3662. Misbranding of Detoxacolon (Hydr-Oxy-Colon) device.   U. S. v. 1 De
vice   *    *    *    (F.D.C. 31715.    Sample No. 30862-L.)
LIBEL FILED :    June 19,1951, Southern District of Illinois.
ALLEGED SHIPMENT: The product was ordered from, and invoiced by, the
United X-Ray & Equipment Co., Los Angeles, Calif.; and various parts were
shipped from Dallas, Tex., on or about June 23, 1950, and from Hollywood,
*        4
Calif., on or about June 22 and 29,1950. There were also in possession of*the
consignee a copy of a booklet entitled "DeWelles Detoxacolon Oxygen Ther-
apy" which had been received from a representative of the United X-Ray
& Equipment Co. and a copy of a booklet entitled "Here's How Oxygen Can
Put New Life Into Tour Practice" which was received either directly or
indirectly from a representative of the company.
PRODUCT: 1 Detoxacolon {Hydr-Oxy-Colon) device at Quincy, 111., together
with the 2 booklets referred to above.
LABEL, IN PART : (When shipped in interstate commerce) "Detoxacolon"; (after
shipment in interstate commerce) "Hydr-Oxy-Colon Therapy Model 6 960
Serial   Licensed under U. S. Patent No. 2420586."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
booklet entitled "DeWelles Detoxacolon Oxygen Therapy" weire false and mis-
leading. These statements represented and suggested that the device was an
adequate and effective treatment for spasticity of the rectum, extreme ulcera-
tion of the lower bowel, common cold, sinusitis, dysentery, flaccid condition of
the sphincters, ulcerative colitis, prolapse of the rectum and sigmoid, asthma,
hay fever, acute coryza, ptosis of the colon, high blood pressure, low blood
pressure, anemia, amebic dysentery, heart conditions, epilepsy, toxemias of
pregnancy, and infections and inflammations of the female reproductive organs;
that the device was an excellent treatment following childbirth to return
muscle tone; and that it would correct any abnormal condition. The device
was not an adequate and effective treatment for such disease conditions, and
it was not capable of fulfilling such promises of benefit made for it.
Further misbranding, Section 502 (j), the device was dangerous to health
when used with the frequency and duration prescribed, recommended, and sug-
gested in its labeling, namely, in the booklet entitled "DeWelles Detoxacolon
Oxygen Therapy," since in the post partum period and in the acute stages of
vaginal infections, treatment as directed would force infective material into
or through the cervical canal, resulting in ascending infection with probable
serious consequences to the health of the patient.
Further misbranding, Section 502 (a), certain statements in the booklet
entitled "Here's How Oxygen Can Put New Life Into Your Practice" were
false and misleading. These statements represented and suggested that the
device was an adequate and effective treatment for many allergies, asthma,
sinusitis, hay fever, arthritis, epilepsy, diabetes, neuritis, rheumatism, high
and low blood pressure, pernicious and secondary anemias, certain varicoses,
functional heart conditions, skin disorders, stomach ulcers, kidney conditions,
parasites, rectal disorders, sluggish colon, infectious and inflammatory diseases
of the female pelvis, colitis, and ulcerated colon; that it would kill certain
infections and decay-producing causes; that it would control and regulate the
activities of the brain, heart, circulation, and breathing; that it would aid di-
gestion, assimilation, elimination, metabolism, gland functions, and acid-alka-
line balance of the blood; that it would give a normal effect to the body in
general; and that it would rebuild the bowels. The device was not an adequate
and effective treatment for such diseases and conditions, and it was not capable
of fulfilling the promises of benefit made for it.
The device was misbranded in the above respects when introduced into,
while in, and while held for sale after shipment in, interstate commerce.
DISPOSITION :   January 5, 1952.   Default decree of condemnation and destruc-
tion.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS*