3388. Misbranding of male hormone tablets.   U. S. v. Marvin Nashkin (Gold
Seal Pharmacal Co.). Plea of guilty. Fine of $250, plus costs.   (F. D. C.
No. 29432.   Sample No. 57056-K.)
INFORMATION FILED : June 28, 1950, Northern District of Ohio, against Marvin
Nashkin, trading as the Gold Seal Pharmacal Co., Cleveland, Ohio.
ALLEGED SHIPMENT : On or about November 28, 1949, from the State of Ohio
into the State of New Jersey.
LABEL, IN PART: "Male Hormone (Methyl Testosterone) Regular Direc-
tions For use by adult males mildly deficient in male hormones when small
dosages of male hormones are prescribed or recommended by a physician for
palliative relief of such symptoms. Daily recommended intake of one light
tablet provides 5 mg. of Methyl Testosterone in specially prepared base for
sublingual use. Suggested Dosage One light tablet upon arising before break-
fast. Tablets should be held between gum and cheek, or under tongue, and
allowed to dissolve slowly, so that hormone is absorbed by mouth tissues (saliva
may be swallowed while tablet is in mouth, but do not swallow tablet). The
maintenance dosage can be extended from 3 to 6 months, under supervision
of a physician."-
NATTJBE or CHARGE: Misbranding^ Section 502 (a), certain statements on the
label of the article and in an accompanying leaflet entitled "Attention! Men!
Hormones" were false and misleading. The statements represented and sug-
gested that the article would be of value to adult males mildly deficient in
male hormones; that it would be of value to men beginning to feel past their
prime; that it would constitute an adequate and effective treatment for dimin-
ished energy and vitality, worry over general health, depressed feeling, fatigue,
irritability, excessive nervousness, and other common symptoms of the male
climacteric; and that it would be efficacious in bringing men happiness and a
longer useful life. The article would not accomplish the purposes claimed, and
it would not constitute an adequate and effective treatment for the condi-
tions so represented and suggested.
Further misbranding, Section 502 (f) (1), the labeling of the article failed
to bear adequate directions, in that the directions for use borne on the labeling
of the article were not adequate directions for use.
DISPOSITION :   February 23, 1951.   A plea of guilty having been entered, the
court imposed a fine of $250, plus costs, against the defendant.