446. Adulteration and misbranding- of Heads-Up Headache Powders and misbrand-
ing of Digesto-Pep and Coldlax. U. S. v. 126 Packages of Heads-Up, 70
Packages of Digesto-Pep, and SI Bottles of Coldlax. Default decree of
condemnation and destruction, (F. D. C. No. 4026. Sample Nos. 20666-E,
20867-E, 20668-E.)
The labeling of the headache powders and the Coldlax failed to bear such ade-
quate warnings as are necessary for the protection of users and failed to bear
adequate directions and the common or usual names of the active ingredients.
The "Heads-Up" contained acetylsalicylic acid, sodium bromide, and phenolph-
thalein in excess of the amount declared. The labels of all products bore false
and misleading representations regarding their curative and therapeutic efficacy.
On March 25, 1941, the United States attorney for the Northern District of
Georgia filed a libel against the above-described drugs at Atlanta, Ga., alleging
that the articles had been shipped in interstate commerce on or about December
10, 1940, by Smith Bros. Drug Co. from Greensboro, N. C.; and charging that
they were misbranded and that the Heads-Up Headache Powders were also
adulterated.
Analyses showed that the average Heads-Up headache powder contained 4.68
grains of aspirin, 6.62 grains of sodium bromide, and 0.57 grain of phenolphtha-
lein; that the Digesto-Pep contained alkaline compounds, including a bismuth
compound and diastase; and that the Coldlax consisted essentially of water,
alcohol, sodium salicylate, a laxative plant drug, menthol, camphor, and traces
of alkaloids,
The Headache Powders were alleged to be adulterated in that their strength
differed from that which they purported or were represented to possess, since
each powder contained materially more acetylsalicylic acid, sodium bromide,
and phenolphthalein than the amounts stated on the label. They were alleged
to be misbranded in that the statement on the label, "Bach Powder Contains:
Acidum Acetylsalicylic * * * 4 Gr. * * * Sodium Bromide * * * 6 Gr.
Phenolphthalein * ? * * ? Gr.," was false and misleading since it was incor-
rect. They were alleged to be misbranded further in that the statements on the
label, "Brace Up ! with Heads-Up," "With Heads-Up You'll Brace Up!," and " 'Go?/
Smiling Thru' As Thousands Do," were false and misleading as the article could
not be depended upon to brace one up or to enable one to "go smiling through"
when suffering from the  various disease conditions mentioned on the label.?fThey were alleged to be misbranded further in that the statements, "Take With?I,
Confidence," "Heads-Up is different    *    *    *    safe    *     *    *    faster," and
"Heads-Up contains no acetanilid, harmful or habit forming drugs," were false and
misleading, since they might cause potentially harmful effects, they were not
essentially different from or safer than various other preparations on the market,
were not safe under all conditions, and contained potentially harmful and habit-
forming drugs. They were alleged to be misbranded further in that the label
failed to bear the common or usual name of each of the active ingredients since
acidum acetyl salicylic is not the common name for aspirin. They were alleged
to be misbranded further in that the labeling failed to bear adequate directions
for use, since the direction "Take one powder every two or three hours as needed"
was not adequate for an article of the composition of Heads-Up Headache
Powders.
The Digesto-Pep was alleged to be misbranded in that the designations
"Digesto-Pep," "Aids Digestion," and "Intended for use in correcting conditions
associated with * * * sluggish digestion," appearing on the label, were false
and misleading, since it was not a digestant of the various constituents of
food, could not be depended upon to produce "pep" and aid digestion and correct
sluggish digestion. It was alleged to be misbranded further in that the state-
ments on the label " 'Keep in step with Digesto-Pep'" and " 'Go smiling thru' as
thousands do" were false and misleading, since the article could not be depended
upon to fulfill the promises of benefit expressed and implied by this language.
The Coldlax was alleged to be misbranded in that the designation "Coldlax"
and the statement "For the relief of colds," appearing on the carton and bottle
label, and the statement "For Colds," appearing in the directions, were false
and misleading, since it did not constitute an adequate treatment for colds;
and in that the unmodified statement "For Coughs" in the directions was false
and misleading, since the article did not constitute an adequate treatment for
coughs from all causes. It was alleged to be misbranded further in that the
statement in the directions, "Coldlax contains no habit forming drugs" was
false and misleading, since it contained aromatic fluidextract of cascara sagrada
by reason of which frequent or continued use of the article might cause de-
pendence upon laxatives to move the bowels; in that the label failed to bear
the common or usual name of each active ingredient, since "Alkaloids" is not
the common or usual name of any constituent of the preparation, and the names
of other constituents were given in abbreviated form; and in that its labeling
failed to bear adequate directions for use, since the directions given did not
limit the period of time over which the article might appropriately be consumed.
The Heads-Up and Coldlax were alleged to be misbranded further in that
their labeling failed to bear adequate warnings against use in those pathological
conditions and by children where use might be dangerous to health and against
unsafe dosage and duration of administration in such manner and form as are
necessary for the protection of users since the labeling failed to bear a warning
that the articles should not be used in cases of nausea, vomiting, abdominal pain,
and other symptoms of appendicitis and did not warn that frequent or continued
use of the articles might result in dependence upon laxatives to move the bowels.
On April 21, 1941, no claimant having appeared, judgment of condemnation
was entered and the products were ordered destroyed.