Joseph Keenan - Comment

Document ID: FDA-2008-P-0090-0004
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 26 2008, at 04:40 PM Eastern Standard Time
Date Posted: February 26 2008, at 12:00 AM Eastern Standard Time
Comment Start Date: February 25 2008, at 12:00 AM Eastern Standard Time
Comment Due Date: May 12 2008, at 11:59 PM Eastern Standard Time
Tracking Number: 803c82cd
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I would like to commend the FDA for their decision to extend the soluble fiber food health claim to extracted barley beta glucan. I have been conducting research on soluble fibers for over 20 years including whole oat, whole barley and solubilized cellulose. In fact, I conducted one of the key studies (JFP 1991:33 (6), 600-608) and co-authored an oat/lipid meta-analysis (JAMA 1992:267 (24), 3317-3325). that led to the FDA approval of the first food health claim for oat beta glucan.I also was the principal investigator for the extracted barley beta glucan clinical trial (BJN 2007: 97, 1162-1168) that demonstrated the remarkable lipid lowering benefits of extracted barley betafiber. Till recently there has been some opinion that it is the intact whole grain (oats,barley,rye) or whole grain flour rather than the beta glucan alone that results in the lipid benefit. However, this well controlled clinical trial demonstrates clearly that extracted beta glucan using the Cargill company's process is as effective at lipid improvement, if not more so, than the whole grain. In addition, this is a product that is easily incorporated into a wide variety of processed foods with good palatibility and performance and no significant untoward effects. As such it will likely be an important enhancement to the heart I would like to commend the FDA for their decision to extend the soluble fiber food health claim to extracted barley beta glucan.

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