Filed October 30, 2015
Penalties include criminal fines, product seizures, injunctions against marketing the product, and civil monetary penalties. 21 U.S.C. §§ 331-334; 21 C.F.R. § 17.2. Unlike with changes to a tobacco product’s physical characteristics, the Tobacco Control Act generally does not require or authorize FDA premarket review for changes to a tobacco product’s label.