3513. Adulteration and misbranding of Estrotron.   U. S. v. 40 Bottles    *    *    *.
(F. D. C. NO. 30930.    Sample No. 29728-L.)
IirBEL FILED :   April 24, 1951, Western District of Washington.
by the Pitman-Moore Co., from Indianapolis, Ind.
PRODUCT : 40 bottles of Estrotron at Seattle, Wash. Examination showed that
the product contained not more than 1.18 milligrams of estrogenic ketosteroids
per cubic centimeter.
LABEL, IN PART: (Bottle and carton) "10 cc. Size * * * Estrotron, 2 mg.
< 20,000 I. U.) per cc. in Peanut Oil. A highly purified estrus producing ex-
tract from the urine of pregnant mares, consisting primarily of estrone with
smaller quantities of naturally occurring estrogens, dissolved in Peanut Oil
and standardized to 20,000 I. U. of activity per cc."   .
NATURE OF CHARGE: Adulteration, Section 501 (c), the strength of the article
differed from that which it was represented to possess, namely, 2 milligrams
of estrogenic ketosteroids per cubic centimeter.
Misbranding, Section 502 (a), the following statements in the labeling of
the article were false and misleading as applied to an article which contained
less than the declared amount of estrogenic ketosteroids per cubic centimeter:
(Bottle and carton label)    "*    *    *   Estrotron, 2 mg. (20,000 I. U.) per cc.
*?* * consisting primarily of estrone with smaller quantities of naturally
occurring estrogens    *    *    *    standardized to 20,000 I. U. of activity per cc.
*?* * " and (accompanying leaflet entitled "Estrotron") " * * *
containing 2 mg. of estrogenic substance per cc. equal in estrogenic activity
to 20,000 I. U. per cc."
DISPOSITION :    June 18, 1951.    Default decree of condemnation and destruction.