U.S. v. Two Plastic Drums, More or Less of an Article of Food, Labeled in Part: Viponte Ltd. Black Currant Oil Batch No. BOOSF 039

Decision Date31 March 1993
Docket NumberNo. 92-1172,92-1172
Citation984 F.2d 814
PartiesUNITED STATES of America, Plaintiff-Appellant, v. TWO PLASTIC DRUMS, MORE or LESS OF AN ARTICLE OF FOOD, LABELED IN PART: VIPONTE LTD. BLACK CURRANT OIL BATCH NO. BOOSF 039, etc., and Traco Labs, Incorporated, Defendants-Appellees.
CourtU.S. Court of Appeals — Seventh Circuit

Douglas Letter, Robert D. Kamenshine (argued), Dept. of Justice, Civ. Div., Appellate Section, Washington, DC, Leslie Kux, Food & Drug Admin., Rockville, MD, for plaintiff-appellant.

Robert Ullman (argued), Jacob Laufer, Steven Shapiro, Bass & Ullman, New York City, Marc Ansel, Erwin, Martinkus, Cole & Ansel, Champaign, IL, for defendants-appellees.

Before CUDAHY and EASTERBROOK, Circuit Judges, and WILL, Senior District Judge. *

CUDAHY, Circuit Judge.

The Food and Drug Administration ("FDA") brings this in rem seizure action under the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq. ("Act"), seeking to condemn and destroy two drums of black currant oil as adulterated under 21 U.S.C. § 342(a)(2)(C) for being a food additive not recognized as safe. The district court granted summary judgment against the FDA, and the government appeals. We affirm.


Black currant oil ("BCO") is extracted from the seeds of the black currant berry and is marketed as a dietary supplement for its unique fatty-acid structures. The FDA argues that BCO is a food additive not generally recognized as safe ("GRAS") and seeks to seize and condemn two drums of BCO pursuant to sections 334 and 342 of the Act. A food is adulterated and subject to seizure under section 334 "if it is, or it bears or contains, any food additive which [the Secretary has not recognized as safe pursuant to section 348]." 21 U.S.C. § 342(a)(2)(C). The determination of whether a substance is a food additive is critical in establishing the safety of the substance because, if the substance is deemed a food additive, it is presumed to be unsafe, and the processor has the burden of showing that the substance is GRAS. On the other hand, if a substance is not a food additive, but food in the generic sense, 1 then the substance is presumed safe and the FDA has the burden of showing that the substance is injurious to health. United States v. An Article of Food ... FoodScience Labs., 678 F.2d 735, 739 (7th Cir.1982).

The Act defines "food additive" as

any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures ... to be safe under the conditions of its intended use....

21 U.S.C. § 321(s). The FDA contends that BCO is a food additive because it is a "component" of food when it is combined with the gelatin and glycerin used to market the BCO in capsules. The gelatin and glycerin encase the BCO to prevent it from becoming rancid. The FDA concedes that if the BCO alone was marketed in bottles for teaspoon consumption, it would not be a food additive, and the FDA would bear the burden of proving that BCO is injurious to health. But the combination of BCO with glycerin and gelatin, the FDA maintains, creates a food consisting of three components, and thus, three food additives. 2 In this instance, therefore, the FDA would require the processor to prove that the substance is safe--something that Traco Labs, the claimant of the two drums of BCO, has not done.

The district court granted summary judgment against the FDA, holding that the FDA's definition of food additive "would obscure any distinction between 'foods' under § 321(f) and 'food additives' under § 321(s)" contrary to the intent of Congress. United States v. Two Plastic Drums, More or Less of An Article of Food ... (Traco Labs), 791 F.Supp. 751, 754-55 (C.D.Ill.1991); see also 761 F.Supp. 70, 74 (C.D.Ill.1991) (order denying FDA's motion for summary judgment).


