Citing the obesity epidemic and the fact that Americans consume about one-third of total calories in the form of foods prepared outside the home, FDA yesterday issued two sweeping final rules on nutrition labeling of foods sold in chain restaurants and similar retail food establishments and vending machines.
There had been considerable controversy over how FDA would define “similar retail food establishments” covered by the menu labeling rule. Would FDA exempt food concessions in movie theatres and other entertainment venues (as it did in its 2011 proposed rule), supermarkets, and convenience stores? In the end, FDA chose to narrow somewhat the types of foods that will be subject to menu labeling rather than exempt broad categories of retail food establishments.
The final rules are highly prescriptive and contain few of the accommodations that had been requested by industry. The rules implement Section 4205 of the Patient Protection and Affordable Care Act of 2010.
Menu Labeling
Who Is Covered?
The menu labeling rule applies to “covered establishments.” A “covered establishment” is defined as a “restaurant or similar retail food establishment” that:
- Is part of a chain with 20 or more locations;
- Doing business under the same name (regardless of type of ownership); and
- Offering for sale substantially the same menu items.
The definition also includes restaurants and similar retail food establishments that would not otherwise be covered (e.g., because they are not part of a chain with 20 or more locations) but that voluntarily register with FDA and agree to comply with the regulation. Some restaurants that are not covered establishments may do this in order to receive the protection of federal preemption from state and local menu labeling laws.
A “restaurant or similar retail food establishment” means any retail establishment that offers “restaurant-type food,” except for schools.
A “restaurant-type food” is a food that is: (a) usually eaten on the premises, while walking away, or soon after arriving at another location (such as a home, a workplace, or a park); and (b) is either (i) a food of the type served in restaurants or other establishments for immediate human consumption, or (ii) is a food processed or prepared primarily in a retail establishment, ready to eat, offered for sale but not for immediate consumption, and not offered for sale outside such establishment.
Covered: quick service restaurants, table service restaurants, take-out and delivery establishments (e.g., pizza take-out establishments), bakeries, cafeterias, coffee shops, grocery stores, convenience stores, big box stores, delis, food concessions in entertainment venues, food service vendors (e.g., ice cream shops, mall cookie counters), and retail confectionery stores. Not covered: schools, food trucks, ice cream trucks, and transportation carriers (e.g., airlines).
Which Foods Are Covered?
The regulation applies to “standard menu items.” A “standard menu item” is defined as a “restaurant-type food” that is routinely included on a menu or menu board or routinely offered for sale as a self-service food or food on display.
As noted above, a “restaurant-type food” is a food that is usually eaten on the premises, while walking away, or soon after arriving at another location. Covered (by way of example): foods served for immediate consumption in a restaurant; food purchased at a drive-through window; take-out and delivery pizza; pizza or nachos sold from a movie theatre concession; foods sold from a hot buffet, a soup bar, or a salad bar; food ordered from a menu or menu board in a grocery store; and self-service foods and foods on display intended for individual consumption (e.g., sandwiches at a deli counter, cookies from a cookie counter, bagels and donuts for individual sale). Not covered: foods that consumers usually store for use at a later time or that are typically eaten over several eating occasions, and foods that are customarily further prepared (e.g., loaves of bread, whole cakes, bags or boxes of candy); foods sold from bulk bins (e.g., granola, nuts); foods not intended solely for individual consumption (e.g., deli salads such as potato salad, chicken salad, cole slaw); and foods usually further prepared before consuming (e.g., deli meats, cheeses).
A “standard menu item” also must be routinely offered on a menu or menu board or as a self-service food or food on display. Not covered: items such as condiments offered for general use; custom orders; daily specials; temporary menu items (foods appearing on a menu or menu board for less than 60 days per calendar year); customary market test foods (food appearing on a menu or menu board for less than 90 consecutive days in order to test consumer acceptance); self-service foods and foods on display for less than 60 days per calendar year or less than 90 consecutive days); and alcoholic beverages that are foods on display and not self-service foods (e.g., a bottle of wine kept behind a bar).
What Information Is Required?
The menu or menu board must provide three items:
- The number of calories per menu item (or per serving for multiple-serving items usually offered for sale divided in discrete serving units, provided the serving unit and number of servings are declared);
- The following succinct statement about total caloric intake: “2,000 calories a day is used for general nutrition advice, but calorie needs vary”; and
- The following statement about the availability of additional nutrition information: “Additional nutrition information available upon request.”
For self-service foods and foods on display, calories must be displayed on a sign adjacent to and clearly associated with the food, a sign attached to a sneeze guard, or a single sign or placard listing the calories for several such foods.
In addition, for each standard menu item, additional nutrition information must be available on the premises of the covered establishment upon request. The additional information must include the following nutrients: total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein. This information may be provided in or on a counter card, sign, poster, handout, brochure, loose leaf binder, electronic device, menu, or any other form that is readily available on the premises and permits the customer to review it upon request.
What is a Menu or Menu Board?
FDA has opted for a broad definition of “menu or menu board” to mean “the primary writing… from which a customer makes an order selection.” The word “primary” does not mean that a covered establishment has only one menu or menu board. According to FDA, a writing will be considered a menu or menu board if it lists at least one standard menu item (or an image depicting a standard menu item) and the price of the standard menu item, and it can be used by a consumer to make an order selection at the time the consumer is viewing the writing. Covered: a traditional menu or menu board, a paper take-out menu, a delivery menu, an online menu, a translite behind the counter that lists a standard menu item and its price, and a drive-through window menu board. Not covered: a poster on a storefront, a coupon or other promotional material, a tray liner, a billboard, and stanchions.
When Must Covered Establishments Comply?
Covered establishments must comply by December 1, 2015.
Is There Federal Preemption?
Yes, the final rule will preempt all state and local laws that impose menu labeling requirements not identical to the federal law.
Vending Machine Labeling
Who Is Covered?
The final rule applies to “covered vending machine food,” which is defined as a food sold from a vending machine that is operated by a person owning or operating 20 or more vending machines or who has voluntarily registered with FDA and agreed to comply with the regulation. A “vending machine” is broadly defined to include any self-service machine that dispenses food without the need to replenish the machine between each vending operation.
Foods sold from vending machines are exempt if a prospective purchaser can view:
- Calories, serving size, and serving per container information in the food’s Nutrition Facts label on the food without any obstruction;
- Calories, serving size, and servings per container information listed in a reproduction of the food’s Nutrition Facts label on the food; or
- Calories (total calories in the item, not calories per serving) on the food label (g., in a front-of-pack (FOP) label).
It is expected that most packaged foods sold in vending machines will provide calorie information in the form of an FOP label and will seek to qualify for the third exemption above. For an FOP calorie label to qualify, however, it must:
- Declare total calories for the entire item;
- Appear in a type size that is at least 50% of the type size of the largest printed matter on the label; and
- Appear with sufficient color and contrasting background as compared to other print on the label so as to permit a prospective purchaser to clearly distinguish it.
What Information Is Required?
A “covered vending machine food” must declare the total number of calories in the food clearly, conspicuously, and prominently in one of several ways (e.g., a sign in, on or adjacent to the vending machine, an electronic display). Vending machines also must provide the vending machine operator’s contact information (name, telephone number, and mailing address or email address) on the face of the vending machine or with the calorie information (e.g., on a sign in, or, or adjacent to the vending machine).
When Must Covered Vending Machines Comply?
“Covered vending machine food” must comply by December 1, 2016.
