Health Canada's ruling in August to allow ADM's CardioAid plant sterols ingredient to be added to foods clears the way for manufacturers in Canada to add heart-healthy phytosterols into a variety of foods and beverages. From start to finish, the approval process took about two years to complete.
The ruling opens up a whole new, fourth market region for Archer Daniels Midland Co, which had previously gained approval for CardioAid in the U.S., European and Chinese markets.
The timing is also fortuitous, as both the American Heart Association and the National Institutes of Health's National Cholesterol Education Program support the dietary use of plant sterols as a complementary approach to help manage cholesterol, in their most recent recommendations.
"These recommendations suggest that physicians along with other health professionals recognize the solid scientific evidence for including plant sterols as part of a healthy diet and lifestyle approach for reducing the risk for developing heart disease," said Dr Brent Flickinger, senior manager, nutritional science, ADM Office of Compliance and Ethics.
In the past few years, published epidemiological studies have observed a beneficial relationship between increased serum plant sterol levels and decreased coronary heart disease risk, as well as decreased total mortality risk, Flickinger said.
In particular, one 2010 study showed a decreased total mortality risk among middle-aged men who consumed phytosterols, in data collected over 22 years, which is a substantial period of time for an epidemiological survey. That study was published in the journal Atherosclerosis.
ADM introduced CardioAid plant sterols in the 1990s, and today offers the commercial product line globally in both powder and water-dispersible forms.
Health Canada has confirmed that plant sterols may be added to the following foods: mayonnaise, margarine, calorie-reduced margarine, yogurt and yogurt drinks, vegetable and fruit juices, salad dressing and unstandardized salad dressings and spreads.
Health Canada has also issued guidance concerning the use of health claims regarding the cholesterol-lowering effect of plant sterols. The following statement may be used for foods meeting the qualifying criteria:
"\[serving size from Nutrition Facts table in metric and common household measures\] of \[naming the product\] provides X% of the daily amount of plant sterols shown to help reduce/lower cholesterol in adults."
One or both of the following statements may be used adjacent to the primary statement:
- "Plant sterols help reduce \[or help lower\] cholesterol."
- "High cholesterol is a risk factor for heart disease."
Other market approvals
In the U.S., CardioAid has received notice from FDA that it has no objection to the inclusion of CardioAid in 19 food categories, the largest number of categories notified for any plant sterol on the market. This includes: in fruit and vegetable juices up to 1g sterol equivalents per serving; in edible oils, up to 4 g/100g; and in margarine and vegetable oil spreads, dressings for salads, beverages, snack bars, dairy analogs, cheese and cream, baked foods, ready-to-eat cereals, mayonnaise, pasta and noodles, sauces, salty snacks, processed soups, puddings, yogurt, confections, and vegetarian meat analogs at a level of 0.4g sterol equivalents per serving.
In the European Union, CardioAid is approved as a novel food for addition to fat spreads; salad dressings (including mayonnaise); milk type products; fermented milk-type products such as yogurt and soya drinks; and cheese-type products.
Earlier this year, ADM received Novel Foods approval from the Ministry of Health of the People's Republic of China for the use of CardioAid. This approval allows Chinese food manufacturers to use plant sterols in foods and beverages.