F.D.A. adopts final rule on soluble fiber claim
WASHINGTON — The Department of Health and Human Services of the Food and Drug Administration on Friday adopted as a final rule the regulation authorizing a health claim on soluble fiber from certain foods and risk of coronary heart disease to include barley betafiber as an additional eligible source of beta-glucan soluble fiber.
The final rule, published in the Aug. 15 issue of the Federal Register, follows an interim rule that was issued Feb. 25 in response to a health claim petition filed in June 2006 by Minneapolis-based Cargill. Cargill claims to be the only producer of barley betafiber, and its Barliv barley betafiber product is the only barley beta-glucan concentrate that currently qualifies for the F.D.A. health claim as defined. Barliv barley betafiber is a concentrated beta-glucan soluble fiber derived from whole grain barley, and, according to Cargill, has been shown to significantly improve total cholesterol and L.D.L. cholesterol levels when consumed as part of a heart-healthy diet.
In the Federal Register notice, the F.D.A. said it concluded that barley betafiber, like other whole oat and barley products, does indeed lower serum total and L.D.L. cholesterol.
The comment period on the interim rule expired May 12, and the F.D.A. said it received five letters of response, none of which gave contrary evidence on the agency’s decisions detailed in the Feb. 25 interim rule.