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HHS/FDA RIN: 0910-AF07 Publication ID: Spring 2005 
Title: Food Labeling: Food Allergen Ingredient Labeling 
Abstract: FDA initially intended to issue a proposed rule to establish requirements for labeling foods that contain common food allergens. The purpose of this rulemaking was to reduce mortality and morbidity by making it easier for persons who have a food allergy to identify when packaged foods contain certain allergenic ingredients. Subsequently, on August 2, 2004, the President signed into law the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP Act) (Pub. L. 108-282), which amended sections 201 and 403 of the Federal, Food, Drug and Cosmetic Act (FFD&C Act). FDA is now in the process of determining the approach it intends to take in light of the new statutory requirements. The FALCP Act amended section 201 of the FFD&C Act to define a major food allergen as: 1) milk, egg, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, pecans, walnuts), wheat, peanuts, and soybeans and 2) any ingredient that contains a protein derived from these foods. Excluded from this definition are: 1) highly refined oils derived from the food source of a major food allergen and ingredients derived from such oils and 2) a food ingredient that is exempt under the petition or notification process specified in the law. The FALCP Act also amended section 403 of the FFD&C Act to require that the labels of packaged foods use plain English terms to identify the food source of each of the major food allergens it contains as an ingredient. This requirement is applicable to all ingredients, including flavors, non-certified colors, and incidental additives. The law provides a choice between two methods for declaring the food sources of any major food allergens contained in the ingredients of packaged foods: either within the ingredient list or in a separate summary statement immediately following or adjacent to the ingredient list. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 101   
Legal Authority: 21 USC 321    21 USC 331    21 USC 343    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
Withdrawn  02/16/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Rhonda Rhoda Kane
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Room 4D008, HFS-820,
College Park, MD 20740
Phone:240 402-1803
Fax:301 436-2636

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