Obesity is a major public health concern in the United States. Two-thirds of adults and one-third of children are overweight or obese. Although many factors contribute to obesity, weight gain is generally the result of an energy imbalance—an excess of calories consumed over calories expended. High rates of obesity and chronic disease have prompted various state and local nutrition labeling initiatives, in addition to other tactics and strategies. The 1990 Nutrition Labeling and Education Act (NLEA, P.L. 101-535 ) authorized the Food and Drug Administration (FDA) to require nutrition labeling of most foods and dietary supplements, but it did not require the labeling of food sold in restaurants. Section 4205 of the Patient Protection and Affordable Care Act (ACA, P.L. 111-148 ) amended the Federal Food, Drug, and Cosmetic Act (FFDCA), establishing nutrition labeling requirements for standard menu items offered for sale in chain restaurants or similar retail food establishments (SRFEs) that have 20 or more locations, that conduct business under the same name regardless of the type of ownership of the locations, and that offer the same menu items for sale. The ACA provision required FDA to promulgate regulations specifying the scope of entities and foods covered by the law, as well as details regarding how the required calorie and nutrition information would be conveyed to consumers. In 2011, FDA proposed two rules delineating nutrition labeling requirements for restaurants and SRFEs, as well as vending machines; both rules were finalized and published in the Federal Register on December 1, 2014. Prior to the final rule, some food establishments had already begun voluntarily posting nutrition information. However, variable state and local regulations had resulted in a patchwork of labeling requirements, making compliance more challenging for chain food establishments. Certain groups, such as the National Restaurant Association, expressed support for a federal nutrition labeling standard, stating that it would ease the regulatory burden on national chain restaurants. This report discusses the role of nutrition labeling in obesity management and prevention; the research on the effectiveness of restaurant menu calorie labeling; FDA's authority to regulate nutrition labeling; and the FDA's final rules on restaurant menu and vending machine labeling. The report also identifies issues for Congress and flags stakeholders' concerns regarding FDA's final menu labeling rule. According to the most recent data from the National Health and Nutrition Examination Survey (NHANES), in 2011-2014, the prevalence of obesity in the United States was 36.5% among adults and 17% among youth. Although rates appear to have stabilized in youth since 2003-2004 (see Figure 1 ), the prevalence of obesity among U.S. adults and children is higher than the Healthy People 2020 goals of 30.5% and 14.5%, respectively. This is of public health concern because obesity is associated with increased risk of a number of health conditions, such as high blood pressure, type 2 diabetes, cardiovascular disease, and stroke. Research has shown that frequent eating out is associated with increased calorie intake, and that food eaten away from the home tends to be of lower nutritional quality and higher in saturated fat and sodium than food prepared at home. Larger portion sizes served in restaurants contribute to greater calorie intake, and analyses of three fast food chain restaurants indicate that portion sizes have not changed since the mid-1990s (1996-2013). Studies also suggest that consumers tend to underestimate the number of calories in restaurant meals. Changes in the prevalence of overweight and obesity in the United States have paralleled changes in calorie consumption. As obesity rates increased, calories consumed by individuals two years and older also increased significantly, from a daily average of 1,875 calories in 1977-1978 to 2,002 calories in 2005-2008. The same study indicates that in 1977-1978, individuals in the United States consumed approximately 18% of calories away from the home, compared with 32% in 2005-2008. More recent NHANES data suggest that obesity rates have been leveling off and even decreasing in some age groups (e.g., among two- to five-year-olds). Data from USDA's Economic Research Service show that average calorie intake has also declined—by 118 calories (about 5%) between 2005-2006 and 2009-2010. During this time period, consumption of calories from food eaten away from home fell by 127 calories per day, and daily fast food calories fell by 53 calories per day. These changes suggest that consumer preferences for nutritious foods may be increasing, and there may be greater use of available nutrition information (e.g., the Nutrition Facts panel), resulting in improved diet quality among consumers. Public health stakeholders have generally supported restaurant menu labeling as a policy option for obesity prevention. Proponents of menu labeling say that providing calorie information in restaurants and food establishments may help consumers make healthier and more informed dietary choices. However, some researchers have found that current evidence does not support a significant impact of menu labeling on calories ordered, suggesting that posting calorie counts does not result in consumers making healthier food choices. It is difficult to predict what effect, if any, mandatory restaurant menu labeling will have on food purchasing and health