3208. Misbranding of methyl testosterone tablets and alpha estradiol tablets.
U. S. v. Norman N. Beil (Research Products). Plea of guilty. Fine of
$800, plus costs. (P. D. C. No. 28120. Sample Nos. 2780-K, 3779-K,
12349-K, 24998-K.)
INFORMATION FILED: January 25, 1950, Northern District of Ohio, against
Norman N. Beil, trading as Research Products, Cleveland, Ohio.
ALLEGED SHIPMENT : On or about January 27, 28, and 31, and February 10,1949,
from the State of Ohio into the States of Maryland, Virginia, Delaware, and
South Dakota.
LABEL, IN PART: (Methyl testosterone tablets). "Male Hormone Tablets
Each Tablet Contains 10 mg. [or "5 mg."] Methyl Testosterone For use when
Methyl Testosterone is indicated for symptoms of Male Hormone Deficiency.
Suggested Average Dose: One (1) tablet daily when the use of male hor-
mones is directed by your physician. Warning: The male sex hormone
should not be used if there is any indication of cancer of the prostate."
Accompanying 2 of the 3 shipments of methyl testosterone tablets were
circulars entitled "The Male Hormone," and one of these shipments also was
accompanied by an instruction sheet entitled "Important Instructions." The
label of the alpha estradiol tablets (female hormones) had been destroyed
by the consignee, but the consignment was accompanied by a copy of the
circular entitled "The Male Hormone," which contained certain representa-
tions regarding the female hormone.
NATURE OF CHARGE: Methyl testosterone tablets. Misbranding, Section 502
(a), (2 shipments) certain statements in the labeling were false and mis-
leading. The labeling represented and suggested that the article would
stimulate growth and development of the sex organs and the male sex charac-
teristics, 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 for the average
man in his late forties an adequate treatment for flushes, sweats, chills,
impaired memory, inability to concentrate on activities and tendency to evade
them, nervousness, depression and general weakness, and poor physical
strength; that the 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. The article
would not be effective for such purposes. Further misbranding, Section 502
(f) (1), (all shipments) the labeling failed to bear adequate directions for
use in that the directions for use appearing in the labeling were inadequate.
to hear adequate warnings against use in those pathological conditions where
the use of the article may be dangerous to health, and against unsafe dosage
and duration of administration in such manner and form as are necessary for
the protection of users since each tablet contained 10 milligrams of methyl
testosterone; and the labeling of the article failed to bear adequate warn-
ings against use by individuals who may have cancer of the prostate since
the ordinary lay user is not familiar with the indications of cancer of the
prostate.
Alpha estradiol tablets. Misbranding, Section 502(a), certain statements
in the labeling, i. e., in the accompanying circular entitled "The Male Hor-
mone," were false and misleading. The labeling represented and suggested
that the article would relieve and postpone the many conditions associated
with middle age, and that the article constituted an adequate treatment for
hot flashes, emotional disturbances and other manifestations associated with
the menopause. The article would not be effective for such purposes.
DISPOSITION : March 24, 1950. A plea of guilty having been entered, the court
fined the defendant $800, plus costs.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS*