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Statement of Need: FDA intends to publish a final rule amending its nutrition labeling regulations to incorporate requirements for trans fatty acids in labeling, nutrient content and health claims for several reasons. First, this final rule responds, in part, to a citizen petition on trans fatty acids in food labeling from the Center for Science in the Public Interest. Also, recent research shows that dietary trans fatty acids raise low density lipoprotein cholesterol (LDL-C), the major diet related risk factor for coronary heart disease (CHD). Finally, the information on trans fatty acids in nutrition labeling is needed to assist consumers in maintaining healthy dietary practices.

Summary of the Legal Basis: The NLEA (Pub. L. 101-535) amended the Federal Food, Drug, and Cosmetic Act (the Act) to provide, among other things, that certain nutrients and food components be included in nutrition labeling. Sections 403(q)(2)(A) and (q)(2)(B) of the Act provide the agency with authority to, by regulation, add or delete nutrients included in the food label or labeling if the agency finds that such action will assist consumers in maintaining healthy dietary practices.

Alternatives: FDA proposed, in the November 1999 proposal, that when trans fatty acids are present in a food, the declaration of saturated fat must bear a symbol that refers to a footnote at the bottom of the nutrition label that states the number of grams of trans fatty acids present in a serving of the product, i.e., "Includes ___ g trans fat." In addition to the proposed option, the agency considered a variety of other options for the declaration of trans fatty acids in the Nutrition Facts panel. The other options were: (1) include trans fatty acids with saturated fat and call the total value "saturated fat;" (2) include trans fatty acids with saturated fat and call the total value "saturated fat," and add an asterisk after the term "saturated fat" when the food contains trans fatty acids that refers to a footnote stating "Contains ____ g trans fat;" (3) include trans fatty acids with saturated fat and call the total value "saturated + trans fat;" and (4) list trans fatty acids separately under saturated fat.

Anticipated Costs and Benefits: FDA has estimated the benefits of the proposed rule in the range of $25 to $50 billion compared with costs in the range of $400 to $900 million (discounted at 7 percent for 20 years). The value of the benefits were estimated based on CHD morbidity and mortality prevented. The costs were estimated based on a formula that included costs for testing, decisionmaking, information panel reprinting, relabeling of the principal display panels and product reformulation.

Risks: The American Heart Association estimates that CHD causes 1.1 million heart attack cases annually, with 33 percent of them fatal. FDA used these estimates as the baseline to estimate the number of cases and fatalities prevented by this rule. The agency estimated the rule would annually prevent 6,300 to 17,100 cases of CHD and 2,100 to 5,600 deaths, using three different methods to estimate these benefits. Thus, the labeling changes resulting from this rule are expected to reduce the risk of CHD, preventing, at a minimum, 6,300 cases of CHD and 2,100 deaths annually.