CardiaBeat set for US supplements entry
use of its sterol-based heart health ingredient CardiaBeat in
dietary supplements, with its approval as a new dietary ingredient
(NDI) by the FDA.
Earlier this year CardiaBeat was affirmed GRAS (generally recognised as safe) by an expert panel, which meant it could be used as a fat replacer in a wide range of food products, including yogurts, spreads and bars.
American consumers' have historically been more receptive to dietary supplements, although this is starting to change with growing awareness and availability of functional foods.
CardiaBeat is now positioned for use for products aimed at the vanguard of consumers who are prepared to give functional foods a try, as well as those who have not yet ventured away from the traditional supplement delivery format.
The could give it a boost in the competitive plant sterols/stanols sector, which is blooming as consumers and health care practitioners move towards alternatives to drugs like statins for the management of cholesterol levels.
Euromonitor International estimated the US dietary supplement market to be worth $8.3bn at retail in 2005, and the functional foods market to be worth $6.3bn.
To date CardiaBeat has been used in only one supplement line, Israel's Dr Fischer. The company said it "is expected to expand to other geographical areas shortly".
According to Dr Ariel Katz, CEO, its additional heart benefits beyond lowering LDL 'bad' cholesterol set it apart from other plant sterol ingredients.
A formulation of enzymatically-derived phytosterols and diglycerides, the ingredient is an extension of Enzymotec's functional oil formulation MultOil, which has evidence to support its potential to prevent and control oxidative stress, reduce total cholesterol and triglyceride levels and inhibiting the atherosclerotic plaque formation cascade.
CardiaBeat was originally developed with the needs of diabetics in mind. Diabetics are two to four times more likely to suffer from heart disease than non-diabetics.
"In the last three years we have performed seven clinical trials in both animals and humans to establish its unique health benefits and advantages over conventional approaches," said Katz.
