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Issue link: https://read.dmtmag.com/i/25410
NATONEWS FDA Health Warning Regulations Nine new text health warnings to appear O Thomas Briant is execu- tive director of the National Association of Tobacco Outlets. NATO’s toll-free number is (866) 869-8888 and the association’s Web site address is www.natocentral.org. In the proposed rule issued in November, the N NOV. 10, 2010, THE FDA’S CENTER FOR Tobacco Products issued a 140 page docu- ment titled “Required Warnings for Cigarette Packages and Advertisement Proposed Rule.”Under the recently enacted FDA tobacco reg- ulatory law, there are two new kinds of warnings for cigarette packages. The proposed rule outlines the changes in the current ciga- rette 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 warn- ings 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 warn- ing labels will need to be accompanied by a pictori- al health warning that shows the health conse- quences 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 under- neath the cellophane or other clear wrapping. 10 JANUARY/FEBRUARY 2011 FDA included examples of thirty-six different pro- posed graphic health warning pictures and the agency intends to select nine of the thirty-six pic- tures 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 regula- tory law by adding provisions including a new definition of “package” to mean “a pack, box, carton, or container of any kind in which ciga- rettes are offered for sale, sold, or otherwise dis- tributed to consumers.” Once finalized, these proposed regulations are scheduled to take effect 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, maga- zines, billboards, posters, point-of-sale displays, direct mailers, Internet web pages, Internet ban- ner 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 advertise- ment will be required to comprise at least 20 per- cent 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. NPN Magazine www.npnweb.com