FDA Draft Guidance on Menu Labeling

by Foley & Lardner LLP
Contact

On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements of section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The stated intent of the draft guidance is to provide clarity regarding the menu labeling requirements and give industry stakeholders more flexibility in implementing them. Comments on the draft guidance can be submitted to FDA beginning November 9, 2017 until January 8, 2018 at http://www.regulations.gov, docket number FDA-2011-F-0172.

The draft guidance outlines options, detailed below, for complying with menu labeling requirements in regards to self-service food; marketing materials; menu boards;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 Pictorial examples of compliant labeling can be found in the draft guidance linked here.

Below is a summary of the most significant clarifications provided in the draft guidance.

Self-Service Food

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

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.

Menu Boards

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.

Build-Your-Own-Pizzas

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).

Franchises

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).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Foley & Lardner LLP | Attorney Advertising

Written by:

Foley & Lardner LLP
Contact
more
less

Foley & Lardner LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.