Federation of Homemakers, Appellant, v. Alexander Schmidt, Commissioner of Food and Drugs, et al, 539 F.2d 740 (D.C. Cir. 1976)

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:

(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 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 name⁴  or a descriptive term.⁵ 

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 convinced that the FDA regulation is well within the zone of reasonableness required of agency rulemaking. We note first that appellant's primary complaint with the new regulation is that the FDA has not decided to issue standards of identity for all new foods, but instead has promulgated regulations which provide for developing new common names as well as for employing standards of identity and imitation labeling. Under the challenged regulation, a nutritionally equivalent or perhaps nutritionally superior food item may still bear the imitation label and a common or standardized name so long as the combination does not mislead the public. Response to Comments, 38 Fed.Reg. 20703 (1973). The manufacturer, however, may choose to use a descriptive label, e. g., "artificially sweetened applesauce;" he may also opt for using a common or usual name and its required labeling. 21 C.F.R. § 102.1(a), (b) (1975) (also promulgated in 1973, 38 Fed.Reg. 6966, and incorporated by reference in section 1.8(e) (2) (ii)). He may establish this common name by everyday use or by petitioning the Commissioner of Food and Drugs to promulgate a regulation prescribing a common or usual name for the food. 21 C.F.R. § 102.2(a) (1975).⁹ 

This regulatory scheme satisfies prior criticisms that the imitation requirement as interpreted by courts had unduly deterred the development of new food products, desirable for consumers, because the manufacturer's product, even if superior, was subject to the disparagement intimated by the imitation label. See, e. g., Report of Panel III-2; White House Conference on Food and Nutrition, Final Report (Dec. 24, 1969); Cody, New Foods and the Imitation Provisions of the Food, Drug, and Cosmetic Act, 25 Food Drug Cosm.L.J. 220 (1970); comment, Imitation Foods: An Emergence from the Twilight Zone, 13 J.Pub. L. 536 (1964). In addition, the FDA reasonably expects this more flexible approach to encourage greater emphasis on nutritional value and consumer knowledge about purchased food products. See Appellee's Br. at 17-20. Furthermore, the regulation provides a safety valve for specific cases arising later in which nutritional equivalency and descriptive labeling do not adequately protect consumers from food substitutes which are inferior in other ways. 21 C.F.R. § 1.8(e) (4) (III) (1975).¹⁰ 

This regulation, directed at the laudable aims of encouraging manufacture of nutritional food products and of better informing consumers so that they may exercise a knowledgeable choice of differing foods within general categories, lies well within the bounds of discretion which the FDA may exercise. The judgment of the trial court is hereby

Affirmed.