As public concern with rising obesity rates has grown, and as individuals consume an increasing proportion of their food outside the home, public health stakeholders have successfully advocated for policies on restaurant menu nutrition labeling at the state and local level. These efforts have resulted in state and local variability of laws and regulations. Businesses that must comply with these laws and regulations have grown supportive of a consistent national policy on restaurant menu labeling requirements. Section 4205 of the Patient Protection and Affordable Care Act (ACA) amended the FDA's nutrition labeling requirements in the Federal Food, Drug, and Cosmetic Act (FFDCA), which were established by the Nutrition Labeling and Education Act of 1990 (NLEA). The ACA provision required nutrition labeling for foods sold in chain restaurants and vending machines. Both were previously exempt from the FDA's nutrition labeling authority. The provision also has a section on federal preemption of state and local laws regarding nutrition labeling in restaurants and SRFE. This report provides a discussion of the role of nutrition labeling in combating obesity, an overview of the FDA's authority to regulate nutrition labeling under the FFDCA, the restaurant menu labeling provision in Section 4205 of the ACA, and the proposed rule implementing this provision. The report also identifies issues that have generated industry and congressional interest regarding the FDA's interpretation of this provision in the proposed rule. Obesity rates have risen substantially in recent decades, from 13% of the adult population in the 1960s to 36% in 2009-2010. Although many factors contribute to an individual's weight, the basic cause of weight gain is an excess of energy intake over energy expenditure. At the population level, this has been reflected in indicators of decreased physical activity and increased calorie consumption. In adults, obesity is associated with a number of other health problems, including diabetes and high blood pressure. These health issues disproportionately affect low-income individuals and certain minorities. The federal government has sought to address these health concerns using a variety of approaches, including programs (e.g., the "Let's Move" campaign) and legislation (e.g., the Healthy, Hunger Free Kids Act) that promote nutrition, healthy weight, and physical activity. At the state and local level, lawmakers have also proposed a variety of approaches, including taxation and prohibition of high-calorie items, and requiring calorie labeling of restaurant food. Studies have shown that the number of calories consumed by individuals in the United States has risen concurrent with rising rates of obesity. The number of overall calories consumed has increased from a daily average of 1,875 calories during 1977-1978 to 2,067 calories during 2005-2008. Increasingly, these calories are consumed outside the home. Recent data from the National Health and Nutrition Examination Survey (NHANES) show that 32% of Americans' calorie intake from 2005-2008 came from foods consumed outside the home, including foods consumed in restaurants and school cafeterias. Consumers tend to underestimate the number of calories in restaurant meals. In one study, lunchtime customers at a fast food restaurant underestimated the calorie content of their lunch by 23%. Calorie labeling on menus has been adopted as one approach to making consumers aware of the amount of calories they are consuming. Calorie labeling on menus has been shown to change consumer behavior—for example, in one study, consumers were less likely to choose higher-calorie items when provided with calorie information on the restaurant menu. Restaurant menu labeling as a policy option for obesity prevention has garnered broad support from the public health community. The Centers for Disease Control and Prevention have deemed menu labeling a "winnable battle," and the approach is supported by the American Heart Association, the American Medical Association, and others. Additionally, this approach has gained popularity with policymakers at the state and local level. Menu labeling laws have been enacted in New York City, California, and several other jurisdictions. For the restaurant industry, state and local regulations have resulted in variable and sometimes conflicting requirements. For example, the California menu labeling law, enacted in 2008, requires restaurants with 20 or more locations in the state to post caloric content, carbohydrates, saturated fat, trans fat, and sodium content. The New Jersey menu labeling law, enacted in 2010, requires chain restaurants with 20 or more locations nationally to display calorie content for all items sold on all drive-thru and indoor menu boards. New York City, perhaps the most widely publicized example, enacted legislation in 2008 to require restaurants that are part of a chain with 15 or more locations nationally to post calorie content. While these differences may seem subtle to policy makers, the restaurant industry has made it clear that complying with varying local laws and regulations is more burdensome than complying with uniform national standards would be. New research on nutrition labeling of menus and menu boards suggests this approach may be successful in helping consumers lower their overall calorie intake. In