Source: http://openjurist.org/653/f2d/339/national-milk-producers-federation-v-harris-e
Timestamp: 2017-03-28 08:26:17
Document Index: 365667289

Matched Legal Cases: ['§ 343', '§ 101', '§ 101', '§ 101', '§ 101', '§ 343', '§ 101', '§ 101', '§ 101']

653 F2d 339 National Milk Producers Federation v. Harris E | OpenJurist
653 F. 2d 339 - National Milk Producers Federation v. Harris E HomeFederal Reporter, Second Series 653 F.2d.
653 F2d 339 National Milk Producers Federation v. Harris E 653 F.2d 339
The NATIONAL MILK PRODUCERS FEDERATION, Land O'Lakes, Inc.,Associated Milk Producers, Inc., ConsolidatedDairy Products Co., Lyle L. Lapham andCharles R. Schell, Appellants,v.The Honorable Patricia HARRIS, Secretary Department ofHealth and Human Services and Dr. Jerre E. Goyan,Commissioner, Food and DrugAdministration, Appellees.
Submitted April 14, 1981.Decided July 9, 1981.
The regulation requires any nutritionally inferior food which is a substitute for and resembles another food to bear a label identifying it as an "imitation" in accord with section 403(c) of the Act, 21 U.S.C. § 343(c) (1976). 21 C.F.R. § 101.3(e)(1) (1980).4 The regulation defines nutritional inferiority as any reduction, in comparison with the content of the resembled food, in the content of essential nutrients which constitute two percent or more of the U.S. Recommended Daily Allowance (U.S. RDA) of protein or listed vitamins and minerals. 21 C.F.R. § 101.3(e)(4) (1980).5 In addition, to be free from the imitation labeling requirement, the regulation provides that a substitute food at least nutritionally equivalent to the food it resembles must have a label bearing a common or usual name or an appropriately descriptive term. 21 C.F.R. § 101.3(e)(2) (1980).6
As already noted, see note 3 supra, the D.C. Circuit upheld the regulation as consistent with the Act and "well within the zone of reasonableness required of agency rulemaking." Federation of Homemakers v. Schmidt, 539 F.2d 740, 743-44 (D.C.Cir.1976).
In 1978 the FDA initiated a rulemaking proceeding to establish standards of identity for food products, including cheese substitutes. See 43 Fed.Reg. 42, 118-42, 141 (1978). The Federation has participated in this proceeding. Should the FDA promulgate regulations that establish standards of identity for cheese substitutes, cheese substitutes would acquire a common or usual name and would thereby qualify for automatic exemption from the imitation labeling requirement. See 21 C.F.R. § 101.3(e)(3) (1980).7
The Federation contends that the issue of statutory authority, as a question of law, should not be deferred to the FDA. We agree that the FDA possesses no special expertise in addressing legal questions, and that the courts are the final arbiters on issues of statutory construction. See Volkswagenwerk v. Federal Maritime Commission, 390 U.S. 261, 272, 88 S.Ct. 929, 19 L.Ed.2d 1090 (1968). Nevertheless, an agency's construction of its operational statute is entitled to deference by the courts. Medical Center of Independence v. Harris, 628 F.2d 1113, 1117-18 (8th Cir. 1980); Blue Cross Association v. Harris, 622 F.2d 972, 978-79 (8th Cir. 1980). Ordinarily, this construction will be upheld if it has a reasonable basis in law and does not frustrate congressional policy. Medical Center of Independence v. Harris, supra, 628 F.2d at 1118.
The executive branch and its departments enjoy a discretion in the initiation of investigative, enforcement, and prosecutorial actions limited only by constitutional strictures and relevant statutory directives. See generally, United States v. Alarik, 439 F.2d 1349 (8th Cir. 1971); Newman v. United States, 382 F.2d 479 (D.C.Cir.1967). As we stated in Terminal Freight Handling Co. v. Solien, 444 F.2d 699 (8th Cir. 1971), cert. denied, 405 U.S. 996, 92 S.Ct. 1246, 31 L.Ed.2d 465 (1972):
After carefully reviewing the Act, we have found no provision which narrows or limits the discretion of the FDA to investigate, enforce, or prosecute alleged violations of the Act or its regulations.11 Thus, we conclude that the Federation's complaint which seeks the initiation of investigative, enforcement, or prosecutorial proceedings fails to state a claim upon which either mandatory or declaratory relief can be granted.12 See Haleston Drug Stores, Inc. v. NLRB, 187 F.2d 418, 420-22 (9th Cir.), cert. denied, 342 U.S. 815, 72 S.Ct. 29, 96 L.Ed. 616 (1951); Crooker v. Securities and Exchange Commission, 161 F.2d 944, 949 (1st Cir. 1947). Cf. Dunlop v. Bachowski, 421 U.S. 560, 95 S.Ct. 1851, 44 L.Ed.2d 377 (1975); Howard v. Hodgson, 490 F.2d 1194 (8th Cir. 1974).
As the D.C. Circuit noted in its opinion rejecting a challenge to the same regulation in issue here, "until promulgation of the challenged regulation, a definition (of the word "imitation") had evolved only indirectly from infrequent cases involving (21 U.S.C. § 343(c) (1976))." Federation of Homemakers v. Schmidt, 539 F.2d 740, 741 (D.C.Cir.1976) (footnote omitted)
21 C.F.R. § 101.3(e)(1) (1980) provides:
21 C.F.R. § 101.3(e)(4) (1980) provides:
21 C.F.R. § 101.3(e)(2) (1980) provides: