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, No. 92-1172

CourtUnited States Courts of Appeals. United States Court of Appeals (7th Circuit)
Writing for the CourtBefore CUDAHY and EASTERBROOK, Circuit Judges, and WILL; CUDAHY
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.
Docket NumberNo. 92-1172
Decision Date31 March 1993

Page 814

984 F.2d 814
61 USLW 2491
UNITED 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.
No. 92-1172.
United States Court of Appeals,
Seventh Circuit.
Argued Oct. 21, 1992.
Decided Jan. 27, 1993.
Rehearing Denied March 31, 1993.

Page 815

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.

Page 816

I.

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).

II.

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

Page 817

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...

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    • United States
    • Federal Register January 06, 2000
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    ...* an Article of Food (Oakmont), 987 F.2d 33 (1st Cir. 1993) and United States v. An Article of Food * * * Viponte Ltd. Black Currant Oil, 984 F.2d 814 (7th Cir. 1993), for the proposition that, before DSHEA was enacted, courts had invalidated an FDA enforcement theory that shifted the burde......
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    • 25 Abril 1997
    ...761 F.Supp. 70, 72 (C.D.Ill. 1991) ("[A] court should examine a wide range of evidence, including ... actual use of the product."), aff'd, 984 F.2d 814 (7th Cir. 1993). Still other courts have expressly relied on actual use as a factor contributing to the establishment of intended use. See ......
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    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • 7 Febrero 2006
    ...in enforcement actions brought directly under the FDCA. See United States v. Two Plastic Drums, More or Less of an Article of Food ..., 984 F.2d 814, 816 (7th Cir.1993) (noting that the FDA has the burden of showing that food is injurious to The FDCA also grants to the Secretary of Health a......
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin., Nos. 97-1604
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    • 14 Agosto 1998
    ...provisions of the Act before it can attain its end, not the end contemplated by Congress. Cf. United States v. Two Plastic Drums, 984 F.2d 814, 819 (7th Cir.1993) (rejecting another recent attempt by the FDA to enlarge its jurisdiction and stating that "the only justification for this Alice......
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9 cases
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • 25 Abril 1997
    ...761 F.Supp. 70, 72 (C.D.Ill. 1991) ("[A] court should examine a wide range of evidence, including ... actual use of the product."), aff'd, 984 F.2d 814 (7th Cir. 1993). Still other courts have expressly relied on actual use as a factor contributing to the establishment of intended use. See ......
  • Nve, Inc. v. Department of Health and Human Serv., No. 04-4481.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • 7 Febrero 2006
    ...in enforcement actions brought directly under the FDCA. See United States v. Two Plastic Drums, More or Less of an Article of Food ..., 984 F.2d 814, 816 (7th Cir.1993) (noting that the FDA has the burden of showing that food is injurious to The FDCA also grants to the Secretary of Health a......
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin., Nos. 97-1604
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    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • 14 Agosto 1998
    ...provisions of the Act before it can attain its end, not the end contemplated by Congress. Cf. United States v. Two Plastic Drums, 984 F.2d 814, 819 (7th Cir.1993) (rejecting another recent attempt by the FDA to enlarge its jurisdiction and stating that "the only justification for this Alice......
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