The term "misbranded" and the phrase defining what amounts to
misbranding in § 8 of the Food and Drugs Act of June 30, 1906,
34 Stat. 768, c. 3915, are aimed at false statements as to identity
of the article, possibly including strength, quality and purity,
dealt with in § 7 of the act, and not at statements as to
curative effect, and so
held that a statement on the
labels of bottles of medicine that the contents are effective as a
cure for cancer, even if misleading, is not covered by the
statute.
177 F. 313 affirmed.
The facts are stated in the opinion.
Page 221 U. S. 495
MR. JUSTICE HOLMES delivered the opinion of the Court.
This is an indictment for delivering for shipment from Missouri
to Washington, District of Columbia, packages and bottles of
medicine bearing labels that stated or implied that the contents
were effective in curing cancer, the defendant well knowing that
such representations were false. On motion of the defendant, the
district judge quashed the indictment (177 F. 313), and the United
States brought this writ of error under the Act of March 2, 1907,
c. 2564, 34 Stat. 1246.
The question is whether the articles were misbranded within the
meaning of § 2 of the Food and Drugs Act of June 30, 1906, c.
3915, 34 Stat. 768, making the delivery of misbranded drugs for
shipment to any other state or territory or the District of
Columbia a punishable offense. By § 6, the term "drug"
includes any substance or mixture intended to be used for the cure,
mitigation, or prevention of disease. By § 8, c. 3915, 34
Stat. 770, the
Page 221 U. S. 496
term "misbranded"
"shall apply to all drugs or articles of food, . . . the package
or label of which shall bear any statement, design, or device
regarding such article, or the ingredients or substances contained
therein, which shall be false or misleading in any particular, and
to any food or drug product which is falsely branded as to the
state, territory, or country in which it is manufactured or
produced. . . . An article shall also be deemed to be misbranded:
In case of drugs: First. If it be an imitation of, or offered for
sale under the name of, another article. Second. [In case of a
substitution of contents] . . . or if the package fail to bear a
statement on the label of the quantity or proportion of any
alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine,
chloroform, cannabis indica, chloral hydrate, or acetanilid, or any
derivative or preparation of any such substances contained
therein."
It is a postulate, as the case comes before us, that in a
certain sense the statement on the label was false, or at least,
misleading. What we have to decide is whether such misleading
statements are aimed at and hit by the words of the act. It seems
to us that the words used convey to an ear trained to the usages of
English speech a different aim, and although the meaning of a
sentence is to be felt, rather than to be proved, generally, and
here, the impression may be strengthened by argument, as we shall
try to show.
We lay on one side as quite unfounded the argument that the
words "statement which shall be misleading in any particular," as
used in the statute, do not apply to drugs at all -- that the
statements referred to are those "regarding such article," and that
"article" means article of food, mentioned by the side of drugs at
the beginning of the section. It is enough to say that the
beginning of the sentence makes such a reading impossible, and that
"article" expressly includes "drugs," a few lines further on in
what we have quoted, not to speak of the reason of the
Page 221 U. S. 497
thing. But we are of opinion that the phrase is aimed not at all
possible false statements, but only at such as determine the
identity of the article, possibly including its strength, quality,
and purity, dealt within § 7. In support of our
interpretation, the first thing to be noticed is the second branch
of the sentence: "Or the ingredients or substances contained
therein." One may say with some confidence that, in idiomatic
English, this half at least, is confined to identity, and means a
false statement as to what the ingredients are. Logically it might
mean more, but idiomatically it does not. But if the false
statement referred to is a misstatement of identity as applied to a
part of its objects, idiom and logic unite in giving it the same
limit when applied to the other branch, the article, whether simple
or one that the ingredients compose. Again, it is to be noticed
that the cases of misbranding, specifically mentioned, and
following the general words that we have construed, are all cases
analogous to the statement of identity, and not at all to inflated
or false commendation of wares. The first is a false statement as
to the country where the article is manufactured or produced -- a
matter quite unnecessary to specify if the preceding words had a
universal scope, yet added as not being within them. The next case
is that of imitation and taking the name of another article, of
which the same may be said, and so of the next, a substitution of
contents. The last is breach of an affirmative requirement to
disclose the proportion of alcohol and certain other noxious
ingredients in the package -- again, a matter of plain past history
concerning the nature and amount of the poisons employed, not an
estimate or prophecy concerning their effect. In further
confirmation, it should be noticed that, although the indictment
alleges a willful fraud, the shipment is punished by the statute if
the article is misbranded, and that the article may be misbranded
without any conscious fraud at all. It was natural enough to throw
this risk on
Page 221 U. S. 498
shippers with regard to the identity of their wares, but a very
different and unlikely step to make them answerable for mistaken
praise. It should be noticed still further that, by § 4, the
determination whether an article is misbranded is left to the
Bureau of Chemistry of the Department of Agriculture, which is most
natural if the question concerns ingredients and kind, but hardly
so as to medical effects.
To avoid misunderstanding, we should add that, for the purposes
of this case, at least, we assume that a label might be of such a
nature as to import a statement concerning identity, within the
statute, although in form only a commendation of the supposed drug.
It may be that a label in such form would exclude certain
substances so plainly to all common understanding as to amount to
an implied statement of what the contents of the package were not,
and it may be that such a negation might fall within the
prohibitions of the act. It may be (we express no opinion upon that
matter) that, if the present indictment had alleged that the
contents of the bottles were water, the label so distinctly implied
that they were other than water as to be a false statement of fact
concerning their nature and kind. But such a statement as to
contents, undescribed and unknown, is shown to be false only in its
commendatory and prophetic aspect, and as such is not within the
act.
In view of what we have said by way of simple interpretation, we
think it unnecessary to go into considerations of wider scope. We
shall say nothing as to the limits of constitutional power, and but
a word as to what Congress was likely to attempt. It was much more
likely to regulate commerce in food and drugs with reference to
plain matter of fact, so that food and drugs should be what they
professed to be, when the kind was stated, than to distort the uses
of its constitutional power to establishing criteria in regions
where opinions are far apart.
See School of
Page 221 U. S. 499
Magnetic Healing v. McAnnulty, 187 U. S.
94. As we have said above, the reference of the question
of misbranding to the Bureau of Chemistry for determination
confirms what would have been our expectation and what is our
understanding of the words immediately in point.
Judgment affirmed.
MR. JUSTICE HUGHES, dissenting:
I am unable to concur in the judgment in this case, for the
following reasons:
The defendant was charged with delivering for shipment in
interstate commerce certain packages and bottles of drugs alleged
to have been misbranded in violation of the Food and Drugs Act of
June 30, 1906, chapter 3915, 34 Stat. 768.
The articles were labeled respectively "Cancerine tablets,"
"Antiseptic tablets," "Blood purifier," "Special No. 4," "Cancerine
No. 17," and "Cancerine No. 1" -- the whole constituting what was
termed in substance "Dr. Johnson's Mild Combination Treatment for
Cancer." There were several counts in the indictment with respect
to the different articles. The labels contained the words,
"Guaranteed under the Pure Food and Drugs Act, June 30, 1906," and
some of the further statements were as follows:
"Blood Purifier. This is an effective tonic and alternative. It
enters the circulation at once, utterly destroying and removing
impurities from the blood and entire system. Acts on the bowels,
kidneys, and skin, eliminating poisons from the system, and when
taken in connection with the Mild Combination Treatment, gives
splendid results in the treatment of cancer and other malignant
diseases. I always advise that the Blood Purifier be continued some
little time after the cancer has been killed and removed and the
sore healed. "
Page 221 U. S. 500
"Special No. 4. . . . It has a strong stimulative and absorptive
power; will remove swelling, arrest development, restore
circulation, and remove pain. Is indicated in all cases of
malignancy where there is a tendency of the disease to spread, and
where there is considerable hardness surrounding the sore. Applied
thoroughly to a lump or to an enlarged gland, will cause it to
soften, become smaller, and be absorbed."
