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CFSAN/Office of Food Safety
January 2009
Additional copies are available from:
Office of Food Safety
Division of Seafood Safety HFS-325
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2300
http://www.cfsan.fda.gov/guidance.html
You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Issued: September 1993
Revised: January 2009
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. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.
This guidance is intended to provide guidance to industry about what FDA considers to be acceptable market names for seafood sold in interstate commerce and to assist manufacturers in labeling seafood products. This guidance defines the different categories of names found in The Seafood List and outlines principles that can be used to label seafood species sold in the United States (U.S.) with an appropriate, nonmisleading statement of identity.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's 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 Agency guidances means that something is suggested or recommended, but not required.
Through the years, the Federal Government has worked to provide consistent and scientifically sound recommendations to industry and consumers about acceptable market names for seafood sold in interstate commerce. This advice was consolidated in 1988 when The Fish List was first published by FDA in cooperation with the National Marine Fisheries Service (NMFS) to provide a source of names that would facilitate consistency and order in the U.S. market place and reduce confusion among consumers. Although The Fish List had significant success in achieving its goal, its usefulness was limited because it did not include invertebrate species. In 1993, The Fish List was revised to include the acceptable market names for domestic and imported invertebrate species sold in interstate commerce, and renamed The Seafood List. The Seafood List provides information to assist manufacturers in properly labeling seafood and to reflect the acceptable market names of new species introduced into the U.S. marketplace.
The use of acceptable market names is essential in the identification of seafood because of the exceptional number and variety of species represented by this unique category of foods. The unparalleled diversity in this category of similar foods means that very few species have just one nationally recognized, common or usual name that allows consumers to unambiguously identify a species in the marketplace. Typically, even the most popular and widely consumed species have acceptable market names that are shared with other species. For example, "salmon," "bass," "tuna," "cod," "halibut," and "snapper" are names commonly used to identify particular species of fish, but these are also names that are sometimes used to represent a group of finfish species. When used as the market name, the group name may properly encompass and adequately identify for consumers any member of the group, but it does not provide enough information for a consumer to identify the specific species, if a consumer desires that level of specificity. The "scientific common name" generally provides that level of specificity and usually is also an acceptable market name.
When determining how to appropriately label seafood, one should either check The Seafood List, or type in the species name using the search box below to identify acceptable market names.
Species that are included on The Seafood List are those that FDA has determined are sold in interstate commerce or are likely to be sold in interstate commerce and are not prohibited by law from sale in interstate commerce.
The column headings in The Seafood List identify four types of names for each species, i.e., market name, scientific common name, scientific name, and vernacular name.
FDA generally evaluates whether a name is an acceptable market name based on the following principles:
A common or usual name required by regulation or law is the required market name of the food (i.e., the "statement of identity" (21 CFR 101.3)).
Common or usual names currently required by regulation or law are "Pacific whiting" (21 CFR 102.46), bonito (21 CFR 102.47), crabmeats (21 CFR 102.50), "Greenland turbot" (21 CFR 102. 57), canned oysters (21 CFR 161.145), canned Pacific salmon (21 CFR 161.170), canned tuna (21 CFR 161.190), and "catfish" (Federal Food, Drug, and Cosmetic Act (FD&C Act); Sec. 403(t) (21 U.S.C. 343(t)). The names of species that are prescribed by regulation or law are marked with an asterisk (*) in The Seafood List.
A name that is false or misleading is not an acceptable market name.
A food is deemed to be misbranded under section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)) if "…its labeling is false or misleading in any particular…" Some examples of how a market name may be false or misleading to a consumer are:
The use of a false or misleading name may prevent correct species identification and thereby affect the ability of processors and consumers to make accurate assessments of the potential safety hazards associated with seafood. Hazards such as allergenic proteins and scombrotoxin formation are associated with some species but not others, presenting potential food safety risks if the food is not accurately labeled. Misbranding may also result in economic fraud, because of the difference in the market value of different but similar species of fish. Geographical designations used as part of a market name should truthfully represent the geographical origin of the species (21 CFR 101.18(c)), or otherwise conform to the provisions of 21 CFR 101.18(c)(4). Geographical designations are sometimes part of a species' common or usual name (e.g., Atlantic salmon). FDA recognizes that these descriptors and those used in some scientific common names can be truthful and meaningful parts of a food's statement of identity. Other uses of a geographical descriptor, for example as part of a coined or fanciful name where the descriptor does not accurately describe the geographical extent of the source of the species, may be misleading and are not recommended. The global spread of aquaculture may further confound the use of place of origin labeling, because a species with natural origins in one region of the world may be aquacultured in another region (e.g., Ictalurus puntatus). Thus, acceptable references in a market name to source waters or place of geographical origin should be used only to describe a species from an exclusive geographical source or fishery, consistent with the requirements of 21 CFR101.18(c).
