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U.S. Department of Health and Human Services

Tobacco Products

Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent


February 2014







FDA is issuing this draft guidance to provide information on its enforcement policy to retailers regarding so called “provisional” tobacco products that become subject to not substantially equivalent orders issued under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).