United States District Court, Central District of Illinois, Danville Division
November 27, 1991
UNITED STATES OF AMERICA, PLAINTIFF,
TWO PLASTIC DRUMS, MORE OR LESS OF AN ARTICLE OF FOOD, LABELED IN PART: VIPONTE LTD. BLACK CURRANT OIL BATCH NO. BOOSF 039, ETC., DEFENDANTS. CLAIM OF TRACO LABS, INC., CLAIMANT.
The opinion of the court was delivered by: Baker, District Judge.
ORDER ON TRACO'S MOTION FOR SUMMARY JUDGMENT
This is an in rem seizure action under the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. § 301-394 (1972 & Supp.) (the
"Act"). The plaintiff, the United States of America, through
the Food and Drug Administration, seeks to condemn and destroy
two drums of black currant oil ("BCO"). BCO is extracted from
the seeds of the black currant berry and is marketed as a
dietary supplement.*fn1 Its proponents claim that it provides
health benefits because of its unique fatty-acid structures.
The claimant, Traco Labs, Inc., asserts that the drums belong
to it and that they cannot be condemned. Traco has moved for
summary judgment pursuant to Fed.R.Civ.P. 56 and the FDA
As the basis for condemning the BCO, the FDA claims that the
BCO is "adulterated." Under the relevant portions of 21 U.S.C. § 342,
"A food shall be deemed to be adulterated — (a)(1) If
it bears or contains any poisonous or deleterious substance
which may render it injurious to health . . . [or (2)(C)] if it
is, or it bears or contains, any food additive which is unsafe
within the meaning of section 348 of this title. . . ." The Act
defines food additive in 21 U.S.C. § 321(s) as
any substance, the intended use of which results
or may reasonably be expected to result, directly
or indirectly, in its becoming a component . . .
of any food . . . if such substance is not
generally recognized, among experts qualified by
scientific training and expertise to evaluate its
safety, as having been shown through scientific
procedures . . . to be safe under the conditions
of its intended use.
Under section 348, a food additive is deemed to be unsafe
unless the Secretary has specifically issued regulations for
Under this statutory scheme, therefore, if the FDA can show
that a substance is a "food additive" that has not been deemed
safe by the Secretary, the proponent of the substance has the
burden of showing that the substance is generally regarded by
experts as safe (GRAS). If the FDA cannot show that the
substance is a food additive, then in order to confiscate it as
an "adulterated food," the FDA has the additional burden of
showing that the substance is injurious to health.
The FDA has claimed throughout this suit that BCO is a food
additive, and therefore has not attempted to prove that it is
injurious to health. According to Dr. Paul Kuznesof, an expert
for the FDA, a gelatin capsule is an FDA-approved functional
component of food which serves as a "convenient system for
delivery of reproducible and quantitative amount of other
and also can serve to cover up the unpleasant taste of the
filler substance. Exh. 2 to plaintiff's opp. to summary
judgment. The FDA's basic contention is that when it is
encapsulated, the BCO becomes a "component" of the entire
supplement, which includes the capsule and the BCO. In January,
1991, the FDA moved for summary judgment, claiming that the
evidence clearly showed that BCO was a food additive and that
the claimants had provided no evidence that it was generally
regarded as safe. This court denied that motion in an order of
April 10, 1991, 761 F. Supp. 70 (C.D.Ill.1991). In so doing,
this court explained that in none of the uses for which BCO was
intended would BCO be a "component" of a dietary supplement,
but rather, BCO is the dietary supplement. Therefore, we
determined that BCO is not a food additive; it is merely a
food. Relying on this court's April 10, 1991 order, Traco now
moves for summary judgment. In objecting to Traco's motion, the
FDA continues to argue that BCO is a food additive within the
meaning of the Act and it urges this court to reconsider its
prior determination. The FDA has not provided this court with a
statement of any genuine issues of fact, but argues instead
that the case can be resolved as a matter of law.
It is important to note that the statutory definition of a
substance under the Act does not depend on any inherent
properties of the substance, but rather, it depends on how the
vendor of the substance intends the substance to be used.
National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325, 333,
(2d Cir. 1977); Nutrilab Inc. v. Schweiker, 713 F.2d 335, 337
(7th Cir. 1983). Therefore, the fact that a substance similar
to BCO has been held to be a food additive in another context
may not be relevant to the facts of this case.
In United States v. An Article of Food . . . FoodScience,
678 F.2d 735 (7th Cir. 1982), the Court of Appeals refused to
recognize an exception to the definition of "food additive" for
principal ingredients. The party urging such an exception had
argued that in enacting the Act, Congress was mainly concerned
with "substances that become a component of or affect food in
some subtle or incidental fashion, such as substances 'intended
for use in producing, manufacturing, packing, processing etc.'"
In that case, analogous to BCO, the substance in question was
sold in tablet form. However, the substance was "the lesser of
two active components of the tablets . . . and account[ed] for
less than 4% of each tablet's weight." The court held,
therefore, that the substance was a food additive.
