Opinion ID: 694671
Heading Depth: 2
Heading Rank: 2

Heading: Effect of the 1990 amendment of section 371(e) on this

Text: 11 court's jurisdiction over regulations promulgated 12 under sections 343(q) and 343(r) 13 Minerals contend that Congress has conferred jurisdiction in this court over the challenged regulations notwithstanding the fact that sections 343(q) and 343(r) are not specifically set forth in section 371(e). Minerals assert that in 1990, when Congress enacted the NLEA, it chose not to amend section 371(e). Accordingly, Minerals assert that Congress found nothing in Section 371 that needed to be changed and so [it] left that section untouched. It would appear that Minerals believe that we can imply from the failure to modify section 371(e) that Congress intended to confer original jurisdiction on this court to review regulations promulgated pursuant to sections 343(q) and 343(r). 14 The only support Minerals cite for this proposition is Judge Malcolm Richard Wilkey's dissent in Independent Cosmetic Mfrs. and Distrib. Inc. v. United States Dep't of Health, Educ. and Welfare, 574 F.2d 553 (D.C.Cir.), cert. denied, 439 U.S. 893, 99 S.Ct. 250, 58 L.Ed.2d 238 (1978). Minerals' reliance on Judge Wilkey's dissent does not advance their cause. In his dissenting expression, Judge Wilkey pointed out that: [t]here is no special statutory review procedure (i.e., court of appeals review) applicable to regulations promulgated pursuant to Sec. 701(a). 5 Id. at 574 (Wilkey, J., dissenting). 15 Minerals' theory is contrary to existing Supreme Court and Tenth Circuit authority. As noted above, federal courts can only exercise that jurisdiction conferred upon them by Congress. Henry, 43 F.3d at 511; Penteco Corp., 929 F.2d at 1521; Tuck, 859 F.2d at 844. We are reluctant to infer new legislative provisions out of [Congressional] silence. Quivira Mining Co. v. United States E.P.A., 728 F.2d 477, 483 (10th Cir.1984).C. No original jurisdiction in this court over 16 regulations promulgated under the FDA's general 17 rule making authority 18 Minerals claim that this court has original jurisdiction over their petitions because the FDA enacted the regulations that are the subject of their petitions pursuant to 21 U.S.C. Sec. 371(a), which grants the FDA its general rule making authority. Minerals have failed to cite any case to support this theory. 19 The Second Circuit, in discussing which court has jurisdiction to review a regulation promulgated pursuant to section 371(a), reasoned that the FDA's general authority 'to promulgate regulations for the efficient enforcement' of the statute, must be challenged in the district court. National Nutritional Foods Ass'n v. FDA, 504 F.2d 761, 772 (2d Cir.1974), cert. denied, 420 U.S. 946, 95 S.Ct. 1326, 43 L.Ed.2d 424 (1975). We agree. We do not have original jurisdiction over Minerals' petitions based upon section 371(a). D. Foods for special dietary uses 20 Minerals argue that we have original jurisdiction over their petitions because regulations promulgated under sections 343(q) and 343(r) affect foods for special dietary uses, which are governed by 21 U.S.C. Sec. 343(j) (1988). 6 Regulations promulgated under section 343(j) are subject to original review by this court pursuant to section 371(f). 21 The only support that Minerals cite for this proposition is a terse passage in their opposition to the FDA's motion to dismiss which states as follows: 22 The foods in issue, particular nutrient supplements designed for and used by those in the at-risk categories (who either have or are susceptible to having certain debilitating illnesses and conditions, including neural tube defects, cardiovascular disease and cancer) are special dietary use foods within the meaning of 21 U.S.C. Sec. 343(j). See generally 21 U.S.C. Sec. 350(c)(3)(A) [ (1988) ] and United States v. Undetermined Quantities of an Article of Drug Labeled as Exachol, 716 F.Supp. 787, 792 (D.C. [sic] S.D.N.Y.1989). Consequently, the statute does apply to vest jurisdiction over this appeal in this Court. 23 (emphasis in the original). 24 Minerals do not offer any argument in support of their theory that section 350(c)(3)(A) or Exachol can be interpreted to confer original jurisdiction over their petitions. Section 350(c)(3)(A) 7 merely defines foods for special dietary uses. It does not contain any support for Minerals' contention that regulations promulgated under sections 343(q) and 343(r) are subject to original review by this court. Exachol was decided in 1989, prior to the enactment of the NLEA in 1990. Exachol does not address the question whether this court has original jurisdiction over petitions challenging regulations promulgated under sections 343(q) and 343(r). 25 When the FDA promulgated the health claim regulation, the nutrient content regulation, and the nutrition labeling regulation, it was following the Congressional mandate to issue these regulations as authorized under sections 343(q) and 343(r). Assuming that sections 343(q) and 343(r) may incidentally affect foods for special dietary uses, only Congress has the power to confer jurisdiction on this court to review, in the first instance, challenges to regulations promulgated under these statutes.E. Public policy does not support original jurisdiction 26 over Minerals' petitions 27 Finally, Minerals maintain that public policy warrants direct appellate review of their petitions. Minerals argue that we must adjudicate their petitions to prevent duplicative litigation in district courts across the nation. Minerals assert that judicial economy weighs against having a trial court adjudicate their petitions because their petitions raise legal issues which will have to be decided de novo in this court. Minerals' public policy argument ignores the principle that this court lacks jurisdiction over a subject matter unless it is conferred by Congress. Henry, 43 F.3d at 511. Public policy considerations of judicial economy cannot be relied upon to expand our jurisdiction in the absence of express Congressional authority. 28 The petitions are DISMISSED.