552. Misbranding  of Floracubes.    U. S. v. Eugene H. Hunter   (Floracube Co.).
Plea of nolo contendere.   Imposition of sentence suspended and defendant
placed on probation for 5 years.     (F. D. C. No. 2899.    Sample No. 7356-E.)
This proiuct was labeled to indicate that it derived its physiological activity in
important respects by means of its lubrication, bulk, alkaline, and germicidal
? See also Nos. 547-550.
qualities; whereas it derived its physiological activity principally from the
ingredient phenolphthalein.
On March 28, 1941, the United States attorney for. the Southern District of
California filed an information against Eugene H. Hunter, trading as Floracube
Co., Los Angeles, Calif., alleging shipment on or about March 9, 1940, from the
State of California into the State of Arizona of quantities of Floracubes,-that
were misbranded.
The article was alleged to be misbranded in that the statements "Floracubes
* - * ??* contain certain lubrication, bulk, alkaline, and germicidal qualities, and
are non-irritating in action. May be used over a long period of time. * * *
Floracubes * * * contain per average dose (1-6 box) less than 2 grains each
of calcium carbonate, sodium bicarbonate, chlorides, podophyllum, magnesium,
phenolphthalein, oil of juniper, boron, buchu, sodium benzoate, cascara, iron and
dextrin. ; Also mineral oil and jelly, agar and celluloses, sugar, artificial color and
flavor,, combined with free oxygen, hydrogen and Ultra Violet. The above ingre-
dients are combined with water under a special process to change their form and
action to meet the requirements of Floracubes. *??*?'* (Additional ingredients
present, less 1 Gr.) Manganese, Aloin, nitrates, florides,1 sassafras, sulphates,
calcium and silica," borne on the carton; were false and misleading since they
represented that the article derived its physiological activity in important re-
spects by reason of its lubrication, bulk, alkaline, and germicidal qualities; that
it was nonirritating in action and mjght safely be used over a long period of
time; and that it contained the ingredients listed in significant amounts a,nd that
these ingredients were combined with water under a special process which
changed their form and action; whereas it derived its physiological activity
practically, if- not entirely, from the ingredient phenolphthalein, which is irri-
tating; it was not germicidal, and could not be used Over a long period of time
without risk of injury; and it did not contain the ingredients listed in significant
amounts, since it contained no appreciable amount, if any, of the ingredients iron,
boron, manganese, fluorine, sodium bicarbonate, calcium as calcium carbonate, or
sodium benzoate, and the ingredients were not combined with water under a
special process which changed their form and action. It was alleged to be mis-
branded further in that it did not bear a label containing the name and place of
business of the manufacturer, packer, or distributor, nor an accurate statement
of the quantity of the contents prominently placed thereon with such conspicuous-
ness, as compared with other words, statements, designs, or devices in the label-
ing, as to render it likely to be read and understood by the ordinary individual
under customary conditions of purchase and use. It was alleged to be misbranded
further in that it was fabricated from two or more ingredients and its label did
not bear the common or usual name of each active ingredient, since the ingre-
dients listed in the labeling were in large part inert and the list did not indicate
that phenolphthalein was the only important active ingredient. It was alleged
to be misbranded further In that its labeling failed to bear adequate directions
for use, and such adequate warnings against use In those pathological conditions
or by children where its use might be dangerous to health, or against unsafe
dosage or methods or duration of administration, in such manner and form as
are necessary for the protection of users, since the labeling did not inform pur-
chasers that the use of the article in cases of abdominal pain, nausea, vomiting,
or other symptoms of appendicitis might result in serious injury, and that fre-
quent or continuous use might result In dependence upon laxatives.
On August 25, 1941, the defendant entered a plea of nolo contendere, and the
court ordered that imposition of sentence be suspended and that the defendant
be placed on probation for a period of 5 years.