Federation of Homemakers v. Schmidt, No. 74-2122

CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
Writing for the CourtBefore McGOWAN, TAMM and ROBB; TAMM
Citation176 U.S.App.D.C. 261,539 F.2d 740
PartiesFEDERATION OF HOMEMAKERS, Appellant, v. Alexander SCHMIDT, Commissioner of Food and Drugs, et al.
Decision Date20 September 1976
Docket NumberNo. 74-2122

Page 740

539 F.2d 740
176 U.S.App.D.C. 261
FEDERATION OF HOMEMAKERS, Appellant,
v.
Alexander SCHMIDT, Commissioner of Food and Drugs, et al.
No. 74-2122.
United States Court of Appeals,
District of Columbia Circuit.
Argued Dec. 8, 1975.
Decided June 10, 1976.
Rehearing Denied Sept. 20, 1976.

Page 741

James S. Turner, Washington, D. C., for appellant.

Richard A. Merrill, Chief Counsel, U. S. Food and Drug Administration, Rockville, Md., for appellees. Stephen H. McNamara, Associate Chief Counsel for Food, U. S. Food and Drug Administration, Howard S. Epstein, Asst. Chief, Consumer Affairs Section, Dept. of Justice, and Peter Barton Hutt, Chief Counsel, U. S. Food and Drug Administration, Washington, D. C., at the time the brief was filed, were on the brief for appellees.

Before McGOWAN, TAMM and ROBB, Circuit Judges.

Opinion for the Court filed by Circuit Judge TAMM.

TAMM, Circuit Judge:

The Food and Drug Administration (FDA) recently promulgated a regulation which, for the first time, attempted to define an imitation food subject to section 403(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 343(c) (1970). The appellants in this case challenge the new regulation as contrary to the terms of the Act and as arbitrary and capricious. We affirm the district court's finding that the regulation fulfills the objectives of the statute in question and is a reasonable exercise of the regulatory power of the FDA.

The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (1970), provides criminal penalties for adulteration or misbranding of any food. Section 403 lists several actions which constitute misbranding, including the failure to label imitation foods:

343. A food shall be deemed to be misbranded

(c) Imitation of another food.

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.

21 U.S.C. § 343(c) (1970). The statute, however, does not define the word "imitation" and, until promulgation of the challenged regulation, a definition had evolved only indirectly from infrequent cases involving the subsection. 1 While those cases presented

Page 742

no clear definition of an imitation food, they did illustrate the applicability of the labeling directive to both standardized and nonstandardized foods. 2 See generally United States v. 651 Cases, More or Less, of Chocolate Chil-Zert, 114 F.Supp. 430, 433 (N.D.N.Y.1953).

In early 1973, the FDA published notice of a proposed rulemaking regarding imitation labeling. 38 Fed.Reg. 2138-39 (1973). Eight months later, the FDA promulgated the new regulation, responding to comments from interested parties. In general, the regulation defined an imitation food as one which "is a substitute for and resembles another food but is nutritionally inferior to that food." 21 C.F.R. § 1.8(e)(1) (1975). "Nutritionally inferior" is defined as having any reduction in the content of essential nutrients which constitute 2% or more of the Required Daily Allowance of protein or of listed vitamins and minerals. 3 The regulation also provides that a substitute food which is not nutritionally inferior must have a label with a common or usual name 4 or a descriptive term. 5

Page 743

The Federation of Homemakers, a national consumer group, 6 filed suit to enjoin enforcement of the new definition by the FDA, but on cross motions for summary judgment, District Judge Joseph C. Waddy held that the regulation is consistent with the statute and Congressional intent. Federation of Homemakers v. Schmidt, 385 F.Supp. 362 (D.D.C.1974). This appeal followed, with plaintiff-appellants arguing that the regulation is contrary to statute as well as arbitrary and capricious. For the reasons discussed herein we affirm the trial court's judgment.

In its explanation of the argument that the regulation contravenes the statute, the Federation of Homemakers relies on many cases in which judges have discussed, in both holdings and dicta, 7 the characteristics of imitation foods. Beginning with the Supreme Court's admonition in 62 Cases of Jam v. United States, 340 U.S. 593, 599, 71 S.Ct. 515, 519, 95 L.Ed. 566 (1951), that "imitation" must be "left . . . to the understanding of ordinary English speech," appellants call our attention to cases in which texture, smell, taste, appearance, manufacture, packaging and marketing all contribute to a determination of whether the food in question must be labeled an imitation. 8 While it is true that these judicial definitions may be reasonable ones, we do not believe that they prevent the promulgation of an equally reasonable definition by the agency charged with administering the Act. Congress chose not to define the parameters of its imitation label requirements; our deference to the enforcing agency's interpretation limits our review to determining only whether the regulation violates the language of the statute or is arbitrary and capricious. See generally Red Lion Broadcasting Co., Inc. v. FCC, 395 U.S. 367, 381, 89 S.Ct. 1794, 23 L.Ed.2d 371 (1967); Udall v. Tallman, 380 U.S. 1, 16-18, 85 S.Ct. 792, 13 L.Ed.2d 616, rehearing denied, 380 U.S. 989, 85 S.Ct. 1325, 14 L.Ed.2d 283 (1965). Neither the legislative history of the companion section regarding standardized foods, 21 U.S.C. § 341 (1970) (discussed in the trial court opinion, supra, 385 F.Supp. at 365-66) nor the undefined use of "imitation" in the statute leads us to conclude that a food nutritionally equivalent to the ordinary food and clearly labeled with a common name established by regulation or with a descriptive term violates Congressional objectives if it is marketed without the imitation label. Indeed, the new regulation successfully reconciles the need to alert the public to inferior products with the proscription in subsection 343(a) against false or misleading labels. See generally Armour and Company v. Freeman, 113 U.S.App.D.C. 37, 304 F.2d 404, 409-14, cert. denied, 370 U.S. 920, 82 S.Ct. 1559, 8 L.Ed.2d 500 (1962) (Prettyman, J., concurring) (ham with water added is not "imitation ham" under similar language of Meat Inspection Act of 1907).

