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FDA Food Allergen Labeling Part 1

October 30, 2015

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (or Title II of Public Law 108-282) is a law that was enacted in August 2004. Among other issues, FALCPA addresses the labeling of all packaged foods regulated by the FDA. This does not include producers of meat products, poultry products, and egg products, which are regulated by the U.S. Department of Agriculture (USDA).


Major Food Allergen

Under FALCPA, a “major food allergen” is an ingredient that is one of the following eight foods or food groups or an ingredient that contains protein derived from one of them:

  1. Milk
  2. Egg
  3. Fish
  4. Crustacean shellfish
  5. Tree nuts
  6. Wheat
  7. Peanuts
  8. Soybeans

Although more than 160 foods have been identified to cause food allergies in sensitive individuals, the “major food allergens” account for 90 percent of all food allergies. Allergens other than the major food allergens are not subject to FALCPA labeling requirements.

All packaged foods regulated by FDA under the FD&C Act that are labeled on or after January 1, 2006, must comply with FALCPA’s food allergen labeling requirements.

Flavors, Colors, and Incidental additives subject to FALCPA labeling requirements

milkALCPA labeling requirements apply to foods that are made with any ingredient, including flavorings, colorings, or incidental additives (e.g., processing aids), that is or contains a major food allergen.

FALCPA’s labeling requirements extend to foods packaged by a retail or foodservice establishment that are offered for human consumption. However, FALCPA’s labeling requirements do not apply to foods provided by a retail food establishment that are placed in a wrapper or container in response to a consumer’s order – such as the paper or box used to convey a sandwich that has been prepared in response to a consumer’s order.

Foods exempt from FALCPA labeling requirements

Under FALCPA, raw agricultural commodities (generally fresh fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil. In addition, FALCPA provides mechanisms by which a manufacturer may request that a food ingredient may be exempt from FALCPA’s labeling requirements.

Major Food Allergens (food source names and examples)

FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp)

Source FDA

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To be Continued…..


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