Authorities Cited: United States Code 21 U.S.C. § 341 21 U.S.C. § 343 21 U.S.C. § 343(a) 21 U.S.C. § 346 21 U.S.C. § 371 28 U.S.C. § 1291 Code of Federal Regulations 21 C.F.R. § 101.17 21 C.F.R. § 201.57(c) Supreme Court 22 U.S. 1 323 U.S. 134 332 U.S. 194, 201-203 435 U.S. 151, 178 435 U.S. 171 450 U.S. 311, 314-315 458 U.S. 141, 153-154 461 U.S. 375, 384-389 464 U.S. 238, 251 471 U.S. 707, 712-717 474 U.S. 409, 422 485 U.S. 495, 500-503 486 U.S. 57, 63 496 U.S. 72, 78-79 507 U.S. 218, 224-227 518 U.S. 470, 485-487 519 U.S. 867 522 U.S. 1050 529 U.S. 89, 108 529 U.S. 861 531 U.S. 341, 348 533 U.S. 218, 228-235 537 U.S. 51, 64-67 Circuit Courts 802 F.2d 1443 837 F.2d 108, 115-116 897 F.2d 34, 39 903 F.2d 445, 453-454 994 F.2d 755, 758-760 79 F.3d 620, 625 112 F.3d 291, 296-297 417 F.3d 384, 386 501 F.3d 29, 51-52 521 F.3d 253, 261-275 522 F.3d 315, 321-322 Federal Rules of Civil Procedure Fed. R. Civ. P. 12(b)(6)