Nearly five years after my colleague reported on the new food menu labeling requirements spawned by the Affordable Care Act, the Food and Drug Administration has released its final rule for restaurant menus and vending machine labeling.  In April, 2011, the FDA introduced two proposed rules relating to requirements for calorie labeling in restaurants and vending machines. However, the rule released last month imposes requirements well beyond those proposals, and covered businesses would be wise to start preparing now for the December 1, 2015 compliance date.

In a departure from the proposed rules, the final menu labeling rules apply to restaurants and “similar retail food establishments” that have 20 or more locations, regardless of type of ownership. Because Congress did not define “restaurant or similar retail establishment” in the Affordable Care Act, for purposes of the final rule the FDA defined the term to mean any retail establishment that offers “restaurant-type food.” Restaurant-type food is food that is “[u]sually eaten on the premises, while walking away, or soon after arriving at another location” and either served in the establishment or prepared primarily in the establishment. Thus, the FDA’s final rule expands the category of covered establishments to potentially include not just restaurants, but also movie theaters, amusement parks, bowling alleys, entertainment venues, convenience stores, coffee shops, bakeries, delis, grocery stores, and fitness clubs.

By eliminating the “primary business test” that was established in the April 2011 proposal, the FDA significantly expanded the final rule’s coverage. The primary business test limited coverage only to those establishments whose primary business is restaurant-type food, or establishments where more than 50% of revenue is generated from the sale of such food.

What remains essentially unchanged is the mandate that covered businesses post calorie amounts by each standard menu item. Covered establishments must also post two prescribed statements on menus and menu boards: a statement regarding daily caloric intake (“2,000 calories a day is used for general nutrition advice, but calorie needs vary”) and a statement regarding the availability of additional nutrition information (“Additional nutrition information available upon request.”).

As noted, the labeling requirements apply to “standard menu items,” which means a restaurant-type food that is routinely included on a menu or routinely offered as a self-service food or food on display. Standard menu items also include alcohol – yet another departure from the 2011 proposed rules. However, bottles of liquor behind a bar or mixed drinks ordered from the bar that do not appear on a menu are not covered. Other excluded items include condiments, daily specials, and temporary menu items (items on the menu less than 60 days in a calendar year).

Regarding the posting of calorie content, businesses must have a “reasonable basis” for nutrient declarations and take “reasonable steps” to ensure that the method of preparation and serving amounts adhere to the factors on which nutrient values were determined. The final rule also provides quite precise requirements for the type size, location and other formatting of the caloric statements (“The number of calories must be listed adjacent to the name or the price of the associated standard menu item, in a type size no smaller than the name or the price of the associated standard menu item, whichever is smaller, in the same color, or a color at least as conspicuous as the name of the associated standard menu item, and with the same contrasting background as the name of the associated standard menu item.”). For some businesses, these requirements may necessitate revising menus that were created in order to comply with state or local menu labeling regulations, since the federal rules expressly preempt existing state and local rules.

The final rule excludes businesses that sell food but do not have a fixed location, such as trains, airplanes and food trucks. Notably, the FDA also excludes schools from the final rule, explaining its rationale as follows:

“Traditionally, the U.S. Department of Agriculture (USDA) has exercised a primary role in setting the standards for foods served in schools through school lunch and breakfast programs. USDA regulates such foods, under various Federal statutes, including the Child Nutrition Act of 1996 and the Richard B. Russell National School Lunch Act. Given the traditional and long-standing role of USDA in setting standards, including nutrition requirements, for foods served in schools through school lunch and breakfast programs, as established by Federal legislation and implemented by Federal Agencies, we conclude that it is reasonable to interpret the term “restaurant or similar retail food establishment” to not include schools. Therefore, we have revised the definition “restaurant or similar retail food establishment” to mean a retail establishment that offers for sale restaurant-type food, except if it is a school as defined in 7 CFR 210.2 or 220.2.”

Although the FDA does not say so explicitly, vending machines in schools will presumably still be covered. Under the final rule, operators or owners with 20 or more vending machines must post calorie counts for all food items as sold. They may rely on the same resources as restaurants to determine calorie content, such as the food’s Nutrition Facts Panel, nutrient databases, or laboratory analyses. Vending machine owners have until December 1, 2016 (a year more than restaurants or similar retail food establishments) to ensure compliance with the final rule.

Even assuming vending machines are covered, the final rule still leaves out two key meals that school-age children are eating during the day – breakfast and lunch. The FDA, while expanding coverage in ways the industry did not expect, explains the school gap away by putting the responsibility on the USDA. It is uncertain whether the USDA will take any regulatory action in this area, and how it will compare to the FDA final rule in terms of detail and consistency. On the one hand, it could be argued that school-age children would not take the calorie information of their meal into account the same way that an adult would, such that any lack of regulation will not have a significant impact. On the other hand, it is arguably the lack of healthy options in school breakfasts and lunches that leads to childhood obesity and other health problems later in life – the very ills the Affordable Care Act sought to correct – and in that sense it would seem the FDA’s rule falls short of its purpose. Aside from the fact that posted nutritional information could enable young people to choose their meals more wisely, the very obligation to post such information might, in fact, motivate food vendors to offer healthier options in schools.