Allergen Nutrition/Food Content Labeling

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ID Author(s) Title / Description Publication Date
7632 Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN) Guidance for Industry: A Food Labeling Guide
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm
Format: HTML
Questions and answers regarding food labeling, which are grouped by the food labeling area of interest. Appendices include "Definitions of Nutrient Claims", "Additional Requirements for Nutrient Content Claims", "Health Claims", "Qualified Health Claims", "Additional FDA Resources", "Calculate the Percent Daily Value (DV) for the Appropriate Nutrients", and more.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20080400Apr 2008
7633 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: Frequently Asked Questions about Medical Foods
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/ucm054048.htm
Format: HTML
Questions and answers regarding the definition of and regulations for medical foods.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20070500May 2007
7352 Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) Food Labeling--Gluten-Free Labeling of Foods
URL: http://www.uspto.gov/web/offices/com/sol/notices/72fr2770.pdf
Format: HTML
Proposed rule in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) regarding establishing a definition of the term 'gluten-free' and uniform conditions for its use in the labeling of foods, in order to provide truthful and accurate information with respect to foods so labeled to the individuals with celiac disease.
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Source: Federal Register, Vol. 72, No. 14, Jan. 23, 2007, p. 2795-2817./GPO Access, U.S. Government Printing Office

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20070123Jan 23, 2007
7119 Landa, M.M. Qualified Health Claims: Letter of Denial - 100 percent Partially Hydrolyzed Whey Protein in Infant Formula and Reduced Risk of Food Allergy in Infants
URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073313.htm
Format: HTML
Letter regarding a qualified health claim for 100 percent partially hydrolyzed whey protein in infant formula and reducing the risk of food allergy in infants. Includes discussion of the scientific evaluation regarding this claim.
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Source: Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20060511May 11, 2006
7077 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 3): Final Guidance
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm
Format: HTML
Questions and answers on allergen labeling requirements in the U.S.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20060406Apr 6, 2006
7121 Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059065.htm
Format: HTML
Guidance regarding the labeling requirements for use of lecithin derived from soy.
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Source: Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20060400Apr 2006
6795 Food and Drug Administration (FDA) Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2006_register&docid=fr30ja06-16
Format: Text
Proposed rule to require food and cosmetic product labels to list the color additives cochineal extract and carmine to assist consumers with allergies to these additives. Includes discussion of regulatory options, costs, and benefits.
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Source: Federal Register, Vol. 71, No. 19, Jan. 30, 2006, p. 4839-4851./GPO Access, U.S. Government Printing Office

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20060130Jan 30, 2006
6652 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2): Final Guidance
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm
Format: HTML
Questions and answers on allergen labeling requirements in the U.S. A more recent edition of this document is available.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20051214Dec 14, 2005
6605 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Advice to Consumers: Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers
URL: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/ucm106890.htm
Format: HTML
Questions and answers on the Food Allergen Labeling and Consumer Protection Act of 2004, including questions on changes to food labels, gluten, and advice for consumers with food allergy.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20051212Dec 12, 2005
6519 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004: Final Guidance
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm
Format: HTML
Questions and answers on allergen labeling requirements in the U.S. A more recent edition of this document is available.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20051005Oct 5, 2005
6464 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282)
URL: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm
Format: HTML
U.S. law regarding food allergen labeling and other related issues.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20040802Aug 2, 2004
3212 European Commission Food Without Fear: New Food Labelling Rules Will Improve Consumer Information on Food Ingredients, in particular Allergens
URL: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/03/1310&format=HTML&aged=0&language=EN&guiLanguage=en
Format: HTML
Release regarding an amendment to the EU food labeling Directive that will affect the listing of ingredients, especially allergens, in foodstuffs. It includes as an annex a "List of potential allergenic ingredients to be labelled".
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Source: European Commission

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20030929Sep 29, 2003
4326 Office of Regulatory Affairs, Food and Drug Administration (FDA) Compliance Policy Guide: Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens
URL: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074526.htm
Format: HTML
Guidance for FDA staff that includes review of policy on the labeling of allergens in foods and on practices to prevent allergen cross-contact.
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Source: Compliance Policy Guides Manual, Aug. 2000, Office of Regulatory Affairs, Food and Drug Administration

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20010419Apr 19, 2001
4331 Canadian Food Inspection Agency (CFIA) A Tool for Managing Allergen Risk in Food Products
URL: http://www.inspection.gc.ca/english/fssa/invenq/inform/toualle.shtml
Format: HTML
Suggested "Allergen Check List for Food Suppliers and Manufacturers" to help food companies obtain information needed for the labeling of food allergens.
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Source: Canadian Food Inspection Agency

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20010126Jan 26, 2001
5196 Smith, N. Seeds of Opportunity: an Assessment of the Benefits, Safety, and Oversight of Plant Genomics and Agricultural Biotechnology
URL: http://www.house.gov/science/smithreport_041300.pdf
Format: PDF
Informational report that summarizes findings from three hearings of the Subcommittee on Basic Research held during the First Session of the 106th Congress. Includes discussion of the oversight of agricultural biotechnology, benefits and risks, regulation, and more. Appendices include "List of Findings and Recommendations" and more.
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Source: House Committee on Science, U.S. House of Representatives

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20000413Apr 13, 2000