Section 17.2 - Maximum penalty amounts

1 Citing brief

  1. Philip Morris USA Inc. et al v. United States Food and Drug Administration et al

    MOTION for Summary Judgment and Memorandum of Law in Support of Motion for Summary Judgment

    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.