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Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Final rule.
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2016
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Health LawHarm ReductionTobacco ControlPreventive MedicineFood ControlFood RegulationRegulatory ConsiderationPublic HealthSmoking Related Lung DiseaseHealth SciencesCosmetic ActPublic PolicyHealth PolicyTobacco UseHealth PromotionChronic Disease PreventionPublic Health PolicyFood SafetyFood RegulationsTobacco ProductTobacco ProductsTobacco PolicyFederal FoodDrug AdministrationRegulation
The Tobacco Control Act grants the FDA authority to regulate cigarettes, cigarette tobacco, roll‑your‑own tobacco, smokeless tobacco, and other products deemed tobacco products. The rule aims to reduce tobacco‑related deaths and diseases by extending FDA authority, prohibiting sales to minors, and mandating health warnings. The FDA final rule deems all products meeting the statutory definition of tobacco product—except accessories—to fall under the FD&C Act, prohibits sales to individuals under 18, and requires health warnings on packages and advertisements.
The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of "tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency's "tobacco product'' authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.