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 the Nutrition Facts Panel of the food before buying, or where the nutrition information is otherwise visible at the point of purchase.55 The details of which vending machines are covered and how the requirements are to be implemented are provided in 21 C.F.R. section 101.8.56
4.6.3 State and Local Preemption
Regarding nutrition labeling, the Federal FD&C Act expressly preempts any state or local law that is not identical to the federal law.57 State and local governments cannot directly or indirectly impose any nutrition labeling requirements on chain retail food establishments that are not “identical to” requirements imposed by FD&C Act section 403(q). States and localities that have their own nutrition labeling requirements may petition FDA for an exemption from preemption.58
However, restaurants and similar retail food establishments that are not chains (i.e., with fewer than 20 locations) and vending machines operated by a person owning or operating fewer than 20 vending machines59 do not fall under the preemption provision because these establishments and vending machines are outside of the federal nutritional labeling requirements. That is, restaurants and vending machines that are exempt from the requirements of FD&C Act section 403(q)(5)(H) continue to be governed by state and local regulations, as applicable, unless those establishments elect to participate exclusively in the federal regulatory program (see below).
4.6.4 Voluntary Election Covered by the Law
A restaurant or similar retail food establishments and vending machines not covered by the federal nutrition labeling law may elect to become subject to the federal requirements by voluntarily registering every other year with the FDA.60 Those restaurants and vending machine operators that elect to participate in the federal program will not be subject to state or local nutrition labeling requirements unless these state or local requirements are identical to federal requirements.
NOTE
1 4.5. Congress Delays Implementation of Restaurant Nutritional Labeling Rule.The Fiscal Year 2016 Omnibus Appropriations Act covering the funding of the federal government, being Pub. L. No: 114‐113 (2015), section 747, delayed implementation of the nutritional labeling rule for restaurant items until after December 1, 2016.
4.7 NUTRIENT CONTENT CLAIMS (NUTRIENT LEVEL DESCRIPTORS)
FDA uses the terminology “nutrient content claims” and “nutrient descriptors,” but note that the FD&C Act identifies regulation for a claim that “characterizes the level of any nutrient” on the label or labeling of the food.61
The FD&C Act stipulates that a claim that characterizes the level of a nutrient may not be made unless the FDA has defined the claim in a regulation and the food meets the requirements of that regulation.62
However, the FDAMA amended the FD&C Act to create an exception to the requirement for explicit authorization of all nutrient content claims by regulation. Nutrient content claims not defined by FDA in regulation may be permitted if the claim was recognized by a scientific body of the U.S. government in a published authoritative statement63 (see Section 4.7.6).
4.7.1 Definition
FDA defines nutrient content claim in regulation to include the following64:
An expressed nutrient content claim, which is any direct statement about the level or range of a nutrient in the food
