5486. Arben capsules.   (F.D.C. No. 40531.   S. Nos. 65-351/5 M.)
QUANTITY : 1 bag containing 3,200 capsules, and 83 42-capsule boxes at Youngs-
town, Ohio, in possession of Dr. R. J. Turner and Fred C. Bennett.
SHIPPED: Between 12-31-56 and 4-18-57, from Miami Beach, Fla., by Arthur
Bennett.
RESULTS OF INVESTIGATION : The capsules in the boxes had been shipped in bulk,
and after receipt by the consignee, were repackaged. Various lots of the
capsules, when shipped, were labeled as containing amphetamine sulfate in
amounts ranging from 1.2 mg. to 5 mg. per capsule.
Examination showed that the capsules contained from 164 percent to 204
percent of the declared amount of amphetamine sulfate per capsule.
LIBELED :    7-24-57, N. Dist. Ohio.
CHARGE :   501 (c)-the strength of the article, when shipped, differed from that i
which it purported and was represented to possess.
502(b) (1) and (2)-while held for sale, the article failed to bear a label
containing the name and place of business of the manufacturer, packer, or dis-
tributor, and an accurate statement of the quantity of contents; 502(e) (2)-
the label of the article, while held for sale, failed to bear the common or
usual name of each active ingredient; and 503(b) (4)-the article was a drug
subject to 503(b)(1), and, while held for sale, its label failed to bear the
statement "Caution: Federal law prohibits dispensing without prescription."
DISPOSITION :   10-23-57.   Default-destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR
ADEQUATE DIRECTIONS OR WARNING STATEMENTS
5487.?Theraphone device and methyl salicylate ointment.    (Inj. No. 315.)
COMPLAINT FOR INJUNCTION FILED: 10-10-57, N. Dist. 111., against Neo-Sound
Corp. of America, Wheeling, 111., and William Dunkler, t/a Wm. Dunkler Lab-
oratories, Ghicago, 111.
ACCOMPANYING LABELING: Leaflets entitled "Theraphone the Neo-Sound In-
strument that can help you"; typed sheet bearing the Neo-Sound Corp. of
America letterhead and a heading containing the words "Here's what Thera-
phone owners say"; leaflets entitled "Instructions for the Use of the Thera-
phone," "New Professional Model Theraphone . . . Dear Doctor," and "Letters
of Satisfaction from Hospitals, Clinics and Doctors who have Used the Neo-
Sound Instrument for some time"; form letter headed "Dear Doctor"; general
"Out-Lay" chart showing location of areas of the human body where treaf
ments should be applied; leaflet headed "Dear Doctor"; sheet headed "Diree-
tions"; pamphlets entitled "Naturopathic Medical Journal * * * of the
Florida Naturopathic Physicians' Association Inc. Fall Issue VoL 2 No. 1"
and "Naturopathic Medical Journal * * * of the Florida Naturopathic Phy-
sicians' Association Inc. Winter Issue Vol. 2 No. 2"; and a sheet entitled
"Selling Points for the Sale of the Professional Model Theraphone."
KESTJI/TS OF INVESTIGATION : The device consisted of 2 models. One model was
designated as a professional model, which was encased in a cylindrical-shaped,
polished aluminum unit measuring approximately 7? inches long by 1-
inches in diameter and which had three sound heads for varying degrees of
penetration and a push-button micro switch. The second model was similar
to the professional model, but it was smaller in size and was encased in a
plastic unit. Both models were operated by house current and had a rubber
electric cord attached, with a common male plug. Each model purported to
be an electrically operated massage vibrator which would produce sound
waves of various frequencies.
CHARGE: The complaint charged that the defendants were violating the Act
by causing the introduction and delivery for introduction into interstate com-
merce of methyl salicylate ointment and the Theraphone device which were
misbranded as follows:
Methyl salicylate ointment. 502(b) (1)-the label of the article failed to
bear the name and place of business of the manufacturer, packer, or distribu-
tor; and 502(f) (1)-the labeling of the article failed to bear adequate direc-
tions for use, in that the labeling failed to bear any directions for use.
Theraphone device. 502(a)-the labeling of the article when viewed as a
whole, as well as through specific claims, and in the setting in which it was
presented, contained false and misleading representations that the action of
the article was markedly different from the action of ordinary massage vibra-'
tors and that the article was adequate and effective in the treatment of
arteriosclerosis, arthritis, muscular rheumatism, gout, inflammation of the
muscles, gallbladder inflammation, gastritis, constipation, neuritis, migraine
^headache, facial palsy, neuralgia, sciatica, bursitis, muscular atrophy, hem-
orrhage, menstrual cramps, tonsillitis, sore throat, sinus conditions, head
colds, cystitis, urethritis, prostatitis, aching feet, congestion, impaired blood
circulation, and all ailments of an inflammatory or circulatory nature.
The complaint charged further that if the defendants were forced by in-
junction to refrain from using the above labeling on interstate shipments of
the device, the defendants would not discontinue interstate distribution of
the device but would, unless enjoined, continue to ship the device in interstate
commerce without labeling stating the conditions and purposes for which the
device was intended, namely, for the treatment of the above-mentioned dis-
eases and conditions. In such case, the device would be misbranded within
the meaning of 502(f) (1), in that its labeling would fail to bear adequate
?directions for use, because of the omission from the labeling of statements of
the conditions and purposes for which the device was intended.
The complaint alleged also that the defendants had been warned by the
Food and Drug Administration through establishment inspections made on
March 16 and 18, September 16, and October 13, 1955, and June 17 and 19,
1957; by letters dated June 7, 1955, and February 8 and June 26, 1956; by a
conference held on June 16, 1955; and by hearings held on January 19 and
February 9, 1956, pursuant to Section 305, that the device was misbranded by
reason of its false and misleading labeling, and that despite such warnings,
the defendants continued to Introduce and deliver for introduction into inter-
state commerce the misbranded device.
DISPOSITION : 12-27-57.   The defendants having consented, the court entered a
decree of permanent injunction enjoining them against the acts complained of.