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Violet Ray and related Quack Medical
Devices on trial:  Misbranding by FDA...

3505. Misbranding of Violetta kits.   U. S. v. 21 Kits, etc.    (F. D. C. No. 30942.
Sample No. 25412-L.)
LIBEL FILED :   May 3,1951, Eastern District of Pennsylvania.
and December 9, 1950, and March 10 and 15, 1951, by Electro-Technic Prod-
ucts, from Chicago, 111.
PRODUCT: 21 brown simulated leather No. 411 Violeita kits, each kit contain-
ing a Violetta generator, to which was attached an electric cord; a No. 1
or "General" electrode; and a leaflet entitled "Warning." In addition to the
above kits, there were 35 unlabeled accessory attachments consisting of
electrodes of various shapes and a number of leaflets entitled "The Advanced
Violetta Kits" and "Violetta Electrodes," at Philadelphia, Pa.
The device was an electrical generator to be plugged into an electric out-
let to produce a high voltage, higher frequency electrical current. The
various shaped electrodes were to be used interchangeably on the generator,
and consisted of hermetically sealed glass tubes, each containing a gas under
low pressure.
NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the
article failed to bear adequate directions for use since its labeling failed
to specify the method of using the device in the treatment of conditions of
the prostate, ear, spine, inside of the throat, vagina, nasal passages, urethra,
rectum, and dental abscesses, and for the removal of moles, warts, and growths,
which were the purposes and conditions for which the device was offered
in the leaflet entitled "Violetta Electrodes" accompanying the device.
Further misbranding, Section 502 (a), the following statements in the
accompanying leaflets entitled "The Advanced Violetta Kits" and "Violetta
Electrodes" were false and misleading since the device was not capable of
producing the effects claimed or of providing benefit in all conditions of the
various organs of the body stated and implied: (Leaflet entitled "The
Advanced Violetta Kits") " * * * electrical aid in treatments of the
skin or the scalp ***,??*** provide the therapeutic values
desired to aid in the correction of skin and scalp deficiencies," "It brings
nourishment to the hair follicles if used as a scalp treatment or, if used
for general body or facial work, the stimulating qualities of the rays carry
the food values in the blood stream to feed the epidermis cells on the surface
of the body," and " * * * for the treatment of many common condi-
tions"; and (leaflet entitled "Violetta Electrodes") " * * * for any
surface application," " * * * very desirable in deep-seated cases," "Used
for all scalp treatments. Stimulates the hair roots and cells," "For spinal
treatments," "Throat Electrode," "Special Vaginal Electrode," "Vaginal Elec-
trode," "Prostatic Electrode," "Length just right to reach prostate gland," "In-
ternal Throat Electrode," "Nasal and Ear Electrode," "A special Ear Elec-
trode * * * fits in the ear passage," "Urethral Electrode," "Kectual
Electrode," "Dental Electrode," and "Dental Abscess."
DISPOSITION :    June 27, 1951.   Default decree of condemnation and destruction.





2807. Misbranding of violet ray device.   U. S. v. 13 Cases, etc   (F. D. O. No.
26995.   Sample Nos. 25833-K, 25834-K.) 
LIBEL FILED :   April 13,1949, District of Minnesota.
ALLEGED SHIPMENT : On or about November 5 and 27 and December 3,1948, and
January 6, February 13, and March 3,1949, by Montgomery Ward & Co., from
Galewood and Chicago, 111., and Oakland, Calif., and by Master Appliances,
Inc., from Chicago, 111.
PRODUCT : 13 cases each containing a circular entitled "The Master High Fre-
quency," a device labeled "20W 115V No. M66 The Master Electric Co.
Chicago," a general electrode, a comb rake electrode, and a throat electrode;
and 26 cases each containing a circular of the same title, a device similarly
labeled, and a general electrode.
Examination showed that each of the devices consisted- essentially of
Geissler's tubes of various shapes, with a transformer assembly to activate
them, designed to apply an intermittent ray discharge to the body.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
circulars were false and misleading since the devices were not effective in the
treatment of the conditions and diseases stated and implied and were not
capable of producing the effects claimed. The statements represented and
suggested that the devices would be effective in the treatment of faulty circu-
lation and impure blood; that they would be effective in preventing deteriora-
tion of the body, failure of the digestive organs to function properly, sluggish-
ness and weakness of the internal organs, and weaknesses peculiar to men
and women; that they would give excellent results in local conditions; that
they would stimulate the circulation; that they would produce a sedative or
quieting effect and would tend to establish a normal equilibrium of the nervous
system; that they would be efficacious in relieving painful sensations and in
soothing irritated nerves; that they would be efficacious as a stimulant and
tonic; that they would be efficacious for facial and body treatment; that
they would be efficacious in the treatment of rheumatism, lumbago, and neu-
ritis ; that they would be efficacious in the treatment of the scalp, spine, eyes,
and ear; that they would be efficacious for stimulating the hair; that they
would be efficacious in the treatment of cystitis, strictures, gonorrhea, and
prostate and vaginal troubles; and that they would promote circulation and
be effective in the treatment of many ailments.
DISPOSITION : August 4,1949. Master Appliances, Inc., Chicago, ill., claimant,
having consented to the entry of a decree, judgment of condemnation was
entered. The court ordered that the devices be released under bond for
relabeling under the supervision of the Federal Security Agency.




6932. Violet ray generator device. i( F.D.C. No. 45940. S. No. 20-531 R.) 
QUANTITY : 14 devices at Sandusky, Ohio, in possession of New Life, Inc. 
SHIPPED: 1-23-61, from Ferndale, Mich., by Renulife Electric Co.
LABEL IN PART : "Renulife Violet Ray Generator Made * * * by Renulife Elec. 
Co., Ferndale, Mich. No. 258 (or other numbers) Model No. 2."
ACCOMPANYING LABELING: Leaflets entitled "Instructions for Operating Renu- 
life Violet Ray Health Generators" and "Health your most priceless asset."
RESULTS OF INVESTIGATION : The literature indicated the device to be a black 
grain leatherette case, 4 1/2" x 10 1/2" x 11 1/2", containing a control panel, three 
electrodes, and a plastic tubular-shaped applicator connected to the control 
panel by an electric cord. The three electrodes, made of metal and glass, were 
in the shape of a tube, bulb, and rake, which plug into the ends of the ap- 
plicator. The electronic circuiting was probably a tesla coil. 
The leaflet entitled "Health your most precious asset" was printed locally.
LIBELED : 6-7-61, N. Dist. Ohio.
CHARGE: 502(a)-while held 'for sale, the labeling accompanying the article 
contained false and misleading representations that the article was adequate 
and effective as a treatment for relieving arthritis, bursitis, dandruff, ec- 
zema, rheumatism, acne, nervous conditions, neuralgia, neuritis, sciatica, and 
poor circulation; and that the article functioned to aid nature in performing 
various bodily responsibilities; and 502(f)(1)-when shipped, its labeling 
failed to bear adequate directions for use in that the labeling failed to state 
the diseases and conditions for which the article was intended.
DISPOSITION: On 7-5-61, New Life, Inc., claimant, filed an answer denying 
that the article was misbranded. Thereafter, on 11-14-61, the claimant hav- 
ing consented, the court entered a decree of condemnation and the article was 
delivered to the Food and Drug Administration.






4319. Misbranding of Master violet ray devices. U. S. v. Master Appliances, Inc.
Plea of guilty. Fine of $2,000, plus costs. (F. D. C. No. 35561. Sample
Nos. 50206-L, 50207-L.)
INFORMATION FILED: October 20, 1953, Northern District of Indiana, against
Master Appliances, Inc., Marion, Ind.
ALLEGED SHIPMENT : On or about October 10, 1951, and April 2, 1952, from the
State of Indiana into the State of New York, of a number of devices known
as Master Violet Ray Outfit No. 2B and Master Violet Ray Outfit No. 9.
PRODUCT : The Master Violet Ray Outfit No. 2B consisted of an electrical device
and 3 glass tubes designated "No. 1 General Electrode," "No. 3 Comb-Rake
Electrode," and "No. 12a Glass Electrode." The device itself consisted of a
spark gap oscillator in a black bakelite-like plastic case having a green control
knob on one end of the case and a hole at the other end. The control knob
varied the size of the spark gap. Any one of the three electrodes could be fitted
into the hole at the end of the case. The electrodes consisted of hollow glass
tubes filled with gas and having metal sleeves on the ends which would fit
into the oscillator.
The Master Violet Ray Outfit No. 9 contained an electrical device and 1 glass
tube designated "No. 1 General Electrode." The device was constructed
similarly to the Master Violet Ray Outfit No. 2B, but was limited to accom-
modate only the "general electrode."
NATURE OF CHARGE : Misbranding, Section 502 (a), certain statements in a leaflet
entitled "Master Appliances for Health and Beauty," accompanying the devices,
were false and misleading. The statements represented and suggested that
the devices would provide an adequate and effective treatment for achieving
good health, for relieving all pain and congestion, for stimulating the circu-
lation, for restoring vigor and youth, for facial blemishes, for baldness, for
preventing baldness, and for innumerable disorders, and that the devices would
insure a clear, healthy complexion. The devices would not provide an adequate
and effective treatment for such purposes and conditions, and they would not
insure a clear, healthy complexion.
DISPOSITION : January 29,1954. The defendant having entered a plea of guilty,
the court fined it $2,000, plus costs.








3458. Misbranding of violet ray device. U. S. v. 2 Cases * * *. (F. D. C.
No. 30801. Sample No. 3858-L.)
LIBEL FILED : Between March 2 and April 24, 1951, District of Maryland.
ALLEGED SHIPMENT: On or about July 24, 1950, by Master Appliances, Inc.,
from Marion, Ind.
PRODUCT : 2 imitation leather cases, each containing a violet ray device, a gen-
eral electrode, a rake electrode, a throat electrode, and circulars entitled "The
Master High Frequency "Violet Ray," "The Master High Frequency Violet
Ray A Professional Aid to Health and Beauty," and "Directions For Oper-
ating," at Baltimore, "Md.
Examinations showed that the product consisted essentially of Geissler tubes
of various shapes with a transformer assembly to activate them, designed to
apply an intermittent ray discharge to the body.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
circulars were false and misleading. The statements represented and sug-
gested that the device would produce pleasing, invigorating, and corrective
effects; that it would be effective as a general treatment by stimulating the
circulation; that it would be effective for beauty, health, and strength; that
it would be efficacious in the treatment of rheumatic pain in the shoulder,
4 United States v. Various Quantities of Articles of Drug, D. C. 83 F. Supp. 882, 887;
United States v. 1 Dozen Bottles, etc., 4 Cir., 146 F. 2d 361, 363. See also, UnTted States
v. Olsen, 9 Cir., 161 F. 2d 669, 671; United States v. 52 Drums Maple Syrup, 2 Cir.,
110 F. 2d 914, 915; United States v. Two Bags, etc., 6 Cir., 147 F. 2d 123, 128.
a sedative or quieting effect and establish a normal equilibrium of the nervous
system; that it would relieve painful sensations; that it would be efficacious
as a stimulant and tonic; that it would be efficacious for facial, body, spinal,
and scalp treatments; that it would stimulate the hair; that it would be
efficacious for treatment of the eyes and ears; that it would be efficacious in
the treatment of cystitis, strictures, gonorrhea, and prostate and vaginal
troubles; that it would promote circulation; that it would aid beauty and
health by gently stimulating the flow of blood; that it would be helpful in
relieving pain and congestion and in restoring good health and vigor; that it
would be helpful in removing facial blemishes and in promoting a clear, health-
ful complexion; and that it would aid in the removal of dandruff and assist
in stopping falling hair. The device was not an effective treatment for the
conditions stated and implied, and it was not capable of producing the effects
claimed.
DISPOSITION : April 24, 1951. Default decree of condemnation. The court
ordered that the devices be released to the Food and Drug Administration.





4178. Misbranding of Master violet ray outfit. U. S. v. 14 Packages, etc.
(F. D. C. No. 35294. Sample Nos. 50206-L, 50207-L.)
LIBEL FILED : June 8,1953, Southern District of New York.
ALLEGED SHIPMENT : On or about October 10, 1951, and April 2, 1952, by Master
Appliances, Inc., from Marion, Ind.
PRODUCT: 14 packages designated "Master Violet Ray Outfit No. 2B," each
package containing an electrical device labeled in part, "Master Appliances
Inc * * * UL Marion, Indiana" and 3 glass tubes designated "No. 1 General
Electrode," "No. 3 Comb-Rake Electrode," and "No. 12a Glass Electrode," and
9 packages designated "Master Violet Ray Outfit No. 9," each package contain-
ing an electrical device labeled, in part, "Master Appliances Inc * * ,* UL
Marion, Indiana" and one glass tube designated "No. 1 General Electrode,"
at New York, N. Y. Each package when shipped contained also a circular
entitled "The Master High Frequency (Violet Ray)." In addition, a number
of leaflets entitled "Master Appliances For Health and Beauty," which had
been shipped by the printer from Chicago, 111., were in the possession of the
consignee. The article (both models) when plugged into an electric outlet,
would provide a high frequency, high voltage electric discharge through par-
tially evacuated glass tubes of various shapes. When held against the body,
the glass tube would conduct the high voltage, high frequency electrical
discharge to the skin.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
above-mentioned leaflet entitled "Master Appliances For Health and Beauty,"
which accompanied the article, were false and misleading. The statements
represented and suggested that the article would provide an adequate and
effective treatment for achieving good health; for relieving all pain and con-
gestion ; for stimulating the circulation; for restoring vigor and youth; for
facial blemishes: for baldness; for preventing baldness; and for innumerable
disorders; and that it would insure a clear, healthy complexion. The article
would not provide an adequate and effective treatment for such conditions,
and it was not capable of fulfilling the promises of benefit made for it. The
article was misbranded in the above respect when introduced into, while in,
and while held for sale after shipment in, interstate commerce.
DISPOSITION : July 9, 1953. Default decree of condemnation and destruction.





