2010-30685. 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: [phone].
• 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, [e-mail] or [e-mail].

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 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.