1703. Misbranding of Hyatrone Androgenic Hormone Preparation. U. S. v. 20
Jars of Hyatrone Androgenic Hormone Preparation, and an accompanying
booklet.    Default decree of condemnation and destruction.     (F.  D.  C.
No. 19013.   Sample No. 7323-H.)
LIBEL FILED :  January 28,1946, District of New Jersey.
ALLEGED SHIPMENT:   From New York, N. Y., by the Johay Corporation.   The
product was shipped on or about August 4, 1945, and the booklet was shipped
subsequent to that date.
PRODUCT: 20 jars of Hyatrone Androgenic Hormone Preparation at Hohokus,
N. J., together with a booklet entitled "Hyatrone * * * Hormone Prepara-
tions for Men and Women."
LABEL, IN PART: "Hyatrone Androgenic Hormone Preparation Contains 36,100
MG Pure Crystalline Testosterone."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements on the
labels of the article, in the booklet, and in a letter addressed to the consignee
by the Johay Corporation, were false and misleading since they represented and
suggested that the article would combat old age, compensate hormone deficiency,
prolong the prime of life, restore the vigor of youth, build new tissues, promote
endurance, improve mental capacity, stimulate new strength, correct impotency,
and renew confidence.   The labeling represented further that the article would .
abolish the troublesome symptoms associated with the male climacteric occur-
ring during middle age; that it would be efficacious in the treatment of emo-
tional instability, despondency, irritability, fatigability, insomnia, diminution
of mental powers, hearing, and potency, and, in severe cases, flushes and sweats;
and that it would be useful in cases of benign prostatic hypertrophy, for the
relief of pain in certain forms of heart disease, such as angina pectoris, and
for the improvement of peripheral circulation in certain arterial diseases, such
as arteriosclerosis. The labeling also represented that use of the article would
result in a clearer brain, better hearing, a stronger voice, improved resistance
of the nervous system against fatigue, promotion of muscular development,
strength, and endurance, and increased potency. The article would hot be ef:
fective to fulfill the promises of benefit stated and implied.
Violation of Section 505, the article was a new drug which should not have
been introduced into interstate commerce since it was not generally recognized,
among experts qualified by scientific training and experience to evaluate the
safety of drugs, as safe for use under the conditions suggested in its labeling,
"Massage into skin y2 level teaspoon of Hyatrone until completely absorbed.
Repeat this treatment each morning and night for six consecutive days. Stop
treatment for five days. Resume treatment for six days. Discontinue for
fourteen days and begin cycle anew until results are satisfactory. Thereafter
only ? level teaspoon is required as a maintainance dose in the above cycle";
and an application filed pursuant to law was not effective with respect to the
article.
DISPOSITION : February 25, 1946. No claimant having appeared, judgment of
condemnation was entered and the product was ordered destroyed.
DRUGS ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH