NOTICE OF JUDGMENT NO. 1194.
(Gi?en pursuant to section 4 of the Food and Drugs Act.)
ALLEGED MISBRANDING OF PEROXIDE  CREAM.
At the December term of the Circuit Court of the United States 
for the Eastern District of New York the United States Attorney 
for said district, acting upon a report of the Secretary of Agricul- 
ture, filed information in said court against the American Drug- 
gists Syndicate, a corporation, New York, N. Y., alleging shipment 
by it, in violation of the Food and Drugs Act, on or about February 
12, 1909, from the State of New York into the District of Columbia, 
of a product labeled " Peroxide Cream " which was misbranded. 
The product was labeled: (On circular) "A. D. S. Toilet Dainties." 
"A. D. S. Peroxide Cream." " It is a pure skin cerate, in which a 
harmless and efficient whitening agent has been successfully incor- 
porated."
Analysis by the Bureau of Chemistry of a sample of said product 
showed the following results: Fatty acids, 29.317 per cent; moisture, 
40.327 per cent; glycerine, 30.156 per cent; gum, 0.416; ash, 0.7417; 
boric acid, small amounts, and indication of a very small quantity of 
peroxide. Misbranding was alleged in the information in two counts; 
in the first count because the label bore statements, designs, and de- 
vices regarding such article and the ingredients and substances con- 
tained therein, which were false and misleading in that the words 
" Peroxide Cream " represented the peroxide as an important ingre- 
dient, and was intended to lead the purchaser to believe that perox- 
ide was an important ingredient of such article, when in fact said 
article contained only an indication of a very small quantity of some 
peroxide, which said quantity was insignificant. Misbranding was 
alleged in the second count for the reason that the circular accom- 
panying the article " A. D. S. Toilet Dainties" bore statements, 
designs, and devices regarding the article and the ingredients and 
substances contained therein, which were false and misleading in 
that the statement "Is a pure skin cerate" was false and mislead- 
ing in that it represented the article to contain wax, when in fact 
the article contained no wax, and was not therefore a cerate.
16642°—No. 1194—11
On January 13, 1911, the American Druggists Syndicate appeared 
and filed a general demurrer to the information. On April 11, 1911, 
the case coming on for hearing on said demurrer, the court .after 
hearing argument of counsel and being fully advised in the premises, 
rendered the following opinion sustaining said demurrer, and dis- 
missing the information:
VEEDER, J. The defendant has demurred to both counts of a criminal in- 
formation charging it with misbranding a drug in violation of the act of June 
30, 1906, C. 3915, par. 2, 34 Stat. 768, known as the Food and Drugs Act. Sec- 
tion two of the act prohibits " the introduction into any State or Territory or 
the District of Columbia from any other State or Territory or the District of 
Columbia of any article of food or drugs which is adulterated or misbranded 
within the meaning of this act", and provides that any person who shall ship 
or deliver for shipment, as therein described, any such article so adulterated 
or misbranded, shall be guilty of a misdemeanor. The offense of misbranding 
is defined in section 6 as follows:
" 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 pack- 
ages 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 manufac- 
tured or produced.
That for the purposes of this act an article shall also be deemed to be mis- 
branded :
In the case of drugs:
First, if it be an imitation of or offered for sale under the name of another 
article.
Second, if the contents of the package as originally put up shall have been 
removed, in whole or in part, and other contents shall have been placed in such 
package, 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 
ecuaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any 
derivative or preparation of any such substances contained therein."
The remainder of the section deals in similar detail with the case of foods.
The first count of the information alleges that the defendant shipped from 
the State of New York to the District of Columbia a certain article and drug, 
which was a mixture of substances for external use, upon which there was a 
label reading: " A. D. S. Peroxide Cream. Cleansing, Soothing and Healing to 
the Skin, Antiseptic, Cooling and Refreshing." Elsewhere upon the carton, and 
upon the package or jar enclosed therein, were immaterial variations of this 
statement of the properties and purposes of the preparation. It is charged that 
this was a misbranding within the meaning of the act, " in that the label then 
and there bore statements, designs and devices regarding the said article and 
the ingredients and the substances contained therein, which were false and 
misleading, in that the words ' Peroxide Cream' represent that peroxide is an 
important ingredient, and tend to lead the purchaser to believe that peroxide is 
an important ingredient of the article, whereas, in truth and in fact, the article 
then and there contained only an indication of a very small quantity of same 
peroxide which said quantity is insignificant."
The scope of the general terms of the definition of misbranding in section 8. 
" any statement, design or device regarding such article, or the ingredients or 
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substances contained therein which shall be false or misleading in any par- 
ticular ", must be ascertained by construing them in connection with the subject 
matter and other provisions of the act. It includes, in the first place; not only 
statements concerning the ingredients or substances contained in the article, 
but certain other statements " regarding such articles." What such statements 
are appears, in the case of drugs, in the paragraph immediately following the 
definition of misbranding; for instance, drugs in imitation of or offered for sale 
under the name of another article. The only possible ground for doubting this 
construction arises from the manner in which the general definition of the term 
misbranding is followed, in the case of drugs, by specifications which purport to 
be additions. The remainder of section 8, dealing with the case of food, is per- 
fectly clear. The first three paragraphs specify the particulars other than state- 
ments regarding the ingredients or substances contained therein which shall be 
deemed misbranding, and then follows the general provision covering any state- 
ment " regarding the ingredients or the substances contained therein which 
shall be false or misleading in any particular." Having regard to the fact, how- 
ever, that the general definition of the term misbranded is expressly applicable 
to both food and drugs, it does not appear that the difference in phraseology 
and form of arrangement of the specific provisions for the two articles affects 
their substantial equality in scope. It is clear that the section does not apply 
to any statement regarding a drug which does not have reference to the in- 
gredients or substances contained therein, or to any of the particulars specified 
in the section in the case of drugs. The same process of reasoning discloses 
the scope of the phrase " false or misleading in any particular." If there is 
any appreciable difference in the import of the words false and misleading, the 
scope of the latter term is to be found in the specific provisions of this section 
in the case of drugs; for instance, where the label fails to state, as required, 
the quantity or proportion of alcohol contained therein. No statement regard- 
ing a drug can therefore be false or misleading in any particular, within the 
meaning of the act, unless it relates to some one or more of the various par- 
ticulars expressly enjoined or prohibited by the act.
