1402. Misbranding1 of Grover Graham Remedy. U. S. v. S. Grover Graham Co., Inc.,
and Henry Wilson. Pleas of guilty. Corporate defendant fined $250;
individual defendant sentenced to 6 months' imprisonment and fined
$250. Execution of prison sentence suspended and individual defendant
placed on probation for 1 year.    (F. D. C. No. 12560.    Sample No. 47774-F.)
On October 23, 1944, the United States attorney for the Southern District of
New York filed an information against S. Grover Graham Co., Inc., Newburgh,
N. Y., and Henry Wilson, president of the corporation, alleging shipment of a
quantity of the above-named product from the State of New York into the State
of Missouri on or about December 21, 1943.
Analysis of samples disclosed that the article consisted essentially of sodium
bromide (approximately 8.5 grains per tablespoonful), magnesia, sodium bicar-
bonate, alcohol, chloroform, and water flavored with oil of peppermint and colored
with a red dye.
The article was alleged to be misbranded (1) because of false and mislead-
ing statements on its label which represented and suggested that it would be effica-
cious in the cure, mitigation, treatment, and prevention of indigestion, dyspepsia,
and other ailments due to imperfect and retarded functioning of the digestive
organs, and that it might be taken with perfect safety as often as necessary; (2)
in that certain information required by law to appear on the label was not placed
thereon in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use, since the
statement, "Sodium Bromide U. S. P. 3??," would not be understood by the
ordinary individual and would not inform that individual of the number of grains
or other measure understood by him in a tablespoonful dose; (3) in that its label-
ing did not bear adequate directions for use, since the directions on the label,
"Take a large tablespoonful after meals three times a day or whenever symptoms
of indigestion occur * * * Dose should be half a wineglassful followed by
another dose in a half hour if necessary. The remedy may be taken with perfect
safety as often as necessary," provided for the consumption of an excessive
amount of sodium bromide and placed no limitation on the number of doses to be
taken daily, whereas consumption of an excessive amount of sodium bromide
might be dangerous, and limitations on the number of doses of the article to be
taken daily should be contained in the directions; (4) in that its labeling failed
to warn that frequent or continued use of the article might lead to mental derange-
ment, skin eruptions, and other serious effects, and that it should not be taken by
those suffering from kidney disease; and (5) in that it was dangerous to health
when used in the dosage and with the frequency and duration prescribed, recom-
mended, and suggested in the labeling, since the directions provided for the con-
sumption of an excessive and dangerous amount of sodium bromide.
On November 20, 1944, pleas of guilty having been entered on behalf of the
defendants, the court imposed a fine of $250 on the corporate defendant. The
individual defendant was sentenced to 6 months' imprisonment and fined $250.
Execution of the prison sentence was suspended, and the individual defendant
was placed on probation for 1 year.'