FDA Approves Another Fiber/Heart-Health Claim

FDA Approves Another Fiber/Heart-Health Claim

WASHINGTON--The Food and Drug Administration amended the healthclaim linking fiber to a reduced risk of coronary heart disease (CHD). Theamended claim will cover, in addition to the broad term "solublefiber," soluble fraction of alpha-amylase hydrolyzed oat bran or whole oatflour with a beta glucan content of up to 10 percent--also known as oatrim. Theclaim goes into effect Oct. 2, when the interim final rule is published in the FederalRegister (www.access.gpo.gov).

FDA had concluded in 1997 that there was significant scientific agreement forbeta glucan soluble fiber in certain whole oat sources lowering the risk of CHDby reducing blood cholesterol levels. In 1998, the agency amended that claim tostate that soluble fiber may reduce the risk of CHD.

On April 21, 2001, Pepsico's Quaker Oats Co. and Cranbury, N.J.-based RhodiaInc. petitioned FDA to amend the 1998 modified health claim, reporting that thesubject of the fiber health claim was broader than what available evidencesupported. They asked that this amendment be made with specific reference tooatrim, known under the Quaker/Rhodia brand name BETATRIM, which is processedeither by alpha-amylase enzymes or by acid/base hydrolysis and has a beta glucansoluble fiber content between 4 percent and 25 percent.

"The petition requested that the amendment specifically referenceQuaker/Rhodia BETATRIM brand name products because they are the only sourceswith demonstrated blood cholesterol-lowering efficacy," FDA noted. "[H]owever,the substance tested in the clinical cholesterol-lowering efficacy study ... wasmanufactured both by Quaker Oats Co. and by ConAgra Inc." The agency addedthat because the claim in not limited to the petitioners' brand name products,it would be available for any substance meeting FDA's definition of oatrim.

Oatrim, which FDA does not challenge as being generally recognized as safe(GRAS), offers benefits when used at a level that provides at least .75 g ofbeta glucan soluble fiber per serving. The agency noted that there are nogenerally accepted or validated criteria for predicting which sources orprocessed forms of beta glucan soluble fiber are capable of reducing CHD risk.However, FDA did report that beta glucan soluble fiber of up to 10 percentoffers heart-health benefits by reducing total cholesterol and low-densitylipoprotein (LDL or "bad") cholesterol levels.