US v. 29 Cartons of*** An Article of Food, No. 92-1945.

CourtUnited States Courts of Appeals. United States Court of Appeals (1st Circuit)
Writing for the CourtSELYA, Circuit , ALDRICH, Senior Circuit , and CYR, Circuit
Citation987 F.2d 33
PartiesUNITED STATES of America, Plaintiff, Appellant, v. 29 CARTONS OF * * * AN ARTICLE OF FOOD, ETC., Defendant. Claim of OAKMONT INVESTMENT CO., INC., Claimant, Appellee.
Docket NumberNo. 92-1945.
Decision Date03 March 1993

987 F.2d 33

UNITED STATES of America, Plaintiff, Appellant,
v.
29 CARTONS OF * * * AN ARTICLE OF FOOD, ETC., Defendant.

Claim of OAKMONT INVESTMENT CO., INC., Claimant, Appellee.

No. 92-1945.

United States Court of Appeals, First Circuit.

Heard February 1, 1993.

Decided March 3, 1993.


987 F.2d 34

Robert D. Kamenshine, Atty., Civil Div., U.S. Dept. of Justice, with whom Stuart M. Gerson, Asst. Atty. Gen., Washington, DC, A. John Pappalardo, U.S. Atty., Boston, MA, Douglas N. Letter, Atty., Civil Div., Margaret J. Porter, Chief Counsel, and Leslie Kux, Associate Chief Counsel, U.S. Food & Drug Admin., Washington, DC, were on brief, for appellant.

Robert Ullman, with whom Jacob Laufer, Steven Shapiro, and Bass & Ullman, New York City, were on brief, for appellee.

Before SELYA, Circuit Judge, ALDRICH, Senior Circuit Judge, and CYR, Circuit Judge.

SELYA, Circuit Judge.

The government seized, and seeks to condemn, twenty-nine cartons of undiluted black currant oil (BCO), in capsule form, owned by claimant-appellee Oakmont Investment Co. (Oakmont), alleging that BCO is a food additive of questionable safety. Because we believe that encapsulated BCO, intended to be ingested as purchased, cannot properly be termed a food additive as defined in the Federal Food, Drug, and Cosmetic Act (the Act), as amended, 21 U.S.C. §§ 301 et seq. (1988), we affirm the district court's dismissal of the government's in rem complaint.

I. BACKGROUND

On October 11, 1988, the United States Food and Drug Administration (FDA) seized 200 bottles of encapsulated BCO, packed in twenty-nine cartons, and brought

987 F.2d 35
an in rem action contending that, under 21 U.S.C. § 342(a)(2)(C), the capsules should be condemned as "adulterated" food because they contain a "food additive," the BCO, that Oakmont had not proven to be safe

At the ensuing bench trial, certain facts were uncontradicted. BCO is a liquid obtained by squeezing black currant berry seeds. It is composed of polyunsaturated fatty acids. In its pure liquid form, it can be ingested by the spoonful as a dietary supplement. However, Oakmont markets BCO in capsules which are to be swallowed whole. The capsules contain pure BCO — nothing more. They are made from gelatin and glycerin (or an equivalent plasticizer) and have no independent nutritional value. Rather, a capsule serves a dual purpose as a container (enabling consumers to ingest predetermined quantities of BCO in solid form) and as a prophylactic (protecting the BCO from rancidity).

On these and other facts, the district court dismissed the government's complaint and ordered the capsules released. See United States v. 29 Cartons, Etc., 792 F.Supp. 139, 142 (D.Mass.1992). The court reasoned that when, as in this case, BCO comprises the only active ingredient within a gelatin capsule, it can properly be classified as a "food," but not as a "food additive." See id. at 141-42. Accordingly, the FDA erred in seizing the bottles on the ground that they "allegedly contain an unsafe food additive." Id. at 142.

When the FDA appealed, the district court stayed its release order.

II. THE REGULATORY LANDSCAPE

To put this case into workable perspective, we first review the relevant statutory provisions. The Act defines "food" as:

(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

21 U.S.C. § 321(f). The FDA concedes that pure BCO (sold, say, as a bottled liquid) falls within section 321(f)(1) and is, therefore, "food." Substances classified as "food" are presumed safe. Thus, the FDA can prevent sale of bottled BCO or any other "food" only if it proves by a preponderance of the evidence that the food is "injurious to health." 21 U.S.C. § 342(a)(1); see, e.g., United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 411, 34 S.Ct. 337, 340, 58 L.Ed. 658 (1914); United States v. An Article of Food FoodScience Labs., Inc., 678 F.2d 735, 741 n. 3 (7th Cir.1982) (Cudahy, J., concurring). Although the FDA suspects that BCO may be unhealthful, it is unable at the present time to translate this suspicion into legally competent proof.

