The novel foods application to FSANZ (Food Standards Australia New Zealand) relates to drinks with at least 20 per cent juice to be fortified at a level of 4.5g per litre.
Coke has for several years had a co-branded Minute Maid juice product fortified with Cargill’s plant sterol ingredient, Heartwise, on the market in the US. A Coke spokesperson told this publication the product “was performing very well”.
A similarly co-branded Benecol plant stanol-fortified drink launched by Pepsi under its Tropicana brand in the UK in 2006 was pulled after little more than a year after notching disappointing sales.
FSANZ noted Coke’s application had as its target population consumers who were “generally over the age of 40, with concerns about their blood cholesterol level”.
Phytosterol esters (derived from vegetable oils) and non-esterified phytosterols (derived from a tall-oil source) have been permitted in edible oil spreads and margarines in Australia since 2001.
November 2006 saw the OK given to the addition of phytosterol esters to breakfast cereals, low-fat milk and low-fat yoghurt. Non-esterified phytosterols from tall oil are permitted in low-fat milk but non-esterified vegetable oil-derived phytosterols have as yet won no approval.
FSANZ said “data on the cholesterol-lowering effects, nutritional effects and safety of phytosterols when added to fruit juice and fruit juice drinks will be taken into consideration.”
Coke’s application includes a clinical study and additional scientific data, but FSANZ will consider information from other sources, including other published studies.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA)-established Acceptable Daily Intake (ADI) would be taken into account.
FSANZ highlighted potential issues pertaining to the application. These included:
- The possibility for cumulative intakes of phytosterols (including current permissions for tall oil phytosterols and phytosterol esters) to exceed the ADI, especially among children, once they are permitted in a broader range of foods.
- The potential for increased juice and juice drink consumption by the target consumers, and concerns around increased energy intakes related to this.
- That in the future, food manufacturers may wish to make health claims on products containing phytosterols.
FSANZ had opened a public consultation until February 11, 2009.
The European Food Safety Authority (EFSA) recently issued a positive opinion on a plant sterol-based health claim submission from Unilever and accompanied it with suggested text that stated:
“Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease".
Cognis recently won hard-to-come-by approval from the Australian Thepareutic Goods Administration (TGA) to use its anti-cholesterol, plant sterol ester ingredient, Vegepure, in food supplements.
That approval means plant sterols can be used in supplements in recommended doses between 2g and 3g (minimum of 1.3g) and come with warnings that state:
“There is no benefit from taking more than 3g/day of phytosterols from all sources” and “Not suitable for pregnant or lactating women”.
It is estimated more than 50 per cent or 6.4 million Australian adults have high blood cholesterol.