657. Adulteration and misbranding of Interferin. U. S. v. 3 Tabes and 3 Boxes
each containing: 1 Tube of Interferin. Default decrees of condemnation
and destruction.     (F. D. C. Nos. 6320, 6741.    Sample Nos. 14766-E, 54630-E.)
This product would be dangerous to health when use as recommended or
suggested in its labeling.
On December 1, 1941, and January 20, 1942, the United States attorney for
the Eastern District of Pennsylvania filed libels against the above-named drug
product at Philadelphia, Pa., alleging that the article had been shipped in inter-
state commerce on or about November 3 and 27, 1941, by the Keefer Laborato-
ries from Chicago, 111.: and charging that it was misbranded and that a portion
was also adulterated.
Analysis showed that the article consisted essentially of potassium soap (ap-
proximately 11.3 percent), sodium soap (approximately 12.5 percent), potassium
iodide (approximately 6 percent), benzoic acid (0.4 percent), fats and/or oils
(0.4 percent), alcohol, and water.
The article in one of the shipments was alleged to be adulterated in that its
purity and quality fell below that which it purported to possess since it was
offered for use by injection into the uterus thereby implying that it was sterile;
whereas it was not sterile but was contaminated with viable bacteria of a
disease-producing type.
The article in the said shipment was alleged to be misbranded in that it was
dangerous to health when used in the dosage and with the frequency and
duration prescribed, recommended, and suggested in the leaflet enclosed in
the retail carton: "Attach uterine canule to tube and insert through the cervi-
cal canal approximately 2 inches into the uterus so that the tip of the canule
rests in the cavum uteri. Now slowly inject Interferin, slightly moving the canule
in different directions so that the tip of the canule will not press against the
uterine tissue wall. Allow three minutes intermission if the patient is restless;
a complete instillation should require about ten minutes. Dosis inject one third
(?) of the tube in cases of pregnancy up to two months; a half {?) in three
month cases; a full tube in four month cases; still later cases, 1? tubes. Gen-
erally speaking a little more Interferin will produce a quicker expulsion of thex
fetus." The said shipment was alleged to be misbranded further in that state-
ments in the labeling which represented that the article had been successfully
on the market since 1933 and had proved its value in more than 5,000 cases with-
out a single fatality known; that it had been developed after extensive research;
that it offered very definite advantages over old methods; and that it was
efficacious and appropriate for the following therapeutic group indications, "A.
Dead fetws, mole, missed abortion. B. Living fetus. 1) Ovum diseases. 2)
Pregnancy toxemias. 3) Complications at labor. 4) Genital tract diseases. 5)
Systematic diseases. T. B. of the lungs, cardiac, kidney, blood, skin, syphilis. 6)
Endocrine disorders. 7) Organic and functional nervous system diseases, in-
tractable vomiting. 8) Special organ diseases, eye, blindness, ear. 9) Unclas-
sified diseases, column fractures, caries. 10) Rape, incest. 11) Eugenic factors;
heredity diseases, insanity, epilepsy, in which in addition to abortion steriliza-
tion is indicated. 12) Social economic indications. Illegitimacy, desertion, wid-
owhood, overburdened impoverished physical depleted mothers"; and that it was
effective and humane were false and misleading since they created the impression
that it was a safe and appropriate medicament for effecting abortion; whereas
it was not but was a dangerous drug. The said shipment was alleged to be
misbranded further in that the statements, "The placenta is usually expelled a
few minutes after the fetus," "Severe hemorrhages are very rarely observed after
the use of Interferin," "the Interferin method is positively superior to dilation and
curettage in cases of gravidity from two and a half to six months," were false
and misleading since the placenta would not usually be expelled a few minutes
after the fetus, severe hemorrhages would frequently occur after use of the article,
and its use was not superior to dilation and curettage in such cases.
The article in the remaining shipment was alleged to be misbranded in that
the name "Interferin" which had become impregnated with the meaning that
the article was designed., for introduction into the uterine cavity for the purpose
of interfering with the normal progress of pregnancy, was false and misleading
since the name represented and suggested that the article was safe and appro-
priate for interfering with the normal progress of pregnancy; whereas it was
not safe or appropriate for such use but was unsafe and dangerous and capable
of producing serious or even fatal consequences. It was alleged to be mis-
branded further in that its label failed to bear adequate directions for use since
there were no adequate directions for the use above referred to.
On January 5 and February 16, 1942, no claimant having appeared, judgments
of condemnation were entered and the product was ordered destroyed.