2916. Misbranding of Mothersill's Airsick Remedy and MothersilTs Seasick
Remedy. U. S. v. 45 dozen Packages, etc (F. D. C. No. 21680. Sample
Nos. 43647-H, 43648-H, 71033-H.)
LIBEL FILED : November 26,1946, Southern District of California; amended libel
filed May 10, 1949.
ALLEGED SHIPMENT: On or about September 3 and 23 and October 11 and 14,
1946, by F. T. Hopkins & Son, from New York, N. Y.
PRODUCT: 45 dozen packages of Mothersill's Airsick Remedy and 272 dozen
packages of Mothersill's Seasick Remedy at Los Angeles, Calif.
LABEL, IN PABT: "Mothersill's Airsick Remedy * * * Each capsule con-
tains IY2 grains of trichlor-tertiary-butyl-alcohol, a chloroform derivative,
?oo grain hyoscine hydrobromide, caffeine and suitable flavorings" and
"Mothersill's Seasick Remedy * * * Each Capsule contains 2 grains of
trichlor-tertiary-butyl-alcohol, a chloroform derivative, ?oo grain hyoscine
hydrobromide, caffeine and suitable flavorings."
NATURE OF CHARGE: Misbranding, Section 502 (a), the statement "Guaranteed
not to contain morphine, chloral, cocaine, opium, coal tar products or their
derivatives," which appeared on the label of both articles, was misleading since
it suggested and created the impression that the articles contained no injurious
drugs, whereas the articles contained hyoscine hydrobromide and chloro-
butanol, which are capable of producing injurious effects.
?See also No. 2912.
877437-50-
Further misbranding, Section 502 (c), the information required by law to
appear on the label was not prominently placed thereon with such conspicuous-
ness (as compared with other words, statements, designs, or devices in the
labeling) and in such terms as to render such information likely to be read and
understood by the ordinary individual under customary conditions of purchase
and use since the statement of the quantity of the contents of the package
appeared inconspicuously placed and in small type; since the name of the habit-
forming ingredient, chlorobutanol, was declared by the name "trichlor-tertiary-
butyl-alcohol," a designation which is not likely to be understood by the
ordinary individual under customary conditions of purchase and use, and the
quantity or proportion thereof, namely, V/2 grains and 2 grains, respectively,
appeared inconspicuously in small type; and since the name and quantity or
proportion of the ingredient, hyoscine hydrobromide, a derivative of hyoscine,
and the name of the active ingredient, caffeine, appeared inconspicuously in
small type on the label.
Further misbranding, Section 502 (d), the articles were drugs for use by man
and contained chlorobutanol, a chemical derivative of chloral, which derivative
has been found by the Administrator of the Federal Security Agency, after
investigation, to be and by regulations designated as habit forming; and the
labels of the articles failed to bear immediately following the name of the
article, the common or usual name of the article and in juxtaposition therewith,
the statement "Warning-May be habit forming."
Further misbranding, Section 502 (f) (2), the labeling of the articles failed
to bear such adequate warnings against unsafe dosage and duration of admin-
istration in such manner and form as are necessary for the protection of users
since the articles contained hyoscine hydrobromide; and the labeling of the
articles failed to warn that use of the articles should be discontinued if dizziness
or blurring of vision occurred, and that use in excess of the recommended
dosage may cause serious nervous disturbance.
DISPOSITION: F. T. Hopkins & Son appeared as claimant and, in accordance
with the agreement of the parties, the libel proceedings were ordered removed
to the District of New Jersey for trial. On November 29, 1949, the claimant
having consented to the entry of a decree, judgment of condemnation was
entered and the court ordered that the products be destroyed.
DRUG ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH