Certain machines bearing no labeling other than name and serial
number were shipped in interstate commerce. Subsequently, but as a
part of the same transaction, there were shipped to the same
consignee certain leaflets containing allegedly false and
misleading statements relative to the value of the machines in the
diagnosis, prevention, treatment and cure of disease. These
leaflets were used by the consignee in explaining the use of the
machines to his patients and in selling some of them to
patients.
Held: the separate shipment of the machines and
leaflets did not prevent the machines from being subject to
condemnation under § 304(a) of the Federal Food, Drug, and
Cosmetic Act, 52 Stat. 1044, 21 U.S.C. § 334, as devices
"misbranded when introduced into" interstate commerce.
Kordel
v. United States, ante, p.
335 U. S. 345. Pp.
335 U. S.
355-358.
164 F.2d 245 reversed.
A federal district court ordered certain machines condemned
under § 304(a) of the Federal Food, Drug, and Cosmetic Act, 52
Stat. 1044, 21 U.S.C. § 334. The Court of Appeals reversed.
164 F.2d 245. This Court granted certiorari. 333 U.S. 872.
Reversed, p.
335 U. S.
358.
Opinion of the Court by MR. JUSTICE DOUGLAS, announced by MR.
JUSTICE REED.
The United States filed a libel under the Federal Food, Drug,
and Cosmetic Act (52 Stat. 1044, 21 U.S.C. § 334)
Page 335 U. S. 356
seeking seizure of 16 machines labeled "Sinuothermic." The libel
alleged that the device was misbranded within the meaning of the
Act, 52 Stat. 1050, 21 U.S.C. § 352(a), in that
representations in a leaflet entitled "The Road to Health" relative
to the curative and therapeutic powers of the device in the
diagnosis, cure, mitigation, treatment, and prevention of disease
were false and misleading. It charged that the leaflet had
accompanied the device in interstate commerce.
Respondent, Fred Urbuteit, appeared as claimant of several of
the devices. He admitted that the devices and leaflets had been
shipped in interstate commerce, but denied that they were shipped
together, or that they were related to each other. He also denied
that the statements made in the leaflet were false or misleading.
The case was tried without a jury, and the articles were ordered
condemned. The judgment was reversed by the Court of Appeals. 164
F.2d 245. The case is here on certiorari to resolve the conflict
between it and
Kordel v. United States, ante, p.
335 U. S. 345.
Respondent Urbuteit terms himself a naturopathic physician, and
conducts the Sinuothermic Institute in Tampa, Florida. The machines
against which the libel was filed are electrical devices allegedly
aiding in the diagnosis and cure of various diseases and physical
disorders such as cancer, diabetes, tuberculosis, arthritis, and
paralysis. The alleged cures effected through its use are described
in the allegedly false and misleading leaflet, "The Road to
Health," published by Urbuteit and distributed for use with the
machines.
Urbuteit shipped from Florida a number of these machines to one
Kelsch, a former pupil of his who lives in Ohio. Kelsch used these
machines in treating his patients and, though he did not receive
them as a merchant, he sold some to patients. As part of this
transaction, Urbuteit contracted to furnish Kelsch with a supply of
leaflets,
Page 335 U. S. 357
which were sent from Florida to Ohio at a different time than
when the machines were forwarded. Kelsch used the leaflets to
explain the machines to his patients.
The leaflets seem to have followed the shipment of the machines.
But, as
Kordel v. United States, supra, holds, that is
immaterial where the advertising matter that was sent was designed
to serve and did in fact serve the purposes of labeling. This
machine bore only the words "U.S. Patent Sinuothermic Trade Mark."
It was the leaflets that explained the usefulness of the device in
the diagnosis, treatment, and cure of various diseases. Measured by
functional standards, as § 201(m)(2) of the Act permits, these
leaflets constituted one of the types of labeling which the Act
condemns.
The power to condemn is contained in § 304(a), and is
confined to articles "adulterated or misbranded when introduced
into or while in interstate commerce."
* We do not,
however, read that provision as requiring the advertising matter to
travel with the machine. The reasons of policy which argue against
that in the case of criminal prosecutions under § 303 are
equally forcible when we come to libels under § 304(a).
Moreover, the common sense of the matter is to view the interstate
transaction in its entirety -- the purpose of the advertising and
its actual use. In this case, it is plain to us that the movements
of machines and leaflets in interstate commerce were a single
interrelated activity, not separate or isolated ones. The Act is
not concerned with the purification of the stream of commerce in
the abstract.
Page 335 U. S. 358
The problem is a practical one of consumer protection, not
dialectics. The fact that the false literature leaves in a separate
mail does not save the article from being misbranded. Where, by
functional standards, the two transactions are integrated, the
requirements of § 304(a) are satisfied though the mailings or
shipments are at different times.
The Court of Appeals held that certain evidence tendered by
Urbuteit as to the therapeutic or curative value of the machines
had been erroneously excluded at the trial, a ruling that we are
not inclined to disturb. Petitioner claims, however, that the error
was not prejudicial. The argument is that, since the evidence of
the false and misleading character of the advertising as respects
the diagnostic capabilities of the machines was overwhelming, that
false representation was adequate to sustain the condemnation,
though it be assumed that the therapeutic phase of the case was not
established. We do not reach that question. Since the case must be
remanded to the Court of Appeals, that question and any others that
have survived will be open for consideration by it.
Reversed.
MR. JUSTICE BLACK, MR. JUSTICE FRANKFURTER, MR. JUSTICE MURPHY,
and MR. JUSTICE JACKSON dissent for the reasons stated in their
dissent in
Kordel v. United States, ante, p.
335 U. S. 345,
although this case arises under the limitation of § 304(a),
"while in interstate commerce," which has a different scope from
§ 301(k), while "held for sale after shipment in interstate
commerce."
* The relevant portion of this section reads as follows:
"Any article of food, drug, device, or cosmetic that is
adulterated or misbranded when introduced into or while in
interstate commerce . . . shall be liable to be proceeded against
while in interstate commerce, or at any time thereafter, on libel
of information and condemned in any district court of the United
States within the jurisdiction of which the article is found. . .
."