Food Allergen Update

At the end of 2006, FDA issued Edition 4 of its Food Allergen Guidance for Industry.

By Leslie Krasny

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Although FDA's guidance documents are recommendations rather than legally enforceable requirements, the positions represent FDA's current thinking on a topic. The revisions address four issues:

  • Tree Nuts

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) lists "tree nuts" as a major food allergen category. However, the statute only lists three examples of tree nuts: almonds, pecans and walnuts. The latest edition of the Food Allergen Guidance includes a comprehensive list of tree nuts for purposes of allergen labeling requirements.

FDA acknowledges that the new list is based on broad scientific categories that may include species with no current food use. FDA is defining the term tree nuts as the following: almond; beech nut; brazil nut; butternut; cashew; chestnut (Chinese, American, European, sequin); chinquapin; coconut; filbert/hazelnut; ginko nut; hickory nut; lichee nut; macadamia nut/bush nut; pecan; pine nut/piñon nut; pili nut; pistachio; shea nut; walnut (English, Persian, Black, Japanese, California) heartnut and butternut.

There are concerns in the industry that the list includes nuts that should not be considered major food allergens due to relatively low or no established allergenicity, such as with coconuts. FDA took the action based on inquiries regarding whether particular foods would be considered tree nuts.

Because FALCPA lists tree nuts in general as a major food allergen category, FDA interprets the statute as requiring all tree nuts to be covered, without reference to evidence of allergenicity. But FDA has stated that if it can be shown a listed tree nut is not botanically similar to recognized tree nuts, FDA may consider taking it off the list.

The petition and notification procedures under FALCPA may be used to seek exemptions from allergen labeling. At press time, no comments have been submitted to FDA regarding the list of tree nuts.

What method may be used for companies planning to change existing packaging that is inconsistent with the recent guidance? FDA's suggests using "contains" stickers below or adjacent to the ingredient declaration to declare any tree nuts that were not listed in the ingredient declaration or any "contains" statement. Although this might result in a duplicate "contains" statement, FDA would not object, at least for a reasonable period of time.

  • Seafood

FDA also clarifies what is meant by the "species" of fish or crustacean shellfish. The acceptable market name provided in the FDA Seafood List should be used in allergen labeling. The FDA Seafood List is a compilation of existing acceptable market names for imported and domestically available seafood. The list was developed by the FDA, in cooperation with the National Marine Fisheries Service (NMFS). The market names in the list have been determined by common usage in the U.S. When more than one name is in use for a species, the acceptable market name has been decided by FDA and NMFS, based on authoritative references.

  • Wheat

FDA states that "wheat" includes any species in the genus Triticum. Therefore, the term "wheat" covers grains including common wheat, durum wheat, club wheat, spelt, semolina, einkorn, emmer, kamut and triticale.

  • Single Ingredient Foods

FDA confirms that single-ingredient foods, which are not required to bear an ingredient declaration, must still include allergen labeling. A single-ingredient food that contains allergenic protein may identify the food source in the name of the food (e.g., "all-purpose wheat flour") or use the "contains" statement (e.g., "contains wheat"). FDA recommends that, if a "contains" statement is used, the statement should be placed immediately above the signature line. However, when the "contains" statement is used on products intended for further manufacturing, the statement should be placed on the principal display panel.


Leslie T. Krasny is a partner at the law firm of Keller and Heckman LLP, San Francisco office specializing in food and drug law with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology and advertising. She is a member of the California Bar and holds a master's degree in cell and molecular biology.
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