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IMPORTANT LINKS PERTAINING TO FDA'S GLUTEN-FREE RULEMAKING

By Mary Lawson,2014-07-08 09:16
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2 AUG 2011 – FEDERAL REGISTER NOTICE REOPENING OF THE COMMENT PERIOD ON FDA'S PROPOSED RULE ON THE GLUTEN-FREE LABELING OF FOODS, AUGUST 3, 2011 ...

    Important Links Pertaining to FDA’s Gluten-Free Rulemaking

    ; Federal Register Notice Reopening of the Comment Period on FDA’s Proposed Rule on the

    Gluten-Free Labeling of Foods, August 3, 2011 http://www.gpo.gov/fdsys/pkg/FR-2011-08-

    03/pdf/2011-19620.pdf

    o Questions and Answers Regarding Gluten-Free Labeling of Foods, August 2, 2011

    http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformat

    ion/Topic-SpecificLabelingInformation/ucm265309.htm

    o Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease:

    Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten,

    May 2011

    http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessm

    entSafetyAssessment/UCM264152.pdf

    o External Peer Review of the FDA/CFSAN Draft Health Hazard Assessment for

    Gluten in Individuals with Celiac Disease: Determination of Tolerable Daily Intake

    Levels and Levels of Concern for Gluten, December 2010

    http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessm

    entSafetyAssessment/UCM264150.pdf

    o FDA Consumer Update: A Glimpse at Gluten-free Food Labeling, August 2, 2011

    http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm

    o FDA News Release, August 2, 2011: FDA Reopens Comment Period on Proposed

    “Gluten-Free” Food Labeling Rule

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265838.htm

    ; Proposed Rule on Gluten Free Labeling of Foods, January 23, 2007

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm

    o Questions and Answers on the Gluten-Free Food Labeling Proposed Rule, January

    23, 2007

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplia

    nceRegulatoryInformation/ucm111487.htm

    ; Federal Register Notice on FDA’s Public Meeting on the Gluten-Free Labeling of Foods and

    Request for Comments, July 19, 2005

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm076941.htm

    o Transcript of FDA’s Public Meeting on Gluten-Free Food Labeling held on August 19,

    2005

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplia

    nceRegulatoryInformation/ucm107204.htm

    o Errata Sheet for Transcript of FDA’s Public Meeting

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplia

    nceRegulatoryInformation/ucm107988.htm

    ; FDA Report Entitled Approaches to Establish Thresholds for Major Food Allergens and for

    Gluten in Food, Revised March 2006

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceReg

    ulatoryInformation/ucm106108.htm

    o FDA's Responses to Public Comments on its Draft Report Approaches to Establish

    Thresholds for Major Food Allergens and for Gluten in Food, Revised March 2006

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplia

    nceRegulatoryInformation/ucm106042.htm

    o Federal Register Notice of Availability on FDA’s Draft Report on Approaches to

    Establish Thresholds for Major Food Allergens and for Gluten in Food and Request

    for Comments/Scientific Data and Information, June 17, 2005

    http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplia

    nceRegulatoryInformation/ucm076934.htm

    The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket will officially open for

    comments will remain open for 60 days after the publishing date of the Federal Register notice

    from August 3, 2011 through October 3, 2011.

To submit your comments electronically to the docket go to www.regulations.gov and:

    (1) Choose “Submit a Comment” from the top task bar.

    (2) Enter the docket number FDA-2005-N-0404 in the “Keyword” space.

    (3) Select “Search.”

    (4) Scroll down to see the “View by Relevance” tab and find the gluten-free proposed

    rulemaking ID number FDA-2005-N- 0404-0135, and then click on the corresponding

    “Submit a Comment” link.

    (5) Enter your comments along with the requested identifying information in the provided

    fields.

To submit your comments to the docket by mail, use the following address:

    The Division of Dockets Management

    HFA-305

    Food and Drug Administration

    5630 Fishers Lane, Room 1061

    Rockville, MD 20852

    Be sure to Include docket number FDA-2005-N-0404 on each page of your written

    comments.

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