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Overall Description of Deadline: Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by section 201 of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act), requires FDA to issue regulations no later than 24 months after the date of enactment of the Tobacco Control Act that require color graphics depicting the negative health consequences of smoking.

Statement of Need: This proposed rule is necessary to amend FDA's regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements and to specify the color graphics that must accompany each textual warning statement.

Summary of the Legal Basis: The proposed rule would implement a provision of the Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the Tobacco Control Act. The Tobacco Control Act amends the FCLAA to require each cigarette package and advertisement to bear one of nine new textual warning statements.

Alternatives: The Agency will compare the proposed rule to two hypothetical alternatives: An otherwise identical rule with a 24-month compliance period and an otherwise identical rule with a 6-month compliance period. Although we will compare the rule to two hypothetical alternatives, they are not viable regulatory options as they are inconsistent with FDA’s statutory mandate.

Anticipated Costs and Benefits: The largest benefits of this proposed rule stem from increased life expectancies for individuals who are induced not to smoke. Other quantifiable benefits come from reductions in cases of non-fatal emphysema, reductions in fire losses, and reductions in medical expenditures. Unquantifiable benefits come from reductions in smokers' non-fatal illnesses other than emphysema, reductions in passive smoking, and reductions in infant and child health effects due to mothers' smoking during pregnancy. Large, one-time costs will arise from the need to change cigarette package labels and remove point-of-sale promotions that do not comply with the new advertising restrictions. Additionally, there will be smaller ongoing FDA enforcement costs.

Risks: This proposed rule would reduce the risk to the public by helping to clearly and effectively convey the negative health consequences of smoking on cigarette packages and in cigarette advertisements, which would help both to discourage non-smokers, including minor children, from initiating cigarette use and to encourage current smokers to consider cessation.