76. Alleged adulteration of Roux Lash and Brow Tint.    U. S. v. 8 Packages, 12
Packages, and 20 Packages of Roux Lash and Brow Tint. Gases ordered 
removed to the Kistrietsot New Jersey for consolidation and trial. Tried 
to the court and jury. Disagreement of jury and mistrial declared. Case 
retried hcfore the court and a jury verdict for claimant. Judgment dis- 
missing libel and ordering product returned to claimant. (F. D. C. Nos. 56, 
62, 63.   Sample Nos. 25976-D, 33229-D, 33230-D.)
This product consisted of three preparations, "No. 1," "No. 2" (Black and 
Brown), and "Stain Remover," respectively. "No. 1" consisted of about 2 percent 
of pyrogallol, with a little sodium lauryl sulfate and about 16 percent isopropyl 
alcohol; the "No. 2 Black" consisted of about 9 percent ammoniacal silver sulfate, 
about 5 percent ammoniacal silver nitrate, and Ho of 1 percent free ammonia 
in water; and "No. 2 Brown" was half the strength of "No. 2 Black." The 
stain remover consisted of % percent solution of sodium hypochlorite.
On August 13 and 24, 1938, the United States attorneys for the District of 
New Jersey and the Northern District of Illinois filed libels against 8 packages 
of Roux Lash and Brow Tint (Black) at Newark, N. J., 12 packages of Roux 
Lash and Brow Tint (Brown), and 26 packages of Roux Lash and Brow Tint 
(Black) at Chicago, Ill., alleging that the article had been shipped in interstate 
commerce on or about July 14 and 23, 1938, from New York, N. Y., by the Roux 
Distributing Co.; and charging that it was adulterated.
The article was alleged to be adulterated in that it contained poisonous and 
deleterious substances, namely, pyrogallol, ammoniacal silver sulfate, and silver 
nitrate, which might have rendered it injurious to users under the conditions 
of use prescribed in the following labeling and under such conditions of use as 
are customary or usual: (Carton) "Caution This product contains a metallic 
salt. It is for external use only and must be used with care"; (circular) 
"10 Rules For Applying Roux Lash And Brow Tint The observance of the 
ten simple rules set forth here below will produce the best results with the 
greatest degree of efficiency. Read these rules carefully. * * * Rule No. 1- 
Sit patron in upright position. Rule No. 2-Instruct patron to keep eyes closed 
during entire treatment. Rule No. 3-Wash the brows and lashes thoroughly 
with a good neutral soap, and dry by padding with soft absorbent cotton. Rule 
No. 4-Place a layer of vaseline on one side of the eyeshield and place this shield 
ander the lower lashes with the vaseline side against the lower lid. Rule No. 
5-Now cover all skin adjacent to brows and lashes with vaseline. Do Not 
Get Any Vaseline On The Hair Structures. Any Part Of The Brows Or Lashes 
That Becomes Covered With Vaseline Or Other Oily Substance Will Not Take 
Coloring.   Rule No. 6-Wind a piece of absorbent cotton around the end of a
toothpick. Saturate this applicator with Solution No. 1, and impregnate the 
brows and lashes with the preparation. Rule No. 7-Allow Solution No. 1 to dry, 
taking about three minutes. Rule No. 8-Now impregnate a new cotton-tipped 
toothpick with Solution No. 2 and thoroughly treat the eyebrows first, and then 
the eyelashes with Solution No. 2. Use Solution No. 2 freely, but not so exces- 
sively as to permit any running. Rule No. 9-After thirty seconds, wash the 
brows with absorbent cotton saturated with a warm soap solution. After one 
minute wash the eyelashes with absorbent cotton saturated with cold water. 
Rule No. 10-If deeper shades are desired, repeat the process. * * * This 
product contains a, metallic salt. It is for external use only and must be used 
with care."
On October 7, 1938, the Roux Distributing Co., claimant, filed a petition in 
the District Court for the District of New Jersey, praying removal of the cases 
to the Eastern District of New York for consolidation and trial. On October 
20, 1938, an order was entered granting the petition of the claimant and ordering 
that the clerks in the respective courts forward all papers to the Eastern District 
of New York, also that any further actions that might be instituted against the 
product toe consolidated with the instant cases.
On November 4,1938, the claimant filed answers admitting the interstate ship- 
ment but denying that the product was adulterated as alleged in the libels and 
praying dismissal of the libels and delivery of the goods.
