3582. Misbranding of Hydr-Oxy-Colon device.   U. S. v. 1 Device, etc.   (F. D. C.
No. 31736.   Sample No. 21292-L.)
LIBEL FILED :    October 3,1951, Southern District of Mississippi.
ALLEGED SHIPMENT:   On or about July 16 and 21, 1951, by the United X-Ray
& Equipment Co., from Los Angeles, Calif., and Dallas, Tex.
PRODUCT:   1 Hydr-Oxy-Colon device at Natchez, Miss., together with a 12-page
booklet entitled "Dewelles Detoxacolon Oxygen Therapy," a 2-page treatment -
chart headed "Pathology Location Appearance Treatment," copy for use in
preparing newspaper advertising entitled "Something New Has Been Added."
and copy for preparing postal cards entitled "Free To You."
The device was designed for the administration of mixed oxygen and water
as an enema.
accompanying printed matter described above were false and misleading.
The statements and designs represented and suggested that the device was
an adequate and effective treatment for asthma, diabetes, arthritis, high blood
pressure, low blood pressure, kidney disorders, neuritis, colitis, prolapse of
the rectum and sigmoid, spastic colitis, ulcerative colitis, ptosis of the colon,
spasticity of the rectum, extreme ulceration of the lower bowel, common cold,
sinusitis, dysentery, flaccid condition of the sphincters, amebic dysentery, heart
conditions, hay fever, acute coryza, anemia, epilepsy, toxemias of pregnancy,
and infections and inflammations of the female reproductive organs; that the
device was an excellent treatment following chMdbirth to return muscle tone;
that it would eliminate distress and disease; and that it would correct chronic
ailments or pathological changes and bring about a restoration of health. The
device was not an adequate and effective treatment for such disease conditions,
and it was not capable of fulfilling the promises of benefit made for it.
Further misbranding, Section 502 (j), the article was dangerous to health
when used with the frequency and duration prescribed, recommended, and
suggested in its labeling since in the post partum period and in the acute
stages of vaginal infections, treatment as directed would force infective mate-
rial into or through the cervical canal, resulting in ascending infection with
probable serious consequences to the health of the patient.
The device was misbranded in the above respects when introduced into, while
in, and while held for sale after shipment in, interstate commerce.
DISPOSITION: November 20, 1951. Default decree of condemnation and
destruction.
DRUGS  ACTIONABLE  BECAUSE  OF  FAILURE TO  BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS*