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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

67 Cited authorities

  1. Motor Vehicle Manufacturers Assoc. of the United States, Inc. v. State Farm Mutual Auto. Ins. Co.

    463 U.S. 29 (1983)   Cited 6,629 times   50 Legal Analyses
    Holding that " `settled course of behavior embodies the agency's informed judgment that, by pursuing that course, it will carry out the policies [of applicable statutes or regulations]'"

  2. FW/PBS, Inc. v. City of Dallas

    493 U.S. 215 (1990)   Cited 2,368 times   2 Legal Analyses
    Holding that the burden is on the plaintiff to allege facts sufficient to establish jurisdiction (quoting McNutt v. General Motors Acceptance Corp., 298 U.S. 178, 189 (1936))

  3. Elrod v. Burns

    427 U.S. 347 (1976)   Cited 4,219 times   7 Legal Analyses
    Holding that local government could not constitutionally base public employment opportunities on political affiliation or nonaffiliation

  4. Food & Drug Administration v. Brown & Williamson Tobacco Corp.

    529 U.S. 120 (2000)   Cited 1,504 times   40 Legal Analyses
    Holding that Congress had not yet empowered the FDA to regulate tobacco products

  5. Kolender v. Lawson

    461 U.S. 352 (1983)   Cited 3,041 times   7 Legal Analyses
    Holding state misdemeanor statute unconstitutionally vague within the meaning of the Due Process Clause

  6. Fed. Commc'ns Comm'n v. Fox Television Stations, Inc.

    556 U.S. 502 (2009)   Cited 1,043 times   21 Legal Analyses
    Holding that agencies may not change their policies "sub silentio "

  7. Central Hudson Gas Elec. v. Public Serv. Comm'n

    447 U.S. 557 (1980)   Cited 2,052 times   105 Legal Analyses
    Holding that a restriction on commercial speech must directly advance a substantial governmental interest

  8. Reno v. American Civil Liberties Union

    521 U.S. 844 (1997)   Cited 987 times   13 Legal Analyses
    Holding parts of § 223 unconstitutional under the First Amendment

  9. Smith v. City of Jackson

    544 U.S. 228 (2005)   Cited 653 times   57 Legal Analyses
    Holding that "when Congress uses the same language in two statutes having similar purposes, particularly when one is enacted shortly after the other, it is appropriate to presume that Congress intended that text to have the same meaning in both statutes."

  10. Brown v. Entertainment Merchants Assn.

    564 U.S. 786 (2011)   Cited 487 times   9 Legal Analyses
    Holding that even if violent video games cause aggression, a state could not prohibit their sale to children

  11. Rule 56 - Summary Judgment

    Fed. R. Civ. P. 56   Cited 328,637 times   158 Legal Analyses
    Holding a party may move for summary judgment on any part of any claim or defense in the lawsuit

  12. Section 706 - Scope of review

    5 U.S.C. § 706   Cited 20,433 times   184 Legal Analyses
    Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

  13. Section 553 - Rule making

    5 U.S.C. § 553   Cited 4,089 times   145 Legal Analyses
    Exempting "interpretative rules," among other things, from the notice-and-comment requirement

  14. Section 331 - Prohibited acts

    21 U.S.C. § 331   Cited 1,512 times   105 Legal Analyses
    Prohibiting the sale of adulterated foods

  15. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,166 times   161 Legal Analyses
    Defining “new drug”

  16. Section 360c - Classification of devices intended for human use

    21 U.S.C. § 360c   Cited 787 times   22 Legal Analyses
    Instructing FDA to determine the safety and effectiveness of a "device" in part by weighing " any probable benefit to health . . . against any probable risk of injury or illness . . ."

  17. Section 333 - Penalties

    21 U.S.C. § 333   Cited 436 times   39 Legal Analyses
    Defining civil and criminal penalties for violations of Section 331

  18. Section 334 - Seizure

    21 U.S.C. § 334   Cited 374 times   5 Legal Analyses
    Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals

  19. Section 332 - Injunction proceedings

    21 U.S.C. § 332   Cited 268 times   6 Legal Analyses
    Granting the district court jurisdiction to restrain violations of FDCA

  20. Section 371 - Regulations and hearings

    21 U.S.C. § 371   Cited 260 times   8 Legal Analyses
    Granting the FDA general authority to promulgate regulations for administration of the Food, Drug, and Cosmetic Act

  21. Section 10.40 - Promulgation of regulations for the efficient enforcement of the law

    21 C.F.R. § 10.40   Cited 10 times

    (a) The Commissioner may propose and promulgate regulations for the efficient enforcement of the laws administered by FDA whenever it is necessary or appropriate to do so. The issuance, amendment, or revocation of a regulation may be initiated in any of the ways specified in § 10.25 . (1) This section applies to any regulation: (i) Not subject to § 10.50 and part 12, or (ii) if it is subject to § 10.50 and part 12, to the extent that those provisions make this section applicable. (2) A regulation

  22. Section 1140.16 - Conditions of manufacture, sale, and distribution

    21 C.F.R. § 1140.16   Cited 4 times   2 Legal Analyses

    (a)Restriction on product names. A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that were sold in the United States on January 1, 1995. (b)Minimum cigarette package size. Except as otherwise provided under this section, no manufacturer, distributor, or retailer may sell or cause to be sold

  23. Section 17.2 - Maximum penalty amounts

    21 C.F.R. § 17.2   Cited 2 times   1 Legal Analyses

    The maximum civil money penalties associated with the statutory provisions authorizing civil money penalties under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act can be found at 45 CFR part 102 . The table of these maximum civil money penalties can be found at 45 CFR 102.3 . 21 C.F.R. §17.2 81 FR 62358, Sept. 9, 2016 81 FR 62358, 9/9/2016