4030. Misbranding of Le Joi device.   U. S. v. 160 Devices, etc.    (F. D. C. No.
33126.    Sample No. 17220-L.)
LIBEL FILED :   May 15,1952, Southern District of California.
ALLEGED SHIPMENT : On or about April 15, 1952, by the Propenex Co., from
Minneapolis, Minn.
PRODUCT : 160 Le Joi devices at Hollywood, Calif., each of which was packed in a
plastic case containing a leaflet entitled "Instructions Le Joi." Additional
leaflets entitled "New Horizons," which were used by the consignee in promot-
ing the sale of the device, were caused to be printed by the consignee in Los
Angeles, Calif., from copies of a similar leaflet originally obtained from the
Propenex Co.
Examination showed that the device consisted of a thin rubber tube with a
locking attachment at each end.
NATURE OF CHARGE: The libel alleged that the device was misbranded while
held for sale after shipment in interstate commerce within the meaning of
Section 502 (a), in that certain statements in the leaflet entitled "New Hori-
zons" accompanying the device were false and misleading. The statements
represented and suggested that use of the device was effective in improving the
sexual capacities of older men by enlarging and reinforcing the sexual organ.
The device was not effective for such purpose, and it would not fulfill the
promises of benefit made for it.
The libel alleged also that if the leaflet entitled "New Horizons" was not part
of the labeling of the device, then the device was misbranded when introduced
into and while in interstate commerce within the meaning of Section 502 (f)
(1), in that its labeling failed to state the purposes and conditions for which
the device was intended, namely, to improve the sexual capacities of older
men by enlarging and reinforcing the sexual organ.
DISPOSITION : June 13, 1952. Default decree of condemnation. The court or-
dered that the product be delivered to the Food and Drug Administration.
DRUGS ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR
OWN STANDARDS