2807. Misbranding of violet ray device. U. S. v. 13 Cases, etc (F. D. O. No.
26995. Sample Nos. 25833-K, 25834-K.) 
LIBEL FILED : April 13,1949, District of Minnesota.
ALLEGED SHIPMENT : On or about November 5 and 27 and December 3,1948, and
January 6, February 13, and March 3,1949, by Montgomery Ward & Co., from
Galewood and Chicago, 111., and Oakland, Calif., and by Master Appliances,
Inc., from Chicago, 111.
PRODUCT : 13 cases each containing a circular entitled "The Master High Fre-
quency," a device labeled "20W 115V No. M66 The Master Electric Co.
Chicago," a general electrode, a comb rake electrode, and a throat electrode;
and 26 cases each containing a circular of the same title, a device similarly
labeled, and a general electrode.
Examination showed that each of the devices consisted- essentially of
Geissler's tubes of various shapes, with a transformer assembly to activate
them, designed to apply an intermittent ray discharge to the body.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
circulars were false and misleading since the devices were not effective in the
treatment of the conditions and diseases stated and implied and were not
capable of producing the effects claimed. The statements represented and
suggested that the devices would be effective in the treatment of faulty circu-
lation and impure blood; that they would be effective in preventing deteriora-
tion of the body, failure of the digestive organs to function properly, sluggish-
ness and weakness of the internal organs, and weaknesses peculiar to men
and women; that they would give excellent results in local conditions; that
they would stimulate the circulation; that they would produce a sedative or
quieting effect and would tend to establish a normal equilibrium of the nervous
system; that they would be efficacious in relieving painful sensations and in
soothing irritated nerves; that they would be efficacious as a stimulant and
tonic; that they would be efficacious for facial and body treatment; that
they would be efficacious in the treatment of rheumatism, lumbago, and neu-
ritis ; that they would be efficacious in the treatment of the scalp, spine, eyes,
and ear; that they would be efficacious for stimulating the hair; that they
would be efficacious in the treatment of cystitis, strictures, gonorrhea, and
prostate and vaginal troubles; and that they would promote circulation and
be effective in the treatment of many ailments.
DISPOSITION : August 4,1949. Master Appliances, Inc., Chicago, ill., claimant,
having consented to the entry of a decree, judgment of condemnation was
entered. The court ordered that the devices be released under bond for
relabeling under the supervision of the Federal Security Agency.






981. Misbranding of R & R Ultra Violet Ray and Radiation Machine. U. S. v.
August H. Riess (Lawndale Laboratories). Plea of not guilty. Tried to
the court. Judgment of guilty. Fine, $250. (F. D. C. No. 8750. Sample
No. 1001-F.)
On January 16, 1943, the United States attorney for the Southern District of
California filed an information against August H. Riess, trading as Lawndale
Laboratories, Lawndale, Calif., alleging shipment on or about June 29, 1942,
from the State of California into the State of Michigan of one of the above-named
devices which was misbranded.
Examination of this product showed that it was essentially a high voltage mer-
cury vapor discharge tube. A spectrograph^ examination indicated that the
gaseous discharge was in an ultraviolet transmitting tube, and that the character
of the radiations from the discharge was primarily of the spectrum of mercury
vapor. The intensity of ultraviolet light emitted was relatively of a weak order
of magnitude and was observed to be some 50 times weaker than an ultraviolet
lamp such as might customarily be used in normal routine of ultraviolet therapy.
The article was alleged to be misbranded in that the statements appearing in its
labeling which represented and suggested that it would be efficacious in the cure,
mitigation, treatment, or prevention of arthritis, acne, asthma, bronchitis, hay
fever, gout, dropsy, constipation, indigestion, jaundice, cold hands and feet, ane-
mia, carbuncles, boils, goiter, deafness, headache and eye trouble, lumbago, mumps,
pleurisy, measles, low blood pressure, liver disease, hardening of the liver, neu-
ritis, rheumatism, high blood pressure, nervousness, paralysis, palsy, locomotor
ataxia, erysipelas, neuralgia, menopause, sprains, stiff neck, quinsy, stiff muscles,
sinus disease, catarrh, varicose veins, psoriasis, fatigue, exhaustion, and female
trouble; would be efficacious in treating affections of the prostate, thyroid
glands, kidneys, bladder, heart, nerves, throat and tonsils, and disturbances of the
sacro-iliac joint; would be efficacious to improve the circulation and bring about
internal cellular massage; would build up the red corpuscles, improve the im-
poverished blood stream, increase glandular activity, and act as a natural tonic
to the entire body; would stimulate increased activity in the glands creating
the digestive juices; would produce an increase of the rapidity of the chemical
changes from which life results; would relieve congestion in a natural manner
?See also Nos. 951, 954-958, 961-978.
and stimulate activity where metabolism is'sluggish,' and "rebuild the body to
healthfulness and happiness; would be invaluable to persons of advanced age or
those whose occupations fail to give sufficient exercise; would stimulate bodily
activity, improve digestion and elimination, restore bowel activity to normal,
improve the circulation of the blood, and generally improve health, were false and
misleading since it would not be efficacious for such purposes or accomplish the
results claimed.
It was alleged to be misbranded further in that the statements appearing in
its labeling, "Ultra Violet Rays * * * Are a Source of Vitamin D, are very
beneficial to the upbuilding of the body, due to the difficulty in obtaining these
Rays in a sufficient quantity under modern conditions, due to indoor occupations,
and climatic conditions, our Laboratories have, after considerable research
and experimentation, produced the R & R Ultra-Violet Ray and Radiation
Machine," were misleading since such statements suggested and created the im-
pression in the mind of the reader that the device would produce ultraviolet rays
of sufficient intensity to produce in the body vitamin D in an amount sufficient to
compensate in an important respect for the deficiency of vitamin D resulting from
indoor occupations and unfavorable climatic conditions, whereas the device would
produce ultraviolet rays of very weak intensity and would produce little, if any,
vitamin D in the body.
On March 10, 1943, the defendant having entered a plea of not guilty, the case
came on for trial before the court. At the conclusion of the testimony the court
found the defendant guilty, and on March 22,1943, imposed a fine of $250.






2850. Misbranding of ultraviolet ray devices. U. S. v. 16 Devices, etc (F. D. O.
No. 26972. Sample No. 41216-K.)
JLIBEL FILED: May 5,1949, Western District of Washington.
AIXEGED SHIPMENT: Between the approximate dates of August 18, 1948, and
. January 14, 1949, by H. T. Chenoweth and the Lawndale Laboratories, from
Los Angeles, Calif.
JPRODUCT: 16 ultraviolet ray devices at Seattle, Vashon, Kent, and Renton,
Wash., together with a number of leaflets entitled "Ultra Violet Ray & Radia-
tion Treatments" and "Violet Ray and Electric Radiation," which were in
possession of Mahdah Brown of Seattle, Wash. Some of the leaflets were
received from H. T. Chenoweth on or about March 4, 1949, in response to a
?request of Mahdah Brown, and other leaflets were received prior to that date.
The .device consisted of a high voltage mercury vapor discharge tube and
transformer.
LABEL, IN PABT: "R & R Ultra Violet Ray and Radiation Instrument For
Therapeutic Use."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
leaflets were false and misleading. These statements represented and sug-
gested that the-devices would be beneficial in upbuilding the body; that they
would stimulate the activity in the glands and tissues of the body and cause
improved circulation in the blood stream; that they would make the user
-w.'-ll, strong, and full of life and energy; that they would relieve distress and
discomfort from aches and pains; that they would aid in building red cor-
puscles ; that they would stimulate sluggish metabolism and relieve congestion;
ithat they would stimulate/bodily activity, improve digestion and elimination,
restore bowel activity to normal, and cause restful sleep; and that they would
'be effective in the treatment of arthritis, rheumatism, sinus, asthma, high
or low blood pressure, varicose veins, poor circulation, and other ills. The
devices would not be effective in the treatment of such conditions. The de-
vices were misbranded when introduced into, while in, and while held for sale
after shipment in, interstate commerce.
piSPOsrnoN: June 6, 1949. Mahdah Brown, 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.
- -





6900. Electrode applicators. (F.D.C. No. 45939. S. Nos. 48-023/39 R.) 
QUANTITY : 205 applicators at Ferndale, Mich., in possession of Renulife Elec- 
tric Co.
SHIPPED: Between February 1957 and February 1961, from Chicago, IlL
ACCOMPANYING LABELING : Leaflets entitled "Electrode Applicators For Use in 
Connection with Renulife Violet Ray Generators," "Health your most price- / 
less asset," and "Instructions for Operating Renulife Violet Ray Health \ 
Generators."
RESULTS OF INVESTIGATION: Examination showed the article to comprise an 
assortment of sealed glass tubes of various sizes, shapes, or configurations, 
with a metal cap attached at one end. Some of the electrodes contained in- 
ternal rods, wires, or discs. . 
The leaflets were printed locally on order of the dealer.
LIBELED : 6-19-61, E. Dist. Mich.
CHARGE: 502(a)-while held for sale, the labeling accompanying the article 
contained false and misleading representations that the article was adequate 
and effective as a treatment for relieving fallen hair, dandruff, tonsilitis, goiter, 
prostate trouble, spinal conditions, eye, ear, and nose conditions, deafness, and 
vaginal inflammation; and for removing blemishes, scars, and warts.
DISPOSITION: 11-7-61; amended decree 11-15-61. Default-portions of the 
article and labeling delivered to the Food and Drug Administration and the 
remainder destroyed.




5239. Holder's electronic condensator device.    (F. D. C. No. 39495.    S. No. 34-
896 M.)
QUANTITY: 1 Holder's Electronic Condensator device, together with various
accessories to be used with the device, at Covington, Ky.
SHIPPED :   About April 1956, from Detroit, Mich., by Colo Products, Inc.
LABEL IN PART: (Device) "Holder's Electronic-Oscillating'Condensator' Gen-
erating Fluid Electrically All Rights Protected Primordial Off On Ozone
Off On Powder Med. High Compensator Control General Body Treatment
Bi Polar Pact Only Eye-Ear-Nose-Throat Treatment Colo Products, Inc.,
Detroit, Mich. * * * Windsor, Can."
ACCOMPANYING LABELING : Booklet entitled "Holder's Electronic High-Frequency
Condensator   Operating Instructions."
RESULTS OP INVESTIGATION : This device was an electronic, high-voltage oscil-
lator and a group of glass electrode applicators. The electrodes were gas-filled
and produced a glow discharge during application. The radio frequencies
emanating were of such low power and low frequency as to have negligible
absorption in the body.
LIBELED :   10-2-56, E. Dist. Ky.
CHARGE: 502 (a)-the labeling accompanying the article, when shipped, con-
tained false and misleading representations that the device was effective for
locating trouble areas and toxic conditions and for determining the seriousness
of the condition; for treating all body ailments, including ailments of the eyes,
ears, throat, tonsils, teeth, face, heart, lungs, liver, gallblader, kidneys, pan-
creas, spleen, stomach, bowels, anus, rectum, breast, ovaries, uterus, vaginae-
cervix, brain, and frontal sinus; and for treating abscess, anemia, arthritis(
rheumatism, paralysis, hay fever, hemorrhoids,  varicose veins, leg ulcers,
multiple sclerosis, mucous colitis, malnutrition, pain, influenza, indigestion,
head noises, and allergic conditions due to a large variety of products.
DISPOSITION : 12-3-56. Default-delivered to the Food and Drug Administra-
tion.





5319. Neu-Clear Therapy Electronic Condensator (2 seizure actions).    (F. D. G.
Nos. 39643, 39644. S. Nos. 19-508/9 M.)
-QUANTITY : 2 devices and various accessories at Portsmouth and New Boston,
Ohio.
SHIPPED:   12-12-55 and 1-1-56, from Detroit, Mich., by Colo Products, Inc.
ISABEL IN PART: (Device) "Neu-Clear Therapy Electronic 'Condensator' Gener-
ating 'Fluid' Electricity."
ACCOMPANYING LABELING: Booklet entitled "Holder's Electronic High-Fre-
quency Condensator   Operating Instructions."
RESULTS OP INVESTIGATION : The device consisted of an electronic, high-voltage
oscillator and a group of glass electrode applicators. The electrodes were gas-
filled and produced a glow discharge during application. The radio frequencies
emanating were of such low power and low frequency as to have negligible
absorption in the body.
LIBELED :    10-23-56, S. Dist. Ohio.
CHARGE: 502 (a)-the labeling accompanying the device, when shipped, con-
tained false and misleading representations that the device was effective for
locating trouble areas and toxic conditions and for determining the seriousness
of the conditions; for treating all body ailments, including ailments of the
eyes, ears, throat, tonsils, teeth, face, heart, lungs, liver, gallbladder, kidney,
pancreas, spleen, stomach, bowels, anus, rectum, breasts, ovaries, uterus,
vagina, cervix, brain, and frontal sinus; and for treating abscess, anemia,
arthritis, rheumatism, paralysis, hay fever, hemorrhoids, varicose veins, leg
ulcers, multiple sclerosis, mucous colitis, malnutrition, pain, influenza, in-
digestion, head noises, and allergic conditions due to a large variety of products.
DISPOSITION :    11-30-56.  Default-destruction.




6162. Ray of Life device.    (F.D.C. No. 44011.   S. No. 51-138 P.)
QUANTITY : 11 devices at St. Paul, Minn., and 2 devices at Stillwater, Minn., in
possession of Henry Amundson.
SHIPPED :   5-20-58, from Racine, Wis.
LABEL IN PART:    "Electronic   High  Frequency  Generator * * * The Ray   of
Life."
RESULTS OF INVESTIGATION :   The device was a type of electronic high-frequency
generator which produced a glow discharge in a variety of gas-filled glass
applicators.
LIBELED :   12-29-59, Dist. Minn.
CHARGE:   502(f) (1)-while held for sale, the labeling of the article failed to
bear adequate directions for use; and 502(j)-the article was dangerous to
health when used as directed.
DISPOSITION:   3-23-60.   Consent-claimed   by   Henry   Amundson,   Stillwater,
Minn., and dismantled.





More interesting devices:

2098. Misbranding  of  Spectro-Chrome.    U.  S. v.  1  Device  Known as  Speetro-
Chrome, and a quantity of printed matter. Tried to the jury. Decree 
of condemnation. Product and printed matter ordered delivered to the 
Food and Drug Administration.     (F. D. C. No. 13226.    Sample No. 82254-F.)
LIBEL FILED : August 11,1944, Eastern District of New York; amended libel filed 
November 15, 1944.
ALLEGED SHIPMENT: On or about July 21, 1944, from Malaga, N. J., by the 
Dinshah Spectro-Chrome Institute.
PRODUCT: 1 device known as Spectro-Chrome at Babylon, N. Y., together with 
a quantity of accompanying printed matter. Examination showed that the 
device consisted of a cabinet equipped with an electrically-operated fan, a 1,000- 
watt electric light bulb, a glass water container, two condensing lenses, and 
several glass slides of various colors
The cabinet had an opening in the 
fruit in which the glass slides could be inserted and through which the light 
from the bulb would emit.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements on the 
label of the device were false and misleading since they represented and sug- 
gested that the device was capable of measuring and restoring human radio- 
active and radioemanative equilibrium by attuned color waves, whereas there 
is no radio-active or radioemanative equilibrium in the human system, and the 
device was incapable of performing any function of measurement, and the 
use of color waves of any type would have no effect on human equilibrium.
Further misbranding, Section 502 (a), certain statements in the accompany- 
ing printed matter, including the printed matter entitled "Spectro-Chrome 
Home Guide," "Spectro-Chrome Way, 1944," and "Spectro-Chrome-In Every 
Home," were false and misleading since the statements represented and sug- 
gested that the device when used in accordance with the directions for use 
-appearing in the printed matter would be effective in the treatment of the follow- 
ing diseases, conditions, and purposes, and that when so used the device would 
" constitute a safe and appropriate treatment therefor: (diseases and conditions 
for which device was recommended) Disorders of the heart, lungs, skin, nutri- 
tion, mentality, and emotions; inflammation with pain, swelling, fever, or red- 
ness ; disorders of blood, genitals, females, children, teeth, motor system, and 
sensory system; gonorrhea, syphilis, ulcers, chancres, smallpox, scarlet fever, 
diphtheria, whooping cough, chickenpox, measles, German measles, mumps, 
fallen womb, habitual tendency to miscarriage, burns of any degree, sunstroke, 
diabetes, sex frigidity, accident, dog bite, eye disorder, ear abscess, mastoid- 
itis, constipation, colds, gastritis, nervousness, ophthalmitis, rectal abscess, 
high blood pressure, poor circulation, tuberculosis, piles, varicose veins, 
aphonia, headache, hay fever, dizziness, sleeplessness, rash, poison ivy, stomach 
ulcers, sciatica, tachycardia, nosebleeding, lung hemorrhage, leg ulcer, prostate 
disorder, kidney disorder, tonsillitis, pleurisy, appendicitis, gout, pneumonia, 
tumors, leaky heart, hiccoughs, arthritis, rheumatism, cataract, X-ray and
radium destruction, cancerous growths, certain types of blindness and deaf- 
ness, and refruitory carbuncles; (purposes for which device was recommended) 
liver energizer, hemoglobin builder, respiratory stimulant, parathyroid depress- 
ant, thyroid energizer, antispasmodic, galactagogue, antirachitic, emetic, 
stomachic, lung builder, motor stimulant, alimentary tract energizer, lymphatic 
activator, splenic depressant, digestant, cathartic, cholagogue, anthelmintic, 
nerve builder, cerebral stimulant, thymus activator, antacid, chronic altera- 
tive, antiscorbutic, laxative, expectorant, bone builder, pituitary stimulant, 
disinfectant, purificatory, antiseptic, germicide, bactericide, detergent, muscle 
and tissue builder, cerebral depressant, acute alterative, tonic, skin builder, 
antipruritic, febrifuge, counter irritant, anodyne, demulcent, vitality builder, 
parathyroid stimulant, thyroid depressant, respiratory depressant, astringent, 
sedative, pain reliever, hemostatic, inspissator, phagocyte builder, splenic stim- 
ulant, cardiae depressant, lymphatic depressant, leukocyte builder, venous 
stimulant, renal depressant, antimalarial, vasodilator, anaphrodisiac, narcotic, 
antipyretic, analgesic, suprarenal stimulant, cardiac energizer, diuretic, emo- 
tional equilibrator, auric builder, arteral stimulant, renal energizer, genital 
exeitant, aphrodisiac, emmenagogue, vasoconstrictor, ecbolic, sex builder in 
subnormal and other diseases and conditions. The device when used in ac- 
cordance with the directions, or when used in any manner whatsoever, was of 
no value in the treatment of any of the diseases and conditions mentioned, 
or for the purposes represented; and when so used, the device may delay 
appropriate treatment of serious diseases, resulting in serious or permanent 
injury to the user. 
DISPOSITION: Dinshah P. Ghadiali, claimant, having filed an answer denying 
that the labeling was misleading, the case came on for trial before a jury on 
May 14,1945. At the conclusion of the trial on June 26,1945, the jury returned 
a verdict in favor of the Government; and on July 9,1945, a decree was entered 
condemning the device and enjoining the claimant from introducing into 
interstate commerce any device labeled similarly to the condemned device.
A notice of appeal to the United States Circuit Court of Appeals for the- 
Second Circuit was subsequently filed by the claimant. The claimant failed 
to perfect his appeal, and on January 3, 1946, the appeal was dismissed.
On February 5, 1946, an order was entered directing that the device and 
accompanying printed matter be delivered to a representative of the Food 
and Drug Administration.