outcomes. However, changes in behavior following implementation of calorie labeling regulations in other jurisdictions prior to publication of the final federal rule (e.g., New York City, Philadelphia, and King County, WA) may provide some insight. Studies examining the relationship between menu labeling and calorie purchasing behavior have yielded mixed findings. Although consumers often report ordering fewer calories as a result of menu labeling, studies examining restaurant transaction data have not consistently reported a decrease in calories purchased after implementation of menu labeling. This section discusses several studies that have evaluated the impact of menu labeling, using survey and transaction data, on calories purchased. Findings from current research are limited because existing studies often vary in scope and methodology. For example, several of the studies that did not find a post-labeling decrease in calories purchased were conducted by the same group of researchers using samples from low-income communities in New York, NY and Newark, NJ, and research has shown that there are socioeconomic disparities in calorie label use, with higher-income individuals being more likely to notice calorie labels. Another study limited its sample population to one chain of restaurants in King County, WA. An additional factor to consider is the time frame between implementation of menu labeling and an assessment of purchasing behavior, as there needs to be enough time for an effect to take place. One study, for instance, did not find an effect at four to six months post-mandatory menu labeling, but it did find a decrease in calories purchased 18 months after implementation. Another study that did not find an effect of menu labeling on calories purchased examined outcomes two months post implementation, which may not have been enough time for an effect to take place. In addition, most of these studies relied on self-reported data to assess customers' awareness and use of calorie labels. Such self-reporting may not be accurate, as evidenced by the inconsistencies between reported calories purchased and actual calories purchased as indicated on receipts. Finally, these studies analyzed the number of calories purchased but not changes in calories consumed, which may differ in response to menu labeling. For example, in full-service restaurants, customers may be more likely to share a meal or eat half the meal and take the rest home, which would not be captured by transaction data. Similarly, in fast food or carry-out establishments, customers may consume only a portion of their meal, which would not be captured by transaction data. In 2009, Starbucks commissioned a Stanford University study to determine how the menu labeling mandate in New York City (NYC) affected its overall sales. Findings indicate that after the implementation of mandatory calorie labeling, average calories per transaction fell by 6% at Starbucks, an effect that lasted 10 months after the calorie posting commenced. This effect was primarily found for food purchases, as the average food calories per transaction fell by 14% (i.e., approximately 14 calories per transaction), while average beverage calories per transaction did not substantially change. Changes in beverage calories may not be reflected in transaction data. For example, if a customer orders a latte and substitutes skim milk for 2% milk, or asks for one pump of syrup instead of the usual three or four, those substitutions would not be captured by transaction data because the cost of the latte would not change. This study also assessed the impact of calorie posting on Starbucks revenue, reporting no statistically significant change in revenue as a result of calorie labeling. Because cost data associated with the policy was unavailable, profits were not measured directly. The effect on revenue was divided into (1) the effect on the number of transactions and (2) the effect on revenue per transaction. The study found that daily store transactions increased by 1.4% on average, while revenue per transaction decreased by 0.8% on average for all Starbucks in NYC, resulting in a zero net impact of calorie posting on Starbucks revenues. In NYC Starbucks stores located within 100 meters of a Dunkin Donuts, daily revenue increased by 3.3% on average. To determine consumers' preliminary knowledge of calories in Starbucks food and beverages, surveys were administered before and after the introduction of a calorie-posting law in Seattle. Pre-menu labeling survey data indicate that Starbucks customers tended to be inaccurate in predicting the number of calories in their beverage and food orders. Specifically, in this study, consumers overestimated the number of calories in beverages and underestimated the number of calories in food. This is consistent with the study's finding that calorie posting discouraged individuals from purchasing food but not beverages. Because consumers tended to underestimate the number of calories in food items, seeing the posted caloric value, which was greater than initially expected, may have led consumers to reduce their food purchases. However, because consumers tended to overestimate beverage calories, calorie posting may not have discouraged people from purchasing beverages. Proponents of menu labeling argue that, in addition to affecting consumer purchasing behavior, mandatory menu labeling may incentivize restaurants to offer lower calorie options and provide consumers with healthier choices.