It appears upon the face of the information that the preparation in question 
contained some peroxide. There was no statement on the label as to the 
quantity or proportion, nor does the act require any such statement in the case 
of peroxide. Certainly, then, the label was not false. In re Wilson, 168 Fed. 
Rep. 566; United States vs. Boeckmann, 176 Fed. Rep., 382. But the informa- 
tion alleges that the label is " false and misleading, in that the words ' Perox- 
ide Cream' represent that peroxide is an important ingredient, and tend to 
lead the purchaser to believe that peroxide is an important ingredient of the 
article, whereas, in truth and in fact, the article then and there contained only 
an indication of a very small quantity of same peroxide, which said quantity is 
insignificant." It is asserted (and it is a fair inference) that the label tends 
to lead purchasers to believe that peroxide is present to such an extent that the 
antiseptic and healing qualities of peroxide may be obtained from its use; 
and it is argued that such is not the fact, and therefore the label is misleading. 
In other words the Government contends that the statement on the label with 
reference to the remedial effect of the article is a misbranding within the mean- 
ing of the act because the article is in fact ineffectual for the purpose indi- 
cated. Assuming that the information is sufficient as a pleading to raise such 
an issue, this contention is based upon an entire misconception of the scope and 
purpose of the act. The purpose was to protect the public against deception in 
the purchase of drugs and food by punishing adulteration and misbranding as 
therein defined. If the label on a drug is not false or misleading in any of the 
particulars enjoined or prohibited by section 8, no offense is committed under 
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that section. By no possible construction can the terms of the act be extended 
to such a boundless field of inquiry as that involved in the accuracy of the 
remedial effects claimed for a drug. Such an inquiry could be pursued only 
through the opinions of contending experts and the experience of those who 
had used the article, and a conclusive determination could seldom, if ever, be 
reached. At all events, it is sufficient to say that the act discloses no purpose 
to hold manufacturers and vendors of preparations like the one in issue here to 
criminal responsibility for misstatements as to their curative or remedial 
effects.   United States vs. Johnson, 177 Fed. Rep. 313.
The second count of the information alleges that there was "enclosed with 
the article a circular entitled "A. D. S. Toilet Dainties," containing the follow- 
ing words under the heading "A. D. S. Peroxide Cream ": " It is a pure skin 
cerate, in which a harmless and efficient whitening agent has been successfully 
incorporated "; and asserts that this was a misbranding " in that the circular 
accompanying the article bore statements, designs and devices regarding the 
said article, and the ingredients and substances contained therein, vvhieh were 
false and misleading, in that the statement ' is a pure skin cerate' is false 
and misleading in that it represents the article to contain, wax, whereas, in 
truth and in fact, the said article did not then and there contain wax,, and was 
not then and there a cerate ". In other words, the information shows that the 
alleged false and misleading statement constituting misbranding appeared, not 
upon the label of the article itself, or upon the package in which the article 
was contained, but upon a separate circular (the title of which indicates that 
it advertised other articles) which was enclosed with the article in the envelop- 
ing package.
The terms brand and label as used in this connection are perfectly clear and 
definite; they indicate a statement, design or device affixed to an article. Con- 
fusion can only arise from the failure to employ uniform phraseology through- 
out the different paragraphs of section 8 to express the same idea. In the 
second numbered paragraph relating to food the phraseology is " if the package 
fail to bear a statement on the label"; in the fourth numbered paragraph 
relating to food the phraseology is, " if the package containing it or its label 
shall bear any statement". Doubtless these variations in expression were em- 
ployed in view of the fact that such articles are commonly sold either in bot- 
tles, jars or cans, in which case the statement, design or device would ordi- 
narily appear on a printed label attached thereto, or in an enveloping carton 
or package, when the statement would ordinarily be printed on the package. 
But the clearest provision in the section (the third numbered paragraph relat- 
ing to food) omits the word label altogether: " If in package form, and the 
contents are stated in terms of weight or measure they are not plainly and 
correctly stated on the outside of the package". The plain sense of the 
language in question is that it embraces any statement, design or device re- 
garding the article, which appears on the outside of the package in which the 
drug is offered for sale, whether such statement be printed upon or otherwise 
affixed to the package itself or impressed upon a separate label which is then 
affixed to the package. An advertising circular enclosed with an article inside 
the carton in which it is offered for sale, does not induce the sale or deceive 
the intending purchaser, and is not within the purview of the act.
The demurrer is sustained.
W. M. HAYS, 
Acting Secretary of Agriculture.
WASHINGTON, D. C, November 4,1911.
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