FDA health claims rules are complicated, and manufacturers are warned to be careful in making claims on packages. In 2009, FDA regulators chastised General Mills, the maker of the iconic Cheerios brand, saying it made inappropriate claims about the cereal's ability to lower cholesterol and treat heart disease by using specific amounts ("you can lower your (LDL) cholesterol 4 percent in six weeks" and "10 percent in one month." In a warning letter, FDA said the language on the Cheerios box suggested the cereal is designed to prevent or treat heart disease, and only FDA-approved drugs are allowed to make such claims.
Some of that is semantics. General Mills responded that the health claims on Cheerios have stood for 12 years, the science was not in question, four peer-reviewed studies support the claims and the FDA's complaints dealt more with language. Nevertheless, General Mills went back to the safer, FDA-dictated claim: "3g of fiber daily from whole grain oat foods like Cheerios cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. Cheerios cereal provides 1g of fiber per serving."
The difficulties are not just with U.S. health claims. Food product manufacturers are opting for more general claims as uncertainty continues around European Food Safety Authority (EFSA) rules on health claims. The Netherlands-based Innova Market Insights counted 1,960 new products with an "active health" positioning January through June of this year, compared to 2,189 new products with this positioning in the corresponding period in 2009. This decline in "active" health claims came despite 18 percent growth in "passive" claims ("low-" and "light") on new products in the same periods.
Nevertheless, product launches positioned on a heart-health platform nearly tripled over the past five years and accounted for nearly 1.5 percent of total food and drinks launches recorded over the 12 month period ending April 2010. The U.S. and Europe account for two-thirds of heart-health launches, and the bakery and cereals sector dominates with over a quarter of the total of new products, ahead of dairy products (12 percent), ready meals and meal components (10 percent) and soft drinks (9 percent). Other sectors featuring significant heart health launches include hot beverages; meat, fish & eggs; fruit & vegetable products and soups, sauces & seasonings.
Products for cholesterol reduction continue to dominate the heart health market in numbers of launches, although the heart-health sector fared better than many, with heart healthy ingredients such as plant sterols/stanols for cholesterol reduction and the Fruitflow anti-thrombotic tomato extract (both providing sufficient evidence to have their health claims approved by EFSA.)
Innova also notes that while some products have a specific heart-health positioning, there are many other products not included where the benefit may be implied but not specifically mentioned. The key is ingredients perceived by consumers to be heart healthy. Ingredients falling into this category include omega-3 fatty acids, whole grains, oats and soy. All of these have also been linked with other health benefits, such as joint health and cognitive health for omega-3 fatty acids, digestive health for whole grains, controlled energy release for oats and women's health and bone health for soy.
There are some new circulatory health ingredients in the offing. The anti-hypertensive market remains relatively limited, according to Innova, but has seen some new developments involving peptides, sourced from milk proteins, in Europe and from sardines in Japan. The use of antioxidant ingredients for heart health is another area that is relatively undeveloped and may have potential, particularly if the antioxidants come from cocoa and fruit, which have additional health halos.
Doctors are beginning to recognize vitamins C and E may be important for your heart, reports Prevention magazine. It isn't known whether a lack of these nutrients can lead to heart disease, but recent research seems to confirm some link.
A 10-year Women's Health Study of 40,000 healthy women, the longest and largest trial ever conducted on vitamin E supplementation, found it significantly reduced (24 percent) the risk of death from cardiovascular disease. Results from the Nurses' Health Study following 85,000 women over 16 years found vitamin C intake of more than 359mg a day from diet plus supplementation reduces CHD risk by 27-28 percent. Based on long-term health studies, other healthy nutrients recommended by physicians include folic acid, selenium and zinc.