Final Rule Information
Menu Labeling Final Rule: Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments - Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.
Guidance for Industry
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11)
- Guidance for Industry: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Small Entity Compliance Guide
- Public Workshops on Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
- FDA Form 3757 for voluntary registration has been approved and posted online.
- For questions related to Menu Labeling contact CalorieLabeling@fda.hhs.gov.
Compliance Date: May 5, 2017
Explanation of Compliance Date: In December 2015, section 747 of the 2016 Omnibus Bill prohibited FDA from using appropriated funding to implement, administer, or enforce the menu labeling requirements until one year after FDA finalized the draft September 2015 menu labeling guidance. While FDA originally issued a statement indicating the Omnibus Bill extended the compliance date, FDA clarified that the compliance date remained December 1, 2016, but, consistent with the Omnibus Bill, FDA would not begin enforcing the final rule until May 5, 2017, which is one year after the date that the Notice of Availability for the final guidance published in the Federal Register.
On December 2, 2016, FDA announced it would soon publish a final rule to align the compliance date for the final rule on menu labeling with the enforcement date of May 5, 2017. The final rule publishes December 30, 2016 in the Federal Register and officially changes the previous compliance date by rulemaking from December 1, 2016 to May 5, 2017. For more information see, the Federal Register Notice Announcing the May 5, 2017 Compliance Date.
- Questions and Answers on Menu and Vending Machines Nutrition Labeling Requirements
- Infographic: Calories Now on the Menu - PDF (6.4MB)
- Consumer Update: How Many Calories? Look at the Menu
- Blog: Providing Consumers More Information with Menu and Vending Labeling
- Food Facts: What You Need to Know about Calorie Labeling on Restaurant Menus and Vending Machines
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part I
- Final Regulatory Impact Analysis: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishment (PDF - 746KB)
- Press Release: FDA finalizes menu and vending machine calorie labeling requirements
Dockets provide information on the development of Federal regulations and other related documents issued by the U.S. government. you will find comments submitted for each final rule in the docket folders.
Menu Labeling Docket: FDA-2011-F-0172
By Dr. Susan Mayne, Director, Center for Food Safety and Applied Nutrition
As a result of language in the omnibus appropriations bill enacted December 18, 2015 (Public Law 114-113 Consolidated Appropriations Act, 2016), FDA is delaying enforcement from December 1, 2016, to the date that is one year after it issues final, Level 1 guidance on menu labeling. The draft Level 1 guidance was issued on Sept. 11, 2015, and FDA is considering all comments received and will issue the final guidance as soon as possible.
FDA appreciates the extensive input received from stakeholders throughout the process of establishing requirements for menu labeling and in developing guidance. We will work flexibly and cooperatively with establishments covered by the menu labeling final rule to facilitate compliance and will provide educational and technical assistance for covered establishments and for our state, local, and tribal regulatory partners.
By Dr. Susan Mayne, Director, Center for Food Safety and Applied Nutrition
Today, the U.S. Food and Drug Administration (FDA) is issuing a draft guidance document that will help companies to comply with the menu labeling final rule, which requires that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments with 20 or more locations. In July, FDA extended the compliance date an additional year, beyond the original December 2015 compliance date, to help facilitate efficient compliance across all covered establishments. The guidance document issued today is an important resource in our efforts to assist those in covered establishments to comply with the rule by December 1, 2016. Ultimately, consumers will be able to make more informed choices for themselves and their families.
We appreciate the extensive input we have received from stakeholders throughout the process of establishing requirements for menu labeling in certain restaurants and other retail food establishments. The guidance document responds to many of the most frequently asked questions that the agency has received to date in emails and during meetings with and presentations to representatives of the range of establishments covered by the new menu labeling rule. These interactions have been invaluable.
This guidance is intended to help establishments implement the rule and better understand the flexibility in the rule. The guidance also answers questions and helps explain how the final requirements work for different types of establishments. The guidance does not and cannot change the final requirements of the menu labeling rule.
The guidance is being issued as a “draft” and we welcome your comments. We will consider all comments before finalizing the guidance and will consider updates to the guidance as needed. We are committed to working collaboratively with establishments covered by the menu labeling final rule, including chain restaurants, covered grocery stores serving restaurant-type food, and others, now and in the future, to answer additional questions. In addition, we will be providing educational and technical assistance for covered establishments and for our state, local, and tribal regulatory partners to support consistent compliance nationwide.
