On April 1, the U.S. Food and Drug Administration (FDA) released proposed regulations regarding its implementation of the menu-labeling provisions of the Patient Protection and Affordable Care Act of 2010 (commonly known as the health care bill).   We previously reported on FDA's release of draft guidance documents regarding implementation of these provisions; however, in January 2011 FDA withdrew that draft document.  The newly released proposed regulations will be followed by a final rule sometime in the future. 

Below are some key provisions in FDA's newly proposed regulations regarding calorie counts for menu items at restaurants:

• Defining a "restaurant or similar retail food establishment" as one which has as its primary business activity the sale of food.  The proposed regulations further define this as a business which presents itself publically as a restaurant or one where more than 50% of the gross floor area is used for food preparation/purchase/service/consumption/storage.  This definition is narrower than the definition in the withdrawn draft guidance and would, under most circumstances, exempt movie theaters, grocery stores, planes/trains, general merchandise stores, and amusement parks. 
• Defining what a "menu" is – including drive-thru menu boards, menus available on the internet, and take-out/delivery menus.  Calories will need to be disclosed on each of these.  However, the proposed regulations exempt advertising which happens to include information on only some menu items.  
• USDA-regulated foods (meat, poultry and eggs) prepared by restaurants must comply with the labeling requirements, but not alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau. 
• In contrast to the withdrawn draft guidance, the regulations allow businesses more flexibility with respect to fonts, colors, backgrounds, and general formatting of the required calorie information.
• Calorie rounding rules will be the same as those used for packaged goods under 21 CFR 101.9(c)(1). 
• For food items with different flavors, varieties, or for combination meals, restaurants will generally need to use calorie ranges (e.g., "Combo Meal #1 is 500-800 calories depending on which options are selected"). 
• Particular language must be used on menus with respect to the suggested daily caloric intake.
• The nutritional information available upon request must include information on trans fats.  For variable or combination items, the nutritional information must declare the nutrients for each variety, flavor, or combination.  The regulations allow flexibility with respect to the format of the required written nutritional information.
• Nutrient tolerances will generally follow existing regulations with respect to packaged goods.  However, restaurants will need to have support for their nutrient calculations available to provide to FDA upon request (whether from nutrient databases, cookbooks, computer programs, or other reasonable means of calculating nutrients.) 

While the regulations do not provide any additional bases for preemption, the accompanying materials do explain that FDA does not consider the express preemption clause in the legislation to include laws requiring warnings relating to safety of the food or a food ingredient.  Presumably this would include warnings under California's Safe Drinking Water and Toxic Enforcement Act (commonly known as Prop 65). 

In addition to releasing the proposed rules related to menu-labeling, FDA also released regulations regarding the labeling of food sold in certain vending machines.  The rules  apply those who own or operate 20 or more vending machines selling food items.  FDA's proposed regulations for vending machines can be found on the FDA menu labeling website.

FDA also indicated its intent to continue to exercise its enforcement discretion for the already-effective measures of the legislation until after it publishes final rules related to nutritional labeling.  FDA proposes to begin enforcement of the newly-proposed regulations six months after publishing the final rule. 

The comment period for these proposed regulations will be open until June 6, 2011.  FDA is encouraging comments on these proposals and has presented several possible alternatives for several of these rules.  We encourage industry participants to provide comments at http://www.regulations.gov, Docket No. FDA-2011-F-0172. 

Faegre & Benson will continue to monitor and report back on future rules and guidance as FDA moves forward with implementing these menu-labeling provisions.