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USCA1 Opinion
March 3, 1993
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
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No. 92-1945
UNITED STATES OF AMERICA,
Plaintiff, Appellant,
v.
29 CARTONS OF * * * AN ARTICLE OF FOOD, ETC.,
Defendant.
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OAKMONT INVESTMENT CO., INC.,
Claimant, Appellee.
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APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Joseph L. Tauro, U.S. District Judge]
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Before
Selya, Circuit Judge,
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Aldrich, Senior Circuit Judge,
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and Cyr, Circuit Judge.
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Robert D. Kamenshine, Attorney, Civil Division, United
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States Dept. of Justice, with whom Stuart M. Gerson, Assistant
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Attorney General, A. John Pappalardo, United States Attorney,
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Douglas N. Letter, Attorney, Civil Division, Margaret J. Porter,
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Chief Counsel, United States Food & Drug Administration, and
Leslie Kux, Associate Chief Counsel, United States Food & Drug
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Administration, were on brief, for appellant.
Robert Ullman, with whom Jacob Laufer, Steven Shapiro, and
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Bass & Ullman were on brief, for appellee.
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March 3, 1993
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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
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affirm the district court's dismissal of the government's in rem
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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
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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.
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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
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seizing the bottles on the ground that they "allegedly contain[]
an unsafe food additive." Id. at 142.
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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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3
e.g., United States v. Lexington Mill & Elevator Co., 232 U.S.
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399, 411 (1914); United States v. An Article of Food [FoodScience
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Labs., Inc.], 678 F.2d 735, 741 n.3 (7th Cir. 1982) (Cudahy, J.,
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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
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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,
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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.,
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2d Sess. (1958), reprinted in 1958 U.S.C.C.A.N. 5300, 5301-02
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(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
4
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.
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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
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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
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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.,
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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
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141 (quoting 21 U.S.C. 321(f)), whereas a food additive is
defined by its effect on another substance, see id., the district
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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
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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
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States v. Two Plastic Drums, Etc., ___ F.2d ___ (7th Cir. 1993)
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[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
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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-
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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].
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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
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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
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"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.
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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 ___
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[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].
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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
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essay a few additional observations.
First: We are reluctant to believe that Congress
First:
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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].
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Second: In the FDA's estimation, a processor's
Second:
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"subjective intent" that only one of a product's components
constitutes the food is irrelevant because "it is the objective
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intended use, i.e., the intent to combine two or more components,
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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
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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:
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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
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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:
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insistence, citing Chevron U. S. A. Inc. v. NRDC, Inc., 467 U.S.
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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
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substance itself." Two Plastic Drums, ___ F.2d at ___ [slip op.
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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,
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Etc., 961 F.2d 808, 812 n.3 (9th Cir.), cert. denied, 113 S. Ct.
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375 (1992); FoodScience, 678 F.2d at 738; United States v. 41
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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
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on issues of statutory construction . . . ."); BATF v. FLRA, 464
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U.S. 89, 98 n.8 (1983) (observing that "deciding what a statute
means" is "the quintessential judicial function"); FTC v.
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Colgate-Palmolive Co., 380 U.S. 374, 385 (1965) (holding that
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"legal standard[s] . . . must get their final meaning from
judicial construction"); Wilcox v. Ives, 864 F.2d 915, 924 (1st
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Cir. 1988) (quoting BATF v. FLRA, supra).
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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
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Educ. v. United States Dep't of Educ., 837 F.2d 536, 541 (1st
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Cir. 1988). "The simple fact that the agency has a position, in
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and of itself, is of only marginal significance." Mayburg v.
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Secretary of HHS, 740 F.2d 100, 106 (1st Cir. 1984). When, as
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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).
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6The longevity of an agency's position is often significant
in assaying the degree of deference owed to it. See Bowen v.
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Georgetown Univ. Hosp., 488 U.S. 204, 212 (1988) (refusing to
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apply Chevron deference to "agency litigating positions that are
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wholly unsupported by regulations, rulings, or administrative
practice"); Skidmore, 323 U.S. at 140 (acknowledging the value of
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"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
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United States v. Articles of Food [Blue-Green Algae], No. 83-
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1180-FR, 1984 WL 1981, at *3-*4 (D. Or. Nov. 8, 1984).
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Document Info
Docket Number： 92-1945
Filed Date： 3/3/1993
Precedential Status： Precedential
Modified Date： 3/3/2016