On November 10, 2010, the FDA’s Center for Tobacco Products issued the 140-page “Required Warnings for Cigarette Packages and Advertisement: Proposed Rule”. It modifies the current package warning labels and requires color graphic warnings to accompany the new text warnings. The FDA began accepting comments on the proposed rule, beginning November 12 until January 11, 2011.

The FDA must issue a final rule by June 22, 2011.

Proposed Text Warning Statements:
The proposed FDA rule requires cigarette packages to include nine new text warnings on a rotating basis, in either black text on white, or the reverse. The new warnings state:

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 Key Elements of the Proposed Rule:
Color images would accompany the warnings on the top half of the front and back panels of every cigarette package, clearly visible through its clear wrapping. This regulation will take affect 15 months after the FDA issues the final rule referred to above and no later than September 22, 2012.

36 proposed graphic health warnings are included in the proposed rule. By June 22, 2011 the FDA will select 9 of them to accompany the new text warnings.

The proposed rule would require cigarette cartons to include the text and color graphic images on the left-hand 50% of the front and rear panels of each carton.

Note: The FDA law as passed by Congress only requires text and color graphic warnings on individual cigarette packages, not cigarette cartons. Beginning on p128 of the proposed rule, the FDA would 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 October 22, 2012, manufacturers would no longer be allowed to distribute any cigarettes for sale in the United States that lack the new graphic health warnings.

Any form of cigarette advertisement in newspapers, magazines, on billboards and 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.
(NATO E-News, 11/11)

For more info on the Proposed Amendment and procedures for filing Comments, click on: http://www.tobaccooutletbusinessnline.com/blogs/fda-solicits-public-comments-on-proposed-color-graphic-warnings-for-cigarette-packs---.html