Frequently Asked Questions
In case you have a question related to the Benecol® food products (like spreads, yoghurts, drinks etc.), please contact your local manufacturer.
Frequently asked questions concerning plant stanol ester and Benecol® products:
Questions and answers related to the new Nutrition and Health Claim legislation in Europe:
Benecol is the global brand name for food products with added plant stanol ester, the patented cholesterol-lowering ingredient. Plant stanol ester effectively reduces total and LDL cholesterol levels in blood. The efficacy and safety of the ingredient in Benecol products has been verified in about 60 published clinical studies. Raisio, a Finnish company, is the owner of both the Benecol brand and the unique patented plant stanol ester ingredient.
Cholesterol is a fat-like compound that is essential for all cells in our body. It also serves as a starting material for bile acids, certain hormones and vitamin D. Because cholesterol is such a vital molecule for the normal functioning of the body, it is synthesized in sufficient quantities by the liver thus, there is no dietary need for cholesterol.
The cholesterol circulating in our bloodstream originates from two sources; 1) from the diet that we eat and 2) from the synthesis in our own body, mainly in the liver, and excreted via the bile into the digestive tract. In the blood, cholesterol is carried in lipoprotein particles, mainly in LDL and HDL liporptein particles.
The main sources are dietary and biliary cholesterol (Cholesterol comes to the dietary tract as dietary cholesterol and as biliary cholesterol). Dietary cholesterol originates from the foods we eat (e.g. egg yolks, meat, cream, butter); only foods from animal sources contain cholesterol. Biliary cholesterol enters the digestive tract with the bile solution. Bile solution comes from the liver and is needed for fat digestion. Normally about 50% of the dietary and biliary cholesterol is absorbed from the digestive tract into the bloodstream but plant stanol ester is able to effectively reduce this absorption. Reduced cholesterol absorption results in reduced blood total and LDL cholesterol levels.
Plant stanol ester works by inhibiting the absorption of cholesterol from the digestive tract into the blood. Plant stanol ester partly blocks the absorption of dietary and biliary cholesterol. A measurable reduction in blood cholesterol levels can be seen in one to two weeks.
When blood LDL cholesterol level exceeds the level needed for normal functioning, cholesterol starts to build up in blood vessel walls causing atherosclerosis. Elevated blood cholesterol is a risk factor for coronary heart disease, stroke and peripheral vascular disease.
Plant stanol ester reduces cholesterol absorption from the digestive tract and thereby the level of "bad" LDL-cholesterol in the blood. Products including plant stanol ester are a dietary means to effectively reduce cholesterol.
Plant stanols are a group of compounds found naturally in plant cells. Small amounts occur in corn, wheat, rye, and other plants. Combining plant stanols with vegetable oil extracts creates plant stanol ester, which is an ideal ingredient in a wide variety of food products. Plant stanol ester is produced at facilities in Raisio in Finland and Charleston in South Carolina in the US.
To date, about 60 clinical studies have been published to in scientific journals, such as the New England Journal of Medicine and Circulation, documenting the excellent effectiveness and safety profile of the plant stanol ester. These studies show that plant stanol ester reduces LDL or ‘bad' cholesterol levels by an average of 10%, but does not affect the levels of ‘good' HDL cholesterol. In clinical studies plant stanol ester has reduced serum LDL cholesterol by up to 15% versus appropriate control.
High cholesterol is not visible or something you could feel. The best and most accurate way to check your cholesterol level is to visit your doctor for a blood cholesterol test.
Cholesterol reference values given for healthy individuals in recent international medical guidelines are:
- Total cholesterol less than 5 mmol/l (<190 mg/dl)
- LDL cholesterol less than 3 mmol/l (<115mg/dl)
- HDL cholesterol at least 1 mmol/l (≥40mg/dl) for men and at least 1.2 mmol/l (≥45 mg/dl) for womenBenecol products are recommended for everyone with elevated cholesterol levels, and for those who want to prevent their cholesterol level from rising. However, pregnant or lactating women and children under 5 have special dietary needs and and should consult their doctor before using any products designed to help manage cholesterol levels.
Your cholesterol levels drop within 2-3 weeks after starting the recommended daily intake of 2g of plant stanols. Regular cholesterol tests will show that plant stanol ester is working.
