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

This proposed rule would establish requirements concerning compliance for using a "gluten-free" labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation:  
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 
Timetable:
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, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-2371
Fax:301 436-2636
Email: carol.dlima@fda.hhs.gov