ADM has received FDA go-ahead for its CardioAid plant sterols to be used in a wider range of food products, which will make it easier for consumers to lower cholesterol without radically changing their diet.
The Archer Daniels Midland company's plant sterol range was first introduced in the US about five years ago, and had GRAS status for use in spreads, salad dressings, health drinks, health bars and yogurt-type products.
The initial offerings were CardioAid phytosterols, used mainly in dietary supplements and other products were added functionaly was not required, and CardioAid-S phytosterol esters for foods.
Eighteen months ago it launched three new variants - CardioAid-GA, -M - which can be used in low-fat or fat free foods and CardioAid-WD for beverages.
"Sterols can be difficult to work with, so we have been developing application-specific solutions," product manager Greg Dodson told NutraIngredients-USA.com.
In fact, ADM is on the point of relaunching CardioAid-GA as it hgas found a way to further improve dispersability and reduce ringing.
This week the company has receive a letter from the FDA that allows food companies to consider CardioAid for a wide range of everyday consumer products: pasta and noodles; salty snacks, milk-type products and processed soups, puddings; soy milk, ice cream and cream substitutes; adult confections; vegetarian meat analogs; cheese and cream; edible vegetable oil (home use); adult ready-to-eat breakfast cereals; baked goods; and fruit/vegetable juices.
Natural health and nutrition president Steven Furcich said: "No other sterol ingredient available today has been reviewed for so many new GRAS food categories."
These products will be able to carry the FDA approved health claim linking sterol and sterol esters to a reduced risk of coronary heart disease by reducing blood cholesterol levels as part of a diet low in saturated fat and cholesterol.
Despite many of the new categories traditionally being regarded as unhealthy, formulators will have to bear in mind saturated fat and cholesterol levels - known to contribute to high cholesterol - in order to comply with the health claim criteria. They must also ensure the products contain no more than 13g of fat per serving and per 50g.
Coronary heart disease is the single leading cause of death in the United States. The American Heart Association estimates that about 1.2 million Americans will have a first or recurrent coronary attack this year, and about 479,000 of these people will die.
About 34.5 million American adults have dangerously high cholesterol levels of 240 mg/dL or higher. Ideally, total cholesterol should be below 200mg/dL and HDL (good) cholesterol 40 mg/dL or higher.
Heath care practitioners are increasingly advising their patients to lower their cholesterol through diet, instead of prescribing statin drugs that are known to come with some serious side effects.
The less dramatically people have to change their eating habits, the more likely they are to follow the advice. Therefore, if they can continue eating favorite foods such as ice cream, cheese or puddings - albeit sterol enriched healthy versions - they are more likely to lower their cholesterol successfully.