The case came on for trial before a jury on March 27, 1939. The hearing of 
the evidence and arguments of counsel were concluded on April 14 and the case 
was submitted to the jury, which, after lengthy deliberation, announced that it 
could not agree on a verdict. The court thereupon declared a mistrial and dis- 
charged the jury. The case was set for trial finally on March 16, 1942, before 
a jury and
~ was concluded on April 1, 1942. The following charge to the jury 
was delivered by the court.
INCH, Judge. "Members of the jury, at last this case comes to you for your 
verdict. ? It has been an interesting case, mostly expert testimony, and you are 
the sole judges of the fact. Nothing said by the court or by the lawyers is to be 
taken in place of your recollection of the testimony. You and you alone decide 
what the truth is, what the facts are. You must take the law from the court 
and apply it to the facts which you and you alone find to be facts. The law 
is very simple in this ease. There is no necessity for a long charge, but it is 
an important law, and therefore I want you to pay a little attention to it as 
we go along-more so than ordinarily. Before we come to that I will explain 
the nature of this action. Perhaps you know it already from the summation. 
This action is an action in rem, as we call it. It is not against the Roux Co. It 
is against certain packages of cosmetics which the Government claims violated 
the law. The Roux Co. comes in as the claimant of those packages. It is not a 
criminal case at all; it is a civil case. In other words, the United States of 
America has seized eight packages more or less of an article labeled in part 'Roux 
Lash and Brow Tint Black,' that was shipped from New York to Newark, N. J. 
It has also seized 12 packages more or less of an article labeled in part 'Roux 
Lash and Brow Tint Brown,' and 25 packages more or less of the said article 
Roux Lash and Brew Tint Black shipped from New York to Chicago, Ill. The 
case has been brought against these packages. It is not against .Roux Labora- 
tories, Inc., which has appeared in this court to claim them, but, of course, Roux 
Laboratories, Inc. is vitally interested in this action because it is their prepara- 
tion. The packages in question were seized after the Government had brought 
charges against them under the Federal Food, Drug, and Cosmetic Act. That 
statute was passed by Congress and approved by the President, and was effective 
insofar as this case is concerned on June 25,1938.
"Now, as I have already mentioned, I want to call particular attention to this 
law, more so than ordinarily, for the reason that it is a new law comparatively 
speaking. It is known as the Federal Food, Drug, and Cosmetic Act of June 1938. 
Prior to 1938 there was the well known Food and Drugs Act, but this was not 
deemed to be sufficient to cover the field of cosmetics; hence Congress passed this 
law which now governs us in this action. Primarily the purpose of the law is the 
same as that of the former law, that is, to prevent injury to the public health by 
the sale and transportation in interstate commerce of adulterated cosmetics, and 
this laudable purpose naturally requires that such a law be given a fair and rea- 
sonable construction to attain its aim. Now, the law is found in Title 21, United 
States Code, Section 301. First we come to section 321 which covers definitions, 
and there we find this definition: 'The term cosmetic means, first, articles in-
tended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise 
applied to the human body or any part thereof for cleansing, beautifying, promot- 
ing attractiveness, or altering the appearance, and second, articles intended for 
use as a component of any such article, except that such term shall not include 
soap. So, while it is a fact for you to find, I think there is no dispute but that 
these articles which we have before us here and which have been seized by the 
Government are cosmetics under this definition. I do not think that is disputed. 
