1. It is a violation of § 301(a) of the Federal Food, Drug, and
Cosmetic Act, 52 Stat. 1040, 21 U.S.C. § 331(a), to ship in
interstate commerce to the same consignee a drug and also false and
misleading pamphlets designed for use in the advertisement, sale,
and use of the drug and constituting an essential supplement to the
label on the drug -- even though the punphlets are shipped
separately and at a different time. Pp.
335 U. S.
346-350.
(a) The phrase "accompanying such article" in § 201(m) defining
"labeling" is not restricted to labels that are on or in the
article or package that is transported. Pp.
335 U. S.
347-350.
(b) That the pamphlets are shipped prior to or subsequent to the
shipment of the drug does not prevent the drug from being
"misbranded" when introduced into commerce within the meaning of §
301(a), in spite of § 301(k), which forbids misbranding of a drug
while it is held for sale after shipment in interstate commerce.
Pp.
335 U. S. 350,
335 U. S.
351-352.
2. That such pamphlets bear a sale price and are offered for
sale is immaterial, since the Act cannot be circumvented by the
easy device of a "sale" of the pamphlets where they perform the
function of labeling. P.
335 U. S.
350.
3. The fact that, in the evolution of the Act, the ban on false
advertising was eliminated and its control was transferred to the
Federal Trade Commission did not eliminate from the Act advertising
which performs the function of labeling. P.
335 U. S.
351.
4. Since the informations charging violations of § 301(a) did
not allege that the acts committed were done "with intent to
defraud," the maximum penalty was imprisonment for not more than a
year, or a fine of not more than $1,000, or both. Therefore,
prosecution by information was authorized by the statute and by §
7(a) of the Rules of Criminal Procedure. P. 348,
n 3.
164 F.2d 913 affirmed.
Petitioner was convicted in a federal district court of
violating § 301(a) of the Federal Food, Drug, and Cosmetic Act, 52
Stat. 1040, 21 U.S.C. § 331(a). 66 F.Supp.
Page 335 U. S. 346
538. The Court of Appeals affirmed. 164 F.2d 913. This Court
granted certiorari. 333 U.S. 872.
Affirmed, p.
335 U. S.
352.
Opinion of the Court by MR. JUSTICE DOUGLAS, announced by MR.
JUSTICE REED.
This case and
United States v. Urbuteit, post, p.
335 U. S. 355,
decided this day, are here on certiorari to resolve a conflict
among the circuits in the construction of the Federal Food, Drug,
and Cosmetic Act of June 25, 1938. 52 Stat. 1040, 21 U.S.C. § 301
et seq.
Kordel was charged by informations containing twenty counts of
introducing or delivering for introduction into interstate commerce
misbranded drugs. He was tried without a jury, found guilty, and
fined two hundred dollars on each count,
66 F.
Supp. 538. This judgment was affirmed on appeal. 164 F.2d
913.
Kordel writes and lectures on health foods from information
derived from studies in public and private libraries. Since 1941,
he has been marketing his own health food products, which appear to
be compounds of various vitamins, minerals, and herbs. The alleged
misbranding consists of statements in circulars or pamphlets
distributed to consumers by the vendors of the products relating to
their efficacy. The petitioner supplies these pamphlets, as well as
the products, to the vendors. Some of the literature was displayed
in stores in which the petitioner's products were on sale. Some of
it was given
Page 335 U. S. 347
away with the sale of products, some sold independently of the
drugs, and some mailed to customers by the vendors.
It is undisputed that petitioner shipped or caused to be shipped
in interstate commerce both the drugs and the literature. Seven of
the counts charged that the drugs and literature were shipped in
the same cartons. The literature involved in the other counts was
shipped separately from the drugs, and at different times -- both
before and after the shipments of the drugs with which they were
associated. The question whether the separate shipment of the
literature saved the drugs from being misbranded within the meaning
of the Act presents the main issue in the case.
Section 301(a) of the Act prohibits the introduction into
interstate commerce of any drug that is adulterated or misbranded.
[
Footnote 1] It is misbranded
according to § 502(a) if its "labeling is false or misleading in
any particular" and unless the labeling bears "adequate directions
for use." § 502(f). The term "labeling" is defined in § 201(m)
to
Page 335 U. S. 348
mean
"all labels [
Footnote 2] and
other written, printed, or graphic matter (1) upon any article or
any of its containers or wrappers, or (2) accompanying such
article."
Section 303 makes the violation of any of the provisions of §
301 a crime. [
Footnote 3]
In this case, the drugs and the literature had a common origin
and a common destination. The literature was used in the sale of
the drugs. It explained their uses. Nowhere else was the purchaser
advised how to use them. It constituted an essential supplement to
the label attached to the package. Thus, the products and the
literature were interdependent, as the Court of Appeals
observed.
It would take an extremely narrow reading of the Act to hold
that these drugs were not misbranded. A criminal
Page 335 U. S. 349
law is not to be read expansively to include what is not plainly
embraced within the language of the statute (
United States v.
Resnick, 299 .S. 207;
Kraus & Bros. v. United
States, 327 U. S. 614,
327 U. S.
621-622), since the purpose fairly to apprise men of the
boundaries of the prohibited action would then be defeated.
United States v. Sullivan, 332 U.
S. 689,
332 U. S. 693;
Winters v. New York, 333 U. S. 507. But
there is no canon against using common sense in reading a criminal
law, so that strained and technical constructions do not defeat its
purpose by creating exceptions from or loopholes in it.
See
Roschen v. Ward, 279 U. S. 337,
279 U. S.
339.
It would, indeed, create an obviously wide loophole to hold that
these drugs would be misbranded if the literature had been shipped
in the same container, but not misbranded if the literature left in
the next or in the preceding mail. The high purpose of the Act to
protect consumers who under present conditions are largely unable
to protect themselves in this field [
Footnote 4] would then be easily defeated. The
administrative agency charged with its enforcement [
Footnote 5] has not given the Act any such
restricted construction. [
Footnote
6] The textual structure of the Act is not agreeable to it.
Accordingly, we conclude that the phrase "accompanying such
article" is not restricted to labels that are on or in the article
on package that is transported.
The first clause of § 201(m) -- all labels "upon any article or
any of its containers or wrappers" -- clearly
Page 335 U. S. 350
embraces advertising. or descriptive matter that goes with the
package in which the articles are transported. The second clause --
"accompanying such article" -- has no specific reference to
packages, containers, or their contents, as did a predecessor
statute.
See Seven Cases v. United States, 239 U.
S. 510,
239 U. S.
513-515. It plainly includes what is contained within
the package, whether or not it is "upon" the article or its wrapper
or container. But the second clause does not say "accompanying such
article in the package or container," and we see no reason for
reading the additional words into the text.
One article or thing is accompanied by another when it
supplements or explains it, in the manner that a committee report
of the Congress accompanies a bill. No physical attachment one to
the other is necessary. It is the textual relationship that is
significant. The analogy to the present case is obvious. We need
not labor the point.
The false and misleading literature in the present case was
designed for use in the distribution and sale of the drug, and it
was so used. The fact that it went in a different mail was wholly
irrelevant whether we judge the transaction by purpose or result.
And to say that the prior or subsequent shipment of the literature
disproves that it "is" misbranded when introduced into commerce
within the meaning of § 301(a) is to overlook the integrated nature
of the transactions established in this case.
Moreover, the fact that some of the booklets carried a selling
price is immaterial on the facts shown here. As stated by the Court
of Appeals, the booklets and drugs were nonetheless interdependent;
they were parts of an integrated distribution program. The Act
cannot be circumvented by the easy device of a "sale" of the
advertising matter where the advertising performs the function of
labeling.
Page 335 U. S. 351
Petitioner points out that, in the evolution of the Act, the ban
on false advertising was eliminated, the control over it being
transferred to the Federal Trade Commission. 52 Stat. 114, 15
U.S.C. § 55(a). We have searched the legislative history in vain,
however, to find any indication that Congress had the purpose to
eliminate from the Act advertising which performs the function of
labeling. Every labeling is, in a sense, an advertisement. The
advertising which we have here performs the same function as it
would if it were on the article or on the containers or wrappers.
As we have said, physical attachment or contiguity is unnecessary
under § 201(m)(2).
There is a suggestion that the offense in this case falls under
§ 301(k) of the Act, which includes misbranding of a drug while it
is held for sale after shipment in interstate commerce. [
Footnote 7] Since the informations
contain no such charge, it is therefore claimed that the judgment
must be reversed. We do not agree. Section 301(k) has a broad
sweep, not restricted to those who introduce or deliver for
introduction drugs in interstate commerce. [
Footnote 8]
See United States v. Sullivan,
supra. Nor is it confined to adulteration or misbranding, as
is § 301(a).
Id. It is, however, restricted to cases where
the article is held for sale after shipment in interstate commerce,
and, unlike § 301(a), it does not reach situations where the
manufacturer sells directly to the consumer.
Cf. United States
v. Urbuteit, supra. Hence, we conclude that we do not disturb
the statutory scheme when we refuse to take from § 301(a) what is
fairly included in it in order to leave
Page 335 U. S. 352
the matter wholly to the service of § 301(k). The reach of §
301(a) is, in this respect, longer. Such a transfer to § 301(k)
would create a new hiatus in the Act, and thus disturb the pattern
which we discern in it.
We have considered the other objections tendered by petitioner,
and find them without merit.
Affirmed.
[
Footnote 1]
Section 301 in relevant part reads as follows:
"The following acts and the causing thereof are hereby
prohibited: "
"(a) The introduction or delivery for introduction into
interstate commerce of any food, drug, device, or cosmetic that is
adulterated or misbranded."
"(b) The adulteration or misbranding of any food, drug, device,
or cosmetic in interstate commerce."
"(c) The receipt in interstate commerce of any food, drug,
device, or cosmetic that is adulterated or misbranded, and the
delivery or proffered delivery thereof for pay or otherwise."
"
* * * *"
"(k) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to, a food, drug, device, or
cosmetic, if such act is done while such article is held for sale
after shipment in interstate commerce and results in such article's
being misbranded."
[
Footnote 2]
The term label is defined as "a display of written, printed, or
graphic matter upon the immediate container of any article." §
201(k).
[
Footnote 3]
"SEC. 303. (a) Any person who violates any of the provisions of
section 301 shall be guilty of a misdemeanor and shall on
conviction thereof be subject to imprisonment for not more than one
year, or a fine of not more than $1,000, or both such imprisonment
and fine; but if the violation is committed after a conviction of
such person under this section has become final, such person shall
be subject to imprisonment for not more than three years, or a fine
of not more than $10,000, or both such imprisonment and fine."
"(b) Notwithstanding the provisions of subsection (a) of this
section, in case of a violation of any of the provisions of section
301, with intent to defraud or mislead, the penalty shall be
imprisonment for not more than three years, or a fine of not more
than $10,000, or both such imprisonment and fine."
The informations, in charging violations of § 301(a), did not
allege that the acts committed were done "with intent to defraud."
Hence, the maximum penalty was imprisonment for not more than a
year, or a fine of not more than $1,000, or both. Prosecution by
information was therefore authorized by the statute (
see Duke
v. United States, 301 U. S. 492) and
by Rule 7(a) of the Federal Rules of Criminal Procedure.
[
Footnote 4]
See United States v. Dotterweich, 320 U.
S. 277,
320 U. S. 280;
United States v. Sullivan, supra, p.
332 U. S.
696.
[
Footnote 5]
See § 701 and § 201(c); 1940 Reorg. Plan No. IV, § 12,
54 Stat. 231, 5 U.S.C. § 133u.
[
Footnote 6]
The Federal Security Agency, by regulation (21 C.F.R.Cum.Supp. §
2.2), has ruled:
"Labeling includes all written, printed, or graphic matter
accompanying an article at any time while such article is in
interstate commerce or held for sale after shipment or delivery in
interstate commerce."
[
Footnote 7]
See note 1
supra.
[
Footnote 8]
The purpose of § 301(k) was described in H.R.Rep. No.2139, 75th
Cong., 3d Sess. 3 (1938), as follows:
"In order to extend the protection of consumers contemplated by
the law to the full extent constitutionally possible, paragraph (k)
has been inserted prohibiting the changing of labels so as to
misbrand articles held for sale after interstate shipment."
MR. JUSTICE BLACK, with whom MR. JUSTICE FRANKFURTER, MR.
JUSTICE MURPHY, and MR. JUSTICE JACKSON concur, dissenting.
