Opinion ID: 694671
Heading Depth: 2
Heading Rank: 1

Heading: Original jurisdiction in this court pursuant to 21 U.S.C.

Text: Sec. 371(f) 7 Minerals assert that we have original jurisdiction over their petitions pursuant to 21 U.S.C. Sec. 371(f)(1). We disagree. 8 21 U.S.C. Sec. 371(f)(1) 1 provides that the United States Court of Appeals for the circuit wherein any person affected resides or has his principal place of business has original jurisdiction over challenges to regulations promulgated pursuant to the statutes expressly set forth in section 371(e)(1). 2 Section 371(e)(1) does not expressly refer to regulations that are promulgated under sections 343(q) and 343(r). The scope of section 371(e) is explicitly limited to any regulation under section 343(j), 344(a), 346, 351(b), or 352(a) or (h).... 21 U.S.C. Sec. 371(e)(1). 9 The FDA, pursuant to its general rule making authority established in section 371(a), 3 promulgated the health claim regulation, the nutrient content regulation, and the nutrition labeling regulation. In 1990, when Congress enacted the NLEA and directed the FDA to issue the instant regulations, it did not instruct the FDA to promulgate section 343(q) or 343(r) 4 pursuant to 21 U.S.C. Sec. 371(e). We agree with the Second Circuit that when Congress wants regulations to be promulgated pursuant to the procedures set forth in 21 U.S.C. Sec. 371(e), it has demonstrated that it knows how to do so. National Ass'n of Pharmaceutical Mfrs. v. FDA, 637 F.2d 877, 887 (2d Cir.1981). Minerals have not met their burden of demonstrating that section 371(f) confers original jurisdiction in this court to review regulations promulgated under sections 343(q) and 343(r). 10