ground that the objections failed to present any genuine or substantial issue of fact.
The February 17, 1984 FDA ruling not only disposes of the plaintiffs' request for a hearing but also deprives a district court of jurisdiction. Section 409(g)(1) of the Act, 21 U.S.C. § 348(g)(1), governs judicial review of FDA orders relating to food additives. The section provides that judicial review of any order ruling or objection to the grant or denial of a food additive petition may be had in the United States Court of Appeals within 60 days after the entry of such order.
The United States Court of Appeals for this circuit has repeatedly held when interpreting similarly crafted statutes that jurisdiction is exclusive, and that jurisdiction does not lie in the district court. E.g., Amusement & Music Operators Association v. Copyright Royalty Tribunal, 204 U.S. App. D.C. 259, 636 F.2d 531 (D.C.Cir.1980) (appeal from the Copyright Royalty Tribunal under 17 U.S.C. § 810), cert. denied, 450 U.S. 912, 101 S. Ct. 1352, 67 L. Ed. 2d 336 (1981); City of Rochester v. Bond, 195 U.S. App. D.C. 345, 603 F.2d 927 (D.C.Cir.1979) (appeal from the Federal Communications Commission under 47 U.S.C. § 402(b)(6) and from the Federal Aviation Administration under 49 U.S.C. § 1486(a)). In Bond, the court stated "if . . . there exists a special statutory review procedure, it is ordinarily supposed that Congress intended that procedure to be the exclusive means of obtaining judicial review in those cases in which it applies." Id. at 931. Indeed our court of appeals has applied that principle even in a situation where the statute providing for review in the appeals court also contained language that such review "shall be in addition to and not in substitution for any other remedies provided by law." Independent Cosmetics Manufacturers v. H.E.W., 187 U.S. App. D.C. 342, 574 F.2d 553 (D.C.Cir.) (quoting from section 701 of the FDC, 21 U.S.C. § 371), cert. denied, 439 U.S. 893, 99 S. Ct. 250, 58 L. Ed. 2d 238 (1978). Thus, in Independent Cosmetics Manufacturers, despite the savings clause, the court of appeals affirmed the district court's dismissal for lack of subject matter jurisdiction.
In short, because the FDA has issued final orders with respect to all of its requests, jurisdiction over any objections plaintiffs may have to those orders relating to aspartame lies in the court of appeals.
Lastly, the plaintiffs claim that at least with respect to the FDA order of July 24, 1981, approving the dry uses of aspartame -- where more than 60 days have elapsed since the FDA issued that order and consequently there no longer is jurisdiction in the court of appeals -- that they should be permitted to press their claims here. However, even with respect to those claims the plaintiffs may obtain review in the court of appeals, if appropriate. Under section 409(h) of the FDC Act, if plaintiffs have new evidence, unavailable to the FDA when it promulgated the dry use regulations, the plaintiffs may petition for reconsideration. 21 C.F.R. § 10.33 provides for reconsideration "on the Commissioner's own initiative or on the petition of an interested party." Section 409(g)(1) of the FDC Act explicitly extends to review of "any order . . . with respect to repeal of a [food additive] regulation." 21 U.S.C. § 348(g)(1). Thus if the FDA would deny a petition for reconsideration, plaintiffs may be able to seek review in the court of appeals at that time.
Based on the foregoing, it is this 22nd day of March, 1984,
That plaintiffs' second motion for a temporary restraining order is denied.
That defendants motion to dismiss is granted.
That plaintiffs' complaint is dismissed pursuant to Fed.R.Civ.P. 12(b)(1) for lack of subject matter jurisdiction.