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HHS/FDA RIN: 0910-AH00 Publication ID: Spring 2016 
Title: Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 

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 
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  02/16/2016  81 FR 3751   
Comment Period Extended  02/22/2016  81 FR 8869   
Final Action  04/00/2017 
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