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May 5, 2016Client Alert

FDA Issues Deeming Rule regarding Tobacco Products

On May 5, 2016, the Food and Drug Administration (FDA) made available an advance version of the final rule “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,” to be published in the Federal Register on May 10, 2016. The rule deems products meeting the statutory definition of “tobacco product” subject to the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. The Tobacco Control Act gave FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco and any other tobacco products that FDA regulations “deem” to be subject to the FD&C Act. With this rule, FDA is now extending the Agency’s “tobacco product” authority under the FD&C Act and “deeming” all products and categories of products that meet the statutory definition of “tobacco product” to be subject to the FD&C Act. Once “deemed” subject to FD&C Act authority, FDA may place “restrictions on the sale and distribution of a tobacco product,” including age-related access restrictions and advertising and promotion restrictions, if it determines such restrictions are appropriate to protect public health.

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