19525. Adulteration and Misbranding of Ergotole.    U. S. v. 286 Bottles of
Ergotole.    Default   decree   of   condemnation,   forfeiture,   and   de- 
struction.     (F. & D. No. 27385.    I. S. No. 42151.    S. No. 5582.)
Examination of the drug product Ergotole showed that it was represented 
to be standardized to the same potency as fluidextraet of ergot, whereas its 
potency was approximately one-third that of the pharmacopoeial requirement 
for fluidextraet of ergot. The article would not produce certain therapeutic 
Tesults claimed for it in the labeling, because of its low potency.
On December 18, 1931, the United States attorney for the District of Colum-, 
bia, acting upon a report by the Secretary of Agriculture, filed in the Supreme* 
Court of the district aforesaid, holding a District Court, a libel praying seizure 
and condemnation of 286 bottles of Ergotole, remaining in the original unbroken, 
packages at Washington, D. C, alleging that the article had been shipped by 
Sharp & Dohme (Inc.), from Philadelphia, Pa., on or about October 6, 1931, 
and had been transported from the State of Pennsylvania into the District of 
Columbia, and charging adulteration and misbranding in violation of th» 
food and drugs act as amended.
Adulteration of the article was alleged in the libel for the reason that it was 
sold under the following standard of strength, (carton and bottle label) 
" Ergotole * * * A Purified Liquid Preparation of Selected Ergot of Rye," 
(circular) "Ergotole is a liquid extract of Ergot of Rye, containing the oxy- 
tocic constituents of the drug * * * Ergotole is biologically assayed by 
the cock's comb method, and standardized to the same potency as the Fluid- 
extract of Ergot," whereas the strength of the article fell below such pro- 
fessed standard.
Misbranding of the article was alleged for the reason that the following 
statements appearing in the labeling were false and misleading: (Carton and 
bottle labels) " Ergotole * * * A Purified Liquid Preparation of Selected 
Ergot of Rye;" (circular) "Ergotole is a liquid extract of Ergot of Rye, con- 
taining the oxytocic constituents of the drug. * * * Ergotole is biologically 
assayed by the cock's comb method, and standardized to the same potency as 
the Fluidextract of Ergot. The chief use for Ergotole is to excite uterine con- 
traction and to check uterine hemorrhage. It is therefore indicated for use in 
the third stage of labor. * * * Ergotole may be administered orally or hy- 
podermically. The suggested average dose for hypodermic administration is ten 
minims, and for oral administration thirty mimims." Misbranding of the article 
was alleged for the further reason that the statement. " The chief use for 
Ergotole is * * * to check uterine hemorrhage," appearing in the labeling 
regarding the curative or therapeutic effects of the article, was false and 
fraudulent, since it contained no ingredient or combination of ingredients | 
capable of producing the effects claimed.
On March 28, 1932, no claimant having appeared for the property, judgment 
of condemnation and forfeiture was entered, and it was ordered by the court 
that the product be destroyed by the United States marshal.
AETHTJB M. HYDE, Secretary of Agriculture.