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Volume XI, Number 19

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FDA Issues Menu Labeling Final Guidance

The enforcement date will likely begin in May 2017.

The US Food and Drug Administration (FDA) issued its final guidance on April 29 on Menu Labeling (Final Guidance).[1],[2] Importantly, the FDA intends to begin enforcing the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (Menu Labeling Final Rule)[3] one year from the date that the Final Guidance’s Notice of Availability (NOA) is published in the Federal Register. The NOA for the Final Guidance is expected to be published in early May 2016. Thus, enforcement of the Menu Labeling Final Rule will likely begin in May 2017.

The 58-page Final Guidance is largely a reprint of the previous draft guidance of the same name. The Final Guidance contains many nonsubstantive changes from the draft guidance and provides additional examples (as well as several new, revised, and/or reformatted questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record-keeping requirements).
The more notable changes in the Final Guidance include the following:

  • The inclusion of examples for temporary menu items (e.g., jack o’lantern cookies or holiday gift tins of popcorn).

  • Exemptions for private off-site catering events from menu labeling, even where the catered items are standard menu items.

  • Mobile vendors who walk through entertainment venues (such as baseball parks) and sell food and beverages are not considered covered establishments, and thus are not required to comply with the Menu Labeling Final Rule.

  • Additional information provided to explain a menu board, where a “menu board” can include multiple forms of written material. The crucial factor of what constitutes a menu board is whether the written material is or is a part of the primary writing from which a customer makes an order selection.

  • Standalone coupons that can be used to place an order (i.e., the coupon contains the name of the standard menu item, the price, and the phone number/website) must provide calorie declaration. However, if a coupon does not include a web address or phone number for placing orders, then it is not considered a menu, and a calorie declaration is not required.

  • An additional description for the inclusion of sauce(s) nutrition information served in multiserving standard menu items.

  • Confirmation that the calorie declaration requirements for electronic menus and menus on the Internet are the same as the requirements for printed menus.

  • Clarification that standard menu items in different sizes are not considered variable menu items unless they come in different flavors, varieties, or combinations and are listed as a single menu item.

  • Additional examples of declarations of calories in combination meal products when a meal comes in multiple sizes with multiple choices of sides.

  • Clarification that, if a covered establishment has multiple digital menu boards with rotating displays, then the disclosure statements should appear on each rotating display of each digital menu board to help ensure that the statements are clear and conspicuous to the consumer and posted prominently.

  • Calorie declarations directly on the package of grab-and-go items should declare the calories for the entire package as they are usually prepared and offered for sale (rather than based on reference amounts customarily consumed (RACCs)).

  • Any substantiation records for nutrient values 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. 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, because this information is no longer beneficial for consumers if they cannot purchase those items.

  • Further explanation of when FDA-required statements from responsible individuals employed at covered establishments for nutrient determinations are required, along with sample statement language.

  • Additional guidelines for alcohol—

    • For caloric declaration of multiple beers that have the same calorie amounts, a single calorie declaration can be used, provided that the declaration specifies that the calorie amount listed represents the calorie amounts for each individual beer variety.

    • Clarification that, to the extent that beers on tap are not self-serve, they are exempt from the requirements for calorie declarations of standard menu items.

    • Further explanation regarding the acceptability of covered establishments’ reliance on calorie information and nutrition information on alcohol beverage labels consistent with Alcohol and Tobacco Tax and Trade determinations.

    • Discussion about the inclusion of calorie information for “suggested” alcohol pairings.

    • The applicability of the Menu Labeling Final Rule to covered establishments that sell only one type of standard menu item (e.g., beer).

As previously stated, the Menu Labeling Final Rule and Final Guidance provide that the categories of covered establishments include not only restaurants and similar retail food establishments, but also movie theaters, amusement parks, bowling alleys, sports arenas, other entertainment venues, food service vendors, food takeout and delivery establishments, quick service restaurants, table service restaurants, convenience stores, coffee shops, bakeries, delis, grocery stores, supercenters, and fitness clubs.
However, the Common Sense Nutrition Disclosure Act of 2015, which passed in the US House of Representatives and is pending in the US Senate, would

  • direct the secretary of the US Department of Health and Human Services to issue new rules that allow a food establishment to post nutritional information exclusively on its website if the majority of its orders are placed online,

  • clarify that advertisements are not necessarily considered menus, and

  • aim to protect establishments from being sued for human error.[4]

We will continue to monitor congressional and FDA menu labeling activities.


[1] FDA CFSAN Constituent Update, FDA Issues Final Guidance on Menu Labeling (Apr. 29, 2016), available here.

[2] A Labeling Guide for Restaurants and Retail Establishments Selling Away From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 C.F.R. 101.11): Guidance for Industry (Apr. 2016), available here.

[3] Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Calorie Labeling of Articles of Food in Vending Machines; Final Rule. 79 Fed. Reg. 71156 (Dec. 1, 2014), available here.

[4] See Text of the Common Sense Nutrition Disclosure Act of 2015, H.R. 2017 (Referred to Senate Committee Feb. 22, 2016), available here.

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Copyright © 2020 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VI, Number 126
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Robert Hibbert, Civil litigation attorney, Morgan Lewis
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Robert G. Hibbert advises clients in the food and agricultural industries on federal regulation, particularly relating to the US Department of Agriculture (USDA), as well as the US Food and Drug Administration (FDA). Clients seek his counsel on labeling, advertising, recalls, food safety compliance, animal health, and new product development issues. Bob’s experience with civil litigation in federal court includes successful challenges to the scope of USDA jurisdiction and authority over major segments of the food processing industry.

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Kathleen Sanzo, Morgan Lewis, Life sciences lawyer
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Kathleen M. Sanzo centers her practice on regulatory and compliance issues connected to products regulated by the US Food and Drug Administration (FDA). She leads and counsels clients on matters relating to prescription, OTC drug, and biotechnology products clinical testing; food, dietary supplement, and cosmetic product manufacture, approval, marketing, and distribution; device promotion and labeling issues; food, drug, and device compliance matters; and all consumer product issues regulated by the US Consumer Product Safety Commission (CPSC) and state enforcement...

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Hilary Lewis, Morganlewis, FDA lawyer, consumer product attorney, medical device
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Hilary L. Lewis counsels clients on US Food and Drug Administration (FDA), US Department of Agriculture (USDA), Federal Trade Commission (FTC), and state regulatory compliance issues involving food and dietary supplements, over-the-counter and prescription drug products, and cosmetics. Hilary applies her background litigating on behalf of FDA-regulated companies to assist clients in their defense against FDA, USDA, and Consumer Product Safety Commission (CPSC) enforcement actions, and has helped companies resolve import detentions, manage product recalls...

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