We review the grant of summary judgment de novo. Overton v. Reilly, 977 F.2d 1190, 1191 (7th Cir.1992). Summary judgment is appropriate when there is no genuine issue of any material fact and the moving party is entitled to judgment as a matter of law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 2511, 91 L.Ed.2d 202 (1986). The sole issue presented in this action is whether BCO, when combined with glycerin and gelatin, is a food additive pursuant to section 321(s). In determining what is a food additive, we look first to the language of the statute itself, Consumer Product Safety Comm'n v. GTE Sylvania, Inc., 447 U.S. 102, 108, 100 S.Ct. 2051, 2056, 64 L.Ed.2d 766 (1980), and if the language of the statute is plain, then it is conclusive absent contrary legislative intent. United States v. Ron Pair Enters., Inc., 489 U.S. 235, 109 S.Ct. 1026, 103 L.Ed.2d 290 (1989). Section 321(s) defines a food additive as "any substance the intended use of which results ... in its becoming a component or otherwise affecting the characteristics of any food...." This language is very broad, and thus, the general rule is that a component of an article of food is a food additive, even if the component in question is the "principal component," i.e. the ingredient sought when purchasing the food. FoodScience, 678 F.2d at 738. Moreover, even substances ordinarily considered "food" in common usage may become food additives in some circumstances. National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377, 391 (2d Cir.1978) (vitamins and minerals may be food additives when added to food). In addition, this court has held that DDT found naturally in fish is a food additive under the broad language of the Act. United States v. Ewig Bros. Co., 502 F.2d 715, 721-24 (7th Cir.1974) (Stevens, J.), cert. denied sub nom., Vita Food Prods. of Illinois, Inc. v. United States, 420 U.S. 945, 95 S.Ct. 1324, 43 L.Ed.2d 423 (1975).

The FDA argues that the statutory language clearly indicates that any and every component of an article of food is a food additive. Although we are mindful of the deference due the FDA in construing the statute it administers, Young v. Community Nutrition Inst., 476 U.S. 974, 981, 106 S.Ct. 2360, 2364-65, 90 L.Ed.2d 959 (1986); Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837, 843-44, 104 S.Ct. 2778, 2782, 81 L.Ed.2d 694 (1984); United States v. 25 Cases, More or Less, of An Article of Device, 942 F.2d 1179, 1182 (7th Cir.1991), deference here is unwarranted since its interpretation is contrary to the language and intent of the Act. Demarest v. Manspeaker, 498 U.S. 184, 111 S.Ct. 599, 112 L.Ed.2d 608 (1991) (administrative interpretation of statute contrary to plain language is not entitled to deference). As an initial matter, we question whether BCO can even be considered a "component" under the Act. The term "component," commonly understood and defined as a "a constituent part" or "ingredient," Webster's Third New International Dictionary 466 (1976), loses its meaning when applied to foods used in conjunction with inactive ingredients, as this case amply evidences. Here, the dietary supplement (the food) is nothing but BCO combined with glycerin and gelatin--two inactive substances used for marketing the BCO in capsule form. The gelatin and glycerin do not interact with or change the character of the BCO, but merely act as a container comparable to a bottle containing liquids marketed for teaspoon consumption. The BCO in question is the dietary supplement and the dietary supplement is the BCO. Therefore, to hold that BCO is a component of the dietary supplement would be to find that BCO is a component of itself. Such an interpretation would defy logic and common sense.

But even assuming that a single active "ingredient" of food can be considered a component of the food, the statutory language does not indicate that every component of food is necessarily a food additive. The Act defines "food additive" as a substance "becoming a component or otherwise affecting the characteristics of any food." 21 U.S.C. § 321(s) (emphasis added). The FDA interpretation of this provision implies that the language "or otherwise" is used disjunctively in such a way that a substance is a food additive if it (1) is a component of any food, or (2) affects the characteristics of a food. We think that this interpretation, however, distorts the plain meaning of the provision. The phrase "or otherwise," as employed here, is not used to express two alternative definitions of a food additive. Rather, it is used in a way to clarify or elaborate, such that "otherwise" is correctly read as "similarly." This view comports with established principles of statutory construction holding that courts should rein in broad and general statutory language when such language is immediately coupled with more limiting language or a specific enumeration. 2A Norman J. Singer, Sutherland on Statutory Construction §§ 47.16, 47.17 (5th ed. 1992) (reviewing doctrines of noscitur a sociis (coupling of words denotes an intention that they be understood in same general sense) and ejusdem generis (general words coupled with statutory enumeration are construed only to embrace objects similar in nature)); see also Toilet Goods Ass'n v. Gardner, 278 F.Supp. 786, 790 (S.D.N.Y.1968) (employing doctrine of ejusdem generis to limit expansive application of color additive provision), aff'd in relevant part, rev'd in part sub nom., Toilet Goods Ass'n v. Finch, 419 F.2d 21 (2d Cir.1969). The phrase "becoming a component" in section 321(s) is immediately...

