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FDA Menu Labeling Guidance Provides Vast Range of Answers


FDA Menu Labeling Guidance Provides Vast Range of Answers

In the publishing of its final guidance on the menu labeling final rule, FDA has added some significant information from that published in the draft guidance, including new or revised questions and answers, additional examples, and focus on areas such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record keeping requirements

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A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II  is intended to help restaurants and similar retail food establishments understand nutrition labeling requirements. Although guidance documents are nonbinding recommendations, they provide critical information to help industry interpret and comply with the rule. Although the rule was effective, Dec 1, 2015, FDA said it will begin enforcing the rule about a year from now – “one year from the date that the Notice of Availability (NOA) is published in the Federal Register” which is expected to be in early May 2016.

At 58 pages, the guidance is quite extensive, so it would be impossible for a single newsletter to address all aspects of the guidance. So, instead, we are addressing some of the most significant information through our own version of a Q&A. (The complete guidance document is available at FDA.gov.)


Why is nutrition labeling being required?

In 2010, the Patient Protection and Affordable Care Act amended the FD&C Act to require that certain restaurants and retail food establishments provide calorie information and, upon request, additional written nutrition information for standard menu items. The final rule was published Dec. 1, 2014.

What is considered to be a “covered establishment”?

A restaurant or similar retail food establishment, as defined below, that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, such as individual franchises) and offering for sale substantially the same menu items. Other retail food establishments may voluntary become subject to the requirements by registering with FDA.

What is required?

  1. In general, covered establishments must provide:

  2. The number of calories contained in a standard menu item listed on a menu or menu board.

  3. For a self-service food or food on display, this must be posted on a sign adjacent to the corresponding food.

  4. The following statement to help consumers understand the calorie information: “2,000 calories a day is used for general nutrition advice, but calorie needs vary.”

  5. The statement: “Additional written nutrition information upon consumer request” (and the availability of this).

How does FDA define a menu/menu board?

A menu or menu board includes any writing of the covered establishment that is a primary writing from which a consumer can make an order selection. Interestingly, this could even be a coupon or ad which could be used by a consumer to order a standard menu item – i.e., it includes the name and price of the item and a phone number or web address where an order can be placed. As such, it would be required to include a calorie declaration for the listed standard menu item.


Can I make nutrient content or health claims for my food?

Yes, but if you make a nutrient content or health claim for a food, you must provide nutrition labeling for such food in accordance with 21 CFR 101.9 upon request, or information on the particular nutrient amounts that are the basis for the claim (such as, “low fat, this smoothie provides less than 3 grams of fat”) which may serve as the functional equivalent of complete nutrition information. This information may be provided on a counter card, sign, poster, handout, booklet, loose-leaf binder, menu, electronic device or other similar means.


Are any foods of a covered established exempt from the rule?

Yes. Exempt foods include:

  • Food that is not a standard menu item (e.g, custom orders, daily specials, temporary market items, or food that is part of a customary market test)

  • Condiments for general use, including those placed on the table or on or behind the counter

  • Self-service food and food on display that is offered for sale for fewer than 60 days per calendar year or fewer than 90 consecutive days to test consumer acceptance.

In general, these foods are exempt from nutrition labeling unless the restaurant or establishment makes a claim about calories or other nutrients or provides other nutrition information.


What is required if I do make a nutrition claim on an exempt item?

As with a standard menu item, if you make a nutrient content or health claim on an exempt item, you must provide nutrition labeling for such food upon request; or information on the nutrient amounts that are the basis for the claim may serve as the functional equivalent of complete nutrition information.


Do I need to provide calorie information at catered events?

The catered event is likely not a covered establishment because it is not a restaurant or similar retail food establishment that offers for sale standard menu items. Therefore, the catered event would not be required to provide calorie or other nutrition information. However, the menu/menu board from which the originating customer made the order selection must have this information. Thus, a covered establishment that offers off-site catering must provide calorie declarations for standard menu items listed on its catering menu.


If I offer a food only once or twice a month, is it considered a standard menu item?

No. A menu item that is not offered routinely, but only for fewer than 60 days per calendar year, is not covered because it fits the definition of a “temporary menu item.”

If a grocery store sells take-home prepared foods (e.g., barbecue meat items, pizza, etc.) listed on our menu/board or self-service buffet, is calorie and other nutrition information required?


If the item, for example, a two-piece barbecue chicken lunch or a slice of pizza, is routinely included on a menu or menu board, or offered at a hot self-service buffet, then that item would be covered and nutrition information must be provided. If the food involves additional preparation, such as reheating, before consuming and is typically eaten over several eating occasions or stored for later use, such food would generally not be covered (e.g., cold, prepared barbecue meat items at a deli counter that is sold by weight and is generally reheated by the consumer before being eaten).


As you can see, the guidance includes a wide range of information, with much of it set up in a similar question/answer format. FDA has also stated that it will continue to conduct webinars and hold menu labeling workshops that focus on specific needs, with information on these to be announced at a later date. Additionally covered establishments can send questions on menu labeling requirements to CalorieLabeling@fda.hhs.gov, or, as always, contact us at TAG for answers and consultation.


About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

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