We encourage covered establishments to consider the information in this draft guidance as they prepare to comply with the final rule by December 2016. We will work flexibly and cooperatively with individual companies making a good faith effort to comply. We believe that this cooperative approach helps to improve the dialogue surrounding the requirements and facilitates successful implementation in a practical way.
As a result of these efforts, consumers will have ready access to calorie information they currently may not have to help them make healthy decisions. That’s a worthy outcome of which we can all be proud.
Statement from FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael R. Taylor, on Menu Labeling Extension of Compliance Date
The U.S. Food and Drug Administration appreciates and takes very seriously the extensive input it has received from stakeholders throughout the process of establishing requirements for menu labeling in restaurants and other retail food establishments. The FDA is committed to working collaboratively with those establishments covered by the menu labeling final rule, including chain restaurants, covered grocery stores, and others to facilitate timely and efficient implementation of the new requirements.
Since the FDA issued the menu labeling final rule on December 1, 2014, the agency has had extensive dialogue with chain restaurants, covered grocery stores and other covered businesses, and answered numerous questions on how the rule can be implemented in specific situations. Industry, trade and other associations, including the grocery industry, have asked for an additional year to comply with the menu labeling final rule, beyond the original December 2015 compliance date. The FDA agrees additional time is necessary for the agency to provide further clarifying guidance to help facilitate efficient compliance across all covered businesses and for covered establishments to come into compliance with the final rule. The FDA is extending the compliance date for the menu labeling rule to December 1, 2016, for those covered by the rule.
To support compliance by this date, the FDA will continue to engage in discussions with the covered businesses and to answer questions about how the rule applies in particular situations. In addition, the FDA plans to issue in August 2015 a draft guidance document that provides answers to some of the more frequently asked and crosscutting questions that the agency has received to further assist covered establishments in complying with the rule. This guidance document will be labeled “draft” to reflect the FDA’s openness to further comments and dialogue and to expanding the guidance as new questions arise. The FDA encourages companies to consider the information in the August guidance as they prepare to comply by December 2016. There will be an opportunity for comment on the draft guidance and the FDA will review any comments received as quickly as possible.
In addition to the guidance, the FDA will also provide educational and technical assistance for the covered businesses and for our state, local, and tribal regulatory partners to support reasonable and consistent compliance nationwide. Now and following the December 1, 2016 compliance date, the FDA will work flexibly and collaboratively with individual companies making a good faith effort to comply with the law.
For more information, see the Federal Register Notice for the Compliance Date Extension.
Compliance Dates of Other Nutrition Initiatives
FDA received questions about the timing of the compliance dates for its various nutrition initiatives and their impact on food manufacturers and is providing the following questions and answers.
Why aren’t the compliance dates for the various nutrition initiatives that manufacturers have to meet more coordinated?
Actually, they are. In summer of 2018, manufacturers will have to comply with key nutrition initiatives. The key dates are as follows:
- On June 18, 2018, manufacturers must ensure that their products no longer contain partially hydrogenated oils for uses that have not been otherwise authorized by FDA.
- On July 26, 2018, manufacturers with $10 million or more in annual food sales will need to comply with the new requirements for the Nutrition Facts label.
- Also on July 26, 2018, vending machine operators with glass front vending machines will have to comply with all requirements of the vending machine labeling rule. FDA delayed the compliance date for calorie declaration requirements for certain food products sold from glass-front vending machines in part to be consistent with the compliance date for the new Nutrition Facts label requirements so that manufacturers can make changes to front-of-pack labeling for products they supply to vending operators at the same time that they make changes to the Nutrition Facts label.
How do menu labeling requirements impact packaged food manufacturers?
The requirements for menu labeling largely affect a different segment of industry—restaurants and similar retail food establishments. We do not expect these requirements to have a great impact on manufacturers. Those establishments that are covered by the menu labeling rule must comply with menu labeling requirements by May 5, 2017.
What about the targets for sodium reduction that FDA is developing?
The targets for sodium reduction that FDA is developing are voluntary so there will be no compliance date. However, we are recommending timeframes for companies that choose to implement the targets, once finalized. FDA has published for public comment draft voluntary targets for reducing sodium in commercially processed and prepared food both in the short-term (2 years) and over the long-term (10 years).