Required Warnings for Cigarette Packages & Advertisements

 
Docket ID: FDA-2010-N-0568
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Section 4 of the FCLAA, as amended by section 201 of the Tobacco Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements on cigarette packages and advertisements. FDA also may adjust the type size, text and format of the required label statements on product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area.
RIN: 0910-AG41
Impacts and Effects: International
CFR Citation: 21 CFR 1141
Priority: Economically Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2011
Agenda Stage of Rulemaking: Completed Action
Major Rule: Yes
Legal Authorities: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 201
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: Private Sector
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: Yes
Energy Effects: No
Included in Regulatory Plan: No
Legal Deadline
ActionSourceDescriptionDate
StatutoryOther06/22/2011
Timetable
ActionDateFR Citation
NPRM11/12/201075 FR 69524
NPRM Comment Period End01/11/2011
Final Action06/22/201176 FR 36628
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Required Warnings for Cigarette Packages & Advertisements
Keyword(s): ctp201018, ctp, cigarette packages
Type: Rulemaking
Docket Status: OPEN
Center: CTP
Docket Item Code: N
 

Primary Documents

View All  (9)
Comment Period Closed
Jan 11, 2011 11:59 PM ET
Notice
Posted: 12/07/2010
ID: FDA-2010-N-0568-0006
Comment Period Closed
Jan 11, 2011 11:59 PM ET
Proposed Rule
Posted: 11/12/2010
ID: FDA-2010-N-0568-0001
Comment Period Closed
Notice
Posted: 10/25/2011
ID: FDA-2010-N-0568-0750
Comment Period Closed
Other
Posted: 09/13/2011
ID: FDA-2010-N-0568-0748
Comment Period Closed
Other
Posted: 09/13/2011
ID: FDA-2010-N-0568-0749

Supporting Documents

View All  (89)
Comments Not Accepted
Supporting & Related Material
Posted: 08/18/2011
ID: FDA-2010-N-0568-0690
Comments Not Accepted
Supporting & Related Material
Posted: 08/18/2011
ID: FDA-2010-N-0568-0738
Comments Not Accepted
Supporting & Related Material
Posted: 08/18/2011
ID: FDA-2010-N-0568-0697

Comments

View All  (657)

1,755
Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Completed
Current Stage
Agency Contact
Gerie Voss
Regulatory Counsel
FDA/HHS
gerie.voss@fda.hhs.gov
877 287-1373
240 276-4193 (Fax)
9200 Corporate Boulevard
Rockville, MD 20850
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.