2253. Misbranding of devices known as Anatatherm.    IT. S. v. 5 Devices    *    *    *.
(F. D. C. No. 23194.   Sample No. 22246-H.)
LIBEL FILED :   June 17, 1947, Eastern District of Missouri.
ALLEGED SHIPMENT : On or about May 31, 1946, by the Miller Electro Research
Laboratories, from Milwaukee, Wis.
PBODTTOT: 5 devices known as Anatatherm at St. Louis, Mo., together with
12 circulars entitled "How the Anatatherm SW 150 Short Wave internal heat
treatment relieves, corrects, stimulates" and 6 circulars entitled "The New
Anatatherm Short Wave Internal Heat Treatment for Health." Examination
showed that Anatatherm was a device to apply short radio waves to the body.
NATURE OF CHAEQE: Misbranding, Section 502 (j), the article was dangerous
to health when used with the frequency or duration prescribed, recommended,
and suggested in its labeling, i. e., "Treatment Duration: Apply average power
of Anatatherm for a period not to exceed one half hour. Three to four treat-
ments per day are generally permissible."
Further misbranding, Section 502 (a), certain statements on the direction
cards packed with the article and in the above-mentioned circulars accompany-
ing the article were false and misleading. These statements represented and
suggested that the article may be safely and efficaciously used in the treatment
of impaired health, sluggish bowels, biliousness, gas pains, intestinal flu, colitis,
painful hemorrhoids, prostatitis, colds, painful breathing, catarrhal congestion,
asthmatic conditions, localized inflammation, neuralgia myalgia, chronic local-
ized arthritis, arthritis deformans, tired, aching joints, neuritis, sluggish kid-
neys, grippe, contusions, muscle strains, myositis ossificans, sprains and disloca-
tions, traumatic tenosynovitis, chronic arthritis, myositis and myofascitis (lum-
bago), fractures, genito-urinary conditions, pelvic infections, respiratory dis-
eases, gastrointestinal diseases, acute and chronic sinusitis, diabetes, paralysis,
abscesses, articular rheumatism, asthma, backache, bladder disorders, blood
clot, boils, Bright's disease, bronchitis, bursitis, catarrh, carbuncle, colic, conges-
tion, constipation, convulsions, cough, cystitis, deafness, discharge, dropsy, ear
disorders, felon, fever, fistula, fracture, furuncles, gall bladder inflammation,
gas pressure, headaches, hepatic disorders, hemorrhoids, indigestion, influenza,
jaundice, kidney inflammation, laryngitis, lesions, lumbago, mastoiditis, muscu-
lar tension, nausea, nephritis, osteitis, ovaritis, peritonitis, pharyngitis, phle-
bitis, pleurisy, pneumonia, quinsy, rheumatism, salpingitis, sciatica, silicosis,
stiff neck, synovitis, teeth abscess, thrombosis, tonsillitis, tooth extractions,
ulcers, and whooping cough. The article may not be safely used and was not
efficacious in the treatment of such diseases, conditions, and symptoms.
DISPOSITION: December 3, 1947. The Miller Electro Research Laboratories,
claimant, having consented to the entry of a decree, judgment of condemnation
was entered and the product was ordered released under bond to be brought into
compliance with the law, under the supervision of the Federal Security Agency.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DEFECTIONS OR WARNING STATEMENTS*