4756.?Testo-Glan Male Formula and Fern-Tone Female Formula.    (Inj. No. 275.)
COMPLAINT FOR INJUNCTION FILED: 3-9-54, E. Dist. N. Y., against Leo Shine,
t/a Glanex Products, Floral Park, N. Y.
LABEL IN PAST: "Testo-Glan Male Formula Regular Strength Each capsule
contains-Hormonal activity as found in wheat-Testosterone (Male Sex
Hormone) .... 0.067 meg. Vitamin E . . . . 0.034 mgms. Survival Factor
. . . . + Vitamin B 1 5 mg. 500? MDR Vitamin B 2 3.5 mg. 175? MDR
Niacinamide .... 15 mg.   [or  "Double Strength Each capsule contains-
?See also Nos. 4741, 4742, 4746, 4750, 4752-4755.
Hormonal activity as found in wheat-Testosterone (Male Sex Hormone) ....
0.067 meg. Vitamin E . . . . 0.034 mgms. Survival Factor . . . . + Vita-
min B 1 10 mg. 1000? MDR Vitamin B 2 7 mg. 350? MDR Niacinamide
.... 30 mg."] Contents 60 Capsules Sole Distributors Glanex Products
* * * Floral Park, N. Y. Directions As a dietary supplement, take 2 capsules
daily" and "Fern-Tone Female Formula Contents 60 Capsules Each capsule
contains-Hormonal activity as found in wheat-Estrone (Female Sex Hor-
mone) 0.005 meg. Vitamin E . . . . 0.034 mgms. Survival Factor .... +
Vitamin B 1 5 mg. 500? MDR Vitamin B 2 3.5 mg. 175? MDR Niacina-
mide .... 15 mg. Sole Distributors Glanex Products 6 North Tyson Ave-
nue Floral Park, N. Y. Directions As a dietary supplement, take 2 capsules
daily."
ACCOMPANYING LABELING : Folder entitled "For Men Past 40 Testo-Glan The
New Extra Safe Male Power Formula" and a form letter addressed to "Dear
Friend" and beginning with the words "Men pasf 40 everywhere are praising
Testo-Glan."
CHARGE : The complaint alleged that the defendant had been and still was intro-
ducing into interstate commerce the above-mentioned articles which were mis-
branded within the meaning of 502 (a) by reason of the following false and
misleading representations in their labeling:
(1)?That the Testo-Glari Male Formula (regular strength and double
strength) contained physiologically active glandular substances; that the
glandular constituents of the article were of value in overcoming glandular
deficiencies in the human male; that the article would increase male power;
that it was an adequate and effective treatment for male sexual weakness, men-
tal depression, loss of appetite, digestive disturbance, loss of muscle power,
listlessness, headaches, loss of vigor, nervousness, vague aches and pains,
sleeplessness, and irritability; and that it contained hormonal activity equiva-
lent to therapeutically significant amounts of testosterone;
(2)?That the Fern-Tone Female Formula would restore sexual desire in
women; that it was an adequate and effective treatment for fatigue, loss of
appetite, nervousness, dizziness, headaches, vague aches and pains, weakness,
mental depression, and sleeplessness; and that it contained hormonal activity
equivalent to therapeutically significant amounts of estrone.
The complaint alleged further that there were no known methods of demon-
strating the presence or absence of the minute quantities of testosterone activity
claimed to be present in the Testo-Glan Male Formula and the minute quantities
of estrone activity claimed to be present in the Fern-Tone Female Formula; that
the commonly employed therapeutic dose of testosterone given orally was at
least 1,000 times the quantity that would be supplied in the recommended
dosage of the Testo-Glan Male Formula based on the label statement of testos-
terone activity content; that the quantity of estrone activity claimed to be
present in the Fern-Tone Female Formula was likewise totally insignificant;
that the statements in the labeling of the articles conveyed to the usual and or-
dinary purchaser the impression that the Testo-Glan Male Formula contained
hormonal activity equivalent to therapeutically significant amounts of testos-
terone and that the Fern-Tone Female Formula contained hormonal activity
equivalent to therapeutically significant amounts of estrone, whereas such was
not the case; and, that even if the articles did contain significant amounts of
hormones, the articles would not accomplish the rejuvenating effects claimed
for them.
DISPOSITION: 4-19-54. The defendant having consented, the court entered a
decree permanently enjoining the defendant against the introduction into inter-
state commerce of "Testo-Glan Male Formula" (regular strength and double
strength) and "Fem-Tone Female Formula," or any similar article of drug
which would bear a label or would be accompanied by labeling containing
false and misleading representations of the nature alleged in the complaint.