3149. Misbranding of Spectro-Chrome.   U. S. v. 1 Device   *   *   *    (and 26
other seizure actions).    (F. D. O. Nos. 16788, 16789 to 16791, incl., 16820
to 16822, incl., 16824,16827,16836,16903 to 16906, incl., 16920,17017,17020,
17270 to 17272, incl., 17276, 17279, 17679, 18139, 18140, 18829, 18888.
Sample Nos. 3227-H, 4094-H, 4145-H, 4157-H, 4173-H, 4176-H to 4178-H,
incl., 4848-H, 16305-H, 16307-H, 16309-H, 16313-H to 16317-H, incl.,
16334-H,  16336-H,  16347-H,  16348-H,  16910-H,  16911-H,  17395-H to
17399-H, incl.)
LIBELS FILED :   Between July 16, 1945, and January 31, 1946, Eastern District
of Wisconsin, Eastern District of Pennsylvania,  and Eastern  District  of
Virginia.
ALLEGED SHIPMENT :    Between the early part of 1943 and November 11, 1945, by
Dinshah P. Ghadiali, from Newfield, N. J.
PRODUCT : 27 Spectro-Chrome devices at Milwaukee, West Bend, Racine, Sheboy-
gan, Barton, Sheboygan Falls, and Hartford, Wis.; Egypt, Pa.; and Portsmouth,
Va.
Examinations showed that the device consisted essentially of a cabinet
equipped with an electric light bulb, an electric fan, a container for water, glass
condenser lenses, and glass slides, each of a different color. The cabinet had
an opening in the front in which the glass slides could be inserted and through
which the light from the bulb would emit.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements on the
label of each device were false and misleading. The statements on the labels
of some of the devices represented and suggested that the devices were capable
of measuring and restoring human radioactive and radioemanative equilib-
rium (normalation of imbalance) by attuned color waves; and the statements
on the label of other devices represented and suggested that the devices were
capable of restoring, maintaining, or otherwise favorably influencing the health
of the user. The devices were incapable of measuring and restoring human
radioactive and radioemanative equilibrium (normalation of imbalance) by
attuned color waves since the devices were incapable of performing any func-
tion of measurement; there is in the human system no radioactive or radio-
emanative equilibrium; the use of color waves would have no effect on normal-
ation of imbalance; the devices were incapable of restoring, maintaining, or
otherwise favorably effecting the health of the user; and use of color waves
would have no effect on health.
Further misbranding, Section 502 (a), certain statements in the printed
and graphic matter accompanying a number of the devices were false and
misleading. The statements represented and suggested that the device when
used as directed would be efficacious in the cure, mitigation, treatment, and
prevention of all disorders of the heart, lungs, skin, nutrition, mentality, emo-
tions, inflammation, disorders with pain, with swelling, with fever, or with
redness, disorders of the blood, genitals, females, children, teeth, motor system,
sensory system, gonorrhea, syphilis, ulcers, chancres, smallpox, scarlet fever,
diphtheria, whooping cough, chicken pox, measles, German measles, mumps,
fallen womb, habitual tendency to miscarriage, burns of any degree, sunstroke,
diabetes, sex frigidity, accident, dog bite, eye disorder, ear abscess, mastoiditis,
constipation, colds, gastritis, nervousness, ophthalmitis, rectal abscess, high
blood pressure, poor circulation, tuberculosis, piles, varicose veins, aphonia,
headache, hay fever, dizziness, sleeplessness, rash, poison ivy, stomach ulcers,
sciatica, tachycardia, nose bleeding, lung hemorrhage, leg ulcer, prostate dis-
order, kidney disorder, tonsilitis, pleurisy, appendicitis, gout, pneumonia, re-
moval of tumors, leaky heart, hiccoughs, arthritis, rheumatism, cataract, and
X-ray and radium destruction; that the article would be effective in the control
of cancerous growths, removal of certain types of blindness and deafness, and
normalation of refractory carbuncles; that the device was a liver energizer,
hemoglobin builder, respiratory stimulant, parathyroid depressant, thyroid
energizer, antispasmodic, galactagogue, antirachitic, emetic, stomachic, lung
builder, motor stimulant, alimentary tract energizer, lymphatic activator,
splenic depressant, digestant, cathartic, cholagogue, anthelmintic, nerve builder,
cerebral stimulant, thymus activator, antacid, chronic alterative, antiscorbutic,
laxative, expectorant, bone builder, pituitary stimulant, disinfectant, purifi-
catory, antiseptic, germicide, bactericide, detergent, muscle and tissue builder,
cerebral depressant, acute alterative, tonic, skin builder, antipruritic, diapho-
retic, febrifuge, counterirritant, anodyne, demulcent, vitality builder, parathy-
roid stimulant, thyroid depressant, respiratory depressant, astringent, seda-
tive, pain reliever, hemostatic, inspissator, phagocyte builder, splenic stimu-
lant, cardiac depressant, lymphatic depressant, leucocyte builder, venous stim-
ulant, renal depressant, antimalarial, vasodilator, anaphrodisiac, narcotic,
antipyretic, analgesic, sex builder in supernormal, suprarenal stimulant, car-
diac energizer, diuretic, emotional equilibrator, auric builder, arterial stimu-
lant, renal energizer, genital excitant, aphrodisiac, emmenagogue, vasocon-
strictor, ecbolic, sex builder in subnormal and other diseases, conditions, symp-
toms, and disorders; and that the device when so used as directed would con-
stitute a safe and appropriate treatment. The device when used in accordance
with the directions for use, or when used in any manner whatsoever, was of
no value in the cure, mitigation, treatment, or prevention of any disease, dis-
order, condition, or symptom, and was of no value in affecting the structure,
or any functions, of the body of man, and when so used as directed, may delay
appropriate treatment of serious diseases, resulting in serious or permanent
injury, or death to the user.
Further misbranding, Section 502 (f) (1), the labeling of one of the devices
failed to bear adequate directions for use since it bore no directions for use.
908270-50?2
DISPOSITION : Between October 23, 1945, and October 11, 1946. The consignees
of 21 of the devices were Rose Regar, Edw. J. Schwalbach, Jacob Leszczynski,
Ella Minnie Severin, Josephine Wysocki, Emma Taves, Elsie Hegel, Geraldine
M. Peter, Agnes Skalecki, Hedwig Bakula, Adam Spaeth, Emma A. Wuerker,
Herman R. Leudtke, Lena Lambrecht, Anna Jessen, Lydia Thieme, Elsie
Wilke, Alfred G. Taddey, William Endwig, Edw. T. Rippey, and Sophie
Walkiewicz.
When the United States marshal first attempted to make seizure of the 21
devices, the consignees refused to surrender them. Accordingly, proceedings
were instituted to compel the consignees to surrender their devices, and as a
result of such proceedings, all of the consignees except Hedwig Bakula and
Emma A. Wuerker complied. Hedwig Bakula and Emma A. Wuerker were
cited for contempt, following the issuance of orders to show cause why their
devices should not be surrendered and their subsequent refusal to comply with
the orders of the court to surrender the devices. Hearings were held in the
matter, and at their conclusion, Hedwig Bakula and Emma A. Wuerker
adjudged guilty of contempt. Each was sentenced to pay a fine of $100 and
to be committed to the custody of the United States marshal for a period of
30 days, with the provision, however, that they could purge themselves of such
contempt by delivering their devices to the marshal within 24 hours. Hedwig
Bakula and Emma A. Wuerker thereupon surrendered their devices.
Following the surrender of the 21 devices held by the above-named consignees,
opportunity to appear as claimants was afforded to these individuals, as well
as to .the consignees of the 6 other devices who had not opposed seizure. How-
ever, no claims for any of the devices were made, and, accordingly, judgments
of condemnation were entered. The court ordered that one of the devices be
delivered to the Food and Drug Administration and that the other devices be
destroyed.
DRUGS ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR
OWN STANDARDS*

