668. Adulteration and misbranding of Pinee.    IT. S. v. 90 Bottles of Pinee.    De
fault decree of condemnation and destruction.     (F. D. C. No. 6549.    Sample
No. 59472-E.)
In addition to containing smaller proportions of acetanilid and alcohol than
those stated on the label, this product failed to bear on its label adequate direc-
tions for use and warning statements. The label also contained false and mis-
leading therapeutic claims; and the statements of the active ingredients and
quantity of contents and directions for use were in type so small as to be illegible.
On December 19, 1941, the United States attorney for the Eastern District of
Virginia filed a libel against the above-named product at Emporia, Va., alleging
that it had been shipped on or about October 1, 1941, by the Pinee Chemical Co.
from Kinston, N. C.; and charging that it was adulterated and misbranded.
Analysis of a sample of the article showed that it consisted essentially of
acetanilid (not more than 3.6 grains per fluid ounce), alcohol (not more than 10.9
percent), small amounts of menthol, camphor, laxative plant drugs, ammonia,
ammonium chloride, licorice, and a trace of alkaloids.
The article was alleged to be adulterated in that its strength differed from that
which it was represented to possess, namely, "Acetanlid 6 grs to oz Maximum
Alcohol 20 per cent."
It was alleged to be misbranded: (1) In that the labeling did not bear adequate
directions for use since those appearing on the label provided for continuous ad-
ministration and such directions were inadequate for a laxative since when
taken in such manner it might create a dependence on laxatives (2) In that
the labeling did not 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 duration of administration in such manner and form as are
necessary for the protection of users since the labeling failed to warn that fre-
quent or continued use might result in dependence on laxatives. (3) In that
the following statements appearing in the labeling, together with the design of
pine trees and pine cones on the bottle label, (carton) "Pinee For Colds," and
(bottle label) "Pinee Colds * * * Very effective In Treatment of Head &
Chest Colds * * * Contents Acetanlid 6 Grs to oz Maximum Alcohol 20 per
cent," were false and misleading since the article contained no ingredient or
combination of ingredients capable of preventing or curing either head or chest
colds or of alleviating the common symptoms characteristic of colds, and it
contained no materials derived from pine trees or pine cones, as implied by the
designs on
' the label. (4) In that the required statements of the active in-
gredients, of the quantity of contents, and the directions for use did not appear
on the label with such prominence or conspicuousness as to render them likely to
be read or understood by the ordinary individual under customary conditions of
purchase and use, since they appeared in type so small as to be illegible.
On February 18,1942, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.