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
Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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