553. Misbranding: of Mackenzie Cold and Grippe Tablets. IT. S. v. 100 Packages
of Mackenzie Cold and Grippe Tablets. Default decree of condemnation
and destruction.     (F. D. C. No. 4876.    Sample No. 60255-E.)
These tablets b,ad been repackaged after shipment and after such repackaging,
in addition to failure to bear adequate warning statements, the labeling bore false
and misleading statements regarding their therapeutic efficacy and the amount
of acetanilid that they contained. The tablets also were deceptively packaged
since approximately 30 percent of the upper space in the carton was empty.
On June 10. 1941, the United States attorney for the Western District of
Washington filed a libel against the above-named product at Seattle, Wash.,
alleging that it had been shipped on or about March 19. 1941, by C. B. Jamieson
& Co. from Detroit. Mich., and that subsequently it had been repackaged by Guy,
Inc., at Seattle, Wash.; and charging that it was misbranded.
Analyses of samples of the article showed that it consisted essentially of
acetanilid (0.94 grain per tablet), caffeine, aloin, atropine sulfate, and capsicum.
The article was alleged to be misbranded: (1) In that its labeling failed to beaf
such adequate warnings as are necessary for the protection of users, against use
in those pathological conditions or by children, where its use might be dangerous
to health, since it might be dangerous to health when used by persons suffering
from nausea, vomiting, abdominal pain, or other symptoms of appendicitis, or by
children; and in that the labeling failed to bear adequate warnings against unsafe
dosage or methods or duration of administration in such manner and form as
are necessary for the protection of users, since frequent or continued use of this
acetanilid-containing preparation might cause serious blood disturbances, anemia,
or collapse, and since its use might result in dependence on a laxative. (2) In
that the statements on the label, "Cold and Grippe Tablets Excellent for a
feverish condition, coryza, hay fever, rhinitis, grippe, aching muscles, colds,
influenza * * * acetanilid 2 gr.," were false and misleading since it was not
an adequate treatment for the conditions named and since each tablet did not
contain 2 grains of acetanilid. (3) In that its package container was so filled
as to be misleading since the bottle was materially shorter than the package
[carton].
On September 29,1941, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.