Health Law Daily FDA releases proposed rule on tobacco product warnings
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Friday, August 16, 2019

FDA releases proposed rule on tobacco product warnings

By Nicole D. Prysby, J.D.

The FDA has released a proposed rule that would establish color graphics that must accompany new textual warnings on cigarette packages and advertising. If finalized, the requirements would become effective 15 months after publication.

New health warnings for cigarette packages and advertisements were proposed in an FDA proposed rule. If finalized, the proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) which requires the FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The requirements would become effective 15 months after publication of the final rule (Proposed rule, 84 FR 42754, August 16, 2019).

The Tobacco Control Act amended the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. The proposal sets forth the 12 possible textual warning statements and requires the use of an accompanying color graphic for each warning. The new health warnings would appear prominently on cigarette packages and in cigarette advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.

The executive summary and additional preamble to the proposed rule discuss the research and data supporting cigarette warnings and explain the FDA’s process for developing the proposed health warnings, which included a research study on textual warning statements and development and testing of images. Comments on the proposed rule are due October 15, 2019.

MainStory: TopStory ProposedRules FDCActNews AdvertisingNews LabelingNews TobaccoNews FedTracker LifeSciences

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