I agree with the Court's interpretation of § 502(a) and § 201(m)
of the Federal Food, Drug, and Cosmetic Act. These sections,
considered together, provide a definition for the "misbranding" of
drugs. I agree that a drug is misbranded within the meaning of the
statute if false and misleading written, printed, or graphic matter
is either placed upon the drug, its container or wrappers, or used
in the sale of the drug as a supplement to the package label to
advise consumers how to use the drug. I agree that false labels
may, within the meaning of the statute, "accompany," that is go
along with, a drug on its interstate journey even though not in the
same carton, on the same train, in the same mail, or delivered for
shipment the same day. But these agreements do not settle all the
problems in this case.
The Federal Food, Drug, and Cosmetic Act does not purport to
make all misbranding of drugs within the foregoing definition a
federal offense. Congressional power to pass the Act is based upon
the commerce clause. Consequently, misbranding is only an offense
if the misbranded drugs bear the statutorily defined relationships
to interstate commerce. For illustration, if a person misbranded a
drug which had not been and was not thereafter introduced into
interstate commerce, there would be no
Page 335 U. S. 353
violation of the federal Act, whatever violation there might be
of state law.
As we pointed out in
United States v. Sullivan,
332 U. S. 689, the
Federal Food, Drug, and Cosmetic Act creates several offenses each
of which separately depends upon the relationship the misbranded
drug then bears to interstate commerce. Section 301(a) forbids the
"introduction or delivery for introduction into interstate
commerce" of misbranded drugs; § 301(b) forbids misbranding while
the drugs are "in interstate commerce;" § 301(c) prohibits the
"receipt" of such drugs in interstate commerce; and § 301(k)
forbids misbranding while drugs are "held for sale after shipment
in interstate commerce."
The twenty counts of the information upon which this
petitioner's conviction rests charge that he had introduced drugs
into interstate commerce, and that "when" he so introduced the
drugs, they were "misbranded . . . in that . . . statements
appearing in . . . bulletins and booklets
accompanying"
the drugs "were false and misleading." (Emphasis supplied.) The
undisputed evidence as to thirteen of these counts showed that,
when the drugs were "introduced" into interstate commerce for
shipment, they were not, within any fair meaning of the word,
"accompanied" by the printed matter relied on as "labeling." The
evidence under one count was that the drugs were shipped July 10,
1942, while the booklets said to be "labels" were sent a year and a
half later, January 18, 1944. Thus, each of these counts charged a
violation of the separate and distinct offense of introducing
misbranded drugs into interstate commerce, prohibited by § 301(a).
The evidence proves the offense, if any, of violation of § 301(k),
which prohibits the misbranding of drugs while held for sale after
an interstate shipment.
Page 335 U. S. 354
The Court's interpretation of § 301(a) seems to me to create a
new offense to make it a crime to introduce drugs into interstate
commerce if they should subsequently be misbranded, even so long as
eighteen months later while held for sale. This judicial action is
justified in part on the ground that the offense Congress created
in § 301(k) for holding misbranded drugs for sale after interstate
shipment might not reach all situations covered by the
congressionally created offense defined by § 301(a). If, as the
Court believes, Congress in § 301(k) has limited the situations for
which it will direct punishment for holding misbranded articles for
sale, I cannot agree that we should rewrite § 301(a) so as to
broaden its coverage. If Congress left a hiatus, Congress should
fill it if it so desires. While I do not doubt the wisdom of
separating these offenses as Congress has here done, we must
remember that there are dangers in splitting up one and the same
transaction into many offenses.
See Blockburger v. United
States, 284 U. S. 299,
284 U. S.
304-305.
These are serious offenses. While petitioner was fined only $200
on each count, or a total of $4,000, the maximum allowable
punishment was $1,000 per count and imprisonment for one year, or
for three years under other circumstances. § 303(a). The approach
of Congress in this field of penal regulation has been cautious.
The language used by Congress in the present law in defining new
offenses has been marked by precision. I think we should exercise a
similar caution before reading into the "introduction into
interstate commerce" offense conduct which patently fits into the
"held for sale" offense.
I would reverse the judgment here insofar as it rests on the
thirteen counts in which the Government charged offenses under §
301(a) and failed to prove them.