To continue reading

Request your trial
9 cases
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin.
    • United States
    • U.S. Court of Appeals — Fourth Circuit
    • August 14, 1998
    ... ... plaintiffs' motion for summary judgment in part and granting the motion in part, the district ... structure or any function of the body." More specifically, the FDA concluded that tobacco ... drug and device require not only that the article "affect the structure or any function of the ... Timbers of Inwood Forest Assoc., Ltd., 484 U.S. 365, 371, 108 S.Ct. 626, 98 L.Ed.2d ... national economy and the potential for a black market, weighing against a ban on tobacco ... Cf. United States v. Two Plastic Drums, 984 F.2d 814, 819 (7th Cir.1993) ... Page 168 ... "does instruct us what a prospectus cannot be if the Act is to be ... , or prevention of a disease," but not if labeled or used for "smoking or chewing or as snuff and ... statutes reveals that they form something less than Congress's "comprehensive program" to ... ...
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin.
    • United States
    • U.S. District Court — Middle District of North Carolina
    • April 25, 1997
    ... ... for Summary Judgment will be granted in part and denied in part ...         I ... must come forward with evidence which shows more than some "metaphysical doubt" that genuine and ... The acquiescence argument is less persuasive in this context ... reagent, or other similar or related article, including any component, part, or accessory, ... for which it is neither advertised nor labeled with the manufacturer's knowledge. The ... Two Plastic Drums, 761 F.Supp. 70, 72 (C.D.Ill. 1991) ("[A] ... restrictions limit certain advertising to a black-and-white text-only format, restrict the trade or ... ...
  • Nve, Inc. v. Department of Health and Human Serv.
    • United States
    • U.S. Court of Appeals — Third Circuit
    • February 7, 2006
    ... ... Department of Health and Human Services; Food and Drug Administration; * Lester M. Crawford, ... not one of the questions of law certified to us by the District Court, it was a part of the ... See United States v. Two Plastic Drums, More or Less of an Article of Food ... , ... of Tex. v. Timbers of Inwood Forest Assocs., Ltd., 484 U.S. 365, 371, 108 S.Ct. 626, 98 L.Ed.2d ... ...
  • 330 West Hubbard Rest. Corp. v. U.S., PLAINTIFF-APPELLANT
    • United States
    • U.S. Court of Appeals — Seventh Circuit
    • February 22, 2000
    ... ... The question before us concerns only the ability of the IRS to use the ... at 843; NLRB v. Food and Commercial Workers, 484 U.S. 112, 123 (1987) ... Two Plastic Drums, 984 F.2d 814, 818 (7th Cir. 1993), we, ... to pay FICA taxes on employee tips of less than $20 per month. Because the IRS did not ... sec. 31.6011(a)-1 ... 5. More recently, two district courts ruled against the ... ...
  • Request a trial to view additional results
1 firm's commentaries
  • A discussion of tara and GRAS status
    • United States
    • LexBlog United States
    • August 5, 2022
    ...§ 402(a)(2)(B) respectively [21 U.S.C. § 402(a)(1) or § 402(a)(2)(B)]. 17. See, United States v. Two Plastic Drums ... Black Currant Oil, 984 F.2d 814 (1993). 18. 21 U.S.C. § 342(a)(1). 19. 21 U.S.C. § 342(a). 20. 21 U.S.C. § 348. 21. 21 U.S.C. § 342(a). (To sign up for a free subscription ......
2 books & journal articles
  • S.O.S. from the FDA: a cry for help in the world of unregulated dietary supplements.
    • United States
    • Albany Law Review Vol. 74 No. 1, September 2010
    • September 22, 2010
    ...at 21 (1994)). (61) See United States v. Oakmont Inv. Co., 987 F.2d 33 (1st Cir. 1993); United States v. Viponte Ltd. Black Currant Oil, 984 F.2d 814 (7th Cir. (62) McNamara, supra note 44, at 90. Congressional records further explain their reasoning: Although a fair reading of the current ......
  • §4.2 Judicial Rulings
    • United States
    • Full Court Press DeWitty on Dietary Supplement Law Title CHAPTER 4 Legislation Leading to DSHEA
    • Invalid date
    ...been exposed to peer review.[15] U.S. v. 29 Cartons of ? An Article of Food, 987 F.2d 33 (1993). [16] 791 F. Supp.751 (1991).[17] Id.[18] 984 F.2d 814 (1993).[19] Id.[20] U.S. v. 29 Cartons . . . 987 F.2d at 38 (1993). Another case involving the use of BCO encapsulated for use as a dietary ......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT