Food Labeling: Gluten-Free Labeling of Foods; Reopening of Comment Period

Document ID: FDA-2005-N-0404-0135
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-19620
CFR Citation: 21 CFR Part 101
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Details Information

Abstract: 0910-ZA26
Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: August 02 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 46671 - 46677
Page Count: 7
Comment Start Date: August 3 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: October 3 2011, at 11:59 PM Eastern Standard Time

Attachments:

List of References Cited in the FR Notice of 8/3/11 on Food Labeling;Gluten-Free Labeling of Foods; Reopening of the Comment Period

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Reference 1 - The Threshold Working Group, “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food,” Revised Report

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Reference 10 - U.S. Department of Agriculture, Agricultural Research Service, Beltsville Human Nutrition Research Center, Food Surveys Research Group (Beltsville, MD), “Continuing Survey of Food Intakes by Individuals 1994-96, 1998 and Diet and Health Knowledge Survey 1994-96: Documentation”

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Reference 11 - Codex Alimentarius Web site, “Welcome” Web page

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Reference 12 - Codex Alimentarius Web site, “Membership of the Commission” Web page,

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Reference 13 - The Commission of the European Communities, “Commission Regulation (EC) No 41/209”

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Reference 14 - Europa: Gateway to the European Union Web site, “Countries” Web page

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Reference 15 - Collin, P., L. Thorell, K. Kaukinen, et al., “The Safe Threshold for Gluten Contamination in Gluten-Free Products. Can Trace Amounts Be Accepted in the Treatment of Coeliac Disease?”

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Reference 16 - Kaukinen, K., P. Collin, K. Holm, et al., “Wheat Starch-Containing Gluten-Free Flour Products in the Treatment of Coeliac Disease and Dermatitis Herpetiformis: A Long-Term Follow-up Study”

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Reference 17 - Peräaho, M., K. Kaukinen, K. Paasikivi, et al., “Wheat-Starch-Based Gluten-Free Products in the Treatment of Newly Detected Coeliac Disease: Prospective and Randomized Study”

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Reference 18 - Hischenhuber, C., R. Crevel, B. Jarry, et al., “Review Article: Safe Amounts of Gluten for Patients With Wheat Allergy or Coeliac Disease”

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Reference 19 - Gibert, A., M. Espadaler, M. Canela, et al., “Consumption of Gluten-Free Products: Should the Threshold Value for Trace Amounts of Gluten Be at 20, 100 or 200 p.p.m.?”

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Reference 2 - Méndez, E., V. Carmen, U. Immer, et al., “Report of a Collaborative Trial to Investigate the Performance of the R5 Enzyme Linked Immunoassay to Determine Gliadin in Gluten-Free Food”

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Reference 20 - Akobeng, A. and A. Thomas, “Systematic Review: Tolerable Amount of Gluten for People With Celiac Disease” June 2008

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Reference 3 - R-Biopharm Gliadin AG Web site, “Ridascreen® Gliadin” (Product Code R7001) accessed July 1, 2011

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Reference 4 - Codex Alimentarius Commission, “Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (Codex Stan 118-1979)”

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Reference 5 - AOAC Research Institute, “Certificate of Performance TestedSM Status, Certificate No. 120601,” AOAC INTERNATIONAL, Gaithersburg, MD, 2010

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Reference 6 - Matsuda, R., Y. Yoshioka, H. Akiyama, et al., “Interlaboratory Evaluation of Two Enzyme-Linked Immunosorbent Assay Kits for the Detection of Egg, Milk, Wheat, Buckwheat, and Peanut in Foods”

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Reference 7a - Morinaga Institute of Biological Science, Inc.“Product: Food Allergen Kits: Food Allergen ELISA Kits”

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Reference 7b - Morinaga Institute of Biological Science, Inc., "Wheat Protein Elisa Kit (Gliadin)"

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Reference 8 - Garber, E, Memorandum, “ELISA Methods Used to Detect Gluten in Foods,” Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, July 15, 2011

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RefereNce 9 - Office of Food Safety, “Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten," Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, May 2011

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Comments

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Total: 412
EMILY MATTHEWS - Comment
Posted: 08/25/2011     ID: FDA-2005-N-0404-0141

Oct 03,2011 11:59 PM ET
Jeff Hastings SanGeorge - Comment
Posted: 08/25/2011     ID: FDA-2005-N-0404-0142

Oct 03,2011 11:59 PM ET
Irene Margaret Conwell - Comment
Posted: 08/25/2011     ID: FDA-2005-N-0404-0143

Oct 03,2011 11:59 PM ET
Brenda A Fisher - Comment
Posted: 08/25/2011     ID: FDA-2005-N-0404-0145

Oct 03,2011 11:59 PM ET
Jillian Marie Kupfer - Comment
Posted: 08/25/2011     ID: FDA-2005-N-0404-0147

Oct 03,2011 11:59 PM ET

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