FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
3661-3680
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys, acting upon reports submitted by the
Federal Security Agency, and include, where indicated, the results of investiga-
tions by the Agency, prior to the institution of the proceedings. Published by
direction of the Federal Security Administrator.
CHARLES W. CRAWFORD, Commissioner of Food and Drugs.
WASHINGTON, D. C, June 16, 1952.
CONTENTS*
Page
Drugs and devices actionable be-
cause of potential danger when
used according to directions. _ 158
Drugs actionable because of failure
to bear adequate directions or
?     warning statements 
  160
Drugs actionable because of con-
tamination with filth 
  168
Page
Drugs actionable because of devi-
ation    from   official   or   own
standards 
  168
Drugs actionable because of false
and misleading claims 
172
Index 
  186
?For presence of a habit-forming narcotic without warning statement, see No. 3665 ;
omission of, or unsatisfactory, ingredients statements, Nos. 3665, 3675 ; failure to bear
a label containing an accurate statement of the quantity of th-e contents, No. 3665 ; failure
to bear a label containing the name and place of business of the manufacturer, packer, or
distributor, No. 3665.
205202-52-
157
T)RUG?4?P DEVICES ACTIONABLE BECAUSE OF POTENTIAL DANGER
s     WHEN USED ACCORDING TO DIRECTIONS 
/""
3661. Misbranding of male and female hormones.  U. S. v. 628 Linguets, etc.
(F. D. C. No. 31936.    Sample Nos. 1039-L, 1040-L, 1062-L.)
LIBEL FILED :    November 2,1951, Southern District of Florida.
ALLEGED SHIPMENT : On or about June 25, 1951, and within the past 18 months
from the date on which the libel was filed, from Cedar Rapids, Iowa.
PRODUCT: 628 5-milligram and 1,835 10-milligram oral androgen male sex
hormone linguets and 887 Vitro No. S18 oral estrogen female sex hormone lin-
guets at Jacksonville, Fla., in possession of the Vitro Co., together with a
number of leaflets entitled "Oral Androgen Male Sex Hormones."
LABEL, IN PART: (Bottle) "Oral Androgen Male Sex Hormone Linguets for
absorption through the oral mucous membranes 5 mg. [or "10 mg."]. Each
linguet contains 5 mg. [or "10 mg."] of the pure methyl ester of testosterone,
with more marked androgenic properties than testosterone when taken by
mouth. Use as Directed by Your Physician. Distributed by the Vitro Com-
pany" and "Linguets Vitro No. 31S Oral Estrogen Female Sex Hormone Lin-
guets for absorption through the oral mucous membranes. Each linguet con-
tains naturally occurring estrogens, with estrons as the chief active principle,
biologically standardized to the equivalent of 0.5 mg. estrogen=5000 I. U."
NATURE OF CHARGE : 5 and 10 milligram oral androgen male sex hormone lin-
guets. Misbranding, Section 502 (j), the articles were dangerous to health
when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in the labeling, namely, in the leaflet entitled
"Oral Androgen Male Sex Hormone," as follows: "5 mg. to 40 mg. 3 times
or more weekly before meals and preferentially in divided doses. Dosage
should be lowered as improvement occurs to minimum maintenance levels."
Further misbranding, Section 502 (f) (2), the labeling of the articles failed to
bear adequate warnings against use in those pathological conditions where
their use 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.
Vitro No. 818 oral estrogen female sex hormone linguets. Misbranding, Sec-
tion 502 (f) (1), the labeling of the article failed to bear adequate directions
for use; and, Section 502 (f) (2), the labeling of the article failed to bear
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.
The articles were misbranded in the above respects while held for sale after
shipment in interstate commerce.
DISPOSITION : December 3, 1951. Default decree of condemnation and destruc-
tion.