1105. Misbranding of Dr. Sibbett's Improved Big Six and Original. Big Six.    U. S.
v. 23% Dozen Bottles and 3% Dozen Bottles of Dr. Sibbett's Improved
Big Six, and 1% Dozen Bottles of Dr. Sibbett's Original Big Six. Default
decree of condemnation and destruction. (F. D. C. No. 9985. Sample Nos.
37674-F, 37675-F.)
On May 21,1943, the United States attorney for the Eastern District of Michi-
gan filed a libel against 23? dozen bottles, each containing 3 fluid ounces, and
3? dozen bottles, each containing 6 fluid ounces, of Dr. Sibbett's Improved Big
Six; and 1? dozen bottles, each containing 6 fluid ounces, of Dr. Sibbett's Original
Big Six at Detroit, Mich.; alleging that the articles had been shipped by the
Sibbett Medicine Co., Cleveland, Ohio, on or about April 9, 1943; and charging
that they were misbranded.
Examination disclosed that the articles were of the same compostion, con-
sisting essentially of 227 grains of Epsom salt per fluid ounce, together with
small amounts of ammonium chloride, caffeine citrate, tincture of ferric chloride,
and oil of lemon in water.
The articles were alleged to be misbranded in that the statements appearing
on their labels which represented and suggested that the articles would be
effective in relieving colds and headaches; that they contained quinine sulfate
and glycerin; and that they contained solution of iron (tincture of iron chloride),
citric acid, caffeine citrate, and oil of lemon in amounts sufficient to constitute
active ingredients, were false and misleading since the articles would not be
effective in relieving colds and headaches, did not contain quinine sulfate and
glycerin, and did not contain solution of iron, citric acid, caffeine citrate, and oil
of lemon in amounts sufficient to constitute active ingredients. The articles were
alleged to be misbranded further (1) in that the words, statements, and informa-
tion required by the law to appear on the label or labeling were not prominently
placed thereon with such conspicuousness as to render them likely to be read and
understood by the ordinary individual under customary conditions of purchase
and use, since the required words, statements, and other information were ob-
scured by a red figure 6 covering the main portion of the label, except the firm's
name and address; and (2) in that the labeling failed to bear adequate directions
for use, since the articles were laxatives and the directions which appeared in
the labeling provided for continuous administration, whereas a laxative should
not be used continuously.
On July 16,1943, no claimant having appeared, judgment of condemnation was
entered and the product was ordered destroyed.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM
OFFICIAL OR OWN STANDARDS3