1553. Misbranding' of Stanley's Stomach Powder, Prescription 1-NN-l Nerve Tab-
lets, Prescription l-KR-7, External No. 1, Prescription 1-H-7, and Pre-
scription Medicine 1-B-7. TJ. S. v. Sophia Strboya Sikoparija (Stanley's
Drug Store). Plea of not guilty. Tried to the jury; verdict of guilty.
Sentence of 57 days in jail. (F. D. C. No. 11379. Sample Nos. 14838-F,
14839-F, 15010-F, 15011-F, 38339-F, 38340-F.)
INFORMATION FILED : May 8, 1944, Eastern District of Texas, against Sophia
Strboya Sikoparija, trading as Stanley's Drug Store, Orange, Tex.
ALLEGED SHIPMENT : Between the approximate dates of January 21 and February
20,1943, from the State of Texas into the States of Wisconsin and California.
PRODUCT : Analyses disclosed that the Stanley's Stomach Powder consisted essen-
tially of sodium bicarbonate and Rochelle salt, flavored with anise oil; that the
Prescription 1-NN-l Nerve Tablets, the Prescription l-RR-7, and the Prescrip-
tion Medicine l-B-7 contained Yz grain of phenobarbital per tablet; that the
External No. 1 consisted essentially of basic aluminum acetate and sodium ace-
tate ; and that the Prescription l-H-7 consisted essentially of extracts of plant
drugs, including a laxative drug such as senna, sugar, alcohol, and water.
NATURE OF CHARGE: Stomach Powder, misbranding, Section 502 (a), certain
label statements were false and misleading since they represented and suggested
that the article would be beneficial in the treatment of stomach disorders; that
it would be efficacious in the cure, mitigation, treatment, or prevention of
stomach pain due to gas, nausea, and heaviness after meals; and that it would
be efficacious to correct indigestion, strengthen the digestive organs, and soothe
and heal stomach tissues, whereas it would not be efficacious for such purposes;
Section 502 (b) (2), the label bore no statement of the quantity of the contents;
and, Section 502 (e) (2), the label did not bear the common or usual names of
the active ingredients of the article.
Prescription 1-NN-l Nerve Tablets, misbranding, Section 502 (a), certain
label statements were false and misleading since they represented and sug-
gested that the article would be efficacious in the cure, mitigation, treatment,
and prevention of nervousness, restlessness, sleeplessness, worry or excitement,
depressed spirits, and nervous headaches, whereas the article would not be effi-
cacious for such purposes; Section 502 (d), the article contained phenobarbital,
a derivative of the narcotic or hypnotic substance barbituric acid, which deriv-
ative has been found to be and by regulations designated as habit forming, and
its label failed to bear the name and quantity or proportion of such derivative
and, in juxtaposition therewith, the statement "Warning-May be habit form-
ing" ; Section 502 (j), the article consisted of tablets, each containing approx-
imately y2 grain of phenobarbital, and it would be dangerous to health when
used in the dosage or with the frequency or duration prescribed, recommended,
or suggested in its labeling, "Direction:   Adults:   Take 1 Tablet three times a
day with full glass of water"; and, Section 502 (b) (2), the label of the article^
bore no statement of the quantity of the contents.
Prescription l-RR-7, misbranding, Section 502 (a), certain statements onv
the label were false and misleading since they represented and suggested that
the article would be efficacious in the cure, mitigation, treatment, and preven-
tion of high blood pressure, headaches, heat and fullness of the head, heat and
redness of the face, dizziness, noise in the ears, sleeplessness at night, and
oppressed breathing due to rush of blood to the head, whereas the article would
not be efficacious for such purposes; Section 502 (d), the article contained pheno-
? barbital and its label failed to bear the required warning; Section 502 (b) (2),
the label of the article bore no statement of the quantity of the contents; and,
Section 502 (f)  (1), the labeling of the article bore no directions for use.
External No. 1, misbranding, Section 502 (a), the label statement, "cover the
sore," was false and misleading since it represented and suggested that the
article would be efficacious in the cure, mitigation, or treatment of sores, whereas
it would not be efficacious for such purposes; Section 502 (b) (2)
the label of the article bore no statement of the quantity of the contents; and,
Section 502 (e) (2), the label of the article failed to bear the common or usual
name of each active ingredient of the article.
Prescription l-H-7, misbranding, Section 502 (a), certain label statements
were false and misleading since they represented and suggested that the
article would be efficacious in the treatment of liver ailments; that it would be
efficacious in the cure, mitigation, treatment, or prevention of disordered
conditions of the liver, stomach, and bowels; and that it would have a tonic
effect upon the large intestine, whereas the article would not be efficacious for
such purposes; Section 502 (e) (2), the label failed to bear the common or
usual names of the active ingredients of the article; and, Section 502 (f) (2), the
article was a laxative and its label failed to warn that it should not be taken
when abdominal pain, nausea, vomiting, or other symptons of appendicitis
were present, and its labeling also failed to warn that frequent or continued
use of the article might result in dependence upon a laxative to move the
bowels.
Prescription Medicine l-B-7, misbranding, Section 502 (a), certain label
statements were false and misleading since they represented and suggested that
the article would be efficacious in the cure, mitigation, treatment, or prevention
of nervousness, sleeplessness, worry, and weak nerves, whereas it would not be
efficacious for such purposes; Section 502 (d), the article contained pheno-
barbital and its label failed to bear the required warning; Section 502 (j), the
article would be dangerous to health when used in the dosage or with the
frequency or duration prescribed, recommended, or suggested in its labeling,
(translation from Slovenian) "Directions: 1 portion 3 times a day before
meals with half a cup of lukewarm water. Later it suffices to use 1 or 2 a
day"; and, Section 502 (c), adequate directions for use required by Section
502 (f) (1) did not appear on the label in such terms as to render them likely to
be read and understood by the ordinary individual under customary conditions
of purchase or use, since that information was not in the English language.
The information also alleged that another article, Hair Milk, was mis-
branded under the provisions of the law applicable to cosmetics, as reported
in notices of judgment on cosmetics.
DISPOSITION ; A plea of not guilty having been entered on behalf of the defendant
the case came on for trial before a jury on October 24, 1944. The jury returned
a verdict of guilty, and on October 25,1944, the court sentenced the defendant to
serve 57 days in jail.