On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act.1 This guidance responds to concerns raised by industry stakeholders about the labeling requirements which were originally published as a final rule on December 1, 2014 (79 Fed Reg. 71156) and codified at 21 CFR 101.11. The implementation of this rule has been delayed multiple times. The rule’s current compliance date is May 7, 2018.
The stated intent of the draft guidance is to provide clarity regarding the menu labeling requirements and give industry stakeholders more flexibility in implementing them. Comments on the draft guidance can be submitted to FDA beginning November 9, 2017 until January 8, 2018 at http://www.regulations.gov, docket number FDA-2011-F-0172.
The draft guidance outlines options, detailed below, for complying with menu labeling requirements in regards to self-service food; marketing materials; menu boards; build-your-own,combination, and family-style food items; and franchises. Pictorial examples of compliant labeling can be found in the draft guidance linked here.
Below is a summary of the most significant clarifications provided in the draft guidance.
Individual signs detailing calorie information are not required to be posted next to each item on a self-service buffet. As long as consumers can view the name, calorie declaration and the serving size while selecting the item, companies can use a variety of means to display the information.
The statement providing context about calories in a daily diet and the availability of additional written nutrition information is not required on every sign for self-service food, so long as it is on a sign/menu board that the consumer an easily read when making selections or ordering food.
Marketing materials, including coupons, generally do not require calorie declarations because they are not considered menus. Only materials from which a customer makes an order selection require a calorie declaration. Written material, such as a poster on a storefront, a coupon, or other promotional materials whose primary purpose is to “entice” customers into the covered established are not covered by the rule. This guidance supersedes previous guidance issued by the Agency and FDA intends to withdraw the Questions and Answers 5.17 and 5.18 contained in the April 2016 guidance.
The rule does not mandate that an establishment must have menu boards at each location where self-service food is offered. However, if establishments have menu boards, they must be labeled to include the required nutrition information. Other alternatives may be used, such as electronic devices, hand-held paper menus or laminated menus.
The draft guidance acknowledges that there is not always a “basic preparation” of a menu item and discusses different methods and contains several examples of declaring calories for “build-your-own” pizzas (and presumably by analogy other “build-your-own” menu items) on menus and menu boards. It notes the Agency’s goal of “accommodating[ing] flexibility, while still providing the required calorie information for consumers to make informed dietary choices.” This includes separate listings for different crusts, sauce options and toppings. A range may be included for options as well as grouping options that have the same number of calories (e.g., crust and sauce options). The draft guidance includes several pictorial examples.
Family-Style Food Items
Family-style items must list calories for the entire menu item (e.g., “family-style salad”: 1,000 Cal”). However, the calorie count for a suggested serving size may also be listed (e.g., “family-style salad”: 1,000 Cal: 150 Cal/Serving, 8 servings).
If establishments that sell restaurant-type food are independently franchised, doing business under the same name and participating in a marketing alliance, they are not covered by the menu labeling requirements if they do not sell substantially the same menu items from location to location.
Compliance and Enforcement
FDA notes in the guidance:
We plan to work cooperatively with covered establishments to come into compliance with the menu labeling requirements. Specifically, we plan to continue with education and outreach, especially in the first year, to help covered establishments achieve compliance.
and indicates it would consider the following to be “minor violations”:
- Inadvertently missing a calorie declaration for a standard menu item on a buffet when other items are labeled;
- Minor discrepancies in the type size/color contrast of calorie declarations, provided that they are readable;
- Minimal variations or inadvertent error that would only minimally impact the calorie declaration or other nutrition information, such as adding extra slices of pepperoni on a pizza or adding an extra dollop of ketchup on a hamburger when not typically added; or
- Not rounding your calorie declaration correctly in accordance with the menu labeling rule.
Finally they note:
[O]ur typical approach following an inspection would be to raise any compliance concerns with the most responsible person (e.g., the manager or owner) at a covered establishment during a close-out inspection meeting or in regulatory meetings with that establishment. If post-inspection issues remain, we may send a letter to the establishment asking for the firm to come into compliance. Any enforcement activities we pursue will be consistent with our public health priorities.
This seems to project a “relaxed” approach to enforcement which would generally be expected for this type of roll-out, but given the change in administration it would appear that additional flexibility may be granted here.
1A “covered establishment” is 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, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that is registered….” See 21 C.F.R 101.11(a).