3 9377. Adulteration and Misbranding of Ergotole. U. S. v. Sixty-four 
l-Ounce Bottles of Erg otole. Default decree of condemnation 
and destruction.    (F. & D. No. 26022.    I. S. No. 28706.    S. No. 4285.)
Examination of a sample of the drug product Ergotole from the shipment 
herein described showed that it contained less of the therapeutically important 
constituents of ergot than represented, and that it would be incapable of pro- 
ducing certain curative and therapeutic effects claimed for it in the labeling, 
because of its low potency.
On March 13, 1931, the United States attorney for the District of Columbia, 
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 sixty-four 1-ounce 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 Baltimore, Md., on or about 
February 25, 1931, and had been transported from the State of Maryland into 
the District of Columbia, and charging adulteration and misbranding in viola- 
tion of the food and drugs act as amended.
Analysis of a sample of Ergotole by this department showed that the potency 
per cubic centimeter was equivalent to not more than one-fifth of a gram of 
ergot.
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 
Free From Irritating constituents, Each cc. Requiring Two and One-Half 
Grams of the Drug in its Preparation;" (circular) "In order to obtain the 
full oxytocic effect of Ergot a preparation should be used which contains the 
water-soluble constituents of Ergot in a maximum and definite amount," 
whereas the strength of the article fell below such professed standard.
Misbranding was alleged for the reason that the following statements appear- 
ing in the labeling were false and misleading: (Carton and bottle) "Ergotole 
* * * A Purified Liquid Preparation of Selected Ergot of Rye * * * 
Each cc. Requiring Two and One-Half Grams of the Drug in its Prepara- 
tion;" (circular) "In order to obtain the full oxytocic effect of Ergot a 
preparation should be used which contains the water-soluble constituents of 
Ergot in a maximum and definite amount." Misbranding was alleged for the 
further reason that the following statements appearing in the labeling, regard- 
ing the curative or therapeutic effects of the article, were false and fraudulent, 
since it contained no ingredient or combination of ingredients capable of 
producing the effects claimed: (Circular) " In order to obtain the full oxytocic 
effect of Ergot a preparation should be used which contains the water-soluble 
constituents of Ergot in a maximum and definite amount. The chief use for 
Ergotole is to excite uterine contraction and to check uterine hemorrhage. 
It is therefore especially valuable in the third stage of labor * * * Ergotole 
may be administered by the mouth in doses of 15 to 60 minims. Hypodermi- 
cally 5 to 20 minims."
On March 25, 1932, no claimant having appeared for the property, judgment 
of condemnation was entered and it was ordered by the court that the product 
be destroyed by the United States marshal.
ARTHUR M. HYDE, Secretary of Agriculture.