Document ID: FDA-2010-N-0568-0006
Agency: fda
Document Type: Notice
Title: Required Warnings for Cigarette Packages and Advertisements; Research Report
Posted Date: 2010-12-07T05:00Z

[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Proposed Rules]
[Pages 75936-75937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30685]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2010-N-0568]
RIN 0910-AG41

Required Warnings for Cigarette Packages and Advertisements; 
Research Report

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has added a document to the docket for the proposed rulemaking 
concerning required textual warnings and accompanying graphics to be 
displayed on cigarette packages and in cigarette advertisements. The 
document is a report entitled ``Report: Experimental Study of Graphic 
Cigarette Warning Labels'' (Experimental Study Report) and it describes 
the results from a research study that quantitatively evaluated the 
relative impact of certain color graphics on consumer attitudes, 
beliefs, perceptions, and intended behaviors related to cigarette 
smoking. The purpose of this notice is to provide the public an 
opportunity to review and comment on the Experimental Study Report.

DATES: Interested persons may submit either electronic or written 
comments by January 11, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0568, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN). All comments 
received may be posted without change to http://www.regulations.gov, 
including any personal information provided. For additional information 
on submitting comments, see the ``Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie Voss or Kristin Davis, Center 
for Tobacco Products, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850-3229, 877-287-1373, gerie.voss@fda.hhs.gov 
or kristin.davis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) was enacted on June 22, 2009, amending the Federal Food, 
Drug, and Cosmetic Act and the Federal Cigarette Labeling and 
Advertising Act (FCLAA), and providing FDA with the authority to 
regulate tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 201 
of the Tobacco Control Act modifies section 4

[[Page 75937]]

of FCLAA (15 U.S.C. 1333) to require that nine new health warning 
statements appear on cigarette packages and in cigarette 
advertisements. Section 201 also states that ``the Secretary [of Health 
and Human Services] shall issue regulations that require color graphics 
depicting the negative health consequences of smoking'' to accompany 
the nine new health warning statements.
    On November 12, 2010, FDA published a proposed rule seeking comment 
on these new requirements (75 FR 69524). The proposed rule provides a 
60-day comment period, which ends January 11, 2011. FDA proposed 
several options for color graphics that could accompany each of the 
nine health warning statements required by FCLAA. These documents are 
available in the docket and on FDA's Web site (http://www.fda.gov/cigarettewarnings). FDA seeks comment on these proposed images.

II. Experimental Study

    In considering and developing appropriate color graphics depicting 
the negative health consequences of smoking to accompany the textual 
warning statements specified in section 4(a)(1) of FCLAA (15 U.S.C. 
1333(a)(1)), FDA assessed the graphic warnings that other countries 
have required for tobacco products, as well as scientific literature 
studying the impact of graphic warnings on smoking behavior and 
evaluating the communication effectiveness of such images. FDA worked 
with various experts in the fields of health communications, marketing 
research, graphic design, and advertising to develop the required 
warnings published with the proposed rule. The proposed rule explained 
that FDA was conducting research to: (1) Measure consumer attitudes, 
beliefs, and intended behaviors related to cigarette smoking in 
response to the proposed color graphics and their accompanying textual 
warning statements; (2) determine whether consumer responses to the 
proposed color graphics and their accompanying textual warning 
statements differ across various groups based on smoking status, age, 
or other demographic variables; and (3) evaluate the relative 
effectiveness of the proposed color graphics and their accompanying 
textual warning statements at conveying information about various 
health risks of smoking, and additionally, at encouraging smoking 
cessation and discouraging smoking initiation (75 FR 7604 (February 22, 
2010); 75 FR 52352 (August 25, 2010)). The proposed rule stated that 
once the research is complete and final analyses of the results are 
available, FDA planned to place a report of the results of the analyses 
in the docket so the public has an opportunity to comment on it.
    FDA has now completed this research and analyzed the results. The 
Experimental Study Report describes FDA's findings and analysis. FDA 
has placed the Experimental Study Report in the docket for the proposed 
rule and is providing notice and an opportunity to comment on it.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
Experimental Study Report and the related rulemaking documents. It is 
only necessary to send one copy of comments. It is no longer necessary 
to send two copies of mailed comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 2, 2010.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2010-30685 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P