U. S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
February 2003

DEPARTMENT OF HEALTH & HUMAN SERVICES	Public Health Service Food and Drug Administration College Park, MD 20740

February 28, 2003

To All Interested Parties:

The purpose of this letter is to provide information about current market names for fish that are outside of the family Ictaluridae and that were previously marketed with the term "catfish" in their names. Due to a recent amendment to section 403 of the Federal Food, Drug, and Cosmetic Act (FFDCA), use of the term "catfish" on labeling, in whole or as part of the common or usual name, is now prohibited for fish in interstate commerce that are not classified within the family Ictaluridae. Information about acceptable current market names for these fish is contained in the chart, below.

This letter replaces our previous letter to you of January, 2002. It also provides further clarification on the changes we explained in our December 2002 guidance entitled "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'." The guidance can be viewed under seafood at http://www.cfsan.fda.gov/~dms/guidance.html

As background, on May 13, 2002, Public Law 107-171, entitled the Farm Security and Rural Investment Act of 2002, became law. Section 10806 amends the food misbranding provision of the FFDCA (section 403) to provide that a food shall be deemed to be misbranded "[i]f it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae."

The most recent hard copy of the Food and Drug Administration guidance, "The Seafood List, FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce 1993" as updated, continues to list a number of fish other than from the family Ictaluridae with the term "catfish" in their names. (The web version of this guidance has been corrected in this regard. This guidance reflected what FDA believed, at that time, were names for seafood that could be used consistent with the food naming provisions of the FFDCA. These provisions, now amended for catfish, provide that a food is misbranded if, among other things, its labeling is false or misleading in any particular (21 USC 343(a)(1)), it is offered for sale under the name of another food (21 USC 343(b)), or its label fails to bear the common or usual name of the food, if any there be (21 USC 343(i)). FDA has also issued a regulation at 21 CFR 102.5 that provides general principles for common or usual names for foods. The regulation explains that a common or usual name must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. It may be a "coined name," created for the purpose of naming the food. However, it may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name. Although the regulation provides that a common or usual name may be established by common usage or by establishment of a regulation, as a practical matter, common or usual names for foods tend to be established through common usage.

FDA's "Seafood List," mentioned previously, provides agency guidance on common or usual names for fish that meet the provisions of 21 CFR 102.5. Those non-Ictalurid species, which are distributed in interstate commerce, including imports, that have been or were intended to be listed as having common or usual names containing the term "catfish," are thus affected by the new legislation; these species are listed in the chart below. We have also included some alternate market names which we have accepted for use after consultation with importers and domestic distributors.

Importers and domestic distributors in interstate commerce whose fish have alternative common or usual names that do not contain the term "catfish" must use those alternative names. If no such alternative name exists, importers and domestic distributors in interstate commerce may develop other common or usual names for these fish by following the principles in 21 CFR 102.5. In applying those principles to this situation, FDA recommends that those who name fish keep the following in mind:

1. To the extent possible, the name should be informative or descriptive to the consumer. An example of a descriptive name now in use is "orange roughy," which was developed because the fish has an orange hue and has rough textured scales.

2. The name should not be deceptive or misleading as to the species designated (for example, the fish should not be named a type of halibut) or have a misleading association with such attributes as color, flavor, value, or existing market forms. For example, "peanut butter fish" would likely be deceptive because the fish in question does not have attributes, such as flavor, reminiscent of peanut butter.

3. Names may be close to pre-existing common usage so long as they are adequately identifying or distinguishing, i.e., so that a consumer is not likely to confuse it with another fish. For example, the name "Flat Whiskered Fish" would likely be an acceptable replacement name for the fish currently listed in the "Seafood List" as "Flat Whiskered Catfish." However, "Sea Fish" or "Mekong Fish" would not likely be adequate replacements for "Sea Catfish" or "Mekong Catfish" because there are many fish in the sea and in the Mekong, and these names would not adequately identify or distinguish these fish to consumers. (In the case of Mekong Catfish, these fish have also been known as Pangasius Catfish; so a likely adequate replacement name could be Pangasius Fish). Additionally, coined names should avoid unusual spelling (e.g., Katfish) or splitting of syllables (e.g., Cat Fish) such that the name bears too close a resemblance to the name of another food.

Although pre-review or rulemaking by FDA is not required for the use of names, FDA is available, as always, to consult on whether a name might be false or misleading or otherwise violative. Individuals who wish to consult with FDA on whether a proposed name might or might not misbrand a fish in accordance with the statute and regulations may do so by contacting:

Ms. Spring Randolph
Consumer Safety Officer
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
HFS-417, Room 3D-037
5100 Paint Branch Parkway
College Park, MD 20740-3835

Telephone: 301-436-1421

Fax: 301-436-2599
Email: srandolp@cfsan.fda.gov

FDA will continue to add to the internet version of The Seafood List acceptable market names for fish that are subject to Section 403(t). The materials in the chart in this letter have already been incorporated. Consequently, it is unlikely that further letters of this type will be needed.