The defendants rejoin that "it is well established `that the
intended use of a product, within the meaning of the [FDCA], is
determined from its label, accompanying labeling, promotional
claims, advertising, and any other relevant source.'" Action on
Smoking, 655 F.2d at 239 (quoting Hanson v. United States,
417 F. Supp. 30, 35 (Minn.), affirmed 540 F.2d 947 (8th Cir.
1976)). But, contend the defendants, the gravamen of the charge
against them here is that there was no labeling on the balloons
they sold. By the defendants' logic, therefore, without at least
an allegation that representations were made by them in labeling
or advertising the balloons, the nitrous oxide they sold cannot
be considered a "drug" for the purposes of the FDCA.
The Court can find no support for the defendants' position.
Labeling is not exclusive evidence of the sellers' intent.
Rather, as the very language quoted by the defendants themselves
states, "it is well established `that the intended use of a
product, within the meaning of the [FDCA], is determined from
its label, accompanying labeling, promotional claims,
advertising, and any other relevant source.'" Action on
Smoking, 655 F.2d at 239 (emphasis added). The court in Action
on Smoking went on to acknowledge that even consumer intent
could be relevant, so long as it was pertinent to demonstrating
the seller's intent: "Whether evidence of consumer intent is a
`relevant source' for these purposes depends upon whether such
evidence is strong enough to justify an inference as to the
vendors' intent." Id. Thus, while it may be true that "`[t]he
vendors' intent in selling the product to the public is the key
element in this statutory definition.'" id., nothing limits
the attempt to discern that intent to labeling or advertising.
Instead, "the crux of FDA jurisdiction over drugs lay in
manufactures' representations as revelatory of their intent."
Id. (emphasis added); United States v. 250 Jars, Etc., of U.S.
Fancy Pure Honey, 218 F. Supp. 208, 211 (E.D.Mich. 1963) ("In
determining that a particular article was intended to be used as
a drug, a court is not limited to the labels on such article or
to the labeling which accompanies it, but may look at all
relevant sources."). Moreover, the focus on the seller's intent
is premised, at least in part, upon the fact that the FDCA
generally is concerned with protecting the public against false
or misleading representations of the healing power of various
articles placed into the stream of interstate commerce. This
case is obviously unique in that, if the government's
allegations are true, the sellers did not need to label or
advertise their product, as the environment provided the
necessary information between buyer and seller. In this context,
therefore, the fact that there was no labeling may actually
bolster the evidence of an intent to sell a mind-altering
article without a prescription — that is, a misbranded drug. The
Court thus concludes that from the surrounding circumstances of
the sales alleged in this case that the government has made a
sufficient showing that the defendants' intent to sell the
nitrous oxide was to affect "the structure or any function of
the body of man," 21 U.S.C. § 321(g)(1)(C), and thus, the
nitrous oxide involved in this case is a "drug" for the purposes
of the FDCA.
B. Whether "Private" Individuals May be Criminally
The parties also dispute whether these particular defendants
may be prosecuted