CPG Sec. 540.700 Labeling of Processed and 
Blended Seafood Products Made Primarily with 
Fish Protein
  
You may submit either electronic or written comments regarding this guidance at any time. 
Submit electronic comments to http://www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket 
number 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  
December 2014 
 
Table of Contents  
I. Introduction  
II. Background  
III. Policy  
IV. Regulatory Action Guidance  
V. Specimen Charges 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic. It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public. You can use an alternative approach if the approach satisfies the requirements 
of the applicable statutes and regulations. If you want to discuss an alternative approach, contact 
the FDA staff responsible for implementing this guidance.   I. Introduction:  
The purpose of this document is to provide guidance for FDA staff on the proper labeling for 
processed and blended seafood products made primarily with fish protein.  
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe our 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 guidances means that something is suggested or recommended, but 
not required.  
II. Background:  
A processed and blended seafood product made primarily with fish protein can be fabricated 
from one or more fish species. An example of this would be surimi, which is a fish protein 
product consisting primarily of the myofibrillar protein fraction from one or more fish species. 
Surimi is an intermediate processed seafood product used in the formulation and fabrication of a 
variety of products that are made to resemble, and be promoted as substitutes for, crabmeat, 
shrimp, lobster, scallops, and other seafood.  
 
Surimi is made from minced fish meat (e.g., pollock, cod, or Pacific whiting) that has been 
Contains Nonbinding Recommendations 4  
 
washed to remove fat and undesirable matter (such as blood, pigments, and odorous substances), 
and then mixed with cryoprotectants (such as sugar or sorbitol) to improve its frozen shelf life. In 
formulating finished seafood products made with surimi, the surimi is typically thawed and 
blended with other ingredients such as the seafood being imitated, seafood flavoring, salt, water, 
and starch or egg white. This mixture is then heat processed and extruded to make fibrous, flake, 
chunk, and composite-molded consumer products. The finished processed seafood products are 
marketed frozen or unfrozen and may be breaded.  
III. Policy:  
A. Name of the Product 
1. If a processed and blended seafood product made primarily with fish protein substitutes and 
resembles a specific type of seafood, including its shape, form, or color, but is nutritionally 
inferior (as defined in 21 CFR 101.3(e)(4)) to that seafood, it must be labeled as imitation in 
accordance with 21 CFR 101.3(e). For example, a processed and blended seafood product made 
primarily with fish protein that is a substitute for crabmeat, resembles crab meat, and is 
nutritionally inferior to crabmeat, must be labeled imitation crabmeat. An additional statement  of product identity may appear on the principal display panel. For example, if the processed and 
blended seafood product is made with the seafood it is intended to resemble, then the following 
statement of identity could be used: Fish Protein Blended with ________. The blank is to be 
filled in with the common or usual name of the specific ingredient, such as snow crab (21 CFR 
101.3).  
2. A processed and blended seafood product made primarily with fish protein that: (1) does not 
resemble a specific type of seafood or seafood body part; or (2) is not a substitute for a specific 
type of seafood or seafood body part need not be labeled as imitation but must bear a name that 
is appropriately descriptive, e.g., Fish Protein Blended with Snow Crab or ______ flavored 
seafood, made with surimi, a fully cooked fish protein. The blank should be filled with the 
common or usual name or an appropriately descriptive name of the seafood that characterizes the 
flavor, e.g., crab, lobster, shrimp (21 CFR 101.3(b)).  
B. Ingredient Statement  
1. All ingredients must be listed in the ingredient statement of the finished product by their 
common or usual names in descending order of predominance by weight, in accordance with 21 
CFR 101.4(a), unless exempted from ingredient declaration under 21 CFR 101.100(a). For 
example the ingredient statement might list the following: "Fish protein (contains one or more of 
the following: pollock, cod, and/or pacific whiting), snow crab, water, sugar, wheat starch, 
sorbitol, artificial flavor, salt, potassium chloride, sodium tripolyphosphate, tetrasodium 
pyrophosphate, glucose, artificial color." Flavors, colors, or incidental additives that are or 
contain major food allergens are not exempted from ingredient declaration and must be declared 
in accordance with section 403(w) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 343(w)).  
2. The fish protein ingredient may be declared in the ingredient statement by the collective name 
fish protein followed with a parenthetical listing of the specific common or usual names of 
each species that may be present, in accordance with 21 CFR 101.4(b)(23), e.g., fish protein 
(contains one or more of the following: pollock, cod, and/or Pacific whiting). Acceptable 
Market Names identified in Guidance for Industry: The Seafood List  FDAs Guide to 
Acceptable Market Names for Seafood Sold in Interstate Commerce should be used in the 
parenthetical listing.  
3. The specific common or usual name of any seafood ingredient must appear in the ingredient 
statement in accordance with 21 CFR 101.4(a) and (b). An acceptable market name of any 
seafood ingredient may be used, when appropriate. For example, the acceptable market name, 
lobster may be used rather than American lobster. (See The Seafood List).  
C. Other Required Labeling   The labeling of processed and blended seafood products made primarily with fish protein 
covered by this CPG must be truthful and non-misleading, consistent with applicable provisions 
of sections 403 and 201(n) of the FD&C Act, including section 403(w) of the FD&C Act relating 
to misbranding with respect to labeling for the presence of major food allergens.  
IV. REGULATORY ACTION GUIDANCE:  
Field Offices should consider recommending legal action for false or misleading labeling of the 
fish protein name for a processed and blended seafood product made primarily with fish protein, 
in the product name or in the ingredient statement, only when the misbranding is included as an 
additional charge to other statutory violations. Field Offices should consult with the Center for 
Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement 
(HFS-605) before recommending a legal action (e.g., seizure, import refusal) based solely on the 
misbranding addressed in this CPG.  
V. SPECIMEN CHARGES:  
Applicable charges will be determined after consulting with CFSAN and based on considering 
all potential misbranding violations associated with the case.  
Material in italics is new or revised.  
Issued: 6/3/1985  
Reissued: 10/30/1989  
Revised: 11/20/2008; 12/18/2014