September 18, 2001

The Honorable Tommy G. Thompson
Secretary of Health and Human Services
Washington, DC 20201-0004

Dear Mr. Secretary:

      The purpose of this letter is to request that the Department of Health and Human Services and the Food and Drug Administration (FDA) consider giving greater priority to an existing rulemaking concerning the trans fatty acid content of foods. There is a growing body of scientific evidence, both experimental and epidemiological, suggesting that consumption of trans fatty acids in foods increases the consumer’s risk of developing coronary heart disease (CHD). We refer to evidence published in quality medical journals such as LANCET, ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY, CIRCULATION, and THE NEW ENGLAND JOURNAL OF MEDICINE. We encourage FDA to review carefully the public comments on its 1999 proposed rulemaking concerning consumer labeling of trans fatty acids and, if appropriate, proceed to a final rulemaking.

     As you know, on November 17, 1999, FDA published a proposed rule entitled "Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims". The rule would amend the current nutrition labeling regulations by requiring the amount of trans fatty acids present in food to be included in the product’s Nutrition Facts panel. The proposal also would create a new nutrient content claim defining "trans fat free" and require a limit on trans fatty acids whenever there are limits on saturated fat in nutrient content claims or health claims. The proposal was mainly based on studies that indicate that consumption of trans fatty acids contributes to increased blood LDL-cholesterol levels, which increase the risk of CHD. As indicated above, recent studies have strengthened that conclusion and shown that trans fatty acids may also work through other mechanisms to increase the risk of CHD.

     Based on assumptions that the proposal will assist consumers in their efforts to reduce their risk of CHD and provide incentives to producers to reformulate food products to reduce the trans fat content, FDA’s preliminary Regulatory Impact Analysis estimated that, 10 years after the effective date, the rule would prevent 7,600 to 17,100 cases of CHD and avert 2,500 to 5,600 deaths per year. Over a 20-year period, FDA estimated the benefits of the proposed rule would range from $25 to $59 billion, while the costs were only $400 million to $850 million.

     In light of these estimates and the recent scientific findings, OMB believes there may be an opportunity here to pursue cost-effective rulemaking that provides significant net benefits to the American people. At the time OMB reviewed the proposed rule, OMB was impressed with the magnitude of the potential net benefits estimated by the underlying analysis. We understand that FDA has gathered additional information from the public as part of the public comment period, and that FDA is in the process of drafting a final rule in response to the comments received. If the regulatory impact analysis still suggests that the potential benefits of this rule far exceed the costs, then I strongly encourage you to finalize this rule or explain the rationale for not moving it forward. This rulemaking appears to be a tremendous opportunity for the FDA to address the nation’s leading cause of death B coronary heart disease B and to save thousands of lives.

     If you should decide to submit a draft final rule to OMB for review, we will conduct a rigorous, careful, and expeditious review. Prior to the review, my staff is eager to work with you to ensure the best possible rule and supporting analysis. At your earliest convenience, my staff would like to meet with FDA’s staff to discuss the comments FDA received on the proposal and the agency’s current thinking on how it plans to proceed.



John D. Graham
Office of Information and Regulatory Affairs