"Cancerine No. 1. . . . Tendency is to convert the sore from an
unhealthy to a healthy condition and promote healing. Also it
destroys and removes dead and unhealthy tissue."
In each case, the indictment alleged that the article was
"wholly worthless," as the defendant well knew.
In quashing the indictment, the district court construed the
statute. The substance of the decision is found in the following
words of the opinion:
"Having regard to the intendment of the whole act, which is to
protect the public health against adulterated, poisonous, and
deleterious food, drugs, etc., the labeling or branding of the
bottle or container, as to the quantity or composition of 'the
ingredients or substances contained therein, which shall be false
or misleading,' by no possible construction can be extended to an
inquiry as to whether or not the prescription be efficacious or
worthless to effect the remedy claimed for it."
And question on this writ of error is whether or not this
construction is correct.
United States v. Keitel,
211 U. S. 370.
What, then, is the true meaning of the statute?
Section 8 provides:
"SEC. 8. That the term 'misbranded,' as used herein, shall apply
to all drugs, or articles of food, or articles which enter into the
composition of food, the package or label of which shall bear any
statement, design, or device regarding such article, or the
ingredients or substances contained therein, which shall be false
or misleading in any
Page 221 U. S. 501
particular, and to any food or drug product which is falsely
branded as to the state, territory, or country in which it is
manufactured or produced."
The words "such article" in this section, as is shown by the
immediate context, refer to "drugs" as well as to "food."
"Drugs" are thus defined in § 6:
"SEC. 6. That the term 'drug,' as used in this act, shall
include all medicines and preparations recognized in the United
States Pharmacopoeia or National Formulary for internal or external
use,
and any substance or mixture of substances intended to be
used for the cure, mitigation, or prevention of disease of either
man or other animals."
Articles, then, intended to be used for curative purposes, such
as those described in the indictment, are within the statute,
though they are not recognized in the United States Pharmacopoeia
or the National Formulary. And the offense of misbranding is
committed if the package or label of such an article bears any
statement regarding it "which shall be false or misleading in any
particular."
But it is said that these words refer only to false statements
which fix the identity of the article. According to the
construction placed upon the statute by the court below in quashing
the indictment, if one puts upon the market, in interstate
commerce, tablets of inert matter or a liquid wholly worthless for
any curative purpose, as he well knows, with the label "Cancer
Cure" or "Remedy for Epilepsy," he is not guilty of an offense,
for, in the sense attributed by that construction to the words of
the statute, he has not made a statement regarding the article
which is false or misleading in any particular.
I fail to find a sufficient warrant for this limitation, and, on
the contrary, it seems to me to be opposed to the intent of
Congress, and to deprive the Act of a very salutary effect.
Page 221 U. S. 502
It is strongly stated that the clause in § 8 -- "or the
ingredients or substances contained therein" -- has reference to
identity, and that this controls the interpretation of the entire
provision. This, in my judgment, is to ascribe an altogether undue
weight to the wording of the clause and to overlook the context.
The clause, it will be observed, is disjunctive. If Congress had
intended to restrict the offense to misstatements as to identity,
it could easily have said so. But it did not say so. To a draftsman
with such a purpose, the language used would not naturally occur.
Indeed, as will presently be shown, Congress refused, with the
question up, so to limit the statute.
Let us look at the context. In the very next sentence, the
section provides (referring to drugs) that an article shall
"
also" be deemed to be misbranded if it be "an imitation
of, or offered for sale under the name of, another article," or in
case of substitution of contents, or of failure to disclose the
quantity or proportion of certain specified ingredients, if
present, such as alcohol, morphine, opium, cocaine, etc.
It is a matter of common knowledge that the "substances" or
"mixtures of substances" which are embraced in the act, although
not recognized by the United States Pharmacopoeia or National
Formulary, are sold under trade names without any disclosure of
constituents save to the extent necessary to meet the specific
requirements of the statute. Are the provisions of the section to
which we have referred, introduced by the word "also," and the one
relating to the place of manufacture, the only provisions as to
descriptive statements which are intended to apply to these
medicinal preparations? Was it supposed that, with respect to this
large class of compositions, nothing being said as to ingredients
except as specifically required, there could be, within the meaning
of the act, no false or misleading statement in
Page 221 U. S. 503
any particular? If false and misleading statements regarding
such articles were put upon their labels, was it not the intent of
Congress to reach them? And was it not for this very purpose that
the general language of § 8 was used?
The legislative history of the section would seem to negative
the contention that Congress intended to limit the provision to
statements as to identity. The provision in question as to
misbranding, as it stood in the original bill in the Senate (then
§ 9), was as follows:
"If the package containing it, or its label, shall bear any
statement regarding the ingredients or the substances contained
therein, which statement shall be false or misleading in any
particular."
The question arose upon this language whether or not it should
be taken as limited strictly to statements with respect to
identity. It was insisted that the words had a broader range, and
the effort was made to procure an amendment which should be so
specific as to afford no basis for the conclusion that anything but
false statements as to identity or constituents was intended. An
amendment was then adopted in the Senate, making the provision
read:
"any statement as to the
constituent ingredients, or
the substances contained therein, which statements shall be false
or misleading in any particular."
With this amendment, the bill was passed by the Senate and went
to the House. There, the provision was changed by striking out the
word "constituent," and inserting the word "regarding," so that it
should read:
"any statement regarding the ingredients or substances contained
in such article, which statement shall be false or misleading in
any particular."
Finally, it appears that, in conference, the bill was amended by
inserting the word "
design, or device," and also the words
"
such article, or," and thus the section became
Page 221 U. S. 504
a part of the law in its present form -- containing the
words:
"any statement, design, or device regarding such article, or the
ingredients or substances contained therein, which shall be false
or misleading in any particular."
It is difficult to support that, the question distinctly raised,
Congress would have rejected the provision of the Senate bill, and
broadened the language in the manner stated, if it had been
intended to confine the prohibition to false statements as to
identity. Reading the act with the sole purpose of giving effect to
the intent of Congress, I cannot escape the conclusion that it was
designed to cover false and misleading statements of fact on the
packages or labels of articles intended for curative purposes,
although the statements relate to curative properties.
It is, of course, true that, when Congress used the words "false
or misleading statement," it referred to a well defined category in
the law, and must be taken to have intended statements of
fact, and not mere expressions of opinion.
The argument is that the curative properties of articles
purveyed as medicinal preparations are matters of opinion, and the
contrariety of views among medical practitioners, and the conflict
between the schools of medicine, are impressively described. But,
granting the wide domain of opinion and allowing the broadest range
to the conflict of medical views, there still remains a field in
which statements as to curative properties are downright falsehoods
and in no sense expressions of judgment. This field I believe this
statute covers.
The construction which the district court has placed upon this
statute is that it cannot be extended to any case where the
substance labeled as a cure, with a description of curative
properties, is "wholly worthless" and is known by the defendant to
be such. That is the charge of the indictment.
Page 221 U. S. 505
The question, then, is whether, if an article is shipped in
interstate commerce, bearing on its label a representation that it
is a cure for a given disease, when, on a showing of the facts,
there would be a unanimous agreement that it was absolutely
worthless and an out-and-out cheat, the act of Congress can be said
to apply to it. To my mind, the answer appears clear. One or two
hypothetical illustrations have been given above. Others may
readily be suggested. The records of actual prosecutions, to which
I am about to refer, show the operation the statute has had, and I
know of no reason why this should be denied to it in the
future.
Our attention has been called to the construction which was
immediately placed upon the enactment by the officers charged with
its enforcement in the Department of Justice and the Department of
Agriculture. It is true that the statute is a recent one, and, of
course, the question is one for judicial decision. But it is not
amiss to note that the natural meaning or the words used in the
statute, reflected in the refusal of Congress to adopt a narrower
provision, was the meaning promptly attributed to it in the
proceedings that were taken to enforce the law. And this appears to
have been acquiesced in by the defendants in many prosecutions in
which the defendants pleaded guilty. We have been referred to the
records of the Department of Agriculture, showing nearly thirty
cases in which either goods had been seized and no defense made, or
pleas of guilty had been entered. Among these are found such cases
as the following:
"No. 29. Hancock's Liquid Sulphur, falsely represented, among
other things, to be 'nature's greatest germicide. . . . The great
cure for . . . diphtheria.' Investigation begun November 22, 1907.
Plea of guilty."
"No. 180. Gowan's Pneumonia Cure, falsely represented, among
other things, that it 'supplies an easily
Page 221 U. S. 506
absorbed food for the lungs that quickly effects a permanent
cure.' Investigation begun November 22, 1907. Criminal information.
Plea of guilty."
"No. 181. 'Eyelin,' falsely represented, among other things,
that it 'repairs and rejuvenates the eye and sight.' Investigation
begun February 13, 1908. Plea of guilty."
"No. 261. 'Sure Thing Tonic,' falsely represented, among other
things, to be 'sure thing tonic. . . . Restores nerve energy.
Renews vital force.' Investigation begun June 3, 1909. Pleaded
guilty."
"No. 424. 'Tuckahoe Lithia Water,' falsely represented, among
other things, to be 'a sure solvent for calculi, either of the
kidneys or liver, especially indicated in all diseases due to uric
diathesis, such as gout, rheumatism, gravel stone, incipient
diabetes, Bright's Disease, inflamed bladder, eczema, stomach,
nervous, and malarial disorders.' Investigation begun July 9, 1908.
Plea of guilty."
"No. 427. 'Cancerine,' falsely represented, among other things,
to be 'a remarkably curative extract, which, if faithfully adhered
to, will entirely eradicate cancerous poison from the system. . . .
A specific cure for cancer in all its forms.' Investigation begun
about April 12, 1909. Criminal information. Plea of guilty."
I find nothing in the language of the statute which requires the
conclusion that these persons who have confessed their guilt in
making false and misleading statements on their labels should be
privileged to conduct their interstate traffic in their so-called
medicines, admittedly worthless, because Congress did not intend to
reach them.
Nor does it seem to me that any serious question arises in this
case as to the power of Congress. I take it to be conceded that
misbranding may cover statements as to strength, quality, and
purity. But so long as the statement is not as to matter of
opinion, but consists of a false
Page 221 U. S. 507
representation of fact -- in labeling the article as a cure when
it is nothing of the sort from any point of view, but wholly
worthless -- there would appear to be no basis for a constitutional
distinction. It is nonetheless descriptive, and falsely
descriptive, of the article. Why should not worthless stuff,
purveyed under false labels as cures, be made contraband of
interstate commerce, as well as lottery tickets?
Champion v.
Ames, 188 U. S. 321.
I entirely agree that in any case brought under the act for
misbranding -- by a false or misleading statement as to curative
properties of an article -- it would be the duty of the court to
direct an acquittal when it appeared that the statement concerned a
matter of opinion. Conviction would stand only where it had been
shown that, apart from any question of opinion, the so-called
remedy was absolutely worthless, and hence the label demonstrably
false; but, in such case, it seems to me to be fully authorized by
the statute.
Accordingly, I reach the conclusion that the court below erred
in the construction that it gave the statute, and hence in quashing
the indictment, and that the judgment should be reversed.
I am authorized to say that MR. JUSTICE HARLAN and MR. JUSTICE
DAY concur in this dissent.