The FDA answers Traco's claims by noting that Traco has
admitted to selling BCO in a capsule form. Although the BCO in
such a capsule may not be mixed with, or react with, any other
ingredient, the Seventh Circuit in FoodScience, 678 F.2d at
738-38, has held that even a substance which is the principal
ingredient in a food may be deemed a food additive. The
majority opinion in FoodScience made no distinction between
active or principal ingredients and other ingredients. The
court simply held that "[t]he term 'component' [in the
definition of food additive] . . . includes large quantities of
unsafe substances as well as small quantities." 678 F.2d at
738. Indeed, the court cited a Second Circuit case which held,
"We do not believe a substance gains immunity from being a food
additive merely because it also qualifies as a food." Id.
(citing National Nutritional Foods Ass'n v. Kennedy,
572 F.2d 377, 391 (2nd Cir.1978)). According to the FDA, enforcement of
the Act demands that it be free to deem a substance a "food
additive," even if a common understanding of the term "food
additive" would not encompass the substance. That, claims the
FDA, is what FoodScience holds.
Yet the facts in FoodScience are readily distinguishable from
the facts in this case. There, the ingredient which the FDA
sought to characterize as a food additive constituted only 4%
of the dietary supplement. 678 F.2d at 737-38. Although the
ingredient was the principal ingredient — the reason that
consumers bought the supplement — the Seventh Circuit rejected
a principal ingredient exception to the Act. Because the
evidence proved that the ingredient was one of several
components of the dietary supplement, the FDA could properly
deem it a food additive, thus forcing the claimant to prove
that it was generally regarded as safe. Id. at 739-40.
In contrast, here, the FDA has presented no evidence that the
BCO is merely a component of the dietary supplement. Traco
asserts — and the FDA does not disprove — that it intended to
sell the seized BCO in its pure form, albeit encapsulated in a
gelatin container.*fn4 The FDA has failed to explain how
placing BCO in a gelatin container converts the BCO into a food
additive. A food additive must be a substance which is intended
to be a component of a food. See § 321(s). But BCO is more than
one of several components or even the principal component in
the dietary supplement capsule. BCO is the supplement, the
capsule's sole raison d'etre. Although the rule set out in
FoodScience is broad, it is not so broad that any substance
which is not consumed directly may be deemed a "food additive."
As Judge Cudahy noted in concurrence, "I believe . . . that
this would be a far different case if [the substance sought to
be condemned] were being marketed as a single ingredient."
FoodScience, 678 F.2d at 741 (Cudahy, J., concurring).
Although there does not appear to be a case holding that a
pure substance which is delivered to consumers by way of a
gelatin capsule may be considered a food additive, there are
cases holding that such a substance may not be considered a
food additive. See, e.g., United States v. Articles of Food
(Blue-Green Algae), No. 83-1180-FR, slip op., 1984 WL 1981
(D.Ore. November 8, 1984) (unpublished opinion); United States
v. An Article of Food (L-Tryptophan), No. 77-687, slip op.,
(D.N.J. January 23, 1979) (unpublished opinion) (Lexis copies
attached to Docket # 45). In Blue-Green Algae, Judge Frye held
that seaweed products sold in gelatin capsules — though
otherwise in their pure form — could not be considered food
additives, but should be considered the food itself. The court
concluded that because "[t]here is no evidence that the purpose
of the products is to affect the characteristics of another
food or to become a component of another food[,] . . . the
court concludes that the intended use of the [product] is not
as a 'food additive.'" Id. at 6.
Similarly, in this case, there is no proof that the BCO
affects the characteristics of another food or becomes a
component of another food. The FDA merely claims, on the
authority of FoodScience, that if a person ingests any other
substance when consuming BCO, then the BCO may be considered a
food additive. The court does not read FoodScience so broadly.
The facts in that case do not dictate such a rule and Judge
Cudahy's concurrence makes clear that at least one member of
the panel expressly rejected such a broad rule.
The court is mindful that it must interpret the Food, Drug,
and Cosmetic Act broadly to aid in protecting the public
health. FoodScience, 678 F.2d at 739 (citing United States v.
Ewig Brothers Co., Inc., 502 F.2d 715, 722 n. 27 (7th
Cir.1975)). It is also mindful, however, that in passing the
1958 food additive amendment to the Act, Congress was primarily
concerned with the addition into food of untested and
potentially unsafe flavor, texture, processing, and
preservative agents. See S.Rep. No. 2422, 85th Cong., 2d Sess.,
reprinted in 1958 U.S.Code Cong. & Admin.News 5300, 5304. BCO
is none of those things. If the FDA believes that BCO is a
harmful food, it may seek to condemn it as an "adulterated
food" under § 342(a)(1). But the agency may not seek to condemn
it by calling it something it is not. Allowing the FDA to call
a single ingredient placed into a gelatin capsule a "food
additive" would eliminate any distinction between "food" and
"food additive," terms which the Act itself defines separately.
Compare § 321(f) with § 321(s). This court cannot permit the
agency charged with enforcing the Act to redefine its terms.
IT IS THEREFORE ORDERED that the plaintiff's motion for
summary judgment (# 40) is denied.
IT IS FURTHER ORDERED that the case is set for trial
beginning December 2, 1991 at 9:00 am.