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]
3221-3240
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 investigations of
the Agency, prior to the institution of the proceedings. Published by direction of
the Federal Security Administrator.
WASHINGTON, D. C,
PAUL B. DUNBAB, Commissioner of Food and Drugs.
CONTENTS *
Page
Drugs actionable because of poten-
tial danger when used accord-
ing to directions?:?208
Drugs and devices actionable be-
cause of failure to bear ade-
quate  directions   or   warning
statements
210
Drug for veterinary use 
214
Drugs and devices actionable be-
cause of deviation from official
or own standards 
215
Drugs and devices actionable be-
cause of false and misleading
claims 
216
Drugs for human use 
216
Drugs for veterinary use 
219
?For presence of a habit-forming narcotic without warning statement, see Nos. 3223, 3224; omission of, or
unsatisfactory, ingredients statements, Nos. 3222-3224,3
226,3227,3235,3240; failure to comply with the pack-
aging requirements of an official compendium, No. 3236; failure to bear a label containing an accurate state-
ment of the quantity of the contents, Nos. 3223, 3224, 3226. 3227, 3240; failure to bear a label containing the
name and place of business of the manufacturer, packer, or distributor, Nos. 3224,3226,3227,3235; cosmetie,,
actionable under the drug provisions of the Act, No. 3227.
207
920446-51
DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED    
ACCORDING TO DIRECTIONS 
3221. Misbranding of Metandren Linguets and Neo-Hombreol tablets. U. S. v.
United Research Laboratories, Inc., and Robert Roberts. Pleas of nolo
contendere.   Corporation fined $75; individual, $3.    (F. D. C. No. 28119.
Sample Nos. 12371-K, 12376-K, 47160-K.)
INFORMATION FILED : January 20,1950, Eastern District of Pennsylvania, against
United Research Laboratories, Inc., Philadelphia, Pa., and Robert Roberts, vice
president of the corporation.
ALLEGED SHIPMENT : On or about April 22, June 17, and July 6, 1949, from the
State of Pennsylvania into the States of New Jersey and West Virginia.
PRODUCT: Examination disclosed that the products consisted of methyl testo-
sterone.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in an
accompanying circular entitled "Hormones and the Male Climacteric" were
false and misleading. The statements represented and suggested that the
articles would be adequate treatments for headache, excessive fatigue, nervous-
ness irritability, insomnia, decreased memory and power of concentration, a
feeling of uncertainty and tremulousness, vasomotor disturbances, such as
flashes, sweats, chills, and parasthesias, vague pains, particularly in the
region of the bladder, a loss of force in the urinary stream, clinical signs of
prostatic hyperplasia or nonspecific prostatitis, decrease in libido and potency,
symptoms of climacteric syndrome, and involutional melancholia; that the
articles would prevent the "clock of life from running down"; and that they
would permit the user to resume with confidence normal business and social
activities. The articles would not be adequate treatments for the conditions
represented; they would not prevent the "clock of life from running down";
and they would not permit the user to resume with confidence normal business
and social activities.
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 methods
and duration of administration since each Metandren Linguet and Neo-Hom-
breol tablet contained 5 milligrams of methyl testosterone; and the labeling of
the articles failed to warn that their use may result in sterility, and that their
use by individuals with carcinoma of the prostate may result in acceleration
of the malignant growth.
Further misbranding, Section 502 (j), the articles were dangerous to health
when used in the dosage and with the frequency prescribed, recommended,
and suggested in their labeling. Each Metandren Linquet and Neo-Hombreol
tablet contained 5 milligrams of methyl testosterone, and the use of articles
containing 5 milligrams of methyl testosterone, i. e., in each Metandren Linguet
and Neo-Hombreol tablet, with the frequency prescribed, recommended, and
suggested in the labeling, namely, 3 to 4 Linguets (tablets) per day, would
be dangerous to health since such use may result in sterility, and since their
use by individuals with carcinoma of the prostate may result in acceleration of
the malignant growth.
DISPOSITION :   May 3, 1950.   Pleas of nolo contendere having been entered, the
court fined the corporation $75 and the individual $3.