United States v. 29 Cartons ( 1993 )


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  • USCA1 Opinion









    March 3, 1993

    UNITED STATES COURT OF APPEALS
    FOR THE FIRST CIRCUIT

    _________________________

    No. 92-1945

    UNITED STATES OF AMERICA,
    Plaintiff, Appellant,

    v.

    29 CARTONS OF * * * AN ARTICLE OF FOOD, ETC.,
    Defendant.
    _________________________

    OAKMONT INVESTMENT CO., INC.,
    Claimant, Appellee.
    _________________________

    APPEAL FROM THE UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF MASSACHUSETTS

    [Hon. Joseph L. Tauro, U.S. District Judge]
    ___________________

    _________________________

    Before

    Selya, Circuit Judge,
    _____________

    Aldrich, Senior Circuit Judge,
    ____________________

    and Cyr, Circuit Judge.
    _____________
    _________________________

    Robert D. Kamenshine, Attorney, Civil Division, United
    ______________________
    States Dept. of Justice, with whom Stuart M. Gerson, Assistant
    ________________
    Attorney General, A. John Pappalardo, United States Attorney,
    ___________________
    Douglas N. Letter, Attorney, Civil Division, Margaret J. Porter,
    _________________ __________________
    Chief Counsel, United States Food & Drug Administration, and
    Leslie Kux, Associate Chief Counsel, United States Food & Drug
    __________
    Administration, were on brief, for appellant.
    Robert Ullman, with whom Jacob Laufer, Steven Shapiro, and
    _____________ ____________ ______________
    Bass & Ullman were on brief, for appellee.
    _____________

    _________________________

    March 3, 1993

    _________________________















    SELYA, Circuit Judge. The government seized, and seeks
    SELYA, Circuit Judge.
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    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
    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


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    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
    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,
    ___

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    e.g., United States v. Lexington Mill & Elevator Co., 232 U.S.
    ____ _____________ _______________________________

    399, 411 (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] add[ed] 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


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    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 ease with which the FDA may regulate a substance's sale.

    III. THE ISSUE
    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,

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    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

    ____________________

    1The district court bifurcated the trial and, during the
    initial phase, determined only that BCO does not meet the first
    prong of the bipartite food additive definition. Thus, the
    district court had no occasion to reach the second prong, viz.,
    ____
    whether BCO is GRAS. Hence, that issue is not before us.

    2In the FDA's view, the second of the two independent
    standards confers potential food additive status on substances
    that, while they are not constituent parts of a food, may
    nevertheless have deleterious effects on food. One example might
    be chemicals used in packaging food.

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    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
    ___ ___


    ____________________

    3We use the adjectival modifier "potential" because gelatin
    and glycerin are concededly GRAS. Hence, these components cannot
    be classified as food additives because neither can fulfill the
    definition's second prong.

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    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
    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., ___ F.2d ___ (7th Cir. 1993)
    ______ _______________________

    [No. 92-1172]. Employing a perspicacious analysis of the Act's

    text and legislative history, the court rejected the FDA's notion

    that all components of a substance are necessarily food
    ___

    additives. The court observed that the "'or otherwise'" phrase

    contained in the statutory definition of a food additive targets

    only those components that "have the purpose or effect of

    altering a food's characteristics." Id. at ___ [slip op. at 6-
    ___

    7]. The subsequent enumeration of sample food additives,

    describing each substance by its "function or by [its] effect on

    food," makes it clear that an additive must stimulate some change

    in a food to which it is added. Id. at ___ [slip op. at 6].
    ___

    Turning to the legislative history, the court observed that the

    FDA's broad definition of a food additive, which would apply to

    all components, even a substance which comprises the only active

    ingredient of the whole, subverts congressional purpose.

    Blurring the distinction between food additives and food in this

    way would permit the agency to tilt a delicately balanced


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    statutory scheme that allocates the burden of proving an

    additive's safety to the processors while leaving the burden of

    establishing a food's safety with the FDA. See id. at ___ [slip
    ___ ___

    op. at 8-9].

    The Seventh Circuit also recognized the incongruity of

    categorizing a food's single active component as an additive.

    Because "that single component does not affect the

    characteristics of the food in question rather, it constitutes

    the food," id. at ___ [slip op. at 7], it has no place within
    ___

    "the common understanding of an additive, defined by Webster as

    'a substance added to another . . . to impart or improve

    desirable properties or suppress undesirable properties.'" Id.
    ___

    at __ n.3 [slip op. at 7 n.3] (citation omitted). Thus, in order

    to qualify as a food additive, a component must be added to a

    food in order to change that food's properties. See id. at ___
    ___ ___

    [slip op. at 7-8]. On that basis, pure BCO, in capsule form, is

    not a food additive. See id. at ___ [slip op. at 11].
    ___ ___

    Judges should hesitate to write lengthy opinions merely

    for the sake of committing their own prose to posterity. Given

    the existence of a cogent, well-reasoned, eminently correct

    opinion closely on point, we embrace it. We will, therefore,

    affirm the judgment below for substantially the reasons

    elucidated in Two Plastic Drums. We pause, nevertheless, to
    __________________

    essay a few additional observations.

    First: We are reluctant to believe that Congress
    First:
    _____

    traffics in absurdities. Since it defies common sense to say


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    that a substance can be a "food additive" when there is no

    (other) food to which it is added, we think that the FDA's

    reading of the Act is nonsensical, and, hence, must be incorrect.

    Moreover, classifying BCO as a "component" merely because it is

    combined with two totally inert substances serving collectively

    as a carrier medium would itself create a bizarre paradox: as

    the Seventh Circuit noted, "to hold that BCO is a component of

    the dietary supplement would be to find that BCO is a component

    of itself." Two Plastic Drums, ___ F.2d at ___ [slip op. at 5].
    _________________

    Second: In the FDA's estimation, a processor's
    Second:
    ______

    "subjective intent" that only one of a product's components

    constitutes the food is irrelevant because "it is the objective
    _________

    intended use, i.e., the intent to combine two or more components,
    ____

    that counts." Appellant's Brief at 11. But, this harangue

    misses the mark. We fully agree that a processor's subjective

    determination of what constitutes a food is not determinative in

    cases of this stripe but neither is the naked fact that more

    than one component has been combined. In the final analysis,

    what counts is the use of an ingredient for its effect on food.

    Here, from an objective standpoint, BCO is not being used for its

    effect on gelatin and glycerine. Thus, contrary to the FDA's

    loudly expressed fears, eschewing its rendition of the statutory

    text will not supplant objectivity with subjectivity.4

    ____________________

    4Moreover, if the FDA worries that processors may muck the
    statutory classifications with convenient recitals of subjective
    intent, we question the agency's espousal of a rule that would
    "arbitrarily classify a substance as either food or food additive
    by how it is marketed rather than by the nature and use of the

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    Third: The FDA also maintains that because "the
    Third:
    _____

    ingredients of multi-ingredient food products, such as cake

    mixes," indisputably fall within the food additive definition,

    the statute could not possibly contain a "requirement that a

    substance must be added to a preexisting food, which it must be
    ___________

    shown actually to affect." Appellant's Brief at 9. We disagree.

    Cake mixes are foods composed of many interacting food additives,

    each with its particular effect on the whole.5 Absent any one

    ingredient, the concoction remains a cake mix, albeit one that

    may be short on sweetness or lumpy in texture. In that sense,

    cake mixes and products of that ilk are a far cry from a dietary

    supplement composed of a single active ingredient. What

    differentiates this case is that, if the BCO is removed, one is

    left with nothing but an empty capsule.

    Fourth: We think it advisable to mention the FDA's
    Fourth:
    ______

    insistence, citing Chevron U. S. A. Inc. v. NRDC, Inc., 467 U.S.
    ______________________ __________

    837, 843 (1984), that we must obey its interpretation of the Act.

