United States: Restaurants & Retail Food Stores: The FDA Is On Its Way; "Misbranding" Is A Crime

Last Updated: December 3 2014
Article by Michael A. Walsh

The Food and Drug Administration (FDA) issued a 395 page Final Rule on Food Labeling entitled the "Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments" (the "Menu Labeling Rule"). FDA didn't come up with the idea for Menu Labeling Rule on its own. Section 4205 of the Patient Protection and Affordable Care Act a/k/a Obamacare (the "Act"), signed into law on March 23, 2010, requires nutrition labeling of "standard" menu items for chain restaurants with 20 or more locations and "similar retail food establishments." The Act directed the FDA to issue rules for the implementation of menu labeling requirements by March 2011. In conformance with those obligations, on December 1, 2014, FDA will publish its formal notice of the final rule to be effective December 1, 2015.

The Menu Labeling Rule applies a regulatory structure similar to "labeling" for drugs and medical devices to govern restaurants and "similar retail food establishments." Similar retail food establishments are defined broadly to include grocery stores, supermarkets, convenience stores, general merchandise stores, lodging facilities, recreational venues, sports venues, performing arts venues, and movie theaters.

What Is Required?

Under the Act, covered entities are required to:

  • Disclose, on menus and menu boards, the number of calories in an item as it is usually prepared and offered for sale;
  • Provide written nutrition information and nutrition claim information to consumers upon request;
  • Provide a "prominent, clear, and conspicuous statement on menus and menu boards about the availability of the written nutrition information; and
  • Provide, on a sign adjacent to each food item, the number of calories in the item or per serving for self-service items and food on display.

The Menu Labeling Rule specifies the nutritional information be displayed next to the name or price. For example, a multiple serving menu item, such as a pizza, requires a calorie count for the total pie (e.g. 1,600 cal) or per slice—as long as it is clear how many slices are in the pie. While most Americans might think the number of slices in a pizza is obvious, Yogi Berra famously told a server to cut his pizza into four slices because he wasn't hungry enough to eat six.

What Food Items Are Covered?

The Menu Labeling Rule's requirements apply to "standard menu items" defined as "food routinely included on a menu or menu board or routinely offered as a self-service food or food on display" but not custom orders, daily specials, food that is part of a customary market test, and temporary menu items, certain self-service foods and "alcohol on display." Alcoholic beverages that are standard menu items are included.

Substantiation: Proving The Accuracy of Menu Labeling.

The term "substantiation" is a term of art under the Food Drug and Cosmetic Act (FDCA), and federal and state regulators have broad discretion in deciding, after the fact, what level of scientific evidence is sufficient. The Menu Labeling Rule requires that a restaurant—or similar retail food establishment—provide an inspector with information substantiating nutrient values including the method and data used to derive these nutrient levels. (21 CFR §101.11(c)(6)) In addition, a "responsible individual" employed at the establishment, its corporate headquarters or parent entity must certify that the information contained in the nutrient analysis is complete and accurate. Only a responsible individual employed at the establishment, however, can "certify" that the establishment took reasonable steps to ensure the method of preparation adhered to the determined values.

What happens if you don't comply or don't get it right?

The Menu Labeling Rule "Misbranding" provision states that "[a] standard menu item offered for sale in a covered establishment shall be deemed misbranded under the FDCA (21 CFR §101.11(f)). It is notable that the Menu Labeling Rule renders menu content "labeling" under the applicable provisions of the FDCA (i.e. 21 USC §343(a)(f) and (q) and §321) and violating the Menu Labeling Rule renders the food "misbranded," constituting an FDCA violation. A violation of the FDCA is a misdemeanor and, in this regard, the Menu Labeling Rule states:

Persons exercising authority and supervisory responsibility over a restaurant or similar retail food establishment can be held responsible for violations under the FD&C Act. See United States v. Park, 421 U.S. 658, 659 (1978). ("The Act imposes upon persons exercising authority and supervisory responsibility reposed in them by a business organization not only a positive duty to seek out and remedy violations but also, and primarily, a duty to implement measures that will insure that violations will not occur....") (citing United States v. Dotterweich, 320 U.S. 277 (1943)). Agency decisions regarding enforcement actions will be determined on a case-by-case basis.

