FDA Seeking Public Comments On Proposed Cigarette Product Warning Labels
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires that cigarette packages and advertisements have larger and more visible graphic health warnings.
FDA issued a proposed rule, Required Warnings for Cigarette Packages and Advertisements, proposing to modify the required warnings that appear on cigarette packages and in cigarette advertisements. These new required warnings would consist of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking.
Timeline for Final Regulations
The Tobacco Control Act requires FDA to issue final regulations requiring these color graphics by June 22, 2011. It also specifies that the requirement for the new health warnings on cigarette packages and advertisements will take effect 15 months after issuance of this final rule.
Proposed Graphic Health Warnings for Cigarette Packages and Advertisements
WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your health.
High Resolution Image Formats
- PDF format (PDF 13 MB) The PDF contains a composite of all of the proposed images. If you do not already have Adobe Acrobat, you can download Acrobat Reader for free.
- JPEG format (6 MB) The zipped folder contains all of the compressed images. If you do not already have WinZip, you can download WinZip a file compression program.
Placement Location on Cigarette Packages
The Tobacco Control Act requires that the nine graphic health warnings appear on the upper portion of the front and rear panels of each cigarette package and comprise at least the top 50 percent of these panels.
Placement Location on Cigarette Advertisement
It also requires that they appear in each cigarette advertisement, and occupy at least 20 percent of the advertisement. For advertisements with a surface area less than 12 square inches, the proposed rule provides a subset of proposed color graphics to accompany the nine textual warning statements.
FDA is seeking public comment on the proposed rule from Friday, November 12, 2010 through Tuesday, January 11, 2011. To submit an official comment during this time period:
- Go to www.regulations.gov and insert docket number FDA-2010-N-0568 into the “search” box and follow the prompts.
- Send a fax, with your comments, to 301-827-6870
- Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
All comments should be identified by Docket ID No. FDA-2010-N-0568. It is only necessary to send one set of comments.
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