This court, in its April 10, 1991 order distinguished
FoodScience from the facts of this case. We pointed out that in
FoodScience, Judge Cudahy, in his concurring opinion, explained
why, in his view, a substance which is marketed as a single
ingredient is not within the definition of "food additive":
Limiting the definition of "food additive" to
substances which are either added to or sold in
combination with other active ingredients not only
comports with common usage, but also makes sense
from the point of view of informing the consumer.
When food substances . . . are combined with other
"beneficial" ingredients and sold under . . .
unrevealing brand names . . ., consumers may well
be unaware of the presence of, or potential
dangers associated with, each of the product's
individual ingredients; a broad prophylactic rule
such as the burden-shifting "food additive"
presumption is therefore appropriate. When
substances . . . are marketed in pure form,
however, and are properly labeled as such,
consumers can more reasonably be expected to know
what they are buying and, thus, can safely be given
the opportunity to weigh for themselves the
benefits and risks of their purchase.
FoodScience, 678 F.2d at 741-42 (emphasis in original) (Cudahy,
The FDA urges this court to reconsider its prior holding
first by pointing out a recent Seventh Circuit decision which
held that the FDA should be given discretion in interpreting
ambiguous provisions of the Act as long as those provisions do
not involve the "very scope of the agency's authority."
United States v. 25 Cases . . . Sensor Pads, 942 F.2d 1179 (7th
Cir. 1991) (aff'g order of June 14, 1990, 89 C 2114 (C.D.Ill)).
In that case, the court agreed with the FDA's interpretation of
the word "devices" but also held that even if the statute were
ambiguous, it would defer to the agency's reasonable
determination. [However, the seventh circuit may be only paying
lip service to the idea of deference to the agency since it did
engage in its own analysis of the meaning of the term.]
The FDA also stresses the importance of National Nutritional
Foods Ass'n v. Kennedy, 572 F.2d 377 (2d Cir. 1978), which held
that vitamins and minerals could be regulated as food
additives. The court held that the fact that an item could be
classified as a food did not preclude it from being classified
as a food additive as well. The opinion in that case did not
specifically deal with whether a vitamin encapsulated as a
single ingredient was a "component" of food. However, the FDA
points out that the regulation in question in that case applied
to dietary supplements that consisted of a single vitamin or
mineral. Nevertheless, this court considered National
Nutritional Foods Ass'n and rejected application of that case
to the facts of this case.
The FDA also brings to the court's attention decisions from
other district courts which differ from this court on whether
a substance such as BCO could be a food additive. In United
States v. Approx. 180 Kg. Bulk Metal Drums . . . Efamol,
761 F. Supp. 180 (D.Me.1991), the District Court of Maine ordered
the condemnation of two types of capsules which contain BCO on
the grounds that the BCO was a food additive that was not GRAS
and not regulated by the FDA. That same court denied
reconsideration based on this court's April 10, 1991 order.
However, that case differs from this case because in that case,
the BCO was not the sole ingredient in the capsules. It was
undisputed in that case that the BCO capsules contained:
(4) "Efamol PMS" capsules containing black currant
oil (hereinafter BCO), fish oil, various vitamins
and minerals; and
(5) "Efamax" capsules containing BCO, fish oil,
various vitamins and minerals and other
Efamol at 182. In this case, on the other hand, the FDA has
taken the position that the BCO would be a food additive even
if it were the sole ingredient in the capsules.*fn4
addition, the FDA cites United States v. Article of Food . . .
Orotic Acid, 414 F. Supp. 793 (E.D.Mo.1976), which concerned
orotic acid, a substance found naturally in cow's milk and also
manufactured through a fermentation process. That court found
the orotic acid to be a food additive, and ordered its
condemnation. However, the opinion does not discuss whether the
orotic acid was intended to be marketed as a single ingredient
or whether it was mixed with other substances before it was to
The FDA also urges that the legislative history of the Act
demonstrates that the term "food additive" should be construed
broadly, to enable the FDA to protect the public. They point
out that their own regulations have recognized "nutrient
substances used in dietary supplements as substances whose
intended use results in their becoming a component of food,"
and that Congress has not disagreed with that interpretation.
Nothing that the FDA has provided in opposition to the
claimant's motion for summary judgment persuades the court to
alter its prior determination that the BCO impounded by the
government in this case is not a food additive under 21 U.S.C. § 321(s).
The definition of food additive urged on this court
by the FDA would obscure any distinction between "foods"
under § 321(f) and "food additives" under § 321(s). The FDA is
correct that many substances that qualify as foods also qualify
as food additives, and as a matter of fact, food additives may
be foods. However, the FDA's reasoning suggests that all foods
that are not generally recognized as safe are food additives,
and Congress could not have intended that result.
IT IS THEREFORE ORDERED that claimant's motion for summary
judgment is granted (docket # 62) and the clerk is order to
enter judgment in favor of the claimant, Traco Labs, Inc.
IT IS FURTHER ORDERED that claimant's motion to bifurcate
pursuant to Fed. R.Civ.P. 42(b) (docket # 81) is moot.