National Milk Producers Federation v. Harris

653 F.2d 339
CourtCourt of Appeals for the Eighth Circuit
DecidedJuly 9, 1981
DocketNo. 80-1687
StatusPublished
Cited by4 cases

This text of 653 F.2d 339 (National Milk Producers Federation v. Harris) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eighth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
National Milk Producers Federation v. Harris, 653 F.2d 339 (8th Cir. 1981).

Opinion

BRIGHT, Circuit Judge.

The National Milk Producers Federation and other representatives of dairy producers (collectively, the Federation)1 brought this suit seeking both mandatory and declaratory relief against the Secretary of Health and Human Services and the' Commissioner of the Food and Drug Administration (collectively, the FDA). In its complaint the Federation alleged the invalidity of a FDA regulation that authorizes qualifying food products to bear a label describing these products as “substitute[s]” rather than as “imitation[s]”. In addition, the complaint alleged that the FDA had unlawfully approved the marketing of food products as cheese substitutes and had unlawfully refused to enforce the regulation against such products.

The FDA moved to dismiss the complaint for failure to state a claim upon which relief could be granted and, in the alternative, for summary judgment. After submission of affidavits, the district court2 granted the FDA’s motion for summary judgment and dismissed the action. In its memorandum and order the district court upheld the validity of the challenged regulation and concluded that the FDA’s enforcement of the regulation was committed to the agency’s discretion. For reasons stated below, we affirm.

[341]*341I. Background.

The Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 301-392 (1976 & Supp. Ill 1979), establishes criminal penalties for the adulteration or misbranding of any food. Section 403(e) of the Act, 21 U.S.C. § 343(c) (1976), provides:

A food shall be deemed to be misbranded—
Imitation of another food (c) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.

The Act, however, contains no provision defining the word “imitation.” 3

In 1973 the FDA held a notice-and-comment rulemaking proceeding to define the statutory term “imitation.” See 38 Fed. Reg. 2138-39 (1973). Eight months after publishing notice of its proposed rulemaking, the FDA promulgated the regulation in issue here and now codified at 21 C.F.R. § 101.3(e) (1980).

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(eX4) (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 identi[342]*342ty 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

In 1979 the Federation filed two petitions with the FDA seeking, respectively, revocation of 21 C.F.R. § 101.3(e) (1980) and withdrawal of the proposed regulations adopting standards of identity for cheese substitutes. At the same time, the Federation sought enforcement action from the FDA against producers of cheese substitutes for misbranding. The FDA notified the Federation that it had forwarded the Federation’s letters together with the labels of allegedly misbranded cheese substitute products “to the respective [FDA district offices] in whose area the manufacturers are located ■for their appropriate attention.” After further correspondence, the FDA informed the Federation that budgetary constraints had forced it to set investigative and enforcement priorities and that it had assigned its lowest priorities to “food economics and food standards.” The FDA accordingly concluded that it “expect[ed] no actions in the near future concerning the cheese substitute products indicated in [the Federation’s] letters.”8

The Federation thereafter filed its complaint in this action. The Federation principally sought mandatory relief ordering the FDA to enforce the Act and the regulation against manufacturers of cheese substitute products and to prevent the agency from sanctioning the use of labels bearing the words “cheese substitute” or the like rather than “imitation cheese.” The Federation also sought declaratory relief holding unlawful the FDA’s “decision to exempt from labeling as ‘imitation’ * * * food products made in semblance of and offered for sale in substitution for any standardized cheese or cheese related product[.]”

II. The Federation's Appeal.

In urging reversal of the district court judgment, the Federation renews its claims for declaratory and mandatory relief. These claims depend roughly on two contentions: (1) that 21 C.F.R. § 101.3(e) (1980) is unlawful under the Act and, in the alternative, (2) that the FDA has violated its own regulation by approving the marketing of products labeled as “cheese substitutes.” Because we reject these contentions, we hold that the district court did not abuse its discretion in declining to issue either mandatory or declaratory relief.

A. The Unlawfulness of the Regulation.

The FDA enacted 21 C.F.R.

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National Milk Producers Federation v. Harris
653 F.2d 339 (Eighth Circuit, 1981)

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653 F.2d 339, Counsel Stack Legal Research, https://law.counselstack.com/opinion/national-milk-producers-federation-v-harris-ca8-1981.