The National Cholesterol Education Program (NCEP) Guidelines recommend 2 grams of plant stanols per day for LDL lowering, which is equivalent to 4 servings of a BENECOLŪ Spread. If you recommend more than 2 daily servings of BENECOLŪ Spread, we suggest your patients use BENECOLŪ Light Spread. BENECOLŪ Regular Spread should continue to be used for cooking and baking.

Q. How much plant stanol ester is contained in a serving of BENECOLŪ Spread?

A. One tablespoon of BENECOLŪ Spread contains 0.85 grams of plant stanol esters (0.5 grams of plant stanol).


Q. Are there any potential side effects from consuming plant stanol esters?

A. No. In clinical studies side effects with plant stanol esters were comparable to placebo. The safety of BENECOLŪ Spreads is supported by over 25 published clinical studies. Millions of people have consumed BENECOLŪ Spreads since they were launched in Finland in 1995 and the U.S. in 1999.

Q. Are plant stanol esters absorbed by the body?

A. Clinical studies have demonstrated that plant stanols are virtually unabsorbed by the body. Plant stanol esters are broken down into stanol and ester components. The stanol is excreted from the body while the fatty acids are absorbed and broken down just like other dietary fats.


Q. What is the difference between plant sterols and stanols?

A. Plant stanols and sterols are structurally very similar to cholesterol, but are found in plant oils. Sitosterol is the primary phytosterol found in vegetable oils. Sitostanols (stanols) are the saturated form of sitosterols, making them extremely stable. Plant stanol esters, the unique ingredient contained in BENECOLŪ Spreads are produced by the hydrogenation of plant sterols and subsequent esterification with fatty acids. Plant stanols are virtually unabsorbed by the body; plant sterols are absorbed to a greater degree.

Q. Are plant stanol esters similar to olestra?

A. No. Plant stanol esters and olestra are completely different and are intended for completely different purposes. Plant stanol esters are the ingredient contained in BENECOLŪ Spreads that promotes healthy cholesterol levels. Olestra is a fat substitute. It is intended to reduce calories, and the calories from fat in foods (such as potato chips and crackers).


EFFICACY


Q. Is there an added benefit from BENECOLŪ Spreads for patients on a low saturated fat, low cholesterol diet?

A. Yes. BENECOLŪ Spreads can be used in conjunction with a low-fat diet to provide additional cholesterol lowering benefit versus diet alone (as shown in an article published in the American Journal of Clinical Nutrition). Since BENECOLŪ blocks absorption of dietary and biliary cholesterol in the digestive tract, patients may receive additional cholesterol reduction by following a diet low in saturated fat and cholesterol in addition to using BENECOLŪ Spreads.

Q. Can BENECOLŪ Spreads be consumed by individuals with diabetes?

A. 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 BENECOLŪ Spreads, or speak with a healthcare professional about how to incorporate BENECOLŪ Spreads into their individualized dietary regimen.


Q. Do BENECOLŪ Spreads have any effect on HDL-C or triglycerides?

A. Plant stanol esters have not been found to affect HDL-cholesterol or triglyceride levels.

Q. Do BENECOLŪ Spreads reduce the risk of CHD (coronary heart disease)?

A. BENECOLŪ 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.


SAFETY


Q. Are there any adverse effects associated with the use of BENECOLŪ Spreads?

A. 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 BENECOLŪ Spread.

Q. Do BENECOLŪ Spreads interact with any drugs?

A. There is no evidence to indicate that BENECOLŪ 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.


Q. Will my patient gain weight when they use BENECOLŪ Spreads?

A. In clinical trials there was no evidence of weight gain with the use of BENECOLŪ Spreads. BENECOLŪ 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.

Q. Will my patients be subject to phytosterolemia when they use BENECOLŪ Spreads?

A. 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 BENECOLŪ Spreads, are virtually unabsorbed by humans.


Q. Do BENECOLŪ Spreads reduce the absorption of carotenoids (beta-carotene)?

A. BENECOLŪ 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.

Q. Is it safe and more effective to consume more than four servings of BENECOLŪ Spreads per day?

A. BENECOLŪ 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 BENECOLŪ Spreads per day. For optimum results, we recommend that patients eat at least 2 servings per day of BENECOLŪ Spreads with meals and snacks. If you recommend more than 2 servings of BENECOLŪ Spread per day, we suggest your patients use BENECOLŪ Light Spread. BENECOLŪ Regular Spread should continue to be used for cooking and baking.


Q. Can children use BENECOLŪ Spreads?

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

Q. Are there certain groups who should not consume BENECOLŪ Spreads?

A. BENECOLŪ 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.


Q. Do plant stanol esters accumulate in the body?

A. No, they are first broken down into the stanol and ester components. Plant stanols are virtually unabsorbed and are excreted. They do not accumulate in the body. The fatty acid ester component is digested and metabolized just like other dietary fats.

Q. Are BENECOLŪ Spreads safe, and do they have side effects?

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


BENECOLŪ AND OTHER CHOLESTEROL-LOWERING PRODUCTS


Q. Can BENECOLŪ Spreads be used in conjunction with a statin for additional cholesterol reduction?

A. 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

Q. Are there any drug interactions with BENECOLŪ Spreads?

A. There is no clinical evidence to indicate that BENECOLŪ Spreads will interfere with any medications. In clinical studies using BENECOLŪ 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.


NUTRITIONAL INFORMATION


Q. Do BENECOLŪ Spreads contain trans fatty acids?

A. BENECOLŪ Spreads contain less than 0.5 grams trans fatty acids per 8 grams serving.

CLINICAL STUDIES


Q. Is there any evidence that BENECOLŪ Spreads promote healthy cholesterol levels?

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

Q. Have the effects of BENECOLŪ Spreads on a vegetarian diet been studied?

A. Clinical trial exclusively with vegetarians has not been conducted. However, a clinical study published in the American Journal of Clinical Nutrition 1999; 69:403-10, demonstrated that additional cholesterol lowering could be achieved when a plant stanol ester margarine is added to a low saturated fat, low cholesterol diet.