These efforts have resulted in state and local variability of laws and regulations. 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). Both were previously exempt from the FDA's nutrition labeling authority. 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. Studies have shown that the number of calories consumed by individuals in the United States has risen concurrent with rising rates of obesity. The FDA is authorized to create nutrition labeling requirements for most foods, and to regulate nutrient content claims and health claims on food labels. The ACA amended the FDA's authorities to require certain restaurants, SRFE, and vending machine operators to provide calorie and other nutrient information. Overview of the Proposed Rule

Introductory material for the proposed rule on nutrition labeling in restaurants and similar retail food establishments provided background information on food consumption outside the home, current nutrition labeling requirements as they apply to packaged foods, and the historic exemption for restaurants and SRFE under NLEA. It also listed the requirements of Section 4205 of the ACA, and the proposed rule included definitions for a number of terms that were not defined in the law. The proposed rule set requirements for covered restaurants and SRFE to implement the rule, provided detail for voluntary registration of establishments that are not covered by the law but that elect to be subject to the requirements of the law, set an effective date, and outlined enforcement mechanisms for establishments that fail to comply. The proposed rule was available for public comment through July 5, 2011, and a final rule is expected by the end of 2012. While some definitions are clear and straightforward, others have generated debate, including the FDA's determination of the scope of covered establishments, variation among establishments, the cost of providing the required information, and the accessibility of calorie and nutrition information to consumers. Specific concerns regarding the impact of the proposed rule, and the industry and congressional response, are also discussed in this section. FDA's Proposed Rule

The FDA has proposed two options for the definition of "restaurants or similar retail food establishments" to be covered by the rule. At issue is the scope of covered establishments. The proposed rule further specifies the foods that would require labeling and food that would be exempt under the proposed rule are listed in Table 2 . These include the cost and burden imposed on businesses implementing the rule.
Rising rates of obesity and the resulting effects on citizens' health and health care costs have prompted federal, state, and local policymakers to consider a number of policy options to reduce obesity levels in the United States, such as exercise promotion, nutrition education, and taxation of certain foods. Labeling of the nutritional content of foods purchased and consumed outside the home has been recommended by researchers and policymakers as one tool to address rising obesity rates.
The Federal Food, Drug, and Cosmetic Act (FFDCA, P.L. 75-717, as amended) authorizes the Food and Drug Administration (FDA) to regulate labeling of most foods other than meat and poultry. Section 4205 of the Patient Protection and Affordable Care Act (ACA, P.L. 111-148, as amended) amended the FDA's nutrition labeling authorities under the FFDCA to require nutrition labeling of foods sold in some chain restaurants and vending machines, both of which were previously exempt from the FDA's nutrition labeling regulations. While the ACA provided general requirements for restaurant menu nutrition labeling, it required the FDA to promulgate regulations specifying the scope of entities affected by the law, the scope of food covered by the law, and certain details regarding how the required calorie and nutrition information is conveyed to consumers.
The FDA's proposed rule on nutrition labeling in restaurants and similar retail food establishments (SRFE), published in April 2011, proposed definitions for a number of terms that are not defined in law. It proposed two options for determining the entities affected by the rule, set requirements for covered restaurants and SRFE to implement the rule, provided details for voluntary registration of establishments that are not covered by the rule but that elect to be subject to the requirements of the rule, proposed an effective date, and outlined enforcement mechanisms for establishments that fail to comply. The comment period on the proposed rule ended on July 5, 2011. The FDA is currently finalizing the rule, and the agency has indicated that it expects to issue the final rule in November 2012.
Several potential concerns for Congress have been emphasized regarding implementation of the proposed rule. First is the scope of the entities affected by the rule. The second is the food that will require calorie and nutrient information under the rule. Other related concerns include the presentation of calorie and nutrient information and the amount of time businesses will have to implement the rule. Some Members of Congress are concerned that the FDA's proposed rule reaches beyond congressional intent and the agency's authority, and have introduced legislation that would limit the scope of the FDA's proposed rule.
This report provides a brief overview of the FDA's authority to regulate nutrition labeling, modifications to these authorities under the ACA, and a discussion of selected aspects of the proposed rule. Concerns regarding the proposed rule raised by industry, Congress, and the public are also discussed.