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Statement of Need: This proposed rule was mandated by section 4205 of the Affordable Care Act.

Summary of the Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act by creating new clause (H) to require that chain restaurants, with 20 or more locations, require certain nutrient disclosure. Specifically, section 4205 required the Secretary of Health and Human Services to issue a proposed regulation to carry out clause (H) of the ACA no later than 1 year of enactment of this clause (i.e., Mar. 23, 2011). FDA has the authority to issue this proposed rule under section 403(q)(5)(H) and 701(a) (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the act vests the Secretary (and, by delegation, the FDA) with the authority to issue regulations for the efficient enforcement of the act. As directed by section 4205, FDA is proposing requirements for menu calorie declaration, as well as other nutrition information declaration to implement the provisions of 403(q)(5)(H). FDA is also proposing the terms and conditions for registering to voluntarily be subject to the requirements of section 4205.

Alternatives: Section 4205 requires the Secretary (and, by delegation, the FDA) to establish, by regulation, requirements for nutrition labeling of standard menu items for chain restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking.

Anticipated Costs and Benefits: Chain restaurants operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant, with fewer than 20 locations, may opt in to the national standard to receive this benefit. Many chain restaurants, with 20 or more locations, will bear costs for adding nutrition information to menus and menu boards. Consumers will benefit from having important nutrition information for the approximately 30 per cent of calories consumed away from home.

Risks: Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information. Completion of this rulemaking will provide consumers information about the nutritional content of food to empower them to make healthier food choices.