On May 5, 2016, FDA published a Notice of Availability (NOA) of its Final Guidance on menu labeling, entitled “Guidance for Industry: 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).”  This Final Guidance is intended to address nutrition labeling requirements, including the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)(5)(H)), and the Final Rule on Nutrition Labeling Of Standard Menu Items In Restaurants And Similar Retail Food Establishments published on December 1, 2014 (the “Menu Labeling Final Rule”).  Notably, publication of the NOA in the Federal Register set May 5, 2017 as the enforcement date for the Menu Labeling Final Rule.

While the Final Guidance is substantially similar to the Draft Guidance published in September 2015, some notable differences include providing additional examples and Q&As on covered establishments (pp. 6, 9-10, 12-17), menus and menu boards (pp. 13-20), catered events and catering menus (pp. 14-15, 18), standard menu items (p. 24), grab and go items (pp. 40-41), record keeping requirements (pp. 42-47), and alcoholic beverages (pp. 50-55).  Any covered establishment should be sure to read the Final Guidance in its entirety.  However, below is a summary of these notable differences.

Covered Establishments
The Final Guidance explains that a “covered establishments” means a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, such as individual franchises) and offering for sale substantially the same menu items (3.5), including, for example, “bakeries, cafeterias, coffee shops, convenience stores, delicatessens, food service facilities and concession stands located within entertainment venues (such as amusement parks, bowling alleys, and movie theatres), food service vendors (such as ice cream shops and mall cookie counters), food takeout or delivery establishments (such as pizza takeout and delivery establishments), grocery stores, retail confectionary stores, superstores, quick service restaurants and table service restaurants” – adding concession stands as an additional example (3.9, Table 1).  However, mobile vendors walking through the stands at stadiums and arenas would not be covered establishments because they “generally do not have a fixed location or site” (5.9).

Menus & Menu Boards
The Final Guidance also attempts to expand on which written materials qualify as menus or menu boards.  However, the examples provided appear to indicate covered establishments will be left with very few, if any, written materials that do not qualify.

FDA explains that “the critical factor [in determining whether a written material is considered a menu or menu board] is whether the written material is or is part of the primary writing of a covered establishment from which a customer makes an order selection” (5.13).  However, establishments should understand that “primary writing” is interpreted from the consumer’s vantage point and refers to the writing the consumer uses to make an order.  (See Final Rule, 79 FR 71156, 71176-77.)  Thus, the Final Guidance explains that any writing (including on the Internet), which lists the name or depicts the image of a standard menu item and the price of the standard menu item, and from which a customer can make an order selection at the time the customer is viewing the writing, will qualify as a menu (5.13). 

The Final Guidance attempts to provide examples of what would not be a menu, stating that “advertising or marketing material (including coupons) generally would not be considered menus or menu boards.”  However, FDA provides one exception that appears, as a practical matter, to swallow the rule (5.18):

in the example of a pizza coupon that includes a phone number or web address where the customer can place an order and that states “1 large pepperoni and sausage pizza $9.99,” the “coupon” can be used by a consumer to make an order selection at the time a consumer is viewing the coupon (i.e., the coupon includes the name of the standard menu item, price of the standard menu item and a phone number or web address where an order can be placed).

How many advertisements or coupons do not include the name (or picture), price and at least the phone number or web address where an order can be placed?  What would be the point of an advertisement or coupon without such information?

It should also be noted that “Calories may not be listed on a webpage or screen that is separate from the associated menu item listed on the electronic or Internet menu” (5.23).

Catered Events & Catering Menus
The Final Guidance explains that catered events are likely not covered establishments because they are not restaurants or similar retail food establishments that offer for sale standard menu items, meaning “customers purchasing items from a catering menu for their catered event would not be required to provide calorie information or other nutrition information to the guests at their catered event” (5.5).  However, the covered establishment offering off-site catering must provide calorie declarations for standard menu items listed on its catering menu provided to customers when making their purchase selections for catered events (5.5, 5.15).

Standard Menu Items
The Final Guidance also explains that a “standard menu item offered in various sizes is not considered a variable menu item unless it comes in different flavors, varieties, or combinations and is listed as a single menu item.”  For example, items “listed on a menu or menu board by name with different sizes, or each size has its own price, each size would constitute a standard menu item rather than a different flavor, variety, or combination, and each standard menu item must include a calorie declaration” (5.33).

Grab & Go Items
For “grab and go” food, calories and additional written nutrition information should be declared for the entire package, (i.e., the entire standard menu item as usually prepared and offered for sale), and not based on reference amounts customarily consumed (RACCs) (5.93).

Record Keeping Requirements
In terms of record keeping requirements, “FDA recommends that any such records should be maintained either at the covered establishment or the corporate headquarters for the duration of the time that the standard menu items are offered for sale at the covered establishment” (6.4).The Final Guidance also explains that “FDA also recognizes that it is not necessary to maintain information on nutrient values for foods that are no longer standard menu items and are no longer offered for sale at a covered establishment as this information is no longer beneficial for consumers if they cannot purchase those items” (6.4). 

However, a covered establishment should consult legal counsel and/or consider maintaining such information in accordance with its ordinary record retention policies, since there is always the possibility of litigation over a particular item for some time after an item is no longer offered for sale, and establishments could face destruction of evidence issues depending on the circumstances.

Alcoholic Beverages
The Final Guidance provides an entire section on alcoholic beverages, expanding upon and adding numerous Q&As that were not part of the Draft Guidance (7.1-7.12).  Specifically, the Final Guidance explains that FDA considers “beers on tap to be alcoholic beverages that are foods on display,” meaning that to the extent that beers on tap are not self-serve, they are exempt from the labeling requirements specified in § 101.11(b)(2)(iii) for standard menu items that are food on display because customers typically order beers on tap from tables from which the bar could be completely out of sight (7.5).  Furthermore, even when a menu or menu board lists beers on tap along with corresponding calorie declarations, calories do not need to be listed on or adjacent to the tap or nozzle (7.6).

The Final Guidance also addresses the circumstances when a covered establishment may use caloric value provided on a voluntary Statement of Average Analysis or voluntary Serving Facts Statement, as opposed to when the covered establishment must round the calories listed on the menu or menu board according to 21 CFR 101.11(b)(2)(i)(A)(2) (7.10).  The Final Guidance further clarifies that calorie declarations are not required for suggested alcoholic beverage pairings, when such pairing items are not offered for sale (7.11), and “Establishments are not excluded from coverage under the menu labeling final rule because they offer for sale only one type of standard menu item” (7.12).

Establishments Can Continue To Provide Comments & Questions To FDA
FDA has explained that it is committed to working flexibly and cooperatively with establishments and to providing educational and technical assistance for state, local, and tribal regulatory partners to support consistent compliance nationwide.  Establishments can continue to submit written comments on this Final Guidance at any time at http://www.regulations.gov (Docket No. FDA–2011–F–0172) and can send questions on menu labeling requirements to CalorieLabeling@fda.hhs.gov.