360. Adulteration  and misbranding:  of Edwenil.     U.  S.  v.  15  Boxes,  et al.,  of
Edwenil.   Default decree of condemnation and destruction.    (F. D. C. No.
1843.   Sample Nos. 10346-E to 10349-E, incl.)
This product would not activate or fortify the natural defenses of the body as
represented and suggested in the labeling.
On April 24,1940, the United States attorney for the Southern District of New
York filed a libel against 15 boxes each containing 10 4-cc. vials of Edwinil; 35
boxes each containing 5 4-cc. vials of Edwenil; 10 boxes each containing 10 10-cc.
vials of Edwenil; and 79 boxes each containing 1 10-cc. vial of Edwenil at New
York, N. Y., alleging that the article had been shipped in interstate commerce
within the period from on or about February 21 to on or about April 2, 1940, by
Spicer & Co. from Glendale, Calif.; and charging that it was adulterated and
misbranded.
Analysis showed that the article consisted of a colorless liquid carrying sus-
pended amorphous white material containing total solids (approximately 1.0 per-
cent) chiefly sodium chloride (approximately 0.8 percent) and suspended matter
(0.1 percent), chiefly silicates and phosphates, and nitrogenous matter (approxi-
mately 0.03 percent), and water.
The article was alleged to be adulterated in that it was represented to pos-
sess a strength and quality sufficient to activate and fortify the natural defenses of
the body against acute and chronic endotoxic infections when administered in
specified doses; whereas it did not possess the strength or quality to activate
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and fortify the natural defenses of the body against acute and chronic endotoxic
infections when so administered.
It was alleged to be misbranded in that representations in the labeling that
it would be efficacious in the treatment of infections of the endotoxic type by acti-
vating the natural defenses were false and misleading since it would not be
efficacious for such purposes. It was alleged to be misbranded further in that it
was offered for sale under the name of another drug, namely, under the name
previously given to an article containing substantially different ingredients and
intended for use in the cure, mitigation, treatment, or prevention of disease in
man.
The article, with the exception of that contained in 8 boxes each containing 10
10-ce. vials, was alleged to be misbranded further in that the label failed to bear
the common or usual name of each active ingredient.
On October 7,1940, the case having been called and the claimant having failed
to appear or answer, judgment of condemnation was entered and the product was
ordered destroyed.