Soluble Fiber Health Claim Amended

FDA amended the health claim, Soluble fiber from certain foods and risk of coronary heart disease (CHD) (Title 21 of the Code of Federal Regulations, Section 101.81), to include barley betafiber as an additional eligible source of beta-glucan soluble fiber. FDA took this action in response to a health claim petition submitted by Cargill, Inc., Minneapolis.

FDA defines barley betafiber as the ethanol-precipitated soluble fraction of cellulase- and alpha-amylase-hydrolyzed whole grain barley flour. The ingredient contains 70% or more beta-glucan, 2 to 12% protein, and less than 3% each of sugars, lipids and inorganic salts. The level necessary to justify the claim is 0.75 grams beta-glucan soluble fiber per serving.

FDA previously concluded there was significant scientific agreement that a claim characterizing the relationship between beta-glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by publicly available scientific evidence. Based on that evidence, FDA now has concluded that barley betafiber is also an appropriate source of beta-glucan soluble fiber.

This interim final rule went into effect Feb. 25, 2008.