FDA Proposes Rules on Cigarette Warnings Labels

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,” which modifies the current cigarette package warning labels and also requires color graphic warnings to accompany the new text warnings, the National Association of Tobacco Outlets (NATO) reported.

The FDA is accepting comments on the proposed rule until Jan. 11, 2011, and then must issue a final rule by June 22, 2011.

The FDA law requires that cigarette packages contain nine new text warnings on a rotating basis in either black text on a white background or white text on a black background.

The wording 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.

Other Important Elements of the Proposed Rule:

  • 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. This regulation will take affect 15 months after the FDA issues the final rule referred to above and no later than Sept. 22, 2012.
  • A total of 36 proposed graphic health warnings are included in the proposed rule and by June 22, 2011 the FDA will select nine of the 36 graphic health warnings to accompany the new text warnings.
  • Cigarette cartons would also be required to have the new text and color graphic warnings on the left 50% of the front and rear panels of cigarette cartons.

Note: The FDA law as passed by Congress only requires the text and color graphic warnings on individual cigarette packages, not cigarette cartons. However, beginning on Page 128 of the proposed rule, 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.”

  • No later than Oct. 22, 2012, manufacturers would no longer be allowed to distribute for sale in the U.S. any cigarettes that do not display the new graphic health warnings.
  • 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% of the advertisement and be located at the top of each advertisement.


Source: NATO (National Association of Tobacco Outlets)



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