A name that has been recognized nationally in the U.S. and commonly used by consumers to identify a species may be an acceptable market name.
A name that has been nationally recognized in the U.S. and commonly used by consumers to identify a species is a common or usual name of a food (21 CFR 102.5(a)) that may be an acceptable market name. Some of the most frequently consumed species in The Seafood List have acceptable market names that are widely recognized by U.S. consumers as referring to a group of similar, related species. For example, the names "tuna," "salmon," and "grouper" can each be used to refer to a variety of species of finfish. Individual species are at times differentiated by acceptable market names that are recognized nationally and commonly used by consumers. Yellowfin tuna, sockeye salmon, and coho salmon are examples of differentiated marketed names. The use of a single unique name for any food is the optimum situation for an orderly market. FDA recognizes, however, that there are instances where more than one acceptable market name for a species is recognized in the marketplace. Moreover, these names may have been used interchangeably in the U.S. without causing confusion or misrepresentation of the true character and identity of the species involved (e.g., "monkfish" and "goosefish" are acceptable market names that may be used interchangeably for various Lophius spp. Conversely, as noted above, several different species may share an acceptable market name without causing apparent market conflict, i.e., the market name "grouper" may be used for several Epinephelus spp. To the extent possible, market names should provide a clear distinction between species that have different qualities and value to consumers (e.g., "pollock" and "cod" are distinct names for distinct species and consumers generally associate higher quality and value with "cod"). FDA also recommends that the market name allow for the selection by consumers from among species with similar names. Market names that express species qualities can be achieved by using the scientific common name, as opposed to the market name (e.g., "snapper" and "red snapper" for which the species Lutjanus campechanus, i.e., "red snapper," is more highly valued than other Lutjanus spp. that may be called "snapper." (FDA Compliance Policy Guide Sec. 540.475 Snapper - Labeling (CPG 7108.21); http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg540-475.html).
The scientific common name is generally an acceptable market name.
The name commonly used to identify the same fish may vary from region to region. A vernacular name (local or regional name) for a species, even though well established in that area, may not be an acceptable market name for use in interstate commerce. In the broader marketplace, a vernacular name may be the same as, or confusingly similar to the name used to identify a different species in another region. Market name conflicts can be avoided by using species-specific scientific common names that are assigned by taxonomists. Because of their specificity, scientific common names allow consumers to more readily differentiate between similar species. FDA generally regards scientific common names as appropriate market names, provided they are not misleading or confusing (Principle 2). In The Seafood List an asterisk (*) is placed beside a scientific common name that cannot be used either because another name is required by regulation or because it is not an acceptable market name based on Principle 2.
An established international name (e.g., established by the Food and Agriculture Organization of the United Nations (FAO)) or a name that is widely recognized and commonly used in the country of origin may be an acceptable market name.
When a species is first introduced into the U.S. market, whether as a new import or a new hybrid, a market name normally is not available. In these instances, an internationally recognized name, such as one recognized by FAO may be an acceptable market name. For example, when a particular species of crab was first introduced in the U.S. market, Principles l and 3 could not be used to develop an acceptable market name. The FAO-recognized name "purple stone crab" was identified as a common name and FDA concluded that this name would be an acceptable market name. Alternatively, a name that is widely recognized and commonly used by consumers in the country of origin may be an acceptable market name. However, neither an internationally recognized name nor the name most commonly used in other countries will be an acceptable market name if it is misleading or confusing (Principle 2).
A coined name may be an acceptable market name.
When other naming conventions are not available, a coined or fanciful name may be an acceptable market name, provided the name is not misleading or confusing (Principle 2). Coined names are useful when a species has an otherwise unappealing scientific common name (e.g., the coined name "orange roughy" is more appealing than the scientific common name "slime head"), or when the use of a market or scientific common name is prohibited by regulation or law. For example, the market name "basa catfish" was used for Pangasius bocourti prior to the passage of section 403(t) of the FD&C Act (21 U.S.C. 343(t)). Under section 403(t), a food is deemed misbranded if it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae. Thus, the market name "basa" was coined for Pangansius bocourti. If an acceptable coined or fanciful name does not already exist, one may coin a new descriptive name provided that it is not misleading or confusing (Principle 2).
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FDA has verified the cited Web addresses, but is not responsible for subsequent changes to them after this document issues.
(1) This guidance has been prepared by the Division of Seafood Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
