426. Adulteration and misbranding of Catawba's Nervine and Acetandyne Pain
Tablets; misbranding of Black Tablets for Kidneys, Bladder, and Uretes,
Catawba's Bu-Q-Ju Diuretic, Catawba's Pep-A-Man Tonic Laxative, and
Nu-Vig-Or Laxative-Tonic. V. S. v. William B. Goebel (Botanical Medi-
cine Co.). Plea of guilty. Fine, $100. (F. D. C. No. 2906. Sample Nos.
340-E, 341-E, 20232-E to 2023-5-E, incl.)
Catawba's Nervine would be dangerous to health when used according to
directions in the labeling, and its labeling also failed to bear adequate directions
for use. Adequate warning statements did not appear in the labeling of the
Nervine and of the Acetandyne Pain Tablets. These two products also failed
to meet their own standards of strength and quality, the Nervine was falsely
labeled as a safe treatment for certain conditions, and the other products all bore
false and misleading therapeutic claims.
On March 28, 1941, the United States attorney for the Middle District of
North Carolina filed an information against William B. Goebel, trading as
Botanical Medicine Co., Kannapolis, N. C, alleging shipment on or about
June 7 and 10, 1940, from the State of North Carolina into the States of Virginia
and South Carolina of a quantity of the above-named products, of which a portion
were misbranded and the remainder were adulterated and misbranded.
Analysis of a sample of Catawba's Nervine showed that it contained not
more than 3.97 grains of sodium bromide per y8 fluid ounce, not more than 3.7
467449'-42-
211
grains of potassium bromide per ? fluid ounce, and not less than 0.93 grain pf
ammonium bromide per ? fluid ounce.   It was alleged to be adulterated In?f"
that its strength differed from or its quality fell below that which it purported?A
or was represented to possess since it was represented to contain 4? grains
of sodium bromide, 4? grains of potassium bromide, and ? grain of ammonium
bromide in each ? fluid ounce; whereas it contained not more than 3.97 grains?v
of sodium bromide, not more than 3.7 grains of potassium bromide, and.not less
than 0.93 grain of ammonium bromide. It was alleged to be misbranded: (1)
In that the statement on the label, "Each teaspoonful (? oz.) Contains Sodium
Bromide 4*? gr. Potassium Bromide 4? gr. Ammonium Bromide ? gr.," was
false and misleading. (2) In that the bottle label represented and suggested
that it constituted
 a safe and appropriate treatment for the conditions men-
tioned thereon; whereas it was a dangerous drug and the labeling failed to
reveal the material fact that its use under the conditions of use prescribed
in the labeling or under such conditions of use as are customary or usual, i. e.,
the use of the drug in accordance with the directions, might lead to mental
derangement. (3) In that it would be dangerous to health when used in the
dosage or with the frequency or duration prescribed, recommended, or suggested
in the labeling, "Adult dose-Take one teaspoonful in half glass of water. If
necessary repeat but do not take over four teaspoonfuls in any twenty-four hour
period." (4) In that its labeling failed to bear adequate directions for use.
(5) In that its labeling failed to bear 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.
Analysis of a sample of Black Tablets for the Kidneys, Bladder, and Uretes
showed that they contained compounds of magnesium and aluminum, cubeb,
copaiba, methyl salicylate, and sugar. They were alleged to be misbranded
in that the statement in the labeling, "For The Kidneys Bladder and Uretes,"
was false and misleading since it represented that the drug was efficacious in
the treatment of disorders of the kidneys, bladder, and uretes (ureter) ; whereas
it was not efficacious for such purposes.
Analysis of a sample of Catawba's Bu-Q-Ju Diuretic showed that it consisted
essentially of extracts of plant drugs (including cubeb and peppermint), sugar,
alcohol, and water. It was alleged to be misbranded in that the statement in
the labeling, "aids the elimination of the toxic poisonous substances," was false
and misleading since the drug was not efficacious for that purpose.
Analysis of a sample of the Acetandyne Pain Tablets showed that they contained
not more than 0.99 grain of acetanilid and not less than 2.79 grains of aspirin
per tablet. They were alleged to be adulterated in that their strength differed
from or their quality fell below that which they purported or were represented
to possess since each tablet was represented to contain 2 grains of acetanilid
and 1 grain of aspirin; whereas each of the tablets contained not more t!han
0.99 grain of acetanilid and not less than 2.79 grains of asipirin. They were
alleged to misbranded in that the statement, (carton) "Acetandyne Pain Tablets
This preparation contains Acetanilid 2 gr. Aspirin 1 gr.," was false and mis-
leading. They were alleged to be misbranded further (1) 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; and (2) in that the statement in the labeling, "Pain Tablets * * ? *
pains caused by menstrual disturbances * * * Menstrual pains," was false
and misleading since it represented that the drug was efficacious in the treatment
of pains caused by menstrual disturbances; whereas they were not efficacious
for such purposes.
Analysis of a sample of Nu-Vig-Or showed that it contained plant material
including cloves, capsicum, an emodin-bearing drug such as senna, and a bitter
principle such as gentian, sulfur, sodium sulfate, magnesium carbonate, and
sodium bicarbonate. It was alleged to be misbranded in that the statement
in the labeling, "Nu-Vig-Or * * * Tonic Nu-Vig-Or is a tonic," was false
and misleading since it represented that the drug would supply new vigor and
would restore vigor; whereas it was not efficacious for such purposes.
Analysis of a sample of Catawba's Pep-A-Man Tonic Laxative showed that it
contained extracts of plant drugs including a laxative drug, aloin, and strychnine
sulfate.    It was alleged to be misbranded in that the statement in the labeling,        7
"Pep-A-Man Tonic," was false and misleading since it represented that the?v..
drug possessed tonic properties and the restorative, vitalizing, and invigorating
properties implied in the name "Pep-A-Man"; whereas it did not possess such
properties.
On April 21,1941, the defendant entered a plea of guilty and the court imposed
a fine of $100 and placed the defendant on probation for 3 years.