the food or meal meets the nutrient requirements for the claim. Presentation of nutrition labeling may be in various forms, including those provided in Sec. 101.45 and other reasonable means.44
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DISCUSSION QUESTION
1 4.4. What if FDA wrote the Restaurant Regulations but Didn’t Enforce Them? Note that in Public Citizen and CSPI v. Shalala, the FDA’s action directly conflicted with an unambiguous requirement in the statute. Congress said restaurants were not exempt from NLEA, but then FDA said that restaurants were exempt. What would have been the result if FDA had written the regulations for restaurants but then said it would not have the resources to enforce them? What if FDA had a rational plan for prioritization of resources to important health and safety concerns, and would a court be likely to overrule the agency’s decision? See ch. 20, sec. 20.5, Administrative Discretion.
4.6 MENU AND VENDING MACHINE LABELING REQUIREMENTS
Section 4205 of the Patient Protection and Affordable Care Act of 2010 (ACA) established requirements for limited nutrition labeling of standard menu items for chain restaurants, similar retail food establishments, and chain vending machine operators.45 Section 4205 also provides that a restaurant or similar retail food establishment that is not a chain establishment may elect to be subject to section’s nutrition labeling requirements by registering every other year with FDA.
The public policy reasoning behind these requirements is summarized as follows:
More than two thirds of adults and about a third of children in the United States are overweight or obese. Overconsumption of calories is one of the primary risk factors for overweight and obesity. About half of consumers’ annual food dollars are spent on, and a third of total calories come from, foods prepared outside the home, including foods from restaurants and similar retail food establishments. Many people do not know, or underestimate, the calorie and nutrient content of these foods. To help make nutrition information for these foods available to consumers in a direct, accessible, and consistent manner to enable consumers to make informed and healthful dietary choices, section 4205 of the ACA requires that calorie and other nutrition information be provided to consumers in restaurants and similar retail food establishments … 46
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In addition, state and local governments had been enacting their own laws requiring nutrition labeling on menus and menu boards to fill the vacuum in the absence of federal requirements. These state and local requirements vary significantly both in the requirements and regarding the establishments to which they apply. This lack of national uniformity created impetus for Congress to step in with a federal law.
FDA issued two food labeling regulations regarding calorie labeling on menus and vending machines. These regulations define the terms and details of which establishments are affected and how the requirements are to be carried out. These regulation titles are as follows:
Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments47
Calorie Labeling of Articles of Food in Vending Machines48
4.6.1 Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Section 403(q) of the FD&C Act requires that the following information must be provided for standard menu items that are sold in chain retail food establishments49:
The number of calories in each standard menu item on a menu or menu board (the calorie disclosure must be “clearly associated with” and “adjacent to” the name of the standard menu item).
A statement on the menu or menu board that puts the calorie information in the context of a recommended total daily caloric intake.
Additional nutrition information for standard menu items in written form (“written nutrition information”), which must be made available to consumers upon request.
A “prominent, clear, and conspicuous” statement on the menu or menu board regarding the availability of the written nutrition information.
The number of calories (per item or per serving) adjacent to self‐service food and food on display. These foods include food sold at salad bars, buffet lines, cafeteria lines or similar self‐service facilities, and self‐service beverages and food on display that is visible to consumers.
On December 1, 2014, FDA published the final rule on nutrition labeling of standard menu items in restaurants and similar retail food service establishments. The rule is codified at 21 C.F.R. § 101.11. The establishments covered under the rule are restaurants or similar retail food establishments that are a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, for example, individual franchises) and offering for sale substantially the same menu items.50
The labeling requirements only apply to foods that are standard menu items. The requirements for nutritional labeling are in two parts. The information that must be listed on the menu or menu board is the following:
The number of calories.51
The following statement, “2,000 calories a day is used for general nutrition advice, but individual calorie needs vary.”52
The following statement, “Additional nutrition information available upon request.”53
The nutrition information for standard menu items that must be available in written form on the premises of the covered establishment and provided to the customer upon request is the following54:
1 total calories (cal);
2 calories from fat (fat cal);
3 total fat (g);
4 saturated fat (g);
5 trans fat (g);
6 cholesterol (mg);
7 sodium (mg);
8 total carbohydrate (g);
9 dietary fiber (g);
10 sugars (g); and
11 protein (g).
The regulation provides considerable detail on the placement, sizes of type, exceptions, and special circumstances. Therefore, establishments covered under this requirement are advised to refer to the rule at 21 C.F.R. § 101.11.
4.6.2 Calorie Labeling of Articles of Food in Vending Machines
For food sold from vending machines operated by persons who own or operate 20 or more vending machines, the operator must put a sign close to each article of food or selection button disclosing the number of calories in a clear and conspicuous manner. An exemption from this requirement is provided when the vending machine allows the purchaser to examine