If that is so, and if you find that is so, then, of course, cosmetics as a rule are not 
subject to seizure; it is, as I have stated, adulterated cosmetics that are to be 
taken off the market; so we come to section 361 of the law, which is as follows- 
and this is the important law governing your verdict-'A cosmetic shall be 
deemed to be adulterated if it bears or contains any poisonous or deleterious 
substance which may render it injurious to users under the conditions of use 
prescribed in the labeling thereof, or under such conditions of use as are cus- 
tomary or usual.' I think I can read it to you again without any harm: 'A cos- 
metic shall be deemed to be adulterated if it bears or contains any poisonous or 
deleterious substance which may render it injurious to users under the conditions 
of use prescribed in the labeling thereof, or under such conditions of use as are 
customary or usual.' I shall refer to this, of course, a little later, but I think now 
you have the law under which we are proceeding. That being so, the Government 
claims that these articles that have been mentioned are adulterated cosmetics 
under this definition. Now, the burden of proving this by a preponderance of 
evidence rests upon the Government. You must be satisfied by a preponderance of 
evidence that these articles are adulterated cosmetics. The claimant, Roux 
Laboratories, Inc., denies any such adulteration and asserts that the Government 
therefore has no right to seize and condemn the cosmetics for that reason. By 
preponderance of evidence is meant not necessarily the greater number of wit- 
nesses but that amount of evidence which taken on the whole produces the stronger 
impression upon your minds and satisfies you of its truth when weighed against 
evidence in opposition thereto. You are the sole judges of the weight of the 
evidence and the credibility of the witnesses. You are entitled to take into con- 
sideration, therefore, the demeanor of the witnesses, their apparent intelligence, 
their opportunity of knowing or seeing the facts about which they testified, their 
interest, if any, and the probability of their testimony. All these things, or the 
lack of them, are to be considered by you in weighing the evidence. You will find 
therefore when you have followed my charge up to this point and return to con- 
sider the law again that the first thing is that a cosmetic shall be deemed to be 
adulterated if it bears or contains any poisonous or deleterious substance. Well, 
of course, you will want to know at once, 'What do you mean exactly by poisonous 
or deleterious substance?' I think that I can best charge you in the language of 
the request of counsel for the claimant as to that. The terms 'poisonous or dele- 
terious' or 'injurious to users' must be given their natural and ordinary meaning. 
Poison has been defined as, first, a potion containing a noxious or deadly ingre- 
dient, any agent which introduced especially in small amounts into an organism 
may chemically produce an injurious or deadly effect. That is poison. A dele- 
terious substance has been defined as a harmful or destructive article. The com- 
mon and generally accepted meaning of the word is having the power of destroying 
or extinguishing life, that is, that which is destructive, poisonous, pernicious. 
They are in about the same category, but those definitions are in order for you to 
take them into the jury room. Now, a cosmetic shall be deemed to be adulterated 
if it bears or contains any poisonous or deleterious substance,-now comes a very 
important part of the law-'which may render it injurious to users under such 
conditions of use as are prescribed in the labeling thereof or under such condi- 
tions of use as are customary or usual.' The term 'may' is here used in its 
ordinary and usual signification; it is an auxiliary verb qualifying the meaning of 
another verb by expressing ability, contingency, or liability, or possibility or prob- 
ability, and you are instructed that, if you find from the evidence that the cos- 
metics involved in this case or either of them contain the substances referred to 
in the Government's libels and that such substances are poisonous or deleterious 
and are likely to result or may result in injury to users under the conditions of 
use prescribed in the labeling thereof or under such conditions of use as are cus- 
tomary or usual, then such articles are adulterated and you should render a 
verdict for the Government. The burden of proof is on the Government to 
satisfy you that that is so.
"Now, it is the general public health that is to be protected by this law, not 
that of any one particular individual.
"These cosmetics came in cartons, and on each carton are printed directions 
for their use with other articles to be used in the application of the liquid, with 
which you are familiar, and the cosmetic itself is contained in little bottles. 
There is no necessity whatever in my opinion for me to go into the details of the 
chemistry. You have had the witnesses for both parties testify before you and 
you have had the summations by the able lawyer for the claimant and by the 
equally able Assistant United States Attorney. There is no necessity in my 
opinion for me to dwell on that. But I call your attention to the fact that 
the Government claims that it has proved that these cosmetics are adulterated 
cosmetics, in that they contain pyrogalloj, ammoniacal silver sulfate, and am- 
moniacal silver nitrate which may render them injurious to users under the con- 
ditions for use prescribed in their labeling or under such conditions of use as 
are customary or usual. This therefore is the issue which you must decide by 
a preponderance of evidence: do the cosmetics in question contain poisonous or 
deleterious substances which may render them injurious to users under the con- 
ditions of use prescribed in the labeling thereof or under such conditions of 
use as are customary or usual 
"Now, there is one more important thing for you to consider under this law. 
The extent of injury is not important: whether it is temporary or permanent 
is not important in this case. However important it is to the victim, Congress 
was protecting the public against any injury. Now, of course, that does not 
mean that a mere inconvenience can be considered an injury, because you must 
follow the definition of what is meant under the law as an injury-a harm, a 
damage to the human being using these preparations-but a person doesn't have 
to go blind to come under the law. A person must, however, at least be harmed, 
injured by the use of this preparation.
