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 ...