2962. Adulteration and misbranding of estrogenic substance in oil and Gynes-
trin estrogenic hormones, and misbranding of Obenoids. U. S. v. Pro-
Medico Laboratories, Inc., and Samuel Heller. Pleas of nolo contendere.
Corporation fined $900; individual defendant fined $9 and placed on 6
months' probation. (F. D. C. No. 17879. Sample Nos. 3826-H, 3905-H,
6708-H, 6709-H, 20195-H.)
INDICTMENT RETURNED :   December 9,1947, Eastern District of New York, against
Pro-Medico Laboratories, Inc., Brooklyn, N. Y., and Samuel Heller, director.
ALLEGED SHIPMENT : Between the approximate dates of December 8, 1944, and
March 6, 1945, from the State of New York into the States of Pennsylvania,
Connecticut, and Oklahoma.
LABEL, IN PART: "A Pro-Medico Product 3,500 cc Estrogenic Substance in
Oil Each cc contains Estrogenic Substance derived from equine urine," "Estro-
genic Hormones Multiple Dose Vial A sterile solution in ampul oil of estro-
genic substances derived from equine urine * * * Manufactured for The
Vale Chemical Co., Inc. Allentown, Penna.," "Gynestrin Estrogenic Hor-
mones An oil solution of estrogenic hormones, derived from equine urine,"
and "Obenoids - Pink   Each Tablet Contains-Phenobarbital ? grain."
NATURE OF CHARGE : Estrogenic substance. Adulteration, Section 501 (d), estro-
genic substance other than as it naturally occurs in and is extracted from
equine urine and containing little or no estrone, had been substituted for
estrogenic substance as it naturally occurs in and is extracted from equine
urine, which the product purported and was represented to be. Misbranding,
Section 502 (a), the label statement "Estrogenic Substance derived from equine
urine" was false and misleading.
Gynestrin estrogenic hormones. Adulteration, Section 501 (d), estrogenic
hormones other than as they naturally occur in and are extracted from equine
urine, had been substituted for estrogenic hormones as they naturally occur
in and are extracted from equine urine, which the product purported and was
represented to be. Misbranding, Section 502 (a), the label statement "Estro-
genic Hormones derived from equine urine" was false and misleading.
Obenoids. Misbranding, Section 502 (a), the label statement "Contains-
Phenobarbital" was false and misleading since the product contained no pheno-
barbital; and, Section 502 (e) (2), the product was not sold under a name
recognized in an official compendium and was fabricated from two or more
ingredients, and its label failed to bear the name and quantity and proportion
of atropine that it contained.
DISPOSITION : On March 1,1949, a motion by the defendant for a bill of particu-
lars was granted to the extent of requiring the Government to state how many
International Estrone Units per cubic centimeter were contained in the estro-
genic substance in oil referred to in counts 1 and 3 of the indictment. On
December 12, 1949, pleas of nolo contendere were entered and the corporation
was fined $900, and the individual defendant was fined $9 and placed on proba-
tion for 6 months.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FALSE AND
MISLEADING CLAIMS
DRUGS FOR HUMAN USE*