"Now, if you find that the Government by a preponderance of evidence has 
proved to you that these cosmetics were so adulterated your verdict should be 
for the Government. If, on the other hand, you find that the cosmetics were not 
so adulterated, your verdict should be for the claimant. As I say, I see no 
reason, nor shall I attempt, to discuss the details of the medical proof, for 
you are well aware of it. The Government has alleged in its libels that these 
articles or cosmetics are adulterated under the provisions of this act, that is, 
that they may render it injurious to users under the conditions of use prescribed 
in the labeling thereof or under such conditions of use as are customary or usual. 
I therefore charge you that, if you find from the evidence that either or both 
of these articles or cosmetics, namely, the packages of Roux Lash and Brow 
Tint Black and Roux Lash and Brow Tint Brown contain any of the substances 
specified in the libels, and that any of such substances are poisonous or deleterious 
substances, and you find that any such poisonous or deleterious substances may 
render these cosmetics injurious to users under the conditions of use prescribed 
in the labeling thereof, or under such conditions of use as are customary or 
usual, then the cosmetics are adulterated and your verdict should be for the 
Government. On the other hand, if you find from the evidence that the substances 
mentioned in the libels are not sufficiently poisonous or deleterious so that they 
may render these cosmetics injurious to users under the conditions of use pre- 
scribed in the labeling thereof, or under such conditions of use as are customary 
or usual, then the cosmetics are not adulterated and your verdict should be for 
the claimant.
"The intent of the claimant, that is, the Roux Laboratories, Inc., has no bearing 
In this case on the facts. It is not a question of intention, good or bad intention. 
The only question that you are to determine is whether or not these two articles 
of cosmetics fall under the ban of the statute. Therefore you will come to this 
finally: is there actual danger of injury to users when the contents are applied 
in the manner recited in the directions which are present in the packages. You 
will have to take all of the evidence in that regard and consider it in coming 
to the conclusion whether the directions are sufficient. There is testimony by 
witnesses for the Government, which is for you to consider, that a liquid such 
as this cosmetic if freely applied to an eyelash may be drawn by capillary attrac- 
tion to the root of the eyelash which is at the margin of the eyelid and that 
the margin of the eyelid is likely then to come in contact with the surface of 
the eyeball, and that even if that does not happen there is a possibility that 
some of this liquid will reach the inside of the eye by reason of an involuntary 
opening of the eye and thus cause the product to be injurious to such user. That 
is testimony for you to consider. But you must also consider the fact that there 
is no claim by the Government, and certainly no assertion by the claimant, that 
this is to be inserted into the eye.   It is a dye for an eyelash or an eyebrow.
It is not intended to go into the eye. The directions ure supposed to be sufficient 
to keep it out of the eye. On the other hand, there is testimony by the claimant, 
which is for you to weigh and consider, that these cosmetics contain no such 
poisonous or deleterious substance which can injure the eye of the user, even 
if it got in there, but that if the directions are reasonably followed none of the 
substances should touch the eyelid or reach the eyeball. Those are facts for 
you to find based on the evidence one way or the other, and in doing that you 
will have to consider all the expert testimony, of which there has been a great 
deal. Whether or not there was such adulteration, of course, is a question of fact 
for you to determine.
"I have already called your attention to the fact that the statute uses the word 
'may,'-not 'will' or 'must,' but 'may' render the substance injurious to the person 
using it.
"Now, ordinarily in the trial of cases in this court witnesses are confined to 
testifying to facts within their personal knowledge and are not permitted to draw 
conclusions or express opinions. This is a general rule, but where the points 
in issue arise out of a particular trial concerning which there are trained minds 
who have special knowledge, learning, or schooling in that particular field such 
persons are called experts and in their case they are entitled to express opinions 
concerning the matter in issue. I therefore charge you that you must weigh 
and value the testimony of the expert chemists, pharmacologists, physicians, 
opthalmologists, and dermatologists who have testified in this case precisely as 
you weigh the testimony of other witnesses, taking into account the probability 
of such expert testimony, the reasonableness of it, the schooling of the person giv- 
ing it, the learning he has in his profession, the breadth of his experience, all of 
those things which go to give weight to or detract from the value of the testimony 
of an expert.
"Now, I think that I have covered the whole field. You know exactly what 
you have to do when you retire to the jury room. You have got to consider all 
the testimony, all the expert opinions, weigh the testimony, bearing in mind that 
the burden of proof is on the Government to satisfy you by a preponderance of 
evidence, first, that these articles that they have seized are cosmetics that have 
been adulterated, and that as such they contain poisonous or deleterious sub- 
stances which may render them injurious to users under the conditions of use 
prescribed in the labeling thereof or under such conditions of use as are cus- 
tomary or usual.
