22176. Adulteration and misbranding of Ergot Aseptic. U. S. v. 59 Pack- 
ages of Ergot Aseptic. Default decree of condemnation, for- 
feiture, and destruction. (F. & D. no. 26338. I. S. no. 27200. S. no. 
4666.)
This case involved a shipment of Ergot Aseptic, a drug preparation which 
was labeled as containing, in each cubic centimeter, the therapeutically im- 
portant principle of 1 gram of ergot. Samples tested were found to have a 
potency, per cubic centimeter, of not more than one-third gram of ergot.
On May 6, 1931, the United States attorney for the Eastern District of 
Louisiana, acting upon a report by the Secretary of Agriculture, filed in the 
district court a libel (amended March 30, 1932) praying seizure and condemna- 
tion of 59 packages of Ergot Aseptic at New Orleans, La., alleging that the 
article had been shipped in interstate commerce, on or about February 17 
and March 3, 1931, by Parke-Davis & Co., from Detroit, Mich., aud charging 
adulteration and misbranding in violation of the Food and Drugs Act.
It was alleged in the libel that the article was adulterated in that its 
strength fell below the professed standard under which it was sold, namely, 
"Ergot  Aseptic   *    *    *    One  CC  Equal   to   One   Gm   (15+%Grs)   Ergot
* *   *   Tested Physiologically and Standardized."
Misbranding was alleged for the reason that the following statements on 
the labeling were false and misleading: (Carton) " Ergot Aseptic * * * One 
CC Equal to one Gm (15% Grs.) Ergot * * * tested physiologically and 
standardized * * * Ergot Aseptic may be administered hypodermically in 
any case in which Ergot is indicated. * * * Accuracy of dose uniformity 
of chemical and physiological tests "; (individual ampoule carton and ampoule 
label) " Ergot Aseptic One CC Equal to One Gm (15+% Grs Ergot"; (circular) 
" Solution of Ergot containing in each cubic centimeter the therapeutic activity 
of one gram (15+% Grains) of Ergot of standard quality. It is standardized 
physiologically by noting the effect of definite graded doses on the vascularity 
of the comb and wattles of the rooster. On the basis of this typical reaction 
of the cocks comb Ergot Aseptic possesses the activity of fluid extract ergot, 
U. S. P.   It represents the full activity of the ergot from which it is prepared
* * * Its therapeutic effect which is simply that of ergot is produced 
promptly * * * It is a *** Potent form of Ergot. * * * Its 
Activity is assured by Physiological assay * * * It is possessed of excep- 
tional potency"; (card insert) "Improved Formula * * * retaining the 
Full Activity."
On March 15, 1934, the claim and answer of Parke Davis & Co., the sole 
intervener, having been withdrawn by permission of the court, judgment of 
condemnation and forfeiture was entered, and it was ordered by the court that 
the product be destroyed. On March 16, 1934, the decree was amended to 
permit release of the product to Parke Davis & Co., under a bond in the sum 
of $500, conditioned that it be returned to Detroit, Mich., to be destroyed under 
the supervision of this Department.
M. L. WILSON, Acting Secretary of Agriculture*
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