Description
This guidance document addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments,* including expanded and new examples of alternatives to aid in compliance. It also clarifies that there are additional options for complying with the labeling requirements and identifies places where FDA intends to be more flexible in its approach. The guidance reflects input from stakeholders, including the public and industry, in response to an interim final rule (IFR) (82 FR 20825, May 4, 2017), as well as comments received on the draft guidance document. The IFR also extended the compliance date for menu labeling, and invited comments to the docket.
Scope & Applicability
Product Classes
10Foods sold in covered establishments requiring nutrition labeling; Items for which calories must be declared as usually prepared and offered for sale.; Food items offered for sale for which calorie declarations are required.; items requiring nutrient content declarations
alcoholic beverages listed for less than 60 days per calendar year
alcoholic beverages served on tap and not listed on menu
beverages served on tap or listed on menu
Food usually eaten on premises or soon after
Restaurant-type food routinely included on a menu or menu board
Dishes like family-style salads or pasta bowls that serve more than one person.
covered pizza parlor that sells build-your-own pizzas with a variety of options
Food offered in locations where customers serve themselves, such as buffets.; Foods such as beverages or buffet items where consumers serve themselves.
Food items visible to consumers for selection.
Stakeholders
2A restaurant or similar retail food establishment that is part of a chain with 20 or more locations; Entities required to comply with menu labeling final rules.; A restaurant or retail food establishment subject to menu labeling rules.; Entities required to comply with menu labeling regulations.; if you choose to use a menu board in your covered establishment; Entities required to comply with menu labeling requirements.; A restaurant or similar retail food establishment meeting specific criteria
The manager or owner at a covered establishment during a close-out inspection meeting.
Regulatory Context
Attributes
10Nutrient declaration requirement for which FDA intends to exercise enforcement discretion
required labeling information
required declarations for menu items
Variations in nutrient content due to size, composition, or growing conditions
Required disclosure of energy content
Optional additional information for multiple-serving items.
provide calorie declarations per slice
The ease with which consumers can read menu boards.
The specific nutritional value required to be declared; The unit of energy measurement required to be declared.; calories for each standard menu item that may be combined; The unit of energy measured and declared for food items.
The portion size associated with the calorie declaration
Related CFR Sections (3)
- 21CFR101.11§ 101.11 Nutrition labeling of standard menu items in covered establishments.
(a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for purposes of this section:Read full regulation →
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Related Warning Letters (5)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
- 2021-12-07
New Drug/Misbranded
Synaptent, LLC
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
See Also (8)
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II (Status: Final)
- Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Status: Final)
- Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (Status: Final)
- Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements (Status: Final)
- Small Entity Compliance Guide: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Status: Final)
- Small Entity Compliance Guide: Nutrient Content Claims Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Status: Final)
- Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)