5. Misbranding of Hed-Lyte.     U. S. v. 93 Bottles of Hed-Lyte.    Default decree
of condemnation and destruction.     (F. D. C. No. 225.    Sample No. 38055-D.)
This drug contained acetanilid, sodium bromide, and caffeine. Its labeling
contained representations that it would relieve pain in simple headaches, simple
neuralgia, and muscular aches and pains; that it was indicated in feverish
conditions due to colds and for nervousness due to excesses; that it would
lessen the perception of pain and distress during menstruation and generally
result in increased comfort, and was of value in relieving nervousness and simple
headache which might be attributed to or might follow alcoholic or tobacco
excess. The labeling contained directions that 2 teaspoonfuls be taken in
water, to be repeated in 30 or 40 minutes if not relieved, and that the third
dose should not be taken until 2 hours after the second, with dosage for children
in proportion.
It would be dangerous to health when used in the dosage or with the fre-
quency or duration so prescribed, recommended, or suggested and its label
failed to reveal facts material with respect to consequences which might
result under the conditions of use prescribed in its labeling or under such
conditions of use as are customary or usual and failed to bear adequate warn-
ings against its use in those pathological conditions or by children where its
use might be dangerous 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.
On May 1, 1939, the United States attorney for the Western District of
Louisiana filed a libel against 93 bottles of Hed-Lyte at Shreveport, La.;
alleging that the article had been shipped in interstate commerce on or about
March 6, 1939, by the Hed-Lyte Co. from Dallas, Tex.; and charging that it
was misbranded for the reasons stated above.
On June 30, 1939, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.