Federal menu labeling laws


May 7, 2018 was the compliance date for the menu labeling final rule.

I.          Summary

This law applies to restaurants and similar retail food establishments that are part of a chain of 20 or more locations, doing business under the same name and offering for sale substantially the same menu items.


II.        Background

In 2010, the Affordable Care Act amended Section 403 of the Federal Food, Drug, and Cosmetic Act of 1938 to establish a nationwide standard for menu labeling. The federal menu labeling provisions of Section 4205 required certain chain restaurants and other “covered establishments” part of a chain with 20 or more locations to provide calorie and other nutrition information for menu items. The FDA issued final regulations implementing those “menu labeling” requirements in 2014, and set a compliance date of May 7, 2018.

On May 5, 2016, the Food and Drug Administration released its final guidance for industry compliance with federal menu labeling laws. The guide is titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11): Guidance for Industry.” The final guidance is intended to provide clarity on the menu labeling regulations the FDA released in 2014 and addresses topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record keeping requirements.


III.       The Guidelines

A.        Covered Establishments

A covered establishment is a restaurant or similar foodservice business with 20 or more locations nationwide operating under the same name and serving substantially the same menu items. This includes concession stands in movies and theme parks, bakeries, convenience stores, food takeout or delivery establishments, and superstores. However, food trucks and mobile vendors walking around at stadiums are not considered covered establishments because they do not have a fixed location or site.


B.        Menus and Menu Boards

The final guidance requires covered establishes provide calorie counts on “menus” and “menu boards.” Thus, determining what constitutes a “menu” and “menu board” is a critical first step toward compliance. Menus and menu boards are defined as the “primary writing” of the covered establishment from which a customer makes an order selection, including but not limited to, breakfast, lunch, dinner menus, dessert menus, beverage menus, children’s menus, takeout menus, menus mailed or delivered from a restaurant, electronic menus, and menus on the internet. The “primary writing” of an establishment may include more than one form of written material.

In the final guidance, the FDA provides different factors to determine whether a writing constitutes a “menu” or “menu board,” including whether the writing lists the name of the menu item, whether the price is listed, whether it is used by the customer to make an order, and whether the phone number, web address, or email address of the establishment is listed for purposes of placing an order. Menus may be in difference forms, such as booklets, pamphlets, or even single sheets of paper. Therefore, a pizza coupon with the menu item, price and web address to place the order is technically considered a menu. This is more expansive than previous guidelines, which did not list web addresses as a factor.

The final guidance also explains the formatting required for menus and menu boards. First, they must include the statement “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” This statement must be posted on the menu or menu board prominently and in a clear and conspicuous manner.

The number of calories must be listed adjacent to the name or price of the associated standard menu item. The calories must be in a type size that is no smaller that used for the name and price of the associated menu item.

Additionally, covered establishments must provide written nutritional information by customer request. The statement “Additional nutrition information available upon request” must be posted on the menu or menu board in a clear and conspicuous manner. The nutritional information may be provided apart from the menu and displayed on a counter card, sign, poster, handout, booklet, loose-leaf binder, menu electronic device or by other similar means.

Although the FDA does not give a specific amount of variance or error allowed in stating the nutritional information, it broadly requires that the information have a “reasonable basis.” Nutrient values, as per 21 CFR 101.11 (c), may be determined by nutrient databases, laboratory analysis, published cookbooks with nutritional information for the recipes, or by other reasonable means.

The written nutrition information must include: total calories (cal); total fat (g); saturated fat (g); trans-fat (g); cholesterol (mg); sodium (mg); total carbohydrate (g); dietary fiber (g); sugars (g); and protein (g).

Finally, the FDA allows for a range of calories for the menu item. An example includes a grilled cheese sandwich that comes with either cheddar or Swiss cheese. Here, a range of calories for the grilled cheese is acceptable.


