Nov 07 2013

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Trans Fat and the FDA

Posted at 12:48 pm under Current Awareness,Federal Legal,Health Law

As noted in articles today in the New York Times, the Boston Globe and other sources, the Food and Drug Administration (FDA) has taken action that could lead to a ban of use of trans fatty acids (trans fat) in processed foods sold in the U.S. FDA notes CDC estimates that eliminating trans fats in partially hydrogenated oils in the diet “could prevent up to 20,000 cases of coronary heart disease (CHD) and up to 7,000 deaths annually.”

A statement from Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, explains FDA’s administrative action and next steps:

Because of the evidence linking trans fats to an increase in the risk of heart disease, however, FDA has preliminarily determined that partially hydrogenated oils are no longer GRAS [generally regarded as safe] for any use in food. We are providing a 60-day comment period to ask for additional information. If, after reviewing the comments and scientific information submitted, FDA makes the final determination that partially hydrogenated oils are not GRAS and are not otherwise authorized for use in food, such oils become unapproved food additives. That would make their use unlawful unless a company or other petitioner could prove to FDA that one or more specific uses are safe under the “reasonable certainty of no harm” safety standard.

A Notice (request for public comments and scientific data) is scheduled for publication in the Federal Register tomorrow. (See the Notice here.)

Existing FDA regulations require including information on trans fat content in food labels. However, as Taylor’s statement acknowledges, for foods containing less than .5 grams of trans fat per serving, the regulations direct that the label indicate zero (0) grams of trans fat. Thus, consumers purchasing foods with labels indicating no trans fat still may be consuming trans fat in amounts up to .5 grams per serving.

At present, FDA states it has “no plans” to adjust the food labeling regulations; however, the  agency notes that “the preliminary determination [announced today] would result in a lowering of actual [trans fat] levels in foods.”

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