Under the Menu Labeling Rule and the FDCA, the FDA retains the discretion to hold those with supervisory responsibility, including those who are "responsible individuals" who certify the menu labeling, criminally liable for a misbranding violation.

What About Civil Litigation?

The Menu Labeling Rule does not expressly preempt consumer trade practices, misrepresentation or other tort claims. The principles of conflict preemption will apply. The industry should be mindful of the emerging theory of parallel state law claims for violations of the FDCA and FDA regulations. The Menu Labeling Rule creates yet more requirements and significant new risks for litigation.

Who Is Covered?

Under the Act: In addition to a restaurant chain with more than 20 locations, the Act also applies to "retail food establishments" whose primary business activity is the sale of food to consumers. A retail establishment's primary business activity is "the sale of food to consumers" if either: 1) the establishment presents or has presented itself publicly as a restaurant; or 2) either a) more than 50 percent of a retail establishment's gross floor area is used for the preparation, purchase, service, consumption or storage of food, or; b) more than 50 percent of the establishment's revenues are generated by the sale of food. If a facility selling restaurant or restaurant-type food is within the confines of other facilities, such as a coffee shop in a bookstore, determining whether the labeling rule will apply will require a case-by-case analysis.

The regulation is more expansive than originally expected. The Act states the new law applies to "restaurants or similar retail food establishments" and "similar retail food establishment" is defined in the Menu Labeling Rule to mean retail establishments that offer restaurant-type food, including:

  • Bakeries,
  • Cafeterias,
  • Coffee shops,
  • Convenience stores,
  • Delicatessens,
  • Food service facilities located within entertainment venues (such as amusement parks, bowling alleys, and movie theatres),
  • Food service vendors (e.g., ice cream shops and mall cookie counters),
  • Food take-out and/or delivery establishments (such as pizza take-out and delivery establishments),
  • Grocery stores,
  • Retail confectionary stores,
  • Superstores,
  • Quick service restaurants, and
  • Table service restaurants.

The Act considers each of these retail food establishments sellers of "restaurant-type food" rendering them "similar" to restaurants and within the scope of the Act and the Menu Labeling Rule.

Who is excluded?

Trains, buses, airplanes and other "mobile food operations without a fixed position or site, such as food trucks" are excluded from the requirements.

Federalism and Voluntarily Compliance?

The Act does not prevent states from enacting labeling requirements for warnings concerning food safety or nutrition labeling for non-covered establishments, e.g. those with less than 20 locations. For non-covered establishments such as certain schools, hospitals, transportation carriers and movie theaters, voluntary registration provides certain preemption from state or local requirements. While the federalism and preemption issue was murky in the earlier version of the rule, the final rule creates food nutrition labeling requirements that preempt non-identical State and local nutrition labeling requirements. It is uncertain whether there will be challenges to the constitutionality of the Menu Labeling Rule on federalism or compelled speech grounds.

FDA adds some optimistic statistics in its estimate of the total number of individual menu items impacted by the Menu Labeling Rule. FDA estimates nationwide that the Menu Labeling Rule will require labeling for 207,052 individual menu items and estimates a mere 15 minutes per menu item to perform the nutrition analysis.


Studies of restaurants that post caloric information found that some restaurants showed changes in per purchase caloric values but others found no change particularly with children. The menu law is "lean" on scientific support for the conclusion that more information on restaurant menus will cause overweight consumers to eat less and be healthier. As with the Act itself, it will be years before we know whether the Restaurant Menu Labeling Rule will achieve any health benefit. In the interim, the regulation goes into effect on December 1, 2015. Businesses should designate "responsible individual[s]" at both the establishment and corporate headquarters to ensure compliance and accurate recordkeeping. This designation should be one of the first steps take to avoid violating the Act or the Menu Labeling Rule.

Stay tuned for updates further detailing how the federal government and the states will enforce the new Menu Labeling Rule.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Michael A. Walsh
In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions