Compliance Policy Guide 
Sec. 540.750 Use of The Seafood List to 
Determine Acceptable Seafood Names 
Guidance for FDA Staff 
Additional copies are available from: 
Office of Food Safety 
Division of Seafood Safety, HFC-325 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-1421 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/compliance-manuals/manual-compliance-policy-guides 
You may submit electronic or written comments regarding this guidance at any time.  
Submit electronic comments to https://www.regulations.gov.  Submit written comments 
on the guidance to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments 
should be identified with Docket No. FDA-2016-D-3004 listed in the notice of 
availability that publishes in the Federal Register. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Office of Regulatory Affairs 
July 2020  Contains Nonbinding Recommendations 
Table of Contents 
I. Introduction
II. Background
III. Policy
IV. Regulatory Action Guidance
V. Specimen Charges
2  Contains Nonbinding Recommendations 
Compliance Policy Guide 
Sec. 540.750 **Use of The Seafood List to 
Determine Acceptable Seafood Names** 
Guidance for FDA Staff 
This guidance represents the current thinking of the Food and Drug Administration 
(FDA) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of 
the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff responsible for this guidance at the phone number listed on the title page. 
**I. Introduction: 
The purpose of this document is to provide guidance for FDA staff regarding use of The 
Seafood List to determine whether a seafood name is acceptable.  
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidance documents describe FDAs current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in FDA guidance documents means 
that something is suggested or recommended, but not required. 
II. Background:
In 1988, FDA, in cooperation with the National Marine Fisheries Service, published the 
first comprehensive list of acceptable market names for domestic and imported fish, 
called The Fish List.  The Fish List helped facilitate consistency and order in the U.S. 
marketplace by providing acceptable fish names that would not mislead consumers about 
the characteristics and value of the fish.  Although the first version of The Fish List 
advanced development and use of non-misleading names for finfish, i.e., vertebrates, its 
usefulness was limited because it did not include invertebrate mollusks and crustaceans.  
In 1993, The Fish List was revised to include the acceptable market names for domestic 
and imported invertebrate species sold in interstate commerce and was renamed The 
Seafood List.    
The Seafood List provides information to industry to help them properly label seafood 
and products containing seafood ingredients (e.g., in the statement of identity (21 CFR 
101.3) and in the ingredient list (21 CFR 101.4)).  The Seafood List may be used in 
3  Contains Nonbinding Recommendations 
conjunction with FDAs Guidance for Industry: The Seafood List - FDAs Guide to 
Acceptable Market Names for Seafood Sold in Interstate Commerce (the Seafood List 
Guidance).  The Seafood List Guidance  provides principles for determining an 
acceptable market name for a new seafood species introduced into the U.S. marketplace.  
The Seafood List Guidance also defines the categories of names found in The Seafood 
List (i.e., acceptable market name, common name, scientific name, and vernacular name).  
III. Policy:
We consider seafood names listed in the Acceptable Market Name(s) column and the 
Common Name column of The Seafood List to be acceptable names, except when The 
Seafood List indicates that the Common Name is prohibited by the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) or regulation.  FDA recognizes these names as suitable 
for the label statement of identity and ingredient list, as required under the FD&C Act.   
When an acceptable name is provided in The Seafood List and the name used on the 
seafood product labeling is not an acceptable name provided in The Seafood List, the 
labeling may be misleading.  In these situations, FDA will consider the circumstances in 
determining whether the seafood product is misbranded under section 403 of the FD&C 
Act (21 U.S.C. 343).   
When an acceptable name for a seafood species is not provided in The Seafood List, FDA 
will consider the circumstances of the situation to determine whether the seafood product 
is misbranded under section 403 of the FD&C Act.  FDAs evaluation will be informed 
by the principles set forth in the Seafood List Guidance.  In some situations, more than 
one provision of section 403 of the FD&C Act may apply.  For example, when a species 
of seafood is labeled with the name of another species of seafood (e.g., pollock labeled as 
cod), FDA may consider the seafood product to be misbranded under section 403(a)(1) of 
the FD&C Act (21 U.S.C. 343(a)(1)) because the labeling is false or misleading and also 
misbranded under section 403(b) of the FD&C Act (21 U.S.C. 343(b)) because the 
seafood is offered for sale under the name of another seafood. 
A. FD&C Act and Regulations
In the Acceptable Market Name(s) column of The Seafood List, a common or usual  
name for a seafood species that has been established by the FD&C Act or by regulation is 
marked with an asterisk (*)(See 21 CFR 102.5 and part 161).  An acceptable market 
name marked with an asterisk must be used to identify the species on the label, including 
in the statement of identity (21 CFR 101.3(b)(1)) and the ingredient list (21 CFR 101.4).  
When a different name from the Acceptable Market Name(s) column is provided in the 
Common Name column of The Seafood List, the acceptable market name marked with 
an asterisk (*) must be used.  (See 21 CFR 102.5 and part 161.) 
4  Contains Nonbinding Recommendations 
The regulations in 21 CFR parts 102 and 161 establish common or usual names for some 
seafood species.  A seafood product that does not bear the name established by regulation 
for a species is misbranded under section 403(i)(1) of the FD&C Act (21 U.S.C. 
343(i)(1)).  A seafood product that is labeled as a food for which a standard of identity is 
established by regulation and that fails to meet the standard is misbranded under section 
403(g) of the FD&C Act (21 U.S.C. 343(g)).  
A dagger () symbol next to a name in the Common Name column of The Seafood List 
indicates that the specific name is not allowed.  For example, The Seafood List identifies 
Whiskered Fish as the acceptable market name for Ariopsis felis and notes that the 
common name is Hardhead Catfish.  There is a dagger next to Hardhead Catfish for 
Ariopsis felis because section 403(t) of the FD&C Act (21 U.S.C. 343(t)) establishes the 
name catfish for fish classified within the family Ictaluridae.  Ariopsis felis is not in the 
family Ictaluridae therefore the name catfish should not be used for this species.  The 
United States Department of Agricultures Food Safety and Inspection Service (FSIS), 
through its mandatory inspection program, regulates fish of the order Siluriformes, 
including catfish, and products derived from these fish (9 CFR chapter III subchapter F).  
Under the FSIS regulation, the labels and labeling only of fish and fish products within 
the family Ictaluridae may bear the term catfish (9 CFR 541.7(d)(2)). 
B.Compliance Policy Guides (CPGs)
CPG Sec. 540.475 Snapper - Labeling provides guidance on use of the term "red 
snapper" as an acceptable market name for Lutjanus campechanus.  FDA may consider a 
fish other than Lutjanus campechanus that is labeled as "red snapper" to be misbranded 
under section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)).  
CPG Sec. 540.150 Caviar, Use of Term - Labeling provides guidance on use of the term 
caviar.  Although the term caviar can be applied to any kind of fish eggs prepared 
after a special method (salting), the unqualified term caviar should be applied only to 
sturgeon roe.  When caviar is made from the roe of fish other than sturgeon, the label 
should indicate the name of the fish.  The roe of other fish may be labeled "_____ 
Caviar," the blank to be filled in with the common or usual name of the fish from which 
the roe was taken.  FDA may consider the unqualified use of the term caviar on the 
label of a fish egg product that is prepared from the roe of fish other than sturgeon to 
misbrand the food under section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)). 
IV. Regulatory Action Guidance:
Field Offices should consider the circumstances of the situation to determine whether a 
product is misbranded under section 403 of the FD&C Act and whether to recommend 
seizure or import refusal, as appropriate, to CFSAN, Office of Compliance, Division of 
5  Contains Nonbinding Recommendations 
Enforcement (HFS-605) when a seafood product is labeled with a name other than a 
name that is:  
1. A common or usual name established for the seafood species by the FD&C Act or
a regulation, or
2. An acceptable name recommended in The Seafood List.
Field Offices should consult with CFSAN, Office of Compliance, Division of 
Enforcement (HFS-605) prior to recommending seizure or import refusal, as appropriate, 
when a name for a seafood species is not established by the FD&C Act or regulation and 
is not provided as an acceptable name in The Seafood List. 
FSIS has regulatory jurisdiction over all fish of the order of Siluriformes, including 
catfish, and products derived from these fish.  Field Offices that encounter an apparent 
violation involving Siluriformes fish and fish products should contact their local FSIS 
representative.  See MOU 225-14-0009 between FSIS and FDA.  
When recommending seizure or import refusal for violations relating to the guidance in 
this CPG, the Field Office should determine whether one or more of the charges in 
section V. Specimen Charges apply and whether other statutory violations also apply.  
Section V. Specimen Charges does not provide an exhaustive list of specimen charges for 
potential violations that may apply to a seafood product.   
V. Specimen Charges
Domestic Seizure
Misbranded - offered for sale under the name of another food 
The article of food was misbranded when introduced into and while in interstate 
commerce and is misbranded while held for sale after shipment in interstate commerce, 
within the meaning of 21 U.S.C. 343(b), in that it is offered for sale under the name of 
another food. 
Misbranded  standard of identity  
The article of food was misbranded when introduced into and while in interstate 
commerce and is misbranded while held for sale after shipment in interstate commerce, 
within the meaning of 21 U.S.C. 343(g)(1), in that it purports to be a food for which a 
definition and standard of identity have been prescribed by regulations as provided by 21 
U.S.C. 341, and the food does not conform to such definition and standard. 
Misbranded  false and misleading 
The article of food was misbranded when introduced into and while in interstate 
commerce and is misbranded while held for sale after shipment in interstate commerce, 
within the meaning of 21 U.S.C. 343(a)(1), in that its labeling is false and misleading. 
6  Contains Nonbinding Recommendations 
Misbranded  common or usual name 
The article of food was misbranded when introduced into and while in interstate 
commerce and is misbranded while held for sale after shipment in interstate commerce, 
within the meaning of 21 U.S.C. 343(i)(1), in that the label fails to bear the common or 
usual name of the food. 
Import Refusal 
Misbranded - offered for sale under the name of another food 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the 
FD&C Act in that it appears to be misbranded within the meaning of section 403(b) of 
the FD&C Act in that it is offered for sale under the name of another food. 
Misbranded  standard of identity 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the 
FD&C Act in that it appears to be misbranded within the meaning of section 403(g)(1) of 
the FD&C Act in that it purports to be a food for which a definition and standard of 
identity have been prescribed by regulations as provided by section 401 of the FD&C Act 
and the food does not conform to such definition and standard. 
Misbranded  false and misleading 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the 
FD&C Act in that it appears to be misbranded within the meaning of section 403(a)(1) of 
the FD&C Act in that its labeling is false and misleading. 
Misbranded  common or usual name 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the 
FD&C Act in that it appears to be misbranded within the meaning of section 403(i)(1) of 
the FD&C Act in that its label fails to bear the common or usual name of the food.** 
**Material between the double asterisks is new or revised.** 
Issued: 8/12/96  
Revised: 5/2005, 07/2020
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