429. Adulteration and misbranding of B-D-Mint Powders.     IT. S. v. 55 Cards of
B-D-Mint   Powders.     Default   decree   of   condemnation  and   destruction.
(F. D. C. No. 3389.    Sample No. 28215-E.)
This product would be dangerous to health when used as directed in the
labeling and was not labeled to indicate the consequences that might result
from its use. Its labeling also bore false and misleading representations regard-
ing its curative and therapeutic efficacy and was further objectionable as indi-
cated below.
On or about November 20, 1940, the United States attorney for the Western
District of Virginia filed a libel against 55 cards, each carrying 28 envelopes
of B-D-Mint Powders, at Pulaski, Va., alleging that the article had been shipped
in interstate commerce by South Bluefleld Pharmacy, Inc., from Bluefleld, W. Va.,?r
on or about October 25, 1940; and charging that it was adulterated and mis-?\
branded. The article was labeled in part: "Prepared By B. D Medicine Co.,
Pulaski, Va."
Analysis showed that the powders each contained approximately 3.83 grains of?(
acetophenetidin, 2.23 grains of acetanilid, 1.5 grains of citrated caffeine, and 3.6
grains of sodium bicarbonate, together with milk sugar and sweetened with
saccharin and flavored with peppermint oil.
The article was alleged to be adulterated in that its strength differed from
that which it purported or was represented to possess, since the envelope was
labeled, "Not Over 2? Grains Each Acetanilid Acetophenetidin"; whereas each
pjwder contained materially more than 2V2 grains of acetophenetidin.
It was alleged to be misbranded in that the statements on the display card,
"No Harmful Ingredients," "Safe," "No After Effect," and the designation
"B-D-Mint" were false and misleading since it contained potentially harmful
ingredients, was not free from danger, might cause serious aftereffects, and
fhe principal active ingredients were not derived from mint.
It was alleged to be misbranded further in that the statements, (envelope)
"Quick Relief, For the Pain and Discomfort Arising From Simple Headache
Neuralgia Muscular Aches and Pains Head Colds and as Nerve Sedative,"
"For * * * Female Pains, Muscular Aches and Pains, Simple Head Colds,
for Reducing Fever, as Nerve Sedative," and (display card) "Quick Relief For
the Pain and Discomfort Arising from Simple Headache Neuralgia Rheuma-
tism Earache Toothache," "Headache Head Colds * * * Neuralgia Nerve
Sedative * * * Muscular Aches and Pains," were false and misleading since
it was not an adequate treatment for the various conditions mentioned and
because of failure of the label to reveal the material fact that its use in such
conditions might cause ill effects.
It was alleged to be misbranded further in that the statement in the labeling,
"Prepared by B. D. Medicine Co., Pulaski, Va.," was false and misleading since
it was prepared by South Bluefleld Pharmacy, Inc., Bluefleld, W. Va. It was
alleged to be misbranded further in that its label failed to bear the common
or usual name of each of the active ingredients together with the statements of
the quantity or proportion of acetanilid and acetophenetidin since the statement
on the label, "Not Over 2? Grains Each Acetanilid Acetophenetidin," was not
such a statement and was not true in fact.
It was alleged to be misbranded further in that the package failed to bear a
statement of the quantity of the contents; and in that its labeling failed to bear
adequate directions for use since the directions appearing on the envelope,
"Take one powder * * * may repeat in one hour if not relieved. After sec-
ond do
se, not oftener than every 2 or 3 hours. If not relieved, after four or
five doses consul t your doctor. Children over 8 years old: One-fourth powder.
May repeat in 2 or 3 hours," were not suitable and appropriate directions for
the use of the article.
It was alleged to be misbranded further in that the 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 or application, in such manner and form, as are
necessary for the protection of users; and in that it was dangerous to health
when used in the dosage or with the frequency or duration prescribed, recom-
mended, and suggested in the labeling.
On May 16, 1941, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.