Description
This draft guidance provides FDA’s recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods), especially in the absence of a common or usual name for the product. These recommendations for manufacturers are intended to help ensure that consumers understand the nature or source of individual plant-based alternative foods, including differences among these products, and have the information they need to make informed purchasing decisions.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Foods marketed as alternatives for animal-derived foods; Labeling of plant-based alternatives to animal-derived foods
Excluded from the scope of this specific guidance
Subject of the draft guidance regarding labeling and naming.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
2The primary regulatory activity addressed in the guidance
The process of establishing a common or usual name for products
Document Types
4The nature of the document regarding plant-based food labeling
Consumers are prompted to review this to understand product composition.
Reviewing this helps consumers with food allergies.
Must be in bold type on the principal display panel
Attributes
3A characteristic consumers seek when making purchasing decisions
Established definitions for foods under section 401 of the FD&C Act.
The nature of the plant origin that should be included in the food name
Technical Details
Substances
3The primary components of the alternative foods
Example of a specific plant source to be identified.
Example of a specific plant source to be identified.
Standards & References
External Standards
1Recommendations for healthy eating patterns
Related CFR Sections (5)
- 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 →
- 21CFR102.5§ 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and maRead full regulation →
- 21CFR101.3§ 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR101.4§ 101.4 Food; designation of ingredients.
- 21CFR101.22§ 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Recent Cases
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-07-19
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
H2 Beverages, Inc.
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
Related Warning Letters (6)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-07-19
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
H2 Beverages, Inc.
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
- 2020-10-20
New Drug/Misbranded
Before Brands Inc
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)