1360. Misbranding: of Sulfa-Seb and Sulfa-Ped.    U. S. v. 50% Dozen Bottles of
Sulfa-Seb and 17% Dozen Bottles of Sulfa-Ped. Tried to the court.
Judgment for the Government. Decree ordering:' the condemnation and
destruction of the labeling: and the release of the product to the claim-
ant.    (F. D. C. No. 11075.   Sample Nos. 3933-F, 3934-F.)
On or about November 10, 1943, the United States attorney for the Western
District of Missouri filed a libel against 50? dozen bottles of Sulfa-Seb and
17? dozen bottles of Sulfa-Ped at Kansas City, Mo. On February 14, 1944, an
amended libel was filed.   It was alleged that the articles had been shipped on
or about October 19,1943, from Royal Oak, Mich., by the Nu-Basic Products Co.;
and charged that they were misbranded. The misbranding charges appear in
the opinion infra.
Examination of samples disclosed that each of the articles contained approx-
imately ? gram of sulfanilamide per fluid ounce, approximately 0.75 gram of
phenol (carbolic acid) per 100 cc, oil, including a large proportion of mineral
oil, and water.
On March 27, 1944, the Nu-Basic Products Co., claimant, having filed-an answer
denying that the products were misbranded as alleged in the libel, the case came
on for trial before the court without a jury. The trial was concluded on March
29,1944, and on April 3, 1944, the court handed down the following memorandum
opinion and findings of fact and conclusion of law:
OTIS, District Judge: "The amended information in libel in this proceeding
was filed February 14,1944. It makes reference to two preparations, one known
as 'Sulfa-Seb,' the other as 'Sulfa-Ped.' The charge is that these preparations are
misbranded within the meaning of Title 21, U. S. C, Section 352. That section
provides inter alia that a drug 'shall be deemed to be misbranded (a) if its label-
ing is false or misleading in any particular' and that it 'shall be deemed to be
misbranded (f) unless its labeling bears . . . such adequate warnings . . .
against unsafe dosage or methods ... of administration or application, in
such manner and form, as are necessary for the protection of users; . . .'
"The information charges that the labeling of the preparation known as
'Sulfa-Seb,' which reads, in part, 'For hair and scalp . . . Designed as a fungicide
to relieve itching, and treat and control the condition resulting from infection
round the follicles of the hair,' is false and misleading in the following respects:
that the article (1) is not an adequate treatment for disease conditions of the
hair and scalp; (2) that it is not fungicidal; and (3) that it will not control
conditions resulting from infection around the follicles of the hair.
"The information charges that the labeling of the preparation known as
'Sulfa-Ped,' which reads, in part, 'A new treatment for Athletes Foot . . .
Designed as a fungicide to relieve discomfort and treat and control the conditions
identified with fungus and bacterial conditions of the feet . . . ,' is false and
misleading in that the preparation is (1) not a treatment for athlete's foot; (2)
is not a fungicide; and (3) will not relieve discomfort and treat and control
conditions identified with fungus and bacterial conditions of the feet.
"The information alleges that both preparations are misbranded for that
the labels contain no such adequate warnings 'as are necessary for the pro-
tection of users since the articles contain sulfanilamide' and no warnings that
'their use [i. e. of the preparations] should be discontinued if a new skin rash
appears or if the skin condition under treatment becomes worse.'
"We begin this memorandum by first discussing the first charge in the informa-
tion, that the preparation known as 'Sulfa-Seb' is false and misleading in the
respects indicated in the information,
"1. There has been no real controversy in the case between counsel for
plaintiff and counsel for claimant touching the applicable law. The language
of the statute is clear enough. If the labeling 'is false and misleading in any
?particular' the preparation bearing the label has been misbranded. Obviously
it is necessary first of all to determine what representation is made by the label
and to determine whether that representation is false and misleading in any
particular. It would seem to be obvious, moreover, that in determining whether5
the representation on a label is false and misleading in any particular all the
language of the label must be considered. None would contend that single words
or phrases should be lifted out and that if those words or phrases separately
considered can be found to be untrue, then the preparation should be condemned
as misbranded. Single words or phrases might be so explained by other language
as that there is no misrepresentation whatever. Fairness requires that the
whole legend upon the label of 'Sulfa-Seb' should be set out so that the label
may be considered as a whole. Accordingly, we do set out the label by inserting
at this point one of the labels:
A    SULFA-DBUG    COMPOUND    SUM1 A-SEB    A    Nu-Basic    [design]     Product    FOB    HAIB    AND
SCALP A proprietary compound of mineral and vegetable oils -which acts as a carrying
agent for Sulfanilamide, the active medlcant. Designed as a fungicide to relieve itching,
and treat and control the condition resulting from infection round the follicles of the
hair, ACTIVE MKDICANT SULFANILAMIDE % GRAM TO BA. FL. OZ. Distributed by SULFA
PRODUCTS co. 1125 Grand Ave. Kansas City, Mo. SHAKE WELL BEFOBE APPLYING ALSO
CONTAINS Phenol (less than 1% by volume) and other inert ingredients in varying
amounts, GUARANTEE Return for refund must be made within 2 weeks of purchase.