As to the arbitrary and capricious issue raised by the Federation of Homemakers, we are...

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9 practice notes
  • Grocery Mfrs. of America, Inc. v. Gerace, Nos. 177
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • February 14, 1985
    ...have upheld its validity. National Milk Producers Federation v. Harris, 653 F.2d 339 (8th Cir.1981); Federation of Homemakers v. Schmidt, 539 F.2d 740 (D.C.Cir.1976). We could scarcely improve on the D.C. Circuit's perspicacious decision in Federation of Homemakers sustaining the FDA's defi......
  • Bilingual Bicultural Coalition on Mass Media, Inc. v. F.C.C., Nos. 75-1855
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • September 16, 1977
    ...332. See Black Broadcasting, 181 U.S.App.D.C. at 184-185, 556 F.2d at 61-62; NOW, 181 U.S.App.D.C. at 78, 555 F.2d at 1015; Alianza, 176 U.S.App.D.C. at 261, 539 F.2d at 740; Columbus Broadcasting, 164 U.S.App.D.C. at 222, 505 F.2d at 329; Bilingual I, 160 U.S.App.D.C. at 393, 492 F.2d at 6......
  • Hercules, Inc. v. E.P.A., Nos. 77-1248
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • November 3, 1978
    ...U.S.App.D.C. 236 at 244, 595 F.2d 621 at 629 (1978) (en banc) (minority workforce statistics); Federation of Homemakers v. Schmidt, 176 U.S.App.D.C. 261, 264-65, 539 F.2d 740, 743-44 (1976) (food content standards). A principal rationale for the "zone of reasonableness" concept is......
  • Grocery Mfrs. of America, Inc. v. Gerace, No. 83 Civ. 8629 (HFW).
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • March 8, 1984
    ...Commissioner argues that the FDA's definition of imitation is contrary to the FDCA and is invalid. In Federation of Homemakers v. Schmidt, 539 F.2d 740 (D.C.Cir.1976), the District of Columbia Circuit Court of Appeals deferred to the expertise of the FDA in promulgating its definition of im......
  • Request a trial to view additional results
9 cases
  • Grocery Mfrs. of America, Inc. v. Gerace, Nos. 177
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • February 14, 1985
    ...have upheld its validity. National Milk Producers Federation v. Harris, 653 F.2d 339 (8th Cir.1981); Federation of Homemakers v. Schmidt, 539 F.2d 740 (D.C.Cir.1976). We could scarcely improve on the D.C. Circuit's perspicacious decision in Federation of Homemakers sustaining the FDA's defi......
  • Bilingual Bicultural Coalition on Mass Media, Inc. v. F.C.C., Nos. 75-1855
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • September 16, 1977
    ...332. See Black Broadcasting, 181 U.S.App.D.C. at 184-185, 556 F.2d at 61-62; NOW, 181 U.S.App.D.C. at 78, 555 F.2d at 1015; Alianza, 176 U.S.App.D.C. at 261, 539 F.2d at 740; Columbus Broadcasting, 164 U.S.App.D.C. at 222, 505 F.2d at 329; Bilingual I, 160 U.S.App.D.C. at 393, 492 F.2d at 6......
  • Hercules, Inc. v. E.P.A., Nos. 77-1248
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • November 3, 1978
    ...U.S.App.D.C. 236 at 244, 595 F.2d 621 at 629 (1978) (en banc) (minority workforce statistics); Federation of Homemakers v. Schmidt, 176 U.S.App.D.C. 261, 264-65, 539 F.2d 740, 743-44 (1976) (food content standards). A principal rationale for the "zone of reasonableness" concept is that it f......
  • Grocery Mfrs. of America, Inc. v. Gerace, No. 83 Civ. 8629 (HFW).
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • March 8, 1984
    ...Commissioner argues that the FDA's definition of imitation is contrary to the FDCA and is invalid. In Federation of Homemakers v. Schmidt, 539 F.2d 740 (D.C.Cir.1976), the District of Columbia Circuit Court of Appeals deferred to the expertise of the FDA in promulgating its definition of im......
  • Request a trial to view additional results

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