Blood levels of cholesterol typically fluctuates by ±10%. It is therefore prudent to establish your cholesterol level by multiple cholesterol tests.
For best results, Benecol products should be consumed daily with meals. Benecol products are recommended as part of a healthy diet and lifestyle.
Yes, you can freely use Benecol products as a dietary tool for lowering your cholesterol level. It is up to your own discretion if you want to consult your doctor. However, if you use cholesterol-lowering medication, it is recommended that you consult your doctor about using food products with added plant stanols or sterols.
Yes, Benecol products have a 14 year history of safe use in man. Furthermore, the effect of plant stanol ester has been studied in clinical studies with the duration of 12 and 18 months. Specific safety studies with plant stanol ester confirm the safety of this ingredient.
Clinical studies show that people on cholesterol medication benefit from using Benecol products. In other words, plant stanol ester has been shown to further reduce blood cholesterol levels in people on statin or other cholesterol lowering medication. However, people on cholesterol lowering medication should discuss their individual needs with their doctor to find the optimum solution.
Your blood cholesterol level will probably still be reduced, depending on the daily intake, but not as effectively.
The cholesterol-lowering effect of plant stanol ester is based on the reduction in the absorption of cholesterol from the digestive tract. This "cholesterol blocking" effect requires plant stanols to be present in the gut and therefore Benecol products should be consumed daily for best cholesterol-lowering effects. However, missing one or two days will most likely not have any significant effect on your blood cholesterol.
Plant stanol ester should be used as part of a healthy diet and lifestyle. You can easily reach the recommended daily intake of 2g of plant stanols by consuming commercially available Benecol foods.
Clinical studies show that a daily intake of up to 9g of plant stanols per day is as safe as consuming the currently recommended amount (2g plant stanols per day).
The long-term cholesterol lowering effect of the plant stanol ester has been verified in well controlled clinical trials, the longest ones being 12 and 18 months long. Furthermore, Benecol products have been on the market for more than 14 years and follow-up of individuals who have been using Benecol products clearly shows the long term cholesterol-lowering effect.
Your cholesterol will return to the levels where they were before you started the use of Benecol products.
Plant stanol ester is made from a fatty acid part and a plant stanol part. The plant stanols themselves are virtually unabsorbable, but the fatty acid part of plant stanol ester is absorbed like any other vegetable oil fatty acids.
No. No side-effects have been reported in the numerous clinical studies that have been carried out. Furthermore, specific safety studies wiht plant stanol ester confirm the safety of this ingredient. Plant stanols are virtually not absorbed into the body but are excreted rapidly the natural way, which is why they do not have any other effects in the body than the cholesterol lowering.
This is a current regulatory restriction in EU member states. Previously it was thought that the cholesterol lowering effect of plant stanol ester levels off at intake over 3g of plant stanols per day. Recent clinical studies however show that further LDL cholesterol reduction can be anticipated with safe higher daily intakes up to 9g plant stanols per day.
Plant stanol ester lowers cholesterol as part of any diet. However, a healthy diet has its own beneficial effect on cholesterol, which is why best results are obtained by combining Benecol products with other recommendable food choices. Furthermore, a healthy diet is always recommended because it has many positive health effects.
No. Plant stanol ester will not reduce your cholesterol too much, because your body will produce enough cholesterol for its needs.
Benecol products do not have any effect on blood vitamin levels. Small reductions have been seen for carotenoids, but the carotenoid levels still remain within reference values.
Furthermore, an adequate consumption of fruit and vegetables, together with plant stanol-enriched products, is sufficient to maintain your original carotenoid levels.Dietary changes are the first-line approach for lowering elevated cholesterol or maintaining blood cholesterol at healthy levels (see question 10). Benecol products are a dietary tool for lowering blood cholesterol levels and the cholesterol lowering effect of Benecol products is additive to that of a recommended, cholesterol lowering diet.
The use of plant stanol ester is a dietary way to lower elevated cholesterol levels. The cost of statin drugs and other cholesterol lowering medication varies from country to country and depends mainly on the refunding by local social welfare programs or insurance companies.
Click here to find your local Benecol product manufacturer.
All Benecol products contain the same cholesterol-lowering ingredient, plant stanol ester, which is supplied by Raisio Nutrition's Ingredients Division. The amount of the ingredient in different Benecol products may vary, so please check the labeling for ensuring the recommended daily intake.
