3957. Misbranding of Niagara devices.   U. S. v. 25 Devices, etc.   (F. D. C. No.
33887.   Sample Nos. 16643-L, 16646-L.)
LIBEL FILED :    September 26, 1952, "Western District of Missouri. 
ALLEGED SHIPMENT: On or about August 9, 1950, and on unknown dates, by
Niamco, Inc., from Dallas, Tex.
PRODUCT: 25 Niagara Hand Unit devices and 20 Niagara Portable devices at
Kansas City, Mo., in the possession of the Niagara Equipment Co., together with
certain written, printed, and graphic matter consisting of a number of sales
manuals entitled "Health Program for Niagara Health Equipment Company,"
a number of booklets entitled "Sales Talk" and "Niagara The Monarch of
Mechano Massage," a number of books entitled "Stories The Feet Can Tell,"
a number of charts entitled "Zone Therapy Chart," and a number of pamphlets
entitled "Niagara Deep Massage." Some of the written, printed, and graphic
matter was shipped from Dallas, Tex.; some was printed in Kansas City, Mo.;
and the origin of the remainder was not known.
The devices were vibrators. The Niagara Hand Unit devices were so de-
signed as to adapt them to be held in the hand while being applied to any part of
the body and the Niagara Portable devices were designed for resting the feet
upon or for sitting or leaning upon.
LABEL, IN PABT: "Niagara of Adamsville, Pa. * * * Hand Unit" and "Niagara
of Adamsville, Pennsylvania   All Purpose Portable Model."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
above-mentioned written, printed, and graphic matter accompanying the de-
vices as labeling were false and misleading. The statements represented and
suggested that the devices constituted an adequate and effective means of
treatment for disorders of the heart, liver, colon, rectum, kidneys, neck,
gallbladder, small intestines, appendix, ileocecal valve, lungs, bronchial tubes,
stomach, spine, knees, pituitary gland, eyes, ears, pancreas, adrenals, spleen,
bladder, glands, uterus, ovaries, prostate, hip, menstruation, circulation, aorta,
larynx, trachea, diaphragm, and mesentery; for constipation, broken arches,
misplaced vertebra, common cold, pneumonia, pernicious anemia, simple
anemia, astigmatism, glaucoma, burning or itching condition of the eyes,
deafness, enlarged tonsils, sore throat, trouble in the throat, troubles in the
head, stiff lame neck, sinus trouble, catarrh of the head, sciatica, hay fever,
hypothyroidism, exophthalmic goiter, neurasthenia, headache, female trouble,
diabetes, asthma, eczema, thrombosis, embolism, indigestion, palpitation,
angina pectoris, gallstones, acute gallbladder attacks, jaundice, atrophy,
sclerosis, varicose veins, pain in or lameness of the back, impinged nerves,
Bright's disease, enlargement or atrophy of the kidneys, floating kidney,
dropsy, lumbago, paralysis, hypertension, bursitis, lame, aching, or stiff
shoulder, neuritis of the shoulder, lame hip, arthritis, hemorrhoids, enlarge-
ment of the prostate, prolapsed rectum, congestion in general, cystitis, tighten-
ing of the muscles of the uterus and vagina, menstrual cramps, pains, aches,
sluggishness, rheumatism, neuritis, underweight, overweight, nervous tension,
fatigue, swollen feet or legs, loss of speech, coronary thrombosis, intermittent
claudication, abdominal angina, feet troubles, swollen joints, stiff knee, fibrous
swelling or infiltration in the interior of the body, accumulation of fibrous,
cartilaginous, or even bony overgrowth in a joint, muscular ailments, and
many other ailments or diseases; and that the devices would be effective to
throw off poisons in the system, hasten the healing of broken bones, insure a
healthy, glowing complexion, effect the same benefits to the user as active
exercise, give the body tone and the user vitality and energy, maintain and
restore normal functions of the body, and insure good health. The devices
did not constitute an adequate and effective means of treatment for such
diseases, symptoms, and conditions, and they were not capable of fulfilling the
promises of benefit made for them.
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 the diseases, symptoms, conditions, and purposes for
which they were offered and recommended by Mrs. Betty Myers, demon-
strator for and on behalf of the consignee, on August 15, 1952, namely, dis-
orders of the kidneys, gallbladder, pituitary thyroid, eyes, ears, colon, liver,
and circulation; for congestion, bronchitis, diabetes, arthritis, swollen ankles
or legs, varicose veins, hay fever, back troubles, sinusitis, headaches, menstrual
cramps, prostate trouble, pains, sluggishness, aches, and growths; and to
speed healing of broken bones and to strengthen muscles.
The devices were misbranded in the above respects while held for sale after
shipment in interstate commerce.
DISPOSITION: March 27, 1953. The Niagara Equipment Co., 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 Federal Security Agency.
DRUGS ACTIONABLE BECAUSE OF FALSE AND MISLEADING CLAIMS*