550. Adulteration and misbranding of Zerbst's Capsules.    IT. S. v. 139 Packages
of Zerbst's Capsules  [25-cent size] and 23 Packages of Zerbst's Capsules
[50-cent size].   Default decree of condemnation and destruction.    (F. D. C.
No. 4970.    Sample No. 60418-E.) 
These products would be potentially dangerous to health when used according
to directions and they failed to bear adequate directions for use and warning
statements. The capsules in the 25-cent-sized packages contained more acetanilid
than the amount stated on the label, and those in the 56-cent-sized packages bore
false and misleading therapeutic claims and failed to bear the required ingredient
and quantity of contents statements.
On June 24, 1941, the United States attorney for the District of Oregon filed a
libel against the above-named products at Portland, Oreg., alleging that they had
been shipped on or about January 20, 1941, by the Zerbst Pharmacal Co. from
St. Joseph, Mo.; and charging that a portion were adulterated and misbranded
and that the remainder were misbranded.
Analyses of samples of the capsules showed that those in the 25-cent packages
contained acetanilid (1? grains per capsule), together with caffeine, resinous
material, camphor, capsicum, aloin, and asafoetida; and that those in the 50-cent
packages contained acetanilid (2? grains per capsule), together with a laxative
plant drug.
The capsules in the 25-cent packages were alleged to be adulterated in that their
strength differed from that which they purported or were represented to possess,
namely, "Each Capsule contains as active ingredients, Acetanilid 1 Grain";
whereas they contained materially more than 1 grain of acetanilid.
The capsules in the packages of both sizes were alleged to be misbranded:
(1) In that they were dangerous to health when used according to the directions
on the label. (2) In that the directions for use, namely, "Adults-To allay the
discomfort in breaking up a common head cold, simple headache, or .neuralgia,
take one capsule every half hour until three are taken [25-cent size] then one
capsule in two or three hours until three more capsules are taken. Children-
12 years old, one capsule repeated in three hours [50-cent size] then one every 2
or 3 hours as may be desired. Children-5 to 10 years old, one-half to one capsule,
repeated in three hours if necessary," were inappropriate for articles of such
composition because of their indefiniteness and because they provided amounts of
acetanilid which might prove harmful to the user and were therefore inadequate.
(3) In that the labels failed to bear adequate warnings against their use by
children or in those pathological conditions where their use might be dangerous
to health and against unsafe dosage or duration of administration in such manner
and form as are necessary for the protection of users, since there was no warning
against, their use by children nor against use in the presence of symptoms of
appendicitis, nor with reference to the deleterious effects of acetanilid in causing
serious blood disturbances, nor against frequent or continued use which might
result in dependence upon the drug.
The capsules in the 50-cent-sized packages were alleged to be misbranded
further (1) in that the statements (box label) "Should give a free evacuation
which is very important in breaking up a cold" and (circular) "For relieving
common head colds" were false and misleading since,they would not break up a
cold nor otherwise favorably influence the course of a head cold; (2) in that the
label failed to bear the common or> usual name of each active ingredient since, of
the several active ingredients present, "only acetanilid was mentioned on the label;
and (3) in that the label did not bear a statement of the quantity of contents of
the retail package.
On August 27, 1941, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR DIRECTIONS
FOR USE OR ADEQUATE WARNING STATEMENTS1