The new nutrition and health claim legislation was prepared to protect the consumers from misleading claims and to help the consumer to make informed decisions. All health claims must be evaluated by the European Food Safety Authority and approved by the European Commission before use, thus enabling the consumer to trust the solid scientific evidence behind health claims.
Previously there were differences in national provisions between EU member states. When the implementation stage of the new legislation is over only approved health claims will exist and the use of all those health claims, which have been rejected because of insufficient scientific evidence, will end. EU level approvals will ensure that health claims within all EU member states will be comparable to each other.
Are there different types of health claims?
There are tree types of health claims:
a. General health claims -> health claims that refer to the normal function of the body (e.g. calcium is good for your bones)
b. Disease risk reduction health claims and children's health claims -> health claims that relate to a decrease in a risk factor for a disease or to normal growth in children (e.g. claims related to cholesterol lowering and the reduction of the disease risk factor for coronary heart disease or to claims like: calcium is needed for normal growth and development of bone in children)
c. Health claims based on new scientific evidence or proprietary dataA nutrition claim states or suggests that a food has beneficial nutritional properties, such as "low fat", "no added sugar" and "high in fibre".
A health claim is any statement on labels, marketing or advertising that health benefits can result from consuming a given food, for instance that a food can lower cholesterol and that elevated cholesterol is a risk factor for coronary heart disease.This completely new category of health claims has been introduced in the new European legislation on nutrition and health claims. Disease risk reduction claims refer to the reduction of a disease risk and must be supported by strong scientific evidence. If the science behind an ingredient (or a food) has been substantiated by the European Food Safety Authority and approved by the EU commission, a disease risk reduction claim can be used.
- What does the disease risk reduction claim for the cholesterol lowering ingredient in Benecol® products say?
The disease risk reduction claim relating to plant stanol ester was among the first disease risk reduction claims authorised by the European Commission confirming that: 'plant stanol ester has been shown to lower blood cholesterol. High cholesterol is a risk factor in the development of Coronary Heart Disease'.
Plant stanol ester should be used as part of a healthy diet and lifestyle. You can easily reach the recommended daily intake of 2g of plant stanols by consuming commercially available Benecol foods.
All general health claims will be evaluated and listed as approved or rejected. Due to the huge amount of health claims to be evaluated it will take some time before unsubstantiated claims will disappear from the market.
Disease risk reduction claims, children's claims and health claims based on new scientific evidence will be approved or rejected on the basis of the scientific evaluations. These evaluations will be performed upon submissions from the food industry -> such new health claims will emerge over time.- The ad said: "Coronary heart disease has multiple risk factors and altering one of these may or may not lower the risk". What does this mean?
Coronary heart disease has several risk factors. Some of these cannot be modified (such as age, sex or genetic background) but many of them can. Such modifiable risk factors are e.g. blood cholesterol, blood pressure and smoking. Lowering cholesterol is likely to reduce the risk of coronary heart disease but it is also important to pay attention to the other modifiable risk factors.
Coronary heart disease (CHD) is a condition in which the small blood vessels that supply blood and oxygen to the heart (coronary arteries) are narrowed. This narrowing is caused by atherosclerosis which occurs when fatty material and plaque build up on the walls of the arteries. As the coronary arteries narrow, blood flow to the heart can slow down or stop, which can cause chest pain, shortness of breath, or a heart attack. Factors like elevated LDL cholesterol, smoking and high blood pressure increase the risk of coronary heart disease.
High cholesterol is one of the main risk factors of Coronary Heart Disease (CHD). According to World Health Organization 2004 global estimates, CHD caused an estimated 7.2 million deaths and accounted for approximately 12.2% of all deaths worldwide. It is estimated that 80% of people with CHD have at least one risk factor that is modifiable by either diet or lifestyle. WHO. Cardiovascular diseases (CVDs). (WHO fact sheet no. 317). Geneva, Switz.: World Health Organization (WHO); 2009. Available at: http://www.who.int/mediacentre/factsheets/fs317/en/index.html [Updated Sep. 2009]
Benecol products and the active ingredient in them (plant stanol ester) are still the same. The new health claim only acknowledges their effective cholesterol-lowering effect even better than before.
