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HHS/FDA RIN: 0910-AH00 Publication ID: Spring 2018 
Title: Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 

This final rule would establish requirements concerning ‘‘gluten-free’’ labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ‘‘gluten-free’’ labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ‘‘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  12/00/2018 
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