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Statement of Need: Almost all of the regulations for the nutrition labeling of foods and dietary supplements have not been amended since mandatory nutrition labeling was first required in 1993. New scientific evidence and consumer research has become available in the last 18 years that can be used to update the content and appearance of information on the Nutrition Facts and Supplement Facts labels so that consumers can use the information more effectively to select foods that will assist them to maintain healthy dietary practices.

Summary of the Legal Basis: FDA's legal basis derives from sections 201, 403, and 701(a) of the Federal Food, Drug, and Cosmetic Act.

Alternatives: The Agency will consider different options for the amount of time that manufacturers have to come into compliance with the requirements of this regulation, when finalized, so that the economic burden to industry can be minimized.

Anticipated Costs and Benefits: If finalized, this rule will affect all foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because all food labels will have to be updated. Much of the information currently provided on the Nutrition Facts and Supplement Facts labels is based on old reference values and scientific information. The proposed changes would provide more current information to assist consumers in constructing a healthful diet. The potential benefit from the proposed rule stems from the improvement in diet among the U.S. population. Diet is a significant factor in the reduction in risk of chronic diseases such as coronary heart disease, certain types of cancer, stroke, diabetes, and obesity.

Risks: If information on the Nutrition Facts and Supplement Facts label is not updated, reference values that serve as the basis for the percent Daily Value will continue to be based on old scientific evidence, and consumers could believe that they are consuming an appropriate amount of nutrients when, in fact, they are not. In addition, consumers would not be able to determine the amount of specific nutrients in a food product because mandatory declaration of those nutrients is not currently required. Furthermore, consumers may continue to overlook information on the label because it is not displayed prominently on the label. Changes to the reference values, nutrients declared on the label, and changes to the format and appearance of the label would reduce the risk of consumers making food choices in the absence of necessary information.