    In our estimation, the purely legal question facing us in this

    case presents no occasion for deference. In this realm of

    judicial expertise, the courts, not the agency, have the last

    ____________________

    substance itself." Two Plastic Drums, ___ F.2d at ___ [slip op.
    _________________
    at 9]. In the words of Sir Francis Bacon, the FDA's suggested
    "remedy is worse than the disease."

    5We do not quarrel with those courts that have held, when
    confronted with multi-ingredient products containing two or more
    active ingredients, that each active ingredient is potentially a
    food additive. See, e.g., United States v. 45/194 Kg. Drums,
    ___ ____ _____________ __________________
    Etc., 961 F.2d 808, 812 n.3 (9th Cir.), cert. denied, 113 S. Ct.
    ____ _____ ______
    375 (1992); FoodScience, 678 F.2d at 738; United States v. 41
    ___________ ______________ __
    Cases, Etc., 420 F.2d 1126, 1130 (5th Cir. 1970).
    ___________

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    word. See id. at 843 n.9 ("The judiciary is the final authority
    ___ ___

    on issues of statutory construction . . . ."); BATF v. FLRA, 464
    ____ ____

    U.S. 89, 98 n.8 (1983) (observing that "deciding what a statute

    means" is "the quintessential judicial function"); FTC v.
    ___

    Colgate-Palmolive Co., 380 U.S. 374, 385 (1965) (holding that
    ______________________

    "legal standard[s] . . . must get their final meaning from

    judicial construction"); Wilcox v. Ives, 864 F.2d 915, 924 (1st
    ______ ____

    Cir. 1988) (quoting BATF v. FLRA, supra).
    ____ ____ _____

    At any rate, the true measure of a court's willingness

    to defer to an agency's interpretation of a statute "depends, in

    the last analysis, on the persuasiveness of the interpretation,

    given all the attendant circumstances." Massachusetts Dep't of
    ______________________

    Educ. v. United States Dep't of Educ., 837 F.2d 536, 541 (1st
    _____ ______________________________

    Cir. 1988). "The simple fact that the agency has a position, in
    ___

    and of itself, is of only marginal significance." Mayburg v.
    _______

    Secretary of HHS, 740 F.2d 100, 106 (1st Cir. 1984). When, as
    _________________

    now, a court is persuaded neither by "the validity of [the

    agency's] reasoning," nor by the interpretive fit between the

    agency's rendition, on the one hand, and the language and

    structure of the statute, on the other hand, a court should not

    defer.6 Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).
    ________ ___________

    ____________________

    6The longevity of an agency's position is often significant
    in assaying the degree of deference owed to it. See Bowen v.
    ___ _____
    Georgetown Univ. Hosp., 488 U.S. 204, 212 (1988) (refusing to
    _______________________
    apply Chevron deference to "agency litigating positions that are
    _______
    wholly unsupported by regulations, rulings, or administrative
    practice"); Skidmore, 323 U.S. at 140 (acknowledging the value of
    ________
    "consistency" in respect to gauging persuasiveness). Here, the
    FDA's position is of recent vintage. Indeed, the original
    complaint in this action pinned food additive status not on BCO
    but on gamma linolenic acid, BCO's fatty acid constituent. And,
    in a prior case involving blue-green algae in gelatin capsule
    form, the FDA argued that the blue-green algae was an additive

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    V. CONCLUSION
    V. CONCLUSION

    We need go no further. The proposition that placing a

    single-ingredient food product into an inert capsule as a

    convenient method of ingestion converts that food into a food

    additive perverts the statutory text, undermines legislative

    intent, and defenestrates common sense. We cannot accept such

    anfractuous reasoning.



    Affirmed.
    Affirmed.
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    ____________________

    because it was to be consumed with water or other foods or
    liquids, not because of its placement in gelatin capsules. See
    ___
    United States v. Articles of Food [Blue-Green Algae], No. 83-
    ______________ _____________________________________
    1180-FR, 1984 WL 1981, at *3-*4 (D. Or. Nov. 8, 1984).

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