EXTERNAL   USE   ONLY     SHAKE   WELL   BEFORE   APPLYING    Directions  for   Use    Massage
thoroughly into scalp. Comb out loosened scale using fine tooth comb. Use often
as necessary to keep scalp moist with preparation. If hair is left too oily from treatment,
remove excess oil by brushing. Set and groom with wetted comb. Wash hair no oftener
than once a week.    Content 4 Fluid Ounces $2.50.    EXTERNAL USE ONLY    MPG. BY-SULFA
PRODUCTS  COMPANY  OP AMERICA?DIV.   NU-BASIC  PROD.   CO.,  ROYAL  OAK,  MICH.
"Any one who inspects this label will at once discern that it contains much
language which is not charged as being false or misleading and which obviously
is not false or misleading. Some of the language is devoted to precise directions
as to how the preparation is to be used. Some of it is a guarantee of return of
money. A part of it is a warning that the preparation is 'for external use only.'
Some of it describes accurately all of the ingredients in the preparation. Much
of that part of the legend which is the object of the government's complaint is
in type so small that it would almost certainly escape being read by any ordinary
purchaser. The most prominent part of the label is the name of the preparation,
'Sulfa-Seb,' a name which certainly means nothing and conveys no significance.
In somewhat smaller type, and yet in legible type as distinguished from the
minute wording of the rest of the label, are the words 'FOE HATE AND SOAIP.' Here
is the real representation which is made to the purchasing public. Nine out of
ten of the purchasers of this preparation in all probability would.read no other
part of the label than the words in conspicuous letters *FOS HAIE AND SCALP.'
(What advertising, what circular, what verbal recommendations may have in-
fluenced purchasers we do not know but very reasonably we may conclude that
an intention to purchase was formed before the label was read). Let us then
first consider whether the 'FOE HAIE AND SOALP' is false and misleading.
"We agree at once with the contention of the Government in this case that there
is an implication in the words 'FOB HAIE AND SCALP' which constitutes a part of
the meaning to the ordinary observer and purchaser. By the use of these words
it is represented that the preparation, when applied externally and in the manner
prescribed by the directions on the label, is beneficial to the hair and scalp, that
the use of the preparation will promote the health of hair and scalp. To say,
however, that the words "FOB HATE AND SOALP' alone (as was said in the argument
by learned counsel for the Government) would mean to an ordinary observer
that the preparation was a panacea for every possible disease that might attack
the hair or scalp seems to us grossly to distort the meaning which the reader
would derive from the language employed. The reasonable interpretation of the
words, considered alone, is that the use of the preparation in the manner directed
will benefit the hair and scalp when affected by such commonly known maladies
as those causing, for example, dandruff, falling hair, threatening baldness.
"When we descend from the words in large type, 'FOE HAIE AND SCALP,' into the
legend minutely printed beneath them, we are given the more specific information
that the preparation is 'Designed as a fungicide to relieve itching' and that is it
'Designed as a fungicide to treat and control the condition resulting from infection
round the follicles of the hair.' Here the words that would mean anything to
the ordinary reader and observer (the word 'fungicide' would mean nothing
except to the rare individual) are the words to 'relieve itching' and the words
'to treat and control the condition resulting from infection around the follicles
of the hair.'
"The impression then created by this label on the ordinary purchaser and.
observer, if he reads only the conspicuous words, is that here is a preparation
that will be helpful in dealing with such common maladies as dandruff, falling
hair, etc., and, if he descends into the minute type, that here is a preparation
that will relieve itching in the scalp and that will beneficially affect a condition
resulting from infection in the scalp.
"With such an interpretation placed upon the label, and we believe it is a fair
interpretation, not a far fetched and distorted one, the question is, is this prepara-
tion one which will benefit the hair and the scalp with respect to the common
maladies referred to and is it a preparation which will relieve itching in the
scalp and will benefit conditions resulting from infection in the hair. If the
preparation will do these things it certainly cannot justly be condemned as
falsely labeled.
"2. The evidence in the case was of two general classes, the testimony of
experts and the testimony of laymen. The testimony of the laymen called by
the Government (there were only a half dozen of these) chiefly related to the
charge of misbranding for failure to warn of dangers. It did not particularly
bear upon the charge which we now are especially considering, namely, was
the label of 'Sulfa-Seb' false and misleading. The testimony of the laymen who
testified for the claimants (there were fifteen of these) did directly bear upon this
charge, either as against 'Sulfa-Seb' or 'Sulfa-Ped.'   But the testimony of a few
laymen, however honest that testimony may be (and we regard the testimony
of each of the laymen appearing in this case as entirely honest) is of slight value
upon the issue under present discussion. There were many thousands of users
of these preparations. The evidence indicated that there were hundreds of users
even in Kansas City. That a small number experienced unsatisfactory results,
which .they ascribed to some deficiency or injurious element in the preparation,
and that a small number experienced satisfactory results which they ascribed
to the preparation, is of small significance. The nature of the simplest disease
is so obscure to a layman that his conclusions touching what will benefit it and
what will not benefit it mean little. We would not say, of course, that if we
were dealing with and had the results of tens of thousands of cases, we would
not have something significant. A few dozen instances are of such trifling value
as that they can almost entirely be disregarded.
"The scientific testimony in a case of this character is the testimony that counts.
Scientific testimony is available to support any meritorious cause, even, as we
know, when the leading physician in a community or the American Medical
Association itself is under attack. Of course, scientific testimony is available to
the Government in support of any meritorious cause presented by the Government.
The Government has its official staff of scientists of outstanding ability and the
government is able to obtain the services of other scientists of outstanding
ability. But private individuals also are able to obtain the testimony of out-
standing men of science provided there is real merit m their cause. Claimants
in this case had the financial ability to obtain testimony. But they put only one
so-called expert (we use the word 'so-called' advisedly) on the stand. They
brought him from San Antonio, Texas, to Kansas City and paid him, according
to his testimony, at the rate of $100 a day and, we suppose, his expenses also.
(We judge that was the zenith of his professional earnings to the present date.)
"The testimony of the young M. D. brought by claimants from Texas was piti-
fully weak. His qualifications were unsatisfactory, his experience in the prac-
tice of medicine was brief and limited, his knowledge of the science of the subject
under inquiry was obviously slight. He could say 'Yes' to leading questions, but
if he had been asked to discuss the sciences involved he would have floundered
hopelessly. He was spared, if not by merciful counsel (who also were flounder-
ing) at least by a merciful court.
"There was a reason for the complete failure of the claimants to support their
contentions by outstanding expert testimony. That testimony just was not
procurable. The failure of the claimants in this respect impressed us as almost
the equivalent of a confession of the general accuracy of the testimony of the
Govermnment's experts. The general effect of that testimony was that while the
preparation 'Sulfa-Seb' might have some slight temporary value in some instances
by way of relieving an itching scalp or by way of temporarily removing dandruff,
it had no real value with respect to any malady of the scalp, whether generally
and commonly known or obscure in character and difficult to diagnose. The gen-
eral effect of the testimony of the experts for the Government, whose qualifica-
tions were outstanding, was certainly to the effect that the preparation known
as 'Sulfa-Seb' constituted no kind of a treatment or control for infection in the
scalp and round the follicles of the hair. We are bound to say that the effect
of the scientific testimony offered by the Government was overwhelming as
against the complete emptiness of the scientific testimony offered by the claimant.
"3. Much of what we have said concerning the preparation known as 'Sulfa-Seb'
is equally applicable to the preparation known as 'Sulfa-Ped.' We set out here
the exact label of 'Sulfa-Ped' which the Government has attacked. There cannot
be any objection to much of this label. Most of it is entirely true and accurate.
But we have reached the conclusion that there is some exaggeration in the label
in that part of the legend in which it is represented that the preparation is a bene-
ficial treatment and a control for 'the conditions identified with fungus and bac-
terial conditions of the feet.'
A SULFA DRUG COMPOUND SULFA-PED A NEW TREATMENT FOR ATHLETE'S FOOT S P     A
nu-Basic Product A proprietary compound of mineral and vegetable oils which acts
as a carrying agent for Sulfanilamide, the active medicant. Designed as a fungicide
to relieve discomfort and treat and control the conditions identified with fungus and
bacterial conditions of the
feet, ACTIVE MEDICANT SULFANILAMIDE % Gram To EA.
FL. oz. SHAKE WELL BEFORE APPLYINO Also Contains Phenol (less then 1% by
volume) and other inert ingredients in varying amounts, GUARANTEE Return for
refund must be made within 2 weeks of purchase, EXTERNAL USE ONLY SHAKE WELL
BEFORE APPLYING Directions for use. Chronic Gases: Massage well into affected
parts, morning and night. Take daily foot bath in warm water before applying night
application. Use only mild soap. Acute Cases: Puncture blebs and permit fluid to
drain out.   Bathe in warm water using mild soap.   Dry thoroughly.   Apply and cover
with white cotton hose.    Use new footwear,    CONTENTS : 4 FL. ozs. $2.BO EXTERNAL
USE ONLY    Distributed by SULFA PRODUCTS  CO.    1125 GRAND AVE. KANSAS CITY, MO. ^
MFG.   BY SULFA    PRODUCTS    COMPANY   OF   AMERICA DIV.    NU-BASIC   PROD.    CO.    BOYAL
OAK, MICH.
CEBTAIN MATTERS OF EVIDENCE
"4. During the trial of the case there was offered in evidence by claimants a
large number of letters (responses received from purportedly satisfied customers
to questionnaires mailed cut by claimants). We refused to receive these letters
in evidence for reasons which were stated at. the time of the ruling. Such letters
are so obviously hearsay that the matter of the propriety of the ruling does not
seem to us to be at all debatable). No question of the good faith of the manufac-
turers or of the claimants is involved in this proceeding. The proceeding is not
brought against individuals. The proceeding is against inanimate preparations.
The preparations, not individuals, are attacked. There is no reason to question
the good faith of any one in this proceeding. We believe the claimants did act
in good faith. The only question in the case is, are the labels on the bottles false
and misleading in the sense that the information conveyed by them to ordinary
readers is erroneous.
"Another matter of evidence, which was taken under submission, is made up of
a number of exhibits, being claimants' Exhibits 14 to 21, inclusive. Objection was
made by the Government to the reception of these exhibits. The exhibits were
scientific treatises, each of which discusses the particular preparation involved in
this proceeding. It seems clear to us that these exhibits were not competent in
evidence. The reasons for that conclusion are elementary. Undoubtedly in the
cross examination of an expert witness he may be asked whether he agrees or does
not agree with certain statements contained in reputable treatises. There is no
convincing authority, however, for the view advanced by learned counsel for the
claimants in this case, to-wit, that as affirmative proof treatises may be offered
in evidence. If the testimony of Dr. X, for example, is desired by a party, he can
call him as a witness so that he can be cross examined in court. If he is beyond the
jurisdiction of the court, undoubtedly the party can take his deposition, when
again he may be cross examined. But it is unthinkable that a party may have
some witness (in this instance it was a layman) say that Dr. X is an authority
in a certain field and then to offer in evidence some book or treatise which may
have been written by Dr. X.
"Notwithstanding our views of the law in this regard are very clear, we have
read all of the exhibits referred to which were offered in evidence by the claim-
ants. For the purpose of this case we overrule the objection to these 'exhibits.
Nothing contained in the exhibits affects the findings of fact which we shall here-
after make. Findings of fact are made as of the time when the information in
libel was filed. What may have been the view of scientific men on dates earlier
than that date, of course, is not controlling. The knowledge of scientists, espe-
cially in a field so new as that which deals with the sulfa-drugs, is a growing
knowledge. The science is in the process of evolution. The best views of the .
ablest scientists two or three years ago may not be especially valuable now.
MATTES OF WARNINGS
"The charge of inadequate warnings upon the labels was an afterthought.
The original information in libel did not contain that charge. We are satisfied
that the evidence does not warrant condemnation of the preparations on account
of failure to include warnings.
FINDINGS OF FACT
"1. The label 'Sulfa-Seb' is false and misleading in that it represents that
the preparation labeled is a remedy effective as a treatment for the commonly
known maladies affecting the scalp and hair, whereas its only value is in relieving
an itching scalp and in temporarily, in some instances, removing dandruff, and it
is false and misleading in that it represents that the preparation labeled is a
treatment or control for infections in the scalp and round the follicles of the hair.
"2. The label 'Sulfa-Ped' is false and misleading in that it represents that the
preparation labeled is a treatment of and will control the conditions identified
with fungus and bacterial conditions of the feet.
j"3. Neither the labels of 'Sulfa-Seb' or 'Sulfa-Ped' is misbranded in that it
does not contain an appropriate warning of dangers incident to the use of the
preparations.
CONCLUSION OF LAW
"The prayer of the amended information in libel should be granted. The
labels on the preparation known as 'Sulfa-Seb' and 'Sulfa-Ped' seized by the
marshal should be condemned. The false and misleading labels on such prepara-
tions should be destroyed."
On the same date, judgment was entered condemning and ordering the destruc-
tion of the labels of the products. It was further ordered that when the labels
had been destroyed the products should be returned to the claimant for use in
compliance with the law.