Published in the Federal Register of August 15, the final rule amends the agency’s Soluble fiber from certain foods and risk of coronary heart disease (CHD) health claim regulation to add barley betafiber as an additional eligible source of beta-glucan soluble fiber.
The amendment comes further to a petition filed by Cargill in June 2006. An interim final rule (IFR) was published in February this year, which meant that since that date manufacturers have been able to place the health claim on their products containing barley betafiber in appropriate amounts.
Since February, FDA has gathered public comments on the IFR. The agency received five responses: three from consumers, one from academia, and one from the Commonwealth of Kentucky.
One consumer comment and the comment from academia supported the IFR, said FDA.
The Commonwealth of Kentucky advised the agency that FDA's ruling on the health claim would not adversely affect the State's actions or conflict with any State laws. FDA said the remaining consumer comments addressed issues that are outside the scope of this rulemaking.
The agency therefore adopted the provisions of the IFR as a final rule, without change.
Cargill's Barliv barley betafiber is a concentrated ß-glucan soluble fiber derived from whole grain barley.
Studies conducted on the ingredient have shown it has cholesterol-lowering benefits, said to be similar to oats.
A six-week clinical study conducted at the University of Minnesota by Joseph Keenan found that when consumed as part of a heart-healthy diet, barley betafiber "significantly" improved total cholesterol and LDL-cholesterol levels.
Heart health claim
In order to qualify for the FDA-approved heart health claim, foods must contain a minimum of 0.75g beta-glucan soluble fiber per serving.
However, according to Cargill, its ingredient can be used at higher concentrations of 3g in products such as baked goods, cereals, snacks, beverages and soups.
An example of the health claim that can be carried by products containing beta-glucan is:
"Diets low in saturated fat and cholesterol that include 3 grams of beta-glucan soluble fiber from barley betafiber may reduce the risk of heart disease. One serving of [insert name of food] provides [insert number] of grams of this soluble fiber."
As well as delivering soluble fiber to a product, barley betafiber can also be used as a thickener in products like soup, or as a texturizer in snack foods.
Cargill said the new health claim is a "significant step" in its "drive to commercialize new products with high relevance to consumers, capitalizing on the increasing demand for heart-healthy products."
The company said it is also exploring the possibility of additional clinical studies that may support broader health benefits for Barliv, "in line with other recognized health benefits".
Heart disease has been the leading cause of death in the United States for at least 50 years.
Preventing the condition has therefore been a priority for US consumers, and these concerns have been rapidly taken up by the food industry.
According to information from Mintel's Global New Products Database (GNPD), heart health was the functional food category that saw the most product launches last year.
GNPD data revealed a massive 244 percent increase in new introductions in this category - from 43 products in 2006 to 148 in 2007. In 2003, only 22 new products were launched in this category, followed by 19 in 2004 and 54 in 2005.