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HHS/FDA RIN: 0910-AG84 Publication ID: Fall 2011 
Title: ●Food Labeling; Gluten-Free Labeling of Foods 
Abstract: Title II of Public Law 108-282 (sec. 206) directed the HHS Secretary to issue a proposed rule by 08/04/2006, and a final rule by 08/04/2008, to define and permit use of the term "gluten-free" in the labeling of foods. The purpose of this rulemaking is to assist persons who have celiac disease to more easily identify foods that they can eat following a "gluten-free" diet. Celiac disease is a genetically inherited chronic inflammatory disorder of the small intestine triggered by ingesting certain storage proteins, commonly referred to as "gluten," that naturally occur in wheat, rye, barely, and crossbred hybrids of these grains (e.g., triticale). Eating foods containing gluten can cause damage to the lining of the small intestine. With continual exposure to gluten, the damage to the small intestine can result in the malabsorption of nutrients, resulting in nutritional deficiencies. Persons with celiac disease are also at higher risk of developing other serious disease health problems and diseases (e.g., growth retardation, short stature, infertility, and intestinal cancers). About 1 percent of the U.S. population is estimated to have celiac disease. FDA issued a proposed rule on gluten-free food labeling on 01/23/07 (72 FR 2795), that proposed to define the "gluten-free," for voluntary use in the labeling of foods, to mean that the food does not contain: (1) An ingredient that is a species of certain prohibited grains; (2) an ingredient derived from those prohibited grains and that has not been processed to remove gluten; (3) an ingredient derived from those prohibited grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or (4) 20 ppm or more gluten. The term "prohibited grains" refers to wheat, rye, barley, and crossbred hybrids of these grains (e.g., triticale, which is a cross between wheat and rye). FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term "gluten-free" in the final rule. On 08/03/11 (76 FR 46671), FDA reopened the comment period on the proposed rule to announce the availability of and seek comments on the completed, expert-reviewed safety assessment. FDA is also seeking comments on whether and, if so, how the safety assessment should affect FDA's definition of "gluten-free" in the final rule, as well as on other related issues. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 101.91   
Legal Authority: title II of PL 108-282    21 USC 321    21 USC 331    21 USC 342    21 USC 343    21 USC 348    21 USC 371   
Legal Deadline:
Action Source Description Date
NPRM  Statutory  Publication of NPRM 01/23/2007   08/04/2006 
Action Date FR Cite
NPRM  01/23/2007  72 FR 2795   
NPRM Comment Period End  04/23/2007    
NPRM Comment Period Reopened  08/03/2011  76 FR 46671   
NPRM Reopened Comment Period End  10/03/2011    
Final Action  11/00/2012    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: 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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