The US Food and Drug Administration (FDA) has authorized use of a health claim for the role of  beta-glucan soluble fiber from barley in reducing the risk of coronary heart disease.   The interim final rule was published in the Federal Register on December 23, 2005 and is in response to a petition submitted by the National Barley Foods Council.  Authorized use of the interim claim in barley food labeling is effective immediately.

The National Barley Foods Council submitted a health claim petition to the FDA in 2004 requesting that the agency amend the existing “Soluble fiber from certain foods and coronary heart disease health claim” at CFR 101.81 to include barley as a source of beta-glucan soluble fiber associated with reducing the risk of coronary heart disease.  The claim is based on consuming 3 grams of beta-glucan soluble fiber daily.

In its review of the scientific evidence provided in the Council’s petition, the FDA noted that five clinical trials testing the impact of consuming whole grain barley and dry milled barley products consistently reported statistically significant lower serum total and LDL-cholesterol levels.  In the trials, subjects consumed diets in which whole grain barley or dry milled barley product ingredients replaced wheat and rice ingredients.  The lowest daily dietary intake of barley beta-glucan soluble fiber that significantly lowered serum total and LDL-cholesterol reported in the trials was three grams per day.  A 2004 study reported a 6 percent and 8 percent reduction in LDL cholesterol following consumption of diets containing barley with 3 grams and 6 grams of beta-glucan soluble fiber, respectively.  For more specific information on barley clinical trials, click here.

The FDA has identified several sources of barley beta-glucan soluble fiber that are eligible for the health claim.  These include whole grain barley, barley bran, barley flakes, barley grits, barley flour, barley meal, sieved barley meal and pearl barley produced from clean, sound dehulled or hulless barley using standard dry milling techniques.  To qualify for the health claim, a food made from these sources must contain at least 0.75 grams of barley beta-glucan soluble fiber per serving.

In its decision to issue the interim ruling, the FDA took into consideration the fact that coronary heart disease continues to be the leading cause of death and permanent disability in the United States.  The FDA noted that allowing manufacturers of qualifying barley food products to use an interim health claim prior to a final ruling may result in a reduction in the risk of heart disease by helping at-risk consumers make healthier food choices now.

“Research has long shown that barley holds tremendous potential as a healthful food choice,” says Mary Sullivan, executive administrator of the National Barley Foods Council.  “The scientific evidence on barley beta-glucan soluble fiber and its ability to reduce cholesterol is indeed significant and we are pleased that the FDA agrees with the findings and has authorized this claim.  We expect to see a definite increase in new barley foods product development as this grain offers food manufacturers great versatility in its use as a viable and heart-healthy ingredient in prepared foods for all day-parts.  It is indeed an exciting time for the US barley industry.”
The National Barley Foods Council is a not-for-profit 501 (a) organization based in Spokane, WA.  Its membership is comprised of five state barley producer groups including the Idaho Barley Commission, Montana Wheat and Barley Committee, North Dakota Barley Council, Oregon Grains Commission and the Washington Barley Commission.