4545. Polyzone device.    (In. No. 284.)
COMPLAINT FOR INJUNCTION FILED: 10-22-54, S. Dist. Calif., against Roy G. 
Collison, to Polyzone Co., Los Angeles, Calif.
ACCOMPANYING LABELING : A leaflet entitled "For Doctors Only Polyzone" and 
a booklet entitled "Polyzone Therapy Manual."
RESULTS OF INVESTIGATION : The device was designed to produce ozone by the 
passage of oxygen through an electrical field.
CHARGE : That the defendant was causing the introduction into interstate com- 
merce of the Polyzone device, which was misbranded under 502 (a) by reason 
of false and misleading representations, namely:
(1) That the ozone produced by the device was beneficial and useful 
for all acute and chronic conditions, arthritis, catarrhal deafness, fistulas,.
orrhoids, indigestion, mixed infections, otitis media, painful tooth sockets 
following dental surgery, pneumonia, poison ivy, poison oak, pruritus an, 
pruritus vulvae, rectal fissures, rectal tumors, rheumatism, sciatica, sore 
throat, spastic sphincters, stomach ulcers, trench mouth, tuberculosis, 
deep burrowing ulcers, internal and external ulcerations, urticaria, uterine 
fibroids, wounds; for disorders, infections, and inflammations of the 
bladder, cervix, colon, ear, eustachian tubes, eyes, gallbladder, gums, 
intestines, liver, male and female pelvis, mouth, nerves, nose, pharynx, 
prostate, rectum, rectal crypts, sinuses, skin, system generally, throat, 
tonsils, urethra, vagina, and vulva; and for inclusion in a test for tubal 
patency; whereas such ozone or any other ozone was not beneficial or 
useful for such conditions and purposes, or for any therapeutic or diag- 
nostic purpose;
(2) That the ozone produced by the device was nontoxic, whereas it was 
capable of producing toxicity when administered to the human body;
(3) That the ozone produced by the device was nonirritating to normal 
body tissues, whereas it was capable of causing irritation to body tissues 
which were normal or abnormal; and,
(4) That the ozone produced by the device was suitable for use in 
the treatment of sinusitis, rhinitis, otitis media, running ears, sore throat, 
trench mouth, tonsillitis, gum infection, painful tooth sockets, poison oak, 
ulcers, wounds, cryptitis, colitis, pneumonia, urethral and bladder irrita- 
tions, prostate trouble, and in a test for tubal patency, whereas the 
labeling failed to reveal the fact, which was material in the light of such 
representations, that ozone was contraindicated for such conditions and 
purposes.
The device was alleged also to be misbranded under 502 (f) (1) in that its 
labeling failed to bear adequate directions for use. 
DISPOSITION: 10-22-54. The defendant having consented, the court entered 
a decree permanently enjoining the defendant against the introduction into 
interstate commerce of the Polyzone device or any other ozone generating 
device when misbranded as alleged in the complaint.
DRUGS ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR
OWN STANDARDS