The FDA recently released two long-awaited final rules that establish detailed requirements for calorie labeling on menus and menu boards and vending machines. Promulgated pursuant to provisions of the Affordable Care Act (ACA) that amended the Federal Food, Drug & Cosmetic Act, the final rule broadly defines “similar retail food establishments” such that many non-restaurants including grocery stores, movie theaters, and entertainment venues will also be subject to the detailed labeling requirements. The rule also prescribes specific technical requirements for the size and color of the font that will be used in the required disclosures.
Menu Labeling Final Rule
Under the final rule, covered food establishments must include three separate disclosures on all menus and menu boards: (1) calorie information for standard menu items and other specified items, (2) the statement that “2,000 calories a day is used for general nutrition advice, but calorie needs vary,” or a substitute statement for children’s menus and menu boards, and (3) a statement that written nutrition information is available upon request. Regarding the third requirement, covered establishments must make the following information available upon request: total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein.
The covered establishment must have a reasonable basis for all nutrient declarations, which the rule specifies would include use of nutrient databases, cookbooks, laboratory analyses, or “other reasonable means.” Along with each specific labeling requirement, the final rule imposes unique format requirements for the prescribed statements. For instance, the statement declaring the number of calories must be: (1) listed adjacent to the name or the price of the associated standard menu item, (2) in a type size no smaller than the type size of the name or the price of the associated standard menu item, whichever is smaller, (3) in the same color, or a color at least as conspicuous as that used for the name of the associated menu item, and (4) with the same contrasting background or a background at least as contrasting as that used for the name of the associated menu item.
Other notable options of the final rule include:
- The variety of establishments covered as “restaurant or similar retail food establishments.” The rule defines the universe of covered establishments, in effect, by whether they provide “restaurant-type food,” except that it excludes schools as defined under existing regulations. “Restaurant-type food,” in turn, is defined to include any food that is: (1) usually eaten on the premises, while walking away, or soon after arriving at another location, and (2) either served at the establishment for immediate consumption, or processed and prepared primarily at the establishment and ready for human consumption. The result is that the same requirements will apply to fast food restaurant meals, grocery store salad bars, and convenience store hot dogs, amongst other items. Foods that would not be covered include those eaten over several occasions or stored for later use (e.g., a whole cake) or foods typically intended for more than one person to eat that may require additional preparation (e.g., deli meats and cheeses).
- Applicability to alcoholic beverages. While the proposed rule would have exempted alcoholic beverages from the labeling requirements, the final rule includes requirements for alcoholic beverages that are standard menu items. The rule explains FDA’s conclusion that, within the menu context, “providing nutrition information for an alcoholic beverage for which other labeling is also regulated by TTB [the Alcohol and Tobacco Tax and Trade Bureau] provides the same public health benefit as providing the information for other foods.” The final rule, however, does exempt alcoholic beverages that are foods on display and not self-service foods (i.e., drinks ordered by consumers but not on the standard menu).
- Substantiation documentation. The final rule provides that covered establishments must provide to FDA, within a reasonable period of time upon request, information substantiating nutrient values including the method and data used to derive these nutrient values. The rule clarifies what FDA will consider to be sufficient information to substantiate nutrient values. Notably, FDA did not cite any specific recordkeeping authority in promulgating this requirement.
State and local governments are prohibited from imposing requirements that are not identical to those imposed by the final rule. Covered establishments will have one year from December 1, 2014 to comply with the final rule.
Vending Machine Final Rule
The final rule that applies to vending machine operators similarly imposes strict calorie labeling requirements. Under that final rule, covered vending machine operators must post calorie information either on a sign close to the article of food or the selection button. The calorie declarations may be adjacent to, rather than in or on the vending machine, provided they are visible at the same time as the food, name, price and selection button. The sign must provide declarations for all foods offered by that particular vending machine, such that operators will need to ensure that the signs are up-to-date with the latest declarations.
The rule applies to vending machines that are operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine is defined to include machines that dispense a variety of foods, including packaged foods, packaged beverages, hot or cold cup beverages, or bulk foods (e.g., nuts or candies). Covered operators must also disclose on or adjacent to the vending machine their contact information, including the operator’s name, telephone number, and mailing or email address. FDA cites the need to contact the operator for enforcement purposes as the reason for this requirement.
While the menu rule will become effective one year from publication, vending machine operators will have two years from December 1, 2014 to comply with the rule.