4238. Misbranding of Pedasine device, Electro-Pulse device, and Vita Motor de-
vice. U. S. v. 11 cartoned Devices, etc. (F. D. C. No. 34675. Sample Nos.
33756-L to 33758-L, incl.)
LIBEL FILED :   February 25,1953, Northern District of Illinois.
ALLEGED SHIPMENT : The Pedasine devices were shipped by R. A. Fischer & Co.,
from Glendale, Calif., on or about November 9, 1951, and November 18, 1952;
the Electro-Pulse devices were shipped by Ray Strahan Mfg., from Los Angeles,
Calif., on or about November 7,1952; and the Vita Motor devices were shipped
by the Vita-Motor Co., from San Diego, Calif., on or about March 30,1951, and
November 19, 1952.
PBODTJCT : 11 cartoned Pedasine devices with accompanying labeling furnished
by the shipper, consisting of leaflets entitled "The Famous Fischer Pedasine
Beneficial for Blood Pressure Cases," "The New Pedasine," and "Operating
Instructions for the Fischer Pedasine";; reprints entitled "Blood Pressure"
and "Diastolic Hypertension"; and catalogs entitled "The Fischer (Glendale)
Line fcf Electro-Medical Apparatus and Accessories."
6 cartoned Electro-Pulse devices with accompanying labeling furnished by
the shipper, consisting of leaflets entitled "Presenting The Electro-Pulse."
2 Vita Motor devices with accompanying labeling furnished by the shipper,
consisting of leaflets entitled "The Physiology of Tissue Surge Percussion,"
318014-54?-3
.instructions of the consignee, the Stanley Physical Therapy-iEquijfeejit &
?Supply Co., and which consisted of,copies of a catalog entitled "TheiPraetical
?Physical Therapist, Volume 7, January 1951," and ; containing-statements
relating to each of the devices.
The devices and their accompanying labeling were, at the time, of .seizure,
in the possession of the Stanley Physical Therapy Equipments Supply. Co.,
at Chicago, 111.
Examination showed that the Pedasine device consisted of an oblong case
?iwith metallic foot plates built into it and that, when plugged into an electric
outlet, the device would produce a sinusoidal current; that the Electro-Pulse
device was a heating and pulsating device; and that the Vita<Mator device was
avibrator.
LABEL, IN PAST: "Pedasine* * * R. A. Fischer & Co. Glendale 3 Calif;
"Electro-Pulse Manufactured by Enn-Tee Electric Company * * * North
Hollywood, Calif."; and "The Vita Motor Percusser    Spynengine Type D."
NATURE OF CHARGE: Pedasine device. Misbranding, Section 502 (a), certain
statements in the accompanying labeling of the device were false and mis-
leading. The statements represented and suggested that the device would
provide an adequate and effective treatment for high blood pressure, paralysis,
arthritis, fallen arches, poor circulation, constipation, flabby skeletal muscles,
flabby visceral muscles, and "many other physical conditions." The device
would not provide an adequate and effective treatment for such conditions.
Electro-Pulse device. Misbranding, Section 502 (a), certain statements in
the accompanying labeling of the device were false and misleading. The
statements represented and suggested that the device would provide an
adequate and effective treatment for rectal and vaginal disorders, chronic
constipation, cryptitis, nocturia, prostate hypertrophy, proctitis, prostatitis,
acute or chronic endometritis, cervicitis, vaginitis, gastrointestinal neuroses,
mucus colitis, hemorrhoids, neurocirculatory disturbances, cephalalgias,
and neuropsychiatry cases. The device would not provide an adequate and
effective treatment for such conditions.
Vita Motor device. Misbranding, Section 502 (a), certain statements in
the accompanying labeling of the device were false and misleading. The
statements represented and suggested that the device would provide an adequate
and effective treatment for amenorrhea, angina pectoris, aneurism of the
aorta, pain in the appendix, asthenopia, bronchial asthma, cardiac asthma,
.atelectasis, bed wetting, catarrh of the bile ducts, pain in the bladder, high
blood pressure, congestion of splanchnic blood vessels, congestion of the
brain, congestion of the bronchial mucosa, bronchitis, spasmodic broncho-
stenosis, cardiospasm, chilblains, chlorosis, cold in the head, spasmodic intes-
tinal colic, constipation, coryza, cough, diabetes mellitus, nervous diarrhea,
drowning, pain of duodenal ulcers, dysmenorrhea, nervous dyspepsia, dyspena
from heart failure, congestion of the ear, deafness (middle ear), cardiac and
renal edema, electrocution, emphysema, enteroptosis, enterospasm, enuresis,
epistaxis, amblyopia, asthenopia, congestion of the eyes, nervous affections of
the eyes, inflammation of the , gallbladder, gallstone, goiter, hay fever,
arrhythmia, heart insufficiency, mitral stenosis, myocarditis, pain in the heart,
palpitation of the heart, tachycardia, valvular insufficiency of the heart,-weak-
ness of the heart, hemoptysis, hemorrhpids, hepatic colic, hepatic congestion,
hiccough, hot flashes at menopause, hyperthyroidism, infantile paralysis, intesti-
nal tympanites, pain in the intestines, prolapsed intestines, catarrhal jaundice.
i inflammation of the kidneys, pain in the kidneys, prolapsed kidneys, cirrhosis of
the:liver, pain in the liver, locomotor ataxia, lumbago, hemorrhage of the
lungs, excessive menstruation, painful menstruation, suppression of menstrua-
. tion, nephritis, neurasthenia, nosebleed, congestion of the ovaries, pertussis,
piles, heart weakness in pneumonia, poliomyelitis, pain in the prostate gland,
pulmonary, atelectasis, pain in the rectum, chronic catarrh of the sinuses,
splanchnoptosis, enlarged spleen in progressive anemia, pain in the spleen,
pain in the stomach, prolapsed stomach, sunstroke, incontinence of urine,
pain in the uterus and appendages, subinvolution of the uterus and appendages,
vasomotor paralysis, vasomotor spasm, congested viscera, whooping cough,
ankylosis, adhesions, generalized atonia, indolent liver and gallbladder, and
excess fat. The device would not provide an adequate and effective treatment
for such conditions.
The devices were misbranded in the above respects when introduced into,
while in, and while held for sale after shipment in, interstate commerce.
DISPOSITION : No claimant having appeared, the court entered a decree of con-
demnation against the Pedasine devices on April 7, 1953, and a decree of con-
demnation against the other devices on July 14, 1953. The court ordered
that the devices and their labeling be delivered to the Food and Drug Ad-
ministration.

