Traco Files Comments With FDA Over Heart Claim

Traco Files Comments With FDA Over Heart Claim

WASHINGTON--Traco Laboratories, based in Champaign, Ill., filed comments withthe Food and Drug Administration (FDA) in December regarding its authorizationof health claims for plant sterol/stanol esters and reduced risk of coronaryheart disease. Among the comments were calls for an immediate effective date, amodel health claim and a three-point proposal for expansion of the claim.

Traco said FDA should allow use of the health claim for plant sterols on thelabels of food and dietary supplements, and that authorization should be allowedfor a variety of dosage forms for dietary supplements as well as otherconventional food delivery systems. "Since plant sterols can be deliveredin systems that meet the guidelines for low fat in both dietary supplements andconventional foods, consumers are able to reduce their cholesterol and risk ofcoronary heart disease, while limiting their fat consumption, on a routine, asopposed to sporadic, basis at every meal," said Sid Tracy, president ofTraco. "It would be difficult for anyone to argue that this would notpromote healthy dietary practices among consumers."

The comments were filed by New York-based Ullman, Shapiro & Ullman. Formore on Traco, visit www.tracolabs.com