Description
“A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods – Part II” is intended to help restaurants and similar retail food establishments understand nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations that may apply to them. Broadly, these requirements include the menu labeling provisions of section 403(q)(5)(H) of the (FD&C Act) [21 U.S.C. 343(q)(5)(H)] and the final rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments we published on December 1, 2014 (79 FR 71156) (menu labeling final rule).
Scope & Applicability
Product Classes
10Restaurant-type food routinely included on a menu or menu board
Packaged items like sandwiches or sushi prepared at retail
Foods such as buffets or salad bars where customers serve themselves
Items with flavors, varieties, or combinations listed as a single menu item.; menu item that includes options such as different flavors or sides; Items like pizza or combination meals with multiple components
A product category exempt from certain mitigation strategies; Exempt under specific conditions related to Treasury permits; Consistency hint provided in prompt
Food usually eaten on premises or soon after
Menu item consisting of more than one food item; meal that includes a main item and a choice of sides
Food prepared based on individual customer request; Item prepared in a specific way based on a customer's request.
Menu item offered on a particular day not routinely listed
Food offered in locations where customers serve themselves, such as buffets.; Foods such as beverages or buffet items where consumers serve themselves.
Stakeholders
5A 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
person who certifies nutrient analysis accuracy
Vendors walking through stands in stadiums; generally not considered covered establishments.
Person noted on the protocol who signs the signature letter
Entities offering restaurant-type food for sale
Regulatory Context
Attributes
10Required disclosure for standard menu items; The specific nutrition data required to be declared on menus.
Covers two years and becomes active from the date of submission
required data for standard menu items
Nutrient levels that can be declared as zero or less than one gram
Additional nutrition information available upon request; Statement that additional nutrition information is available upon request
2,000 calories a day is used for general nutrition advice, but calorie needs vary; Required statement regarding daily calorie intake
Required disclosure of energy content
Requirement for visibility of calorie declarations.
Must be at least as conspicuous as that used for the name of the menu item.
Requirement for established name to be at least half as large as proprietary name.
Related CFR Sections (6)
- 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 →
- 21CFR101.14§ 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following definitions apply:Read full regulation →
- 21CFR101.13§ 101.13 Nutrient content claims—general principles.
(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →
- 21CFR101.10§ 101.10 Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims.
Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this part ) or a health claim (as defined in § 101.14 and permitted by a regulation in subpart E of this part ) iRead full regulation →
- 21CFR210.2§ 210.2 Applicability of current good manufacturing practice regulations.
(a) The regulations in this part and in parts 211 , 213 , 225 , and 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, Read full regulation →
Related Warning Letters (7)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 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.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part I (Status: Final)
- Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Status: Final)
- Guidance for Industry: Menu Labeling Supplemental Guidance (Status: Final)
- Draft Guidance for Industry: Menu Labeling Supplemental Guidance (Edition 2) (Status: Draft)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Chapter 1 - General (Status: Final)
- Using Electronic Means to Distribute Certain Product Information: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)