C.        Catered Events and Catering Menus

The FDA notes that a catered event is not likely a covered establishment because it does not offer for sale standard menu items. This means that customers who purchase items from a catering menu for their catered event do not need to provide calorie or other nutritional information to the guests of the catered event. However, if a covered establishment offers off-site catering, it must provide calorie information for standard menu items listed on their catering menus.


D.        Alcoholic Beverages

While alcohol must still be labeled, the final guidance provides more detailed instructions for alcoholic beverages. For example, the FDA clarified that beers on tap are exempt from the labeling requirements because they are “food on display” and not self-serve. Even if a menu or menu board lists the calories for beers, they do not have to be listed on or next to the tap or nozzle. Additionally, the final guidance states that the calories for suggested alcoholic beverage pairings do not have to be labeled on the menu if the pairing item is not for sale.


E.        Record Keeping Requirements

The final guidance indicates that records requested by a health official must be provided in four to six weeks. The FDA recommends that these records should be maintained at the covered establishment or the corporate headquarters for the time that the menu item is offered for sale. It is not necessary to maintain records on nutrient values for foods that are no longer offered for sale at a covered establishment. However, the FDA recommends that covered establishments consult legal counsel concerning maintaining the information in accordance with its ordinary record retention policies.


IV.       California Menu Labeling Law

California has had its own menu labeling law since 2009, which applied to restaurants with 20 or more locations within California. However, effective December 1, 2016, California restaurants must conform to the existing FDA menu labeling regulations promulgated under Affordable Care Act. See California Health and Safety Code Section 114094.

To comply with the California requirements (which are identical to the federal requirements), covered California establishments must include the caloric content adjacent to the menu items on their menus, menu boards, and drive-through menu boards. Additionally, the establishment must provide required additional nutritional information in writing upon request.


V.        Penalties

The Federal Food, Drug, and Cosmetic Act deems the failure to label or accurately label a standard menu item a violation of Menu Labeling Requirements.

Penalties for misbranding food are established in the Federal Food, Drug, and Cosmetic Act, and violations of 21 CFR 101.11 may result in enforcement action. For example, introducing, delivering for introduction, or receiving a misbranded food in interstate commerce, or misbranding a food while it is in interstate commerce or being held for sale after shipment in interstate commerce, are prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331). Consequently, misdemeanor penalties may be assessed for any violation of Section 331 (imprisonment for not more than one year or a fine of not more than $1,000 or both). If any such violation, however, constitutes a second conviction or is found to have been committed “with the intent to defraud or mislead,” the violation becomes a felony carrying a three-year maximum period of imprisonment and a fine of not more than $10,000 or both.

In addition, under section 302 of the FD&C Act (21 U.S.C. 332), the United States can bring a civil action in Federal court to enjoin a person who commits a prohibited action. Under section 304(a)(1) of the FD&C Act (21 U.S.C. 334(a)(1)), a food that is misbranded when introduced into or while in interstate commerce or while held for sale after shipment in interstate commerce may be seized by order of a Federal court. 18 U.S.C. 3571 overrides the maximum FDCA fines and establishes limits of $100,000 for most misdemeanors and $250,000 for most felonies in the case of individual defendants.


VI.       Conclusion

The final guidance document, provides detailed explanations on a variety of subjects and answers to specific scenarios that may not have been clear before. The FDA issued a statement that it is committed to working with covered establishments and to providing assistance for regulatory partners to support compliance nationwide. Establishments can submit written comments on the final guidance at http://www.regulations.gov (Docket No. FDA– 2011–F–0172) and can send questions on menu labeling requirements to CalorieLabeling@fda.hhs.gov.


​​Fisher Phillips LogoThis report was reviewed and updated in 2020 by Fisher Phillips.  Fisher Phillips provides this information for general informational purposes only. The information is not, and should not be relied upon or regarded as, legal advice. No one should act or refrain from acting on the basis of such content or information, without first consulting with and engaging a qualified, licensed attorney, authorized to practice law in such person’s particular jurisdiction, concerning the particular facts and circumstances of the matter at issue.