On Nov. 10, 2010, the FDA’s Center for Tobacco Products issued a 140 page document titled “Required Warnings for Cigarette Packages and Advertisement Proposed Rule.” Under the recently enacted FDA tobacco regulatory law, there are two new kinds of warnings for cigarette packages. The proposed rule outlines the changes in the current cigarette package text health warnings and also proposes specific color graphic warning pictures to accompany the new text warnings.
Text Warnings: The FDA law requires that nine new text health warnings appear on a rotating basis on cigarette packages and cigarette advertisements in either black text on a white background or white text on a black background. These new text warnings will replace the current Surgeon General’s health warnings that appear on cigarette packages and in cigarette advertisements.
The wording for each of the nine new warnings is as follows:
- WARNING: Cigarettes are addictive
- WARNING: Cigarettes cause cancer
- WARNING: Tobacco smoke can harm your children
- WARNING: Cigarettes cause fatal lung disease
- 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.
Picture Warnings: Each of these new text warning labels will need to be accompanied by a pictorial health warning that shows the health consequences of smoking. These color graphic pictures would accompany the new text warnings on the top half of the front and back panels of every cigarette package and would need to be clearly visible underneath the cellophane or other clear wrapping.
In the proposed rule issued in November, the FDA included examples of thirty-six different proposed graphic health warning pictures and the agency intends to select nine of the thirty-six pictures as the final graphic health warnings by June 22, 2011.
Moreover, the FDA is proposing that cigarette cartons would also be required to have the new text and color graphic warnings on the left 50 percent of the front and rear panels of cigarette cartons. It is important to note that the FDA law as passed by Congress only requires the text and color graphic warnings on individual cigarette packages, not cigarette cartons. However, the FDA is proposing to amend the tobacco regulatory law by adding provisions including a new definition of “package” to mean “a pack, box, carton, or container of any kind in which cigarettes are offered for sale, sold, or otherwise distributed to consumers.”
Once finalized, these proposed regulations are scheduled to take affect fifteen months after the FDA issues the final rule on cigarette package and advertisement warnings, which means the health warnings would go into effect no later than Sept. 22, 2012. Then, manufacturers would only have thirty days after the actual effective date to sell the old style cigarette packages that do not contain the pictorial health warnings.
Cigarette Advertisements: Once the text and picture health warning rule is adopted, any form of cigarette advertisement in newspapers, magazines, billboards, posters, point-of-sale displays, direct mailers, Internet web pages, Internet banner ads, pamphlets, brochures, coupons, catalogs and matchbooks would be required to display the text and graphic health warnings. The text and color graphic warning on a cigarette advertisement will be required to comprise at least 20 percent of the advertisement and be located at the top of each advertisement.
Public comments regarding the proposed health warning rule were accepted by the FDA. NATO drafted and submitted a set of comments to the FDA on the proposed health warning rule. After reviewing all of the publicly submitted comments, the FDA will issue its final rule regarding the health warning statements.
(Thomas Briant, the Executive Director of NATO, can be contacted at 1-866-869-8888 or via e-mail at firstname.lastname@example.org).