4147. Misbranding of Niagara device.   U. S. v. 13 Devices, etc.    (F. D. C. No.
34938.   Sample Nos. 20731-L, 48670-L.)
LIBEL FILED :   April 8,1953, Southern District of Iowa.
ALLEGED SHIPMENT : On or about January 9 and February 20,1953, by Niamco,
Inc., from Dallas, Tex.
PBODXJCT: 13 Niagara Hand Unit devices and 7 all purpose Niagara Portable
devices at Des Moines, Iowa, In the possession of the Niagara Massage Units
Co., together with an accompanying placard entitled "Poor Circulation."
Examination showed that the devices were vibrators. The hand unit device
was so designed as to adapt it to be held in the hand while being applied to
any part of the body, and the all purpose device was designed for sitting or
leaning upon or for resting the feet upon.
RESULTS OF INVESTIGATION: The above-mentioned placard was posted on the
wall of the consignee's office, where the devices were demonstrated to poten-
tial purchasers. In addition, the devices were represented orally to be effective
in treating the diseases and conditions hereinafter mentioned. Such repre-
sentations were made by a saleslady for the consignee.
LABEL, IN PAET: "Niagara of Adamsville, Pennsylvania Hand Unit [or "All
Purpose Portable Model No. 5"]."
NATURE OF CHARGE: Misbranding, Section 502 (a), the placard accompanying
the devices contained statements which represented and suggested that the
devices were effective for circulatory disorders, which statements were false
and misleading since the devices were not effective for circulatory disorders.
Further misbranding, Section 502 (f) (1), the labeling of the devices failed
to bear adequate directions for use for the purposes for which they were
intended, namely, for treating disorders of the heart, kidneys, circulation,
gallbladder, colon, rectum, respiratory tract, joints, and nervous system; and
for canqer, osteomyelitis, constipation, ulcers of the colon, multiple sclerosis,
and asthma.
The devices were misbranded in the above respects while held for sale after
shipment in interstate commerce.
DISPOSITION : June 26, 1953. John L. Naughton, trading as the Niagara Mas-
sage Units Co., Des Moines, Iowa, claimant, having consented to the entry of a
decree, judgment of condemnation was entered and the court ordered that the
devices be released under bond for relabeling under the supervision of the
Department of Health, Education, and Welfare.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS*