Description
This guidance is intended to provide guidance to industry about what FDA considers to be acceptable market and common names for seafood sold in the United States and to help manufacturers in labeling seafood products. This guidance provides more information on the acceptable market name, common name, scientific name, and vernacular name of seafood species sold in the United States. These names are listed in FDA’s guide entitledThe Seafood List.
Scope & Applicability
Product Classes
1Product category subject to FDA HACCP regulations.; Presence, detection and growth of Listeria monocytogenes.
Regulatory Context
Attributes
2The Latin genus and species name used for exact identification
The name FDA recognizes as suitable for the label statement of identity
Identified Hazards
Hazards
2Safety risk that requires accurate species identification
Safety hazard associated with specific seafood species
Related CFR Sections (5)
- 21CFR101.18§ 101.18 Misbranding of food.
(a) Among representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic.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 →
- 21CFR161.190§ 161.190 Canned tuna.
(a) Identity.Read full regulation →
- 21CFR101.4§ 101.4 Food; designation of ingredients.
- 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 →
Related Warning Letters (9)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, Inc.
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2022-09-13
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
CR Grupo Comercial Alvacora S.A.
- 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
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
- 2020-10-20
New Drug/Misbranded
Before Brands Inc
See Also (8)
- CPG Sec 560.200 Country of Origin Labeling (Status: Final)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Guidance for Industry: Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term "Catfish" (Status: Final)
- CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (Status: Final)
- Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (Status: Final)
- Guidance for Industry: Proper Labeling of Honey and Honey Products (Status: Final)
- Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (Status: Final)
- Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon (Status: Draft)