97. Misbranding of Dormalgin.    U. S. v.  100 Packages and 450 Packages of
Dormalgin.    Default decree of condemnation and destruction.     (F. D. C
No. 275.    Sample No. 67359-D.)
This product contained butyl-bromallylbarbituric acid and aminopyrine. It
was labeled to indicate that it was an appropriate and harmless medicament,
whereas it was a dangerous drug. Its labeling bore false and misleading repre-
sentations regarding its efficacy in the conditions indicated hereinafter.
On or about July 10, 1939, the United States attorney for the District of
Connecticut filed a libel against 100 packages, each containing 10 tablets, and
450 packages, each containing 5 tablets of Dormalgin, a? Darien, Conn., alleging
that the article had been shipped in interstate commerce on or about December
10, 1935, by Lawson M. Luth from Geneva, N. Y.; and charging that it was
misbranded.
It was alleged to be misbranded in that representations in the labeling that
it had been submitted to the most severe laboratory and clinical tests; that the
most rigid research examinations had been conducted by prominent clinics and
medical men in private practice; that its effectiveness and harmlessness had
been repeatedly emphasized by physicians qualified to judge such a preparation j
that it vanished with the pain leaving no after effects; that it was completely
split up when it had finished its appointed work; that it was burned up in the
body leaving no disagreeable after effects such as benumbed head, lassitude,
fatigue, or drowsiness;. that it was an effective and nonpoisonous analgesic
free from cumulative, concurrent, and after effects and was indicated for all
painful diseases; that there was no danger of habit forming as is the case
with alkaloids containing analgesics; that it would agree with patients even
in large doses and had the advantage of being free from hypnotic concurrent
and after effects; that experiments had proved its harmlessness; that it
would not produce the slightest detrimental effect on heart and kidneys even
when administered in large doses; that it had been developed by a concern
which enjoys an international reputation as a manufacturer of the highest grade
pharmaceuticals and which maintained a pharmaceutical laboratory world
famous for its products; that many preparations are on the market to relieve
pain but many are ineffective and many of these which will relieve pain are
actually harmful, in that they contain narcotics and other dangerous habit-
forming drugs or ingredients which affect the heart and kidneys and that even
preparations with salicylic acid as a base, such as aspirin, are not easily
tolerated by a large group of people, but that the Dormalgin contained no habit-
forming or harmful drugs; which representations were false and misleading In
that they created the impression that the article was an appropriate and
harmless medicament for the conditions mentioned therein; whereas it was
not such an appropriate and harmless medicament but was a dangerous drug.
It was alleged to be misbranded further In that Its labeling bore representa-
tions that it was efficacious for the relief of toothache, sciatica, neuritis, rheu-
matism, lumbago, gout, painful menstruation, that it was indicated for all
painful diseases and was a valuable nerve tonic and bore directions that in
the treatment of painful menstruation one tablet should be taken and repeated
after 8 hours; that in the treatment of rheumatism, gout, and lumbago one
tablet should be taken morning and night and doubled if the case was severe;
and in the treatment of toothache 2 tablets should be taken and that if not
relieved1 one more should be taken after 8 hours; which representations and
directions were false and misleading in that the article was not efficacious for
the purposes recommended.
On November 17, 1939, no claimant having appeared, judgment of condemna-
tion was entered and the product was ordered destroyed.