5339. Sun-Kraft Dual Ray lamp.    (F. D. C. No. 39258.   S. No. 52-303 M.)
QUANTITY :   318 devices at Brooklyn, N. T.
SHIPPED:   3-26-56, from Philadelphia, Pa., by Lawrence Sales Corp.
LABEL IN PART :    (Base of device) "Sun-Kraft Inc.   Chicago   U. S. A.   12246";
(plate attached to device) "Model H-l   Sun-Kraft Inc."
ACCOMPANYING LABELING:   Booklet entitled "Operation of Your Dual Ray."
RESULTS OF INVESTIGATION : Examination showed that the device consisted of
a cold quartz type lamp mounted on a metallic base and equipped with a
timing mechanism and reflector. This type of lamp emits ultraviolet and
infrared radiations.
LIBELED :   5-28-56, E. Dist. N. T.
CJHABGE: 502 (a)-the labeling accompanying the device, when shipped, con-
tained false and misleading representations that the device provided an
adequate and effective treatment for calcium deficiency, acne, psoriasis, many
variations of eczema, scalp conditions, skin tuberculosis, skin ulcers, slow
healing wounds, arthritis, rheumatism, neuritis, neuralgia, sinusitis, con-
junctivitis, certain forms of inflammation of the middle ear, bronchitis, and
skin abscesses; and that it was effective for the prevention of rickets.
DISPOSITION: 12-17-56. Consent-claimed by Professional Surplus Co., Inc.,
Brooklyn, N. T., and relabeled in accordance with the Act.


2869. Misbranding of Sun Kraft Ultra-Violet Ray Lamp. U. S. v. 2,733 Devices
* * *. (F.D.O. No. 26596. Sample No. 41302-K.)
LIBEL FILED: February 18, 1949, Western District of Washington.
ALLEGED SHIPMENT: By Sun-Kraft, Inc., from Chicago, 111. The devices were
shipped on or about April 2,1947, together with a number of booklets; a num-
ber of placards were shipped on or about April 15, 1947.
PBODTXCT: 2,733 Sun Kraft Ultra-Violet Ray Lamps at Seattle, Wash., in pos-
session of Puget Sound Appliance Sales Co., Inc., together with a number of
booklets entitled "How to Use Your Sun-Kraft" and placards entitled "Sun-
Kraft Quartz Ultra Violet Kay Therapeutic Lamp $64.50 Complete." In addi-
tion, a number of leaflets entitled "Special Factory Purchase," which the con-
signee had had printed locally, were in the consignee's possession.
Examination showed that the device consisted of a cold quartz type lamp
mounted on a metallic base, and equipped with a timing mechanism. This
type of lamp would emit ultraviolet radiations.
NATURE OF CHARGE: Misbranding, Section 502 (a), the following statements in
the labeling of the device were false and misleading since the device-was not
a so-called sun lamp and was not effective in the treatment of the following
conditions, stated and implied: (On device) "Sun-Kraft"; (in booklet) "Ul-
traviolet rays are useful in the treatment of many conditions. * * * Sun-
Kraft * * * For any condition not mentioned here * * ,*. For many
skin conditions. * * * Acne, psoriasis, many varieties of eczema, scalp
conditions and skin tuberculosis * * * For skin ulcers and slow healing
wounds. Physicians have found that ulcers and wounds that fair to heal be-
cause of superimposed infection * * * For reducing bacteria content of
air"; (on display placard) "* * '* Great aid in relieving respiratory
conditions." The device was misbranded in the above respect when intro-
duced into and while in interstate commerce.
Further misbranding, Section 502 (a), the statements in the leaflets, "Sun-
Kraft * * * Helps clear up skin diseases * * * Benefits cold and
asthma sufferers Kills bacteria," were false and misleading since the device
was not effective in the treatment of the conditions, stated and implied. The
device was misbranded in this respect while held for sale after shipment in
interstate commerce.
DISPOSITION : September 26,1949. Puget Sound Appliance Sales Co., Inc., claim-
ant, having consented to the entry of a decree, judgment of condemnation was
entered and the product was ordered released under bond for relabeling, under
the supervision of the Federal Security Agency.



2038. Misbranding of Sun-Kraft Health Lamps. U. S. v. 941 Sun-Kraft Health
Lamps, and a quantity of printed matter. Decree of condemnation.
Product ordered released under bond. (F. D. C. No. 18705. Sample No.
4387-H.)
LIBEL FILED : December 28,1945, Eastern District of Pennsylvania.
ALLEGED SHIPMENT : On or about August 28 and October 23, 1945, by Sun Kraft,
Inc., from Chicago, 111.
PBODTJCT : 941 Sutv-Kraft Health Lamps at Philadelphia, Pa.; also a number of
leaflets entitled "Sun-Kraft Cold Quartz Ultraviolet Ray Therapy Lamp," a
number of sales manuals entitled "Sun-Kraft Ultra Violet Generator," and a
number of display cards entitled "Sun-Kraft Quartz Ultraviolet Ray Therapy
Lamps." Attached to each lamp was an envelope containing an additional
copy of the leaflet and a booklet entitled "How to Use Your Sun-Kraft."
Examination showed that the device consisted of a cold quartz type lamp
mounted on a metal base which would emit ultraviolet radiations of a com-
paratively low intensity.
LABEL, IN PART : "Sun - Kraft Mercury Quartz Ultra Violet Health Lamp."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements and
designs appearing in the labeling were false and misleading since they repre-
sented and suggested that the device would be efficacious in the treatment of
acne vulgaris, alopecia areata, anemia, angina pectoris, arithritis, asthma,
birth marks (port wine), bronchial asthma, burns (X-ray), chilblains, cuts,
eczema (dry or weeping), ecthyma, erysipelas, fractures, frost bite, high blood
pressure, impetigo, loss of hair (following severe infections), lupus vulgaris,
low metabolism,* pityriasis rosea, polyarthritis, pruritus, psoriasis; pyodermia,
rickets, sinus, tuberculosis of the skin, ulcers, varicose ulcer,- "vascykar" nevi,
whooping cough, wounds (gun shot), sinus pains, rheumatism, lumbago, ar-
thritis, neuritis, athlete's foot, ringworm, dandruff, lacerations, contusions and
strains, hay fever, and catarrh and colds; that the article would kill bacteria,
strengthen bones and teeth, stimulate circulation, relieve pains caused by
respiratory ailments, prevent infections and contagious diseases, help the
healing of stubborn wounds, clear up blemishes and pimples, induce quiek heal-
ing and promote positive antiseptic action in treating cuts, wounds, and
bruises, maintain a healthy complexion, prevent loss of hair and promote its
growth, promote and preserve radiant health, build up resistance to disease, in-
sure sturdy growth and sound development of babies and children, and sterilize
rooms. The device was not capable of producing the benefits and results stated
and implied.
DISPOSITION : January 18, 1946. W. A. Leiser and Co., Philadelphia, Pa., hav-
ing appeared as claimant, judgment of condemnation was entered and the
product was ordered released under bond to be relabeled under the super-
vision of the Food and Drug Administration.



















  C) Jeff Behary, 2011