3832. Adulteration and misbranding of male hormone tablets.   U. S. v. 76 Boxes,
etc    (F. D. C. No. 33289.    Sample Nos. 32442-L, 32445-L, 32449-L.)
LIBEL FILED :   June 12,1952, Western District of Arkansas.
ALLEGED SHIPMENT : On or about March 28 and April 22, 1952, by Captivante
Laboratories, from New York, N. Y.
PRODUCT : Male hormone tablets. 76 boxes, 31 boxes, and 161 boxes, each con-
taining 60 tablets of the article at Hot Springs, Ark., in the possession of the
Yale Pharmacal Co., together with a number of accompanying form letters com-
mencing with "Confidentially this letter can change your whole life," "Personal
private gland information for men only," "Dear Customer: We thank you for
your recent order," and "Dear Customer: In checking our files," and a number
of leaflets entitled "Request for progress report on your case" and "Discover
new, safe, more effective combination of male sex hormones." Some of the
form letters and leaflets were printed at New York, N. Y., and others were
printed locally.
Analysis showed that each tablet of the article in the 76-box lot contained not
more than 1.2 mg. of methyltestosterone and not more than a trace of ethinyl-
estradiol.
LABEL, IN PART : (76-box lot) "Yale Testrex Male Sex Hormones 60 Tablets-
Super-Strength (Double Potency) * * * Ingredients per tablet 5 mg.
Methyl Testosterone with Ethinyl Estradiol .002," (31-box lot) "Yale Testrex
242335-53?2
Methyl Testosterone with Ethinyl Estradiol .001," and (161-box lot) "Yale
Testrex Male Sex Hormones 60 Tablets * * * Ingredients per tablet
2.5 mg. Methyl Testosterone with Ethinyl Estradiol .0025 mg." -
NATURE OF CHARGE: Adulteration, Section 501 (c), the strength of the article
(all lots) differed from that which it purported and was represented to possess.
Misbranding, Section 502 (a), certain statements in the accompanying
form letters and leaflets were false and misleading since the article (all
lots) was not capable of fulfilling the promises of benefit stated and implied.
The statements represented and suggested that the article would be effective
to restore one's masculine drive, ambition, energy, and ability to do things
one wants to do; that it would enable one to lead happier, more contented,
and more forceful business and home lives; that it would be effective in reju-
venating men; that it would be effective to correct sex hormone deficiencies;
that it would be effective in the treatment of the symptoms of the male change
of life, such as aches and pains, tired out feeling, lack of desire to enjoy one's
self, nervousness, fear, and frustration; that it would be effective to restore
prematurely old men to useful, active lives; that use of the article would
result in new vigor, new vitality, increased virility, added strength, and new
energy; that the article would give one a new lease on life, enable weak
effeminate men to become more masculine, restore waning physical and men-
tal powers in men, and enable aging men to recapture the pleasures of their
youth.
The article was adulterated and misbranded when introduced into and
while in interstate commerce, and it also was misbranded while held, for sale
after shipment in interstate commerce.
DISPOSITION :    September 23,1952.   Default decree of condemnation and destruc-
tion.