3686. Misbranding of testosterone.   U. S. v. Joseph C. Mills.   Plea of guilty.
Defendant sentenced to 7 days in prison.    (F. D. 0. No. 32745.   Sample
No. 28263-L.)
INFORMATION FILED: January 21, 1952, District of Arizona, against Joseph 0.
Mills, Tucson, Ariz.
ALLEGED SHIPMENT : On or about January 25, 1951, from the State of Arizona
into the State of California, of a number of unlabeled ampuls of testosterone.
NATURE OF CHARGE: Misbranding, Sections 502 (b) (1) and (2), the article
failed to bear a label containing the name and place of business of the manu-
facturer, packer, or distributor, and an accurate statement of the quantity of
the contents; Section 502 (e) (2), the article was not designated solely by
a name recognized in an official compendium and was fabricated from two
or more ingredients, and it failed to bear a label containing the common
or usual name of each active ingredient; and, Section 502 (f) (1), the labeling
of the article failed to bear adequate 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 or
by children where its use may be dangerous to health, and against unsafe
dosage and method and duration of administration, and such manner and
form, as are necessary for the protection of users, in that the article was
for use by injection into or through the skin and contained 24.7 milligrams
of testosterone (male sex hormone) per cubic centimeter; and the labeling of
the article failed to warn that its use by females may have masculinizing
effects such as the development of excessive hair growth on the face and
body, coarsening of the voice, acne, suppression of normal menstruation,
enlargement of the clitoris, and decreasing the size of the breasts; that its
use by males with carcinoma of the prostate may result in acceleration of the
malignant growth; and that its use by children may induce precocious puberty.
DISPOSITION :   March 12,1952.   A plea of guilty having been entered, the court    ^
imposed a sentence of 7 days in prison.