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FALCPA Creates Potential Challenges for the Food Industry

Beginning January 1, 2006, FALCPA will require labeling of any ingredient that is one or is derived from: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, or soybeans.

Key points:

  1. Includes product cross-contact and flavorings, colorings, incidental additives, and packaging.

  2. Requires declaration of the specific type of nut (g., almonds, pecans, or walnuts), the species of fish (e.g., bass, flounder, or cod), and the kind of crustacean shellfish (e.g., crab, lobster, or shrimp), respectively.

  3. Only exclusions are highly refined oils and alcoholic beverages.

  4. There are two ways to label products, within statement of ingredients or in separate statement, but must include common or usual name of allergen.

  5. For example – Ingredient listing: MILK – listed with other ingredients CASEIN (MILK) or WHEY (MILK) – adding the food source in parentheses where the technical term is used in ingredient list.

  6. A statement immediately following the ingredient list – ALLERGEN INFORMATION: Contains Milk – immediately following or next to the ingredient list; or CONTAINS MILK – at the end of ingredient list.


  1. Food ingredients may contain little to no protein, but are required to be labeled as an allergen if they are derived from allergenic food.

  2. Scientific evidence must be used to assert that ingredients are free of allergenic proteins and qualify for exemption process review.

  3. Examples of “problem ingredients”: soy lecithin, wheat starch, soy sauce, Worcestershire sauce, starter cultures, lactoferrin, lysozyme, fish gelatin, caramel, butter, butter oil, diacetyl, tocopherol / Vitamin E, xanthan gum, sorbitol, lactitol, maltitol, amino acids, enzymes, vinegars, flavors and natural essences derived from allergenic food such as tree nuts.

  4. The labeling will present a challenge to consumers who have previously eaten food products without an adverse reaction, and now will see many more allergen listings on the package.

  5. Because FALCPA does not contain an exemption for major allergens that may be present in small quantities thought to be inconsequential, consumers will have no way of knowing whether the food formulation has changed; or whether the manufacturer received new information indicating that a major allergen may now be present in the food; or whether the manufacturer is only adding the name of the major allergen.


FDA- The Law

FDA – Guidance for Industry

Consumer Issues: Food Allergy & Anaphylaxis Network

Example of Industry Issues: National Coffee Association

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