US v. 29 Cartons of*** An Article of Food

• Decision Date: 03 March 1993
• Docket Number: No. 92-1945.,92-1945.
• Citation: 987 F.2d 33
• Parties: UNITED STATES of America, Plaintiff, Appellant, v. 29 CARTONS OF * * * AN ARTICLE OF FOOD, ETC., Defendant. Claim of OAKMONT INVESTMENT CO., INC., Claimant, Appellee.
• Court: U.S. Court of Appeals — First Circuit

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.

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 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:

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 of the food additive definition, a substance must either (1) be a component of food, or (2) otherwise affect the characteristics of food. Because each constituent part or element of a food (that is, each "component") necessarily affects the food's characteristics, the FDA considers every component, at least potentially, see infra note 3, to be a food additive.² Drawing on this interpretation, the FDA asserts that the seized capsules are composed of three consumable components — BCO, gelatin, and glycerin — and that, therefore, each of these three ingredients is subject to potential regulation as a food additive.³

As Oakmont parses the statute, it creates only a single, unitary food additive standard. The phrase "or otherwise affecting the characteristics of any food" signals that a component is potentially a food additive only if it affects the characteristics of some food to which it is added. Unlike the FDA's interpretation, Oakmont's interpretation attaches no significance to a substance's mere presence as a component of a whole. It focuses instead on the substance's affirmative use in a way that affects food.

Applying its interpretation of the statute to the facts at bar, Oakmont argued below, as it does here, that the BCO contained in the seized capsules is itself a food and not a component of some other food, that it is intended so to serve, and that its sale in a convenient carrier medium does not transmogrify it into a food additive. In holding that food is defined "by its `use for food,'" 29 Cartons, 792 F.Supp. at 141 (quoting 21 U.S.C. § 321(f)), whereas a food additive is defined by its effect on another substance, see id., the district court substantially adopted Oakmont's reading of the law and its focus on a substance's intended function.

In specific terms, then, we must determine whether, as the FDA would have it, any element of any substance that has more than one component may be branded a food additive, or, rather, whether, as Oakmont urges and the court below believed, such treatment should be reserved for elements which, when so added, effect a change (or, at least, could be expected to effect a change) in some other active ingredient.

IV. FOOD FOR THOUGHT

The Seventh Circuit has recently grappled with a factually similar case presenting this very issue. See United States v. Two Plastic Drums, Etc., 984 F.2d 814 (7th Cir.1993). Employing a...