4742. Nu Youth tablets.    (F. D. C. No. 36655.   S. Nos. 40-225 L, 58-142 L.)
INFORMATION FILED :   7-28-55, S. Dist. Calif., against Frederic S. Weichman, t/a
N-Y Distributing Co., Los Angeles, Calif.
SHIPPED :   1-15-54 and 1-20-54, from California to Arizona and Illinois.
LABEL IN PAST : (Btl.) "Each tablet contains 5 mg. Methylandrostenediol sug-
gested dosage. One tablet upon arising before breakfast and one tablet shortly
before retiring. For adult males not for children or young adults Caution:
Do not take more than dosage recommended. Continued use extending over
six months to be avoided, except under supervision of a physician. Do not
use in cases of cardiac and kidney disease, cancer of the prostate, defects of
spermatogenesis, sterility or debilitation due to disease. Indications: Used in
place of testosterone, methyltestosterone and testosterone propionate for its
androgenic effect and as an anabolic agent   *    *    *    Nu Youth. 60 Tablets."
ACCOMPANYING LABELING : Leaflets entitled "The Evidence" and undated letters
addressed to "My Dear Friend" and signed by "Charles St. Regis" under the
letterhead of N-Y Distributing Co.
CHARGE : 502 (a)-the labeling of the article when shipped contained false and
misleading representations that the drug was a new, improved, safe sex hor-
mone; that it could be used in place of testosterone, methyltestosterone, and
testosterone propionate for its androgenic effect; and that it would be adequate
and effective for providing renewed vigor, endurance, strength, and vitality
in men over 40; for rejuvenating men by replenishing their deficient sex glands;
for restoring masculine sex drive; for banishing mental fatigue; for boosting
muscle power; for replenishing energy and endurance; for increasing mental
alertness and ending irritability; for providing health, sexual aliveness, and
emotional stability; for sex problems and impotency; for restoring waning
physical and mental powers in men; for providing pep and vitality; and for
providing the proper functioning and well-being of the human body; 502 (f)
(1)-the labeling of the article failed to bear adequate directions for use;
502 (j)-the article was dangerous to health when used in the dosage and with
the frequency and duration recommended in its labeling; 503 (b) (1)-the
article was dispensed without a prescription therefor from a practitioner li-
censed by law to administer the drug; and 503 (b) (4)-the article was subject
to 503 (b) (1), and at a time prior to dispensing, its label failed to bear the
statement "Caution: Federal law prohibits dispensing without prescription."
PLEA :   Guilty.
DISPOSITION :   9-26-55.   $200 fine.
DRUGS REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE
HAD BEEN ISSUED