"Now, of course, it doesn't mean that some person that is allergic to some- 
thing can be considered protected by this law, because he is an exceptional 
individual. It doesn't mean, as I have already said, possible inconvenience 
without any harm to the eye, but it does mean that the general public, the 
general users must be protected against cosmetics that are adulterated and 
which may in spite of the instructions, in spite of the ordinary and customary 
use injure in some way-to a small or to a great extent is immaterial.
"W(hen you retire you will consider, of course, and it needs no proof, that 
the eyes of a human being are shown by the evidence to be delicate and that 
they are vastly important to our lives, and that the eyelashes are in close 
proximity to the eye. If this thing that is before you now results in some 
hardship to the claimant, the importance of the health of the public outweighs 
any such consideration. If, on the other hand, the claimant has an article, a 
cosmetic that is not adulterated and that the law does not condemn, why, then 
of course in the absence of proof to the contrary by a preponderance of evidence 
your verdict should be promptly for it. There is no difficulty about that. The 
only difficulty is when you retire that some of you may consider that you have 
got your own opinions and will not be changed by anyone on the jury. Now, 
the duty of a juror is individual, of course. That doesn't mean that you are 
to put yourself in one corner and say, *I won't listen to argument: I won't 
listen to anything at all. I am satisfied just where I am.' That leads to 
disagreement. That leads to expense for the claimant and for the Govern- 
ment. It means more trouble and more time. There should be no difficulty 
about a sensible common sense consideration of this case. That is your duty. 
Don't leave your common sense behind. When you go into the jury room sit 
down and say, 'Now, the Judge has told us that the Government must prove 
by a preponderance of evidence, which he has defined, that these cosmetics 
are adulterated in that they contain a poisonous or deleterious substance which 
may render it injurious to users under the conditions of use prescribed in the 
labeling thereof or under such conditions of use as are customary or usual. 
Do  they contain  such  a  substance?   If so,  may  such  substances  render  it
injurious to any extent within the definition of an injury-harm, damage to 
users generally under the conditions of use prescribed in the labeling thereof, 
or are the directions so excellent and so positive, that no one could do damage 
to their eye by following the directions?' If the Government has failed to 
satisfy you to that extent, bring in a verdict for the claimant. If on the 
other hand, you are satisfied that the Government has carried the burden and 
that here is an adulterated cosmetic that should be taken off the market under 
the law, then it is you duty to bring in a verdict for the Government. Your 
duty is plain. We are not concerned with anything else except this particular 
issue. We are protecting the people of the country against adulterated cosmetics 
where the labeling is not sufficient or the customary use is not sufficient, and 
at the same time we want every manufacturer to feel he has had a fair trial 
and that unless the Government proves its case by a preponderance of evidence 
it can go on manufacturing by reason of the verdict of the jury. Any exceptions 
or requests?"
Mr. PAEKER. "Perfectly satisfactory, your honor."
Mr. HAYJS. "I want to take exception to that part of your honor's charge to 
the effect that the Government's case is made out when it proves its case by a 
prepondei ance of evidence."
THE COUE.T. "Yes.   All right."
Mr. HAYES. "And I want to take exception to all those parts of your honor's 
charge as to the extent of injury which may allow condemnation of the product."
THE COUBT. "All right.   Overruled."
Mr. HAYES. "With reference to the requests to charge, I don't want to take 
up the time of your honor before the jury here."
THE COURT. "Come on. Let us get along with it. I don't want to get into 
any argument."
Mr. HAYES. "I ask your honor to charge the jury that any use of this product 
under conditions and for purposes not reasonably prescribed in the directions 
cannot be considered."
THE COURT. "I shall not charge anything more than I have already charged. 
Your requests were all handed up before the summations in accordance with our 
rules and have been considered. I give you an exception for the failure to charge 
any of those I haven't charged."
Mr. HAYES. "Very well."
THE COURT. "YOU may retire and we will excuse our additional juror with 
thanks.
"You, Mr. Foreman, can have any of the exhibits. You can take them all 
with you if you want them or you can leave them here. Just suit yourselves. 
You had better consult with your fellow jurors and if you want them all the 
exhibits will go right with you."
On the same day, April 14, 1942, the jury returned a verdict for the claimant, 
and judgment was entered ordering the consolidated case dismissed and the 
product returned to the claimant. 
3