2932. Misbranding of Male Hormone tablets, Menformon Dosules, Female
tablets, and Metandren Linguets. U. S. v. El-O-Pathic Pharmacy, Inc^
and Martin A. Clemens (as manager and director of the corporation and
as an individual trading as M. A. Clemens Pharmacy). Pleas of not
guilty. Tried to the court; verdict of guilty. Fine of $700 against cor-
poration and $700 against Martin A. Clemens. (F. D. C. No. 25607.
Sample Nos. 3G046-K,-30047-K, 30068-K, 30919-K, >31204-K; 31208-K,
31217-K to 31220-K, incl., 31610-K.)
the El-O-Pathic Pharmacy, Inc., Los Angeles, Calif., and Martin A. Clemens,
manager and director of the corporation and trading individually as the M. A.
Clemens Pharmacy, Los Angeles, Calif.
ALLEGED VIOLATION : The El-O-Pathic Pharmacy, Inc., Los Angeles, Calif., and
Martin A. Clemens, acting as manager and director of the El-O-Pathic Phar-
macy, Inc., and trading individually as the M. A. Clemens Pharmacy, on or
about October 26 and 30, November 1 and 6, and December 8 and 28, 1947, and
January 9 and 19, 1948, caused the introduction into interstate commerce, at
Los Angeles, Calif., for delivery to Tucson a^id Phoenix, Ariz., and Seattle,
Wash., of quantities of products labeled Male Hormone tablets, Female tablets,
Menformon Dosules and Metandren Unguets.   When introduced into inter-
. state commerce, the drugs were accompanied by circulars entitled "Male and
Female Sex Hormones."
The defendants also made over-the-counter sales of three lots of the drug
labeled Male Hormone. The drug had been shipped in interstate commmerce
from Nutley, Bloomfleld, and Summit, N. J., to Los Angeles, Calif., and while
held for sale after such shipment, it was repacked by the defendants into
envelopes and sold to various persons without a physician's prescription,
accompanied by circulars entitled "Male and Female Sex Hormones," which
acts of the defendants resulted in the drug being misbranded.
LABEL, IN PART: (Male Hormone) "Each tablet contains 25 mg. [or "5 mg."]
testosterone the form of the true male [all labels with one exception contained
the word "sex"] hormone which is most highly effective for administration by
mouth"; (Metandren Linguets) "Each linguet contains 5 mg. of Metandren
(methyltestosterone), orally active androgen"; (Menformon Dosules) "(Fe-
male Sex Hormone Ointment in individual dose containers for accuracy of
dosage). Each Dosule contains 1 gram of ointment. The active ingredient
of Menformon Dosules is Non-Crystalline Estrone in natural combination with
insignificant quantities of other naturally occurring female sex hormones
(equilin and equilenin) derived from pregnant mare's urine. The content
of estrogenic substance present in each dosule represents the estrus producing
activity of 2000 International units of 0.2 mg. of standard crystalline keto-
hydroxyestratriene (estrone)." The Female tablets bore no labeling on the
box but the word "Female."
NATURE OF CHARGE: Male Hormone tablets. Misbranding, Section 502 (a),
certain statements in the labeling of the article were false and misleading.
The statements represented and suggested that the article would stimulate
growth and development of the sex organs, and the male sex characteristics
such as distribution of hair, muscular development, and depth of voice; that it
would correct lack of sexual power and impotence; that it would relieve and
postpone the many conditions associated with middle age and would improve
the sense of well-being; that it constituted an adequate treatment for flushes,
sweats, chills, impaired memory, inability to concentrate on activities and
tendency to evade them, nervousness, depression, general weakness, and lack
of physical strength; that use of the article would result in improved physical
and mental work and would exert a tonic action resulting in renewed vigor; and
that the article would impart a better attitude toward social life and would
cause nervousness, exhaustion, and melancholy to disappear in the average
man in his late forties. The article would not constitute an adequate treat-
ment for the conditions represented and would not fulfill the promises of
benefit stated and implied.   Further misbranding, Section 502  (f)   (2), the
labeling of the four shipments of the article failed to bear adequate warnings
against use in those pathological conditions where its use may be dangerous
to health, in such manner and form as are necessary for the protection of
users, since each tablet contained 25 milligrams  (or 5 milligrams)  of male
hormone (methyl testosterone) ; and the labeling of the four shipments failed
to warn that use of the product may result in sterility and that its use by in- ,
dividuals with early and incipient carcinoma of the prostate may result in   \i
acceleration of the malignant growth.   Further misbranding, Section 502 (j),
the article in all shipments and sales was dangerous to health when used
in the- dosage and with the frequency prescribed, recommended, and suggested
in its labeling since each tablet contained 25 milligrams (or 5 milligrams) of
male hormone (methyl testosterone), and the use of an article containing 25
milligrams of male hormone in each tablet with the frequency prescribed, rec-
ommended, and suggested in the labeling, namely, as directed on some of the
box labels, "1-2 tablets daily" or "2 tablets 3 times daily," and as directed in
the circular "One tablet a day," would be dangerous to health in that such use
of the article may result in sterility; and such use by individuals with early
and incipient carcinoma of the prostate may result in acceleration of the malig-
nant growth.
Menformon Bosules. ' Misbranding, Section 502 (a), certain statements in
' the labeling of the article were false and misleading.   The statements repre-
sented and suggested that the article would be efficacious to develop the female
breasts, and to stimulate mammary growth and result in definite breast growth
of considerable degree, and that it would be efficacious in the treatment of
underdeveloped breasts.    The article would not be efficacious for such pur-
poses.
Female tablets. Misbranding, Section 502 (b) (2), the label of the article
bore no statement of the quantity of the contents; Section 502 (e) (1), the
article was not designated solely by a name recognized in an official compen-
dium, and its label failed to bear the common or usual name of the article; and,
Section 502 (f) (1), the labeling of the article bore no directions for use.
Further misbranding, Section 502 (f) (2), the labeling of the article failed to
bear adequate warnings against use in those pathological conditions where its
use may be dangerous to health, in such manner and form as are necessary for
the protection of users, since each tablet of the article contained 0.5 milligrams
of alpha-estradiol; and the labeling of the article failed to warn that its un-
restricted use may result in injury to the female generative system and that its
use by females with early and incipient carcinoma of the breast, cervix, and
uterus may result in acceleration of the malignant growth.
Metandren Linguets. Misbranding, Section 502 (a), the labeling of the
article contained false and misleading statements of the same nature as the-
false and misleading statements described above, with respect to the Male Hor-
mone tablets; Section 502 (f) (1), the labeling of the article bore no directions
for use. Further misbranding, Section 502 (f) (2), the labeling of.the article
-failed to bear adequate warnings against use in those pathological conditlons-
" where its use may be dangerous to health and against unsafe dosage and dura-
tion of administration, in such manner and form as are necessary for the protec-
tion of users, since each linguet of the article contained 5 milligrams of male
hormone (methyl testosterone): and the laheling of the article failed to wara.
that its unrestricted use may result in sterility and that unrestricted use of the-
result in acceleration of the malignant growth.
DISPOSITION : Pleas of not guilty having been entered, the case came on for trial
before the court without a jury on June 22, 1949. On July 13, 1949, the court
returned a verdict of guilty on all counts as to both defendants and imposed a
'nne of $700 against the corporation and $700 against the individual.