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