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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 with the Food and Drug Administration (FDA) in December regarding its authorization of health claims for plant sterol/stanol esters and reduced risk of coronary heart disease. Among the comments were calls for an immediate effective date, a model 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 the labels of food and dietary supplements, and that authorization should be allowed for a variety of dosage forms for dietary supplements as well as other conventional food delivery systems. "Since plant sterols can be delivered in systems that meet the guidelines for low fat in both dietary supplements and conventional foods, consumers are able to reduce their cholesterol and risk of coronary heart disease, while limiting their fat consumption, on a routine, as opposed to sporadic, basis at every meal," said Sid Tracy, president of Traco. "It would be difficult for anyone to argue that this would not promote healthy dietary practices among consumers."

The comments were filed by New York-based Ullman, Shapiro & Ullman. For more on Traco, visit

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