3459. Misbranding of Duframe Anal Tubette. U. S. v. 5,000 Devices, etc   (F. D. C.
No. 30250.    Sample No. 58803-K.)
LIBEL FILED:    November 21, 1950, Northern District of Illinois.
ALLEGED SHIPMENT: On various dates between April 14 and October 21, 1948,
from Detroit, Mich.
PBODTJCT: 5,000 devices known as Duframe Anal Tubette at Chicago, 111., in
possession of the Duframe Tubette Co. Some of the devices were unlabeled,
and others had been packed and labeled in part by the consignee. They
were accompanied by a number of copies of leaflets entitled "About Gas * * *
About Constipation" and "Instructions," a testimonial letter signed "Mrs. Anne
Schwab," and form letters starting "Thank you for your inquiry" and "Thank
you for your letter and order."
The device consisted of a hollow rubber tube about 80 millimeters long
and 14 millimeters outside diameter. The inside diameter was about 8 milli-
meters at one end, constricted to about 3 millimeters at the other end. The
tube was bent at a right angle near the constricted end.
RESULTS OF INVESTIGATION : A copy of each leaflet and testimonial was packed
with each device, and the form letters were sent to interested persons.
LABEL, IN PAET :    (Carton) "Duframe   Anal Tubette."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
accompanying leaflets and letters were false and misleading. The statements
represented and suggested that the device was effective in the relief of
dizziness, headache, pain in the abdomen and other parts of the body, bloat,
swelling due to gas, and chronic constipation and gas pains due to intestinal
disorders or organic complaints; that the device was effective in regulating
the bowel, normalizing the bowel, and preventing constipation; and that the
device would help release toxic poisons. The device would not be effective for
the purposes represented. The device was misbranded while held for sale after
shipment in interstate commerce.
DISPOSITION:   July 6, 1951.   The Duframe Tubette Co., claimant, having con-
sented to the entry of a decree, judgment of condemnation was entered and
the court ordered that the devices be released under bond for the purpose of (
bringing them into compliance with the law, by destroying the existing labeling
and advertising material and relabeling the devices, under the supervision of
the Federal Security Agency.
DRtfGS FOR VETERINARY USE