Congress is not to be denied the exercise of its constitutional
authority over interstate commerce and of its power to adopt means
necessary and convenient to such exercise merely because those
means have the quality of police regulations.
Hoke v. United
States, 227 U. S. 308.
The Sherley Amendment of August 23, 1912, to the Food &
Drugs Act under which misbranding includes false and fraudulent
statements regarding curative effects of drugs is within the power
of Congress to regulate interstate and foreign commerce.
Such regulation of interstate commerce is within the power of
Congress whether the statement be contained in the original package
or on the containers of the article.
See McDermott v.
Wisconsin, 228 U. S. 115.
The legislative history of the Sherley Amendment shows why the
word "contain" was inserted therein.
The Sherley Amendment to the Food & Drugs Act does not by
reason of uncertainty operate as a deprivation of property without
due process of law under the Fifth Amendment, nor does it prevent
the laying of definite charge of violating it under the Sixth
Amendment, as it in terms requires that the statements, to fall
within its prohibition, must be false and fraudulent.
The phrase "false and fraudulent" as used in the Sherley
Amendment to the Food & Drugs Act must be taken with its
accepted legal meaning, and to condemn under the amendment it must
be found that the statements were put with the package with actual
intent to deceive.
An intent to deceive may be derived from facts and
circumstances, but it must be established, and can be established,
by proof of their falsity as to statements accompanying drugs, such
as to the effect
Page 239 U. S. 511
that they have preventive and curative power over such diseases
as pneumonia and tuberculosis.
Averments in a libel under § 8 of the Food & Drugs Act
should receive a sensible construction. They must definitely charge
the statutory offense of misbranding, but if there is enough to
apprise those interested in the goods that they were charged with
misbranding because statements as to curative power accompanying
the articles in interstate commerce were false and fraudulent, as
stating they would cure diseases which they could not cure, and
were made with intent to deceive, they are sufficient to sustain
the libel.
The facts, which involve the constitutionality, construction and
application, of provisions of § 8 of the Food and Drugs Act as
amended in 1912 in regard to misbranding of drugs, are stated in
the opinion.
Page 239 U. S. 512
MR. JUSTICE HUGHES delivered the opinion of the Court.
Libels were filed by the United States, in December, 1912, to
condemn certain articles of drugs (known as "Eckman's Alterative")
as misbranded in violation of § 8 of the Food & Drugs Act. The
articles had been shipped in interstate commerce, from Chicago to
Omaha, and remained at the latter place unsold and in the unbroken
original packages. The two causes present the same questions, the
libels being identical save with respect to quantities and the
persons in possession. In each case, demurrers were filed by the
shipper, the Eckman Manufacturing Company, which challenged both
the sufficiency of the libels under the applicable provision of the
statute and the constitutionality of that provision.
Page 239 U. S. 513
The demurrers were overruled, and, the Eckman Company having
elected to stand on the demurrers, judgments of condemnation were
entered.
Section 8 of the Food & Drugs Act, as amended by the Act of
August 23, 1912, c. 352, 37 Stat. 416, provides, with respect to
the misbranding of drugs, as follows:
"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 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."
"That, for the purposes of this Act, an article shall also be
deemed to be misbranded. In case of drugs:"
"
* * * *"
"Third. If its package or label shall bear or contain any
statement, design, or device regarding the curative or therapeutic
effect of such article or any of the ingredients or substances
contained therein which is false and fraudulent."
The amendment of 1912 consisted in the addition of paragraph
"Third," which is the provision here involved.
It is alleged in each libel that every one of the cases of drugs
sought to be condemned contained twelve bottles, each of which was
labeled as follows:
"Eckman's Alterative -- contains twelve percent of alcohol by
weight, or fourteen percent by volume -- used as a solvent. For all
throat and lung diseases including Bronchitis, Bronchial Catarrh,
Asthma, Hay Fever, Coughs and Colds, and Catarrh of the Stomach and
Bowels, and Tuberculosis (Consumption). . . . Two dollars a bottle.
Prepared only by Eckman Mfg. Co. Laboratory Philadelphia, Penna.,
U.S.A. "
Page 239 U. S. 514
And in every package containing one of the bottles there was
contained a circular with this statement:
"Effective as a preventative for Pneumonia. . . . We know it has
cured and that it has and will cure Tuberculosis."
The libel charges that the statement "effective as a
preventative for pneumonia" is
"false, fraudulent, and misleading in this, to-wit, that it
conveys the impression to purchasers that said article of drugs can
be used as an effective preventative for pneumonia, whereas, in
truth and in fact said article of drugs could not be so used,"
and that the statement, "we know it has cured" and that it "will
cure tuberculosis" is
"false, fraudulent, and misleading in this, to-wit, that it
conveys the impression to purchasers that said article of drugs
will cure tuberculosis, or consumption, whereas, in truth and in
fact said article of drugs would not cure tuberculosis, or
consumption, there being no medicinal substance nor mixture of
substances known at present which can be relied upon for the
effective treatment or cure of tuberculosis, or consumption."
The principal question presented on this writ of error is with
respect to the validity of the amendment of 1912.
So far as it is objected that this measure, though relating to
articles transported in interstate commerce, is an encroachment
upon the reserved powers of the states, the objection is not to be
distinguished in substance from that which was overruled in
sustaining the White Slave Act, 36 Stat. 825, c. 395.
Hoke v.
United States, 227 U. S. 308.
There, after stating that "if the facility of interstate
transportation" can be denied in the case of lotteries, obscene
literature, diseased cattle and persons, and impure food and drugs,
the like facility could be taken away from "the systematic
enticement of and the enslavement in prostitution and debauchery of
women," the Court concluded with the reassertion of
Page 239 U. S. 515
the simple principle that Congress is not to be denied the
exercise of its constitutional authority over interstate commerce,
and its power to adopt not only means necessary but convenient to
its exercise, because these means may have the quality of police
regulations.
Id., pp.
227 U. S.
322-323.
See Gloucester Ferry Co. v.
Pennsylvania, 114 U. S. 196,
114 U. S. 215;
Hipolite Egg Co. v. United States, 220 U. S.
45,
220 U. S. 57;
Lottery Case, 188 U. S. 321.
It is urged that the amendment of 1912 does not embrace
circulars contained in the package, but only applies to those
statements which appear on the package or on the bottles themselves
-- that is, it is said that the word "contain" in the amendment
must have the same meaning in the case of both "package" and
"label." Reference is made to the original provision in the first
sentence of § 8 with respect to the statements, etc., which the
package or label shall "bear." And it is insisted that, if the
amendment of 1912 covers statements in circulars which are
contained in the package, it is unconstitutional. Such statements,
it is said, are not so related to the commodity as to form part of
the commerce which is within the regulating power of Congress.
But it appears from the legislative history of the act that the
word "contain" was inserted in the amendment to hit precisely the
case of circulars or printed matter placed inside the package, and
we think that is due fair import of the provision. Cong.Rec. 62d
Cong., 2d Sess. Vol. 48, Part 11, p. 11,322. And the power of
Congress manifestly does not depend upon the mere location of the
statement accompanying the article -- that is, upon the question
whether the statement is on or in the package which is transported
in interstate commerce. The further contention that Congress may
not deal with the package thus transported in the sense of the
immediate container of the article as it is intended for
consumption is met by
McDermott v. Wisconsin, 228 U.
S. 115. There, the
Page 239 U. S. 516
Court said:
"That the word 'package' or its equivalent expression, as used
by Congress in sections 7 and 8 in defining what shall constitute
adulteration and what shall constitute misbranding within the
meaning of the act [food and drugs act] clearly refers to the
immediate container of the article which is intended for
consumption by the public, there can be no question. . . . Limiting
the requirements of the act as to adulteration and misbranding
simply to the outside wrapping or box containing the packages
intended to be purchased by the consumer, so that the importer, by
removing and destroying such covering, could prevent the operation
of the law on the imported article yet unsold, would render the act
nugatory and its provisions wholly inadequate to accomplish the
purposes for which it was passed."
And, after stating that the requirements of the act, thus
construed, were clearly within the power of Congress over the
facilities of interstate commerce, the Court added that the
doctrine of original packages set forth in repeated decisions,
which protected the importer in the right to sell the imported
goods, was not
"intended to limit the right of Congress, now asserted, to keep
the channels of interstate commerce free from the carriage of
injurious or fraudulently branded articles, and to choose
appropriate means to that end."
Id., pp.
228 U. S.
130-131,
228 U. S. 137.
Referring to the nature of the statements which are within the
purview of the amendment, it is said that a distinction should be
taken between articles that are illicit, immoral, or harmful and
those which are legitimate, and that the amendment goes beyond
statements dealing with identity or ingredients. But the question
remains as to what may be regarded as "illicit," and we find no
ground for saying that Congress may not condemn the interstate
transportation of swindling preparations designed to cheat
credulous sufferers, and make such preparations, accompanied by
false and fraudulent statements,
Page 239 U. S. 517
illicit with respect to interstate commerce, as well as, for
example, lottery tickets. The fact that the amendment is not
limited, as was the original statute, to statements regarding
identity or composition (
United States v. Johnson,
221 U. S. 488)
does not mark a constitutional distinction. The false and
fraudulent statement which the amendment describes accompanies the
article in the package, and thus gives to the article its character
in interstate commerce.
Finally, the statute is attacked upon the ground that it enters
the domain of speculation (
American School v. McAnnulty,
187 U. S. 94) and,
by virtue of consequent uncertainty, operates as a deprivation of
liberty and property without due process of law in violation of the
Fifth Amendment of the Constitution, and does not permit of the
laying of a definite charge as required by the Sixth Amendment. We
think that this objection proceeds upon a misconstruction of the
provision. Congress deliberately excluded the field where there are
honest differences of opinion between schools and of opinion
between schools and practitioners. Cong.Rec. 62d Cong., 2d Sess.
Vol. 48, Part 12, Appx. p. 675. It point that the words "false and
fraudulent" were used. This phrase must be taken with its accepted
legal meaning, and thus it must be found that the statement
contained in the package was put there to accompany the goods with
actual intent to deceive -- an intent which may be derived from the
facts and circumstances, but which must be established.
Id., 676. That false and fraudulent representations may be
made with respect to the curative effect of substances is obvious.
It is said that the owner has the right to give his views regarding
the effect of his drugs. But state of mind is itself a fact, and
may be a material fact, and false and fraudulent representations
may be made about it, and persons who make or deal in substances or
compositions
Page 239 U. S. 518
alleged to be curative are in a position to have superior
knowledge, and may be held to good faith in their statements.
Russell v.
Clark, 7 Cranch 69,
11 U. S. 92;
Durland v. United States, 161 U.
S. 306,
161 U. S. 313;
Stebbins v. Eddy, 4 Mason, 414, 423;
Kohler Mfg. Co.
v. Beeshore, 59 F. 572, 574;
Missouri Drug Co. v.
Wyman, 129 F. 623, 628;
McDonald v. Smith, 139 Mich.
211;
Hedin v. Minneapolis Medical Institute, 62 Minn. 146,
149;
Hickey v. Morrell, 102 N.Y. 454, 463;
Regina v.
Giles, 10 Cox, C.C. 44;
Smith v. Land & House
Corporation, L.R., 28 Ch.Div. 7, 15. It cannot be said, for
example, that one who should put inert matter or a worthless
composition in the channels of trade, labeled or described in an
accompanying circular as a cure for disease, when he knows it is
not, is beyond the reach of the lawmaking power. Congress
recognized that there was a wide field in which assertions as to
curative effect are in no sense honest expressions of opinion, but
constitute absolute falsehoods, and in the nature of the case can
be deemed to have been made only with fraudulent purpose. The
amendment of 1912 applies to this field, and we have no doubt of
its validity.
With respect to the sufficiency of the averments of the libels,
it is enough to say that these averments should receive a sensible
construction. There must be a definite charge of the statutory
offense, but we are not at liberty to indulge in hypercriticism in
order to escape the plain import of the words used. There is no
question as to the adequacy of the description of the article, or
of the shipments, or of the packages. It is said that there was no
proper statement of the contents of the circular. But the libels
give the words of the circular, and we think that the allegations
were sufficient to show the manner in which they were used. The
objection that it was not alleged that the statements in question
appeared on the original packages or on the bottles themselves, as
already pointed
Page 239 U. S. 519
out, is based on a misconstruction of the statutory provision.
The remaining and most important criticism is that the libels did
not sufficiently show that the statements were false and
fraudulent. But it was alleged that they were false and fraudulent,
and with respect to tuberculosis it was averred that the statement
was that the article "has cured" and "will cure," whereas "in truth
and in fact" it would "not cure," and that there was no "medicinal
substance nor mixture of substances known at present" which could
be relied upon to effect a cure. We think that this was enough to
apprise those interested in the goods of the charge which they must
meet. It was, in substance, a charge that, contrary to the statute,
the article had been made the subject of interstate transportation
with a statement contained in the package that the article had
cured and would cure tuberculosis, and that this statement was
contrary to the fact, and was made with actual intent to
deceive.
Judgment affirmed.
MR. JUSTICE McREYNOLDS took no part in the consideration or
decision of these cases.