one study in New York City, one in six fast food consumers reported using the posted calorie information, and those customers also purchased 106 fewer calories of food than those who did not use the posted calorie information. In King County, Washington, researchers found that the nutrition labeling law affected restaurants' behavior as well. They found that calorie content, saturated fat, and sodium were lower in entrees at chain restaurants within 18 months of implementation of a county-wide nutrition labeling regulation. However, because these laws and regulations are fairly recent, the long-term impact of state and local menu labeling regulations on population level obesity rates has not been widely studied. One indirect consequence of variable state and local regulations regarding restaurant menu labeling is the advent of restaurant industry support for a national menu labeling policy. Major industry groups such as the National Restaurant Association supported inclusion of a restaurant menu labeling provision in the ACA. In advance of the FDA's final rule on the national menu labeling law, some establishments have moved forward with menu nutrition labeling. McDonald's, the largest fast food company in the United States, announced in September 2012 that it would list calorie information on all restaurant and drive-thru menu boards. Federal responsibility for food safety and food labeling rests primarily with the FDA and the Department of Agriculture (USDA). The FDA is responsible for ensuring that all domestic and imported food products, except for most meats and poultry, are safe, nutritious, and accurately labeled. The 1938 Federal Food, Drug, and Cosmetic Act (FFDCA) granted FDA the authority to regulate food products and their ingredients. FDA's authority over nutrition labeling of those products was created by the Nutrition Labeling and Education Act (NLEA), which amended Section 403 of the FFDCA (to provide the FDA with the authority to require and regulate nutrition labeling), and added a new Section 403A (to preempt state and local nutrition labeling regulations). The ACA further amended these sections to provide FDA the authority to regulate nutrition labeling of restaurants, similar retail food establishments (SRFE), and vending machine operators that are part of a chain of 20 or more. This section provides an overview of the statutory authorities of the FDA that are relevant to this issue, and how those authorities were amended by the ACA. The FDA is authorized to create nutrition labeling requirements for most foods, and to regulate nutrient content claims and health claims on food labels. Under the FFDCA, FDA may deem foods misbranded unless health and nutrition claims are made according to FDA regulations. Introduction of misbranded food into commerce, misbranding of food that is in commerce, or receipt and delivery of misbranded food in commerce are prohibited. There are a number of conditions under which a food would be deemed misbranded, including if its label is "false or misleading." Generally, the FDA relies on food companies to voluntarily recall misbranded products, either on their own initiative or upon regulators' request. However, the agency does have the authority to pursue other enforcement actions against regulated firms, individuals, and products that fail to comply with the FFDCA. These actions include warning letters, seizures, injunctions, civil monetary penalties, and prosecution. The FFDCA requires all food regulated by the FDA to bear labeling with the serving size, total calories per serving, total calories per serving derived from fat, and the amount of various nutrients. It also provides the Secretary the authority to remove or otherwise change nutrient information requirements by regulation. The FDA has the authority to further specify requirements for the layout and design of the label to assist consumers. The FFDCA has provisions regarding its preemption of state and local nutrition labeling laws. The FFDCA provides several exemptions from nutrition labeling requirements. Infant formula and medical foods, which are subject to other labeling requirements, are exempt from the nutrition labeling requirements. Foods in packaging that is too small to comply with the required information, food that contains insignificant amounts of all the nutrients required to be listed, and foods offered by an individual who has grossed less than $500,000 from food sales (or who grosses less than $50,000 annually in food sales) unless the individual makes a health or nutrition claim for that food are also exempt. Foods with insignificant amounts of more than one-half the required nutrients may use a simplified labeling format. Prior to passage of the ACA, two other categories of food were also exempt from nutrition labeling requirements. These categories were (1) food "which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or used in such establishments," and (2) food "which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is the type described" in (1) and "which is offered for sale to consumers but not for immediate consumption in such establishment and which is not offered for sale outside such establishment." As noted, prior to passage of the ACA, restaurant-type food and food from vending machines were exempt from nutrition labeling authorities in the FFDCA.