In addition to regulating the sale of food per se, the Act contains provisions anent food additives. These provisions are designed to protect consumers against the introduction of untested and potentially unsafe substances, such as flavor, texture, or preservative agents, into food. A gloss was added to the treatment of food additives in 1958. See Pub.L. No. 85-929, 72 Stat. 1784 (1958) (codified in scattered sections of 21 U.S.C.). Unlike section 342(a)(1), which places the burden of proving injuriousness upon the government in respect to foods, the food additives amendment allocates the burden quite differently: the FDA can prevent the sale of products containing a food additive unless and until the processor shows that the substance, when added to food, is generally recognized as safe (in the vernacular, "GRAS"). See S.Rep. No. 2422, 85th Cong., 2d Sess. (1958), reprinted in 1958 U.S.C.C.A.N. 5300, 5301-02 (explaining the processor's burden "of proving that a newly discovered substance which ... is added to the food we eat is safe"). Thus, in contrast to the Act's treatment of "food," any substance that meets the Act's definition of a "food additive" is presumed to be "unsafe" under 21 U.S.C. § 348 until the FDA, or more particularly, the Commissioner of Food and Drugs, has promulgated a regulation prescribing conditions assuring safe use. See 21 U.S.C. § 348(a)(2); 21 C.F.R. § 5.10(a)(1) (1992).

The 1958 amendment defines a food additive in pertinent part as:

987 F.2d 36
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). To be labeled a food additive, then, a substance must (1) be intended, or reasonably expected, to become a component of food or to otherwise affect the characteristics of food, and (2) not be GRAS.

The Act thus creates a distinction between foods and food additives which has meaningful consequences for purveyors and for the public. The distinction also significantly affects the case with which the FDA may regulate a substance's sale.

III. THE ISSUE

This appeal revolves around the question of whether the FDA or Oakmont must carry out the research necessary to show that BCO is, or is not, GRAS. The issue reduces to whether pure BCO, when sold in encapsulated form, must be regulated as a "food" within the meaning of section 321(f) or as a "food additive" within the meaning of section 321(s).

The meat of the parties' disagreement lies in their differing interpretations of that portion of the Act which states that a substance can be a food additive if its intended use results, or may be expected to result, "in its becoming a component or otherwise affecting the characteristics of any food." 21 U.S.C. § 321(s).1 The FDA reads the quoted language as creating two independent and disjunctive standards: to satisfy the first prong...

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24 practice notes
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    • United States
    • Federal Register January 06, 2000
    • January 6, 2000
    ...a dietary supplement is misbranded. The comment cited two court opinions, United States v. 29 Cartons * * * 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 propositi......
  • In re Pharmaceutical Industry, M.D.L. No. 1456 (D. Mass. 5/13/2003), M.D.L. No. 1456.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • May 13, 2003
    ...that "deciding what a statute means" is "the quintessential judicial function"); United States v. 29 Cartons of *** An Article of Food, 987 F.2d 33, 38 (1st Cir 1993) (same). The fact that congressional hearings have been held, congressional reports generated, and executive branch statement......
  • In re Pharm Indus. Average Wholesale Price Lit., No. 1456,
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    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
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    ...that "deciding what a statute means" is "the quintessential judicial function"); United States v. 29 Cartons of an Article of Food, 987 F.2d 33, 38 (1st Cir.1993) (same). The fact that congressional hearings have been held, congressional reports generated, and executive branch statements on......
  • Alliance For Natural Health U.S. v. Sebelius, Civil Action No. 09–1523 (BAH).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • April 6, 2011
    ...under its authority to regulate food additives. See [775 F.Supp.2d 117] United States v. 29 Cartons of * * * an Article of Food, 987 F.2d 33, 35–36 (1st Cir.1993). Since DSHEA's enactment, dietary supplements have remained generally regulated as a subset of foods, rather than drugs, but sev......
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23 cases
  • In re Pharmaceutical Industry, M.D.L. No. 1456 (D. Mass. 5/13/2003), M.D.L. No. 1456.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • May 13, 2003
    ...that "deciding what a statute means" is "the quintessential judicial function"); United States v. 29 Cartons of *** An Article of Food, 987 F.2d 33, 38 (1st Cir 1993) (same). The fact that congressional hearings have been held, congressional reports generated, and executive branch statement......
  • In re Pharm Indus. Average Wholesale Price Lit., No. 1456,
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • May 13, 2003
    ...that "deciding what a statute means" is "the quintessential judicial function"); United States v. 29 Cartons of an Article of Food, 987 F.2d 33, 38 (1st Cir.1993) (same). The fact that congressional hearings have been held, congressional reports generated, and executive branch statements on......
  • Alliance For Natural Health U.S. v. Sebelius, Civil Action No. 09–1523 (BAH).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • April 6, 2011
    ...under its authority to regulate food additives. See [775 F.Supp.2d 117] United States v. 29 Cartons of * * * an Article of Food, 987 F.2d 33, 35–36 (1st Cir.1993). Since DSHEA's enactment, dietary supplements have remained generally regulated as a subset of foods, rather than drugs, but sev......
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