614. Misbranding: of Dye's Compound Tablets and Dye's Laxative Pellets.    U. S.
-v. 8 Dozen Packages of Dye's Compound Tablets and 2 Dozen Packages of
Dye's Laxative Pellets.   Default decrees of condemnation and destruction.
(F. D. C. Nos. 5083, 5084, 5636.   Sample Nos. 7678-E, 7679-E.)
The labeling of the laxative pellets failed to bear adequate directions for
use and such adequate warnings as are necessary for the protection of users.
The labeling of both products bore false and misleading curative and thera-
peutic claims, and the containers were substantially larger than was necessary.
On July 8 and September 11, 1941, the United States attorney for the South-
ern District of California filed libels against the above-named drugs at Los
Angeles, Calif., alleging that they had been shipped in interstate commerce
on or about May. 8 and 21 and June 10, 1941 by Dr. J. H. Dye Medical Co.
from Buffalo, N. Y.; and charging that they were misbranded.
Analyses of samples showed that the compound tablets consisted of plant
extractives, including valeric acid and alkaloid-containing plant drugs; and that
the laxative pellets consisted essentially of aloin, podophyllum resin, and
hydrastis.
The laxative pellets were alleged to be misbranded (1). in. that the labeling
did not bear adequate directions for use since the directions called for the
administration of a laxative over an indefinite period of time; (2) in that the
labeling did not bear adequate warnings against use in those pathological
conditions where its use might be dangerous to health or against unsafe dura-
tion of administration in such manner and form as are necessary for the pro-
tection of users, since the labeling did not warn that frequent and continued
use might result in dependence iipon a laxative and that a laxative should not?f
be taken when suffering from nausea, vomiting, abdominal pain, or other symp-?V
toms of appendicitis; and (3) in. that the following statements on the label,
"To assist in relieving headaches, coated tongue, bad breath, aggravated, pimply?r
skin, lassitude, indigestion and other distressing symptoms due to temporary?(
constipation," and similar statements in Spanish, borne on the label, were false
and misleading since the article would not be efficacious for the purposes
recommended.
Dye's Compound Tablets were alleged to be misbranded in that statements
on the label which represented that it would relieve the distressing symptom of
functional dysmenorrhea, painful symptoms of certain female functional irreg-
ularities, and symptoms such as headache, nervousness, irritability, headache,
backache, nausea, -debility, rings under the eyes, melancholia, hysteria, loss
of appetite, lack of sleep, and pains in various parts of the body; that it would
build up physical resistance, improve digestion and assist one in obtaining more
nourishment; that it would promote happy life and would increase vitality
and personal magnetism, thus making every attractive woman full of animation;
and that it was an appropriate preventive and treatment for amenorrhea, dys-
menorrhea, menopause, menorrhagia, metritis, and ovaritis, were false and
misleading since it contained no ingredients capable of producing such effects.
Both products were alleged to be misbranded further in that the, containers
were so filled as to be misleading.
On August 14 and October 6, 1941, no claimant having appeared, judgments
of condemnation were entered and the products were ordered destroyed.