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HHS/FDA RIN: 0910-AF12 Publication ID: Spring 2005 
Title: Cochineal Extract and Carmine Label Declaration 
Abstract: The purpose of this proposed rule is to protect consumers who have allergies to the color additives carmine and cochineal extract by requiring label declaration on products under FDA jurisdiction. This action responds to adverse event reports received by FDA and to a citizen petition submitted to FDA. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 73.100(d)    21 CFR 73.1100(c)    21 CFR 73.2087(c)    21 CFR 101.22(k)    21 CFR 201.100(b)    21 CFR 201.324   
Legal Authority: 21 USC 379e(b)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Mical E. Honigfort
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-265, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1278
Fax:301 436-2972
Email: mical.honigfort@fda.hhs.gov