661. Misbranding: of Nichol's Long- Life For Health and Dickson's Laxative
Diuretic. U. S. v. James B. Nichols (J. B. Nichols & Sons and Nichols
Chemical Co.). Plea of guilty. Fine of $100 and jail sentence of -
months. Sentences suspended and defendant placed on probation for 3
years.    (F. D. C. No. 5475.   Sample Nos. 39561-E, 39562-E.)
The labeling of the Laxative Diuretic failed to bear adequate warning state-
ments ; that of both products bore false and misleading therapeutic claims and
inadequate ingredient and quantity of contents statements. The bottles con-
taining both products were paneled in such manner as to be deceptive.
On January 26, 1942, the United States attorney for the Western District of
Tennessee filed a libel against James B. Nichols, trading as J. B. Nichols & Sons,
and as Nichols Chemical Co. at Memphis, Tenn., alleging shipment on or about
November 12, 1940, from the State of Tennessee into the State of Arkansas of
quantities of the above-named products that were misbranded.
Analyses of samples of the products showed that Nichol's Long Life for Health
consisted of extracts of plant drugs, alcohol (13.0 percent by volume), and water;
and that Dickson's Laxative Diuretic consisted essentially of Epsom salt, small
proportions of caramel, methenamine, hysocyamine, salicyclic acid, sulfuric acid,
and benzoic acid, minute amounts of strychnine and saccharin, and water.
Dickson's Laxative Diuretic was alleged to be misbranded: (1) In that its
labeling did not bear adequate warnings against use in those pathological con-
ditions where its use might be injurious 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, since its labeling did not bear a warning that it should
not be used when abdominal pain, nausea, vomiting, or other symptoms of
appendicitis are present, and that frequent or continued use might result in
dependence on laxatives. (2) In that statements appearing on the bottle label
which represented that each bottle contained 8 ounces of the drug, that it was
efficacious as an aid in eliminating and correcting disorders of the alimentary
canal and urinary organs, and that it would be efficacious in the treatment of
biliousness, headache, gas on the stomach, and backache, were false and mis-
leading since each bottle did not contain 8 ounces of the drug, but did contain a
smaller amount, it was not efficacious as an aid in eliminating or correcting
disorders of the alimentary canal or urinary organs and it would not be efficacious
in the treatment of biliousness, gas on the stomach, or backache. (3) In that
it was fabricated from two or more ingredients and its label did not bear the
common or usual name of each active ingredient, including the quantity or
proportion of hyoscyamine and strychnine, since (a) the declaration of "hyeci-
amus" was meaningless; (b) the label bore no statement of the quantity or pro-
portion of strychnine; and (c) it failed to bear the common or usual name of
methenamine since the designation "Utropian," appearing on the label, is not the
common or usual name of methenamine. (4) In that it was in package form
and the labeling failed to bear an accurate statement of the quantity of contents
in terms of measure. (5) In that its container (bottle) was so made and formed
as to be misleading.
Nichol's Long Life for Health was alleged to be misbranded: (1) In that
statements on the bottle label representing that it would be efficacious to prolong
life; to maintain health, and that it would be efficacious for colds in the chest;
nervousness, weakness, and all cold conditions of the system that cause consump-
tion, were false and misleading since it would not be efficacious for such purposes.
(2) In that it was fabricated from two or more ingredients and its label did not
bear the common or usual name of each active ingredient including the quantity,
kind, and proportion of alcohol that it contained. (3) In that it was in package
form and did not bear a label containing the name and place of business of the
manufacturer, packer, or distributor. (4) In that it was in package form and did
not bear a label containing an accurate statement of the quantity of contents in
terms of measure. (5) In that its container was so made, formed, or filled as to
be misleading.
On February 10, 1942, a plea of guilty was entered on behalf of the defendant
and the court imposed a fine of $100 and a jail sentence of 6 months. Payment of
the fine and the jail sentence were suspended and the defendant was placed on
probation for 3 years.