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HHS/FDA RIN: 0910-AH00 Publication ID: Fall 2017 
Title: Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 


FDA was required by statute to establish criteria for the voluntary labeling of food as "gluten-free” to assist consumers with celiac disease who must avoid gluten in their diet.  In 2013, FDA issued a final rule on gluten-free” labeling that established criteria for when food may be labeled "gluten-free.” The final rule included methods that FDA would use for testing for the presence of gluten, which are appropriate for many food types, but not for fermented and hydrolyzed foods.   FDA then issued a proposed rule entitled "Gluten-Free Labeling of Fermented or Hydrolyzed Foods” to propose requirements for maintenance of certain records that provide alternative means for the agency to verify that manufacturers of fermented and hydrolyzed foods have complied with the federal criteria for foods voluntarily labeled "gluten-free.” 

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 101.91(c)   
Legal Authority: sec. 206 of the Food Allergen Labeling and Consumer Protection Act    21 U.S.C. 343(a)(1)    21 U.S.C. 321(n)    21 U.S.C. 371(a)   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    08/04/2006 
Final  Statutory    08/04/2008 
Action Date FR Cite
NPRM  11/18/2015  80 FR 71990   
NPRM Comment Period Reopened  01/22/2016  81 FR 3751   
NPRM Comment Period End  02/16/2016 
NPRM Comment Period Reopened   02/22/2016  81 FR 8869   
NPRM Comment Period Reopened End  04/25/2016 
Final Rule  10/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Carol D'Lima
Staff Fellow
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, Room 4D022, HFS 820, 5001 Campus Drive,
College Park, MD 20740
Phone:240 402-2371
Fax:301 436-2636