21529. Misbranding of Ergrot-Apiol A.  P.   C.     U.  S.  v.  96  Tins  and 24  Tins
of Ergrot-Apiol A. P. C. Consent decrees of condemnation and 
forfeiture. Product ordered destroyed. (F. & D. nos. 30536, 30874. 
Sample nos. 32128-A, 42979-A.)
Examination of the drug product involved in these cases disclosed that it 
contained no ingredient or combination of ingredients capable of producing 
certain curative and therapeutic effects claimed in the labeling.
On June 2 and August 8, 1933, the United States attorney for the Middle 
District of Pennsylvania, acting upon reports by the Secretary of Agriculture,
filed in the district court libels praying seizure and condemnation of 96 tins of 
Ergot-Apiol A.P.C. at Scranton, Pa., and 24 tins of the product at Wilkes- 
boro, Pa., alleging that the former had been shipped in interstate commerce, 
on or about April 4 and April 5, 1933, by the American Pharmaceutical "Co., 
Inc., from New York, N.Y., to Scranton, Pa., and that the latter had been 
shipped on or about June 19, 1933, by the said American Pharmaceutical Co., 
Inc., through the Biddle Purchasing Agency, from New York, N.Y., to Pilcha- 
rd, Pa., and charging misbranding in violation of the Food and Drugs Act 
as amended.
Analysis of a sample of the article by this Department showed that it con- 
sisted essentially of material derived from plants including a nonvolatile oil 
such as apiol, a volatile oil such as savin oil, and a small proportion of ergot 
alkaloids.
It was alleged in the libels that the article was misbranded in that the fol- 
lowing statements appearing in the labeling, regarding the curative and thera- 
peutic effects of the article, were false and fraudulent: (Display carton ac- 
companying portion) "For Amenorrhea, Dysmenorrhea and Menstrual Dis- 
orders"; (tin container, all lots) "In the treatment of amenorrhea, dysmenor- 
rhea and menstrual disorders"; (circular accompanying all lots) "For 
Amenorrhea, Dysmenorrhea and Menstrual Disorders * * * For the Treat- 
ment of Menstrual Disorders Relieves Pain * * * for use in the treatment 
of Menstrual disorders * * * Ergot-Apiol A.P.C. is of value, and in 
general is indicated, in the conditions described below. * * * Amenorrhea— 
When menstrual flow is absent or scanty as a result of shock, exposure, or 
nervous strain, 1 capsule should be given 3 times a day for 3 days, then in- 
creased to 2 capsules 3 times a day until flow has been established, when it 
is reduced to one capsule twice a day. Dysmenorrhea—In cases where the 
complaint is chronic Ergot-Apiol should be taken a few days in advance of 
the period and continued until the flow has ceased. In most cases one capsule 
4 times a day is sufficient, but when pain is unusually severe 2 capsules may 
be given 4 times a day. Menorrhagia—When the flow is excessive, result- 
ing in weakness and lack of energy, one capsule may be administered 4 times a 
day. Menostasis—to re-establish the flow 2 tablets may be administered 
3 or 4 times a day, in conjunction with, frequent sitz baths if preferred. 
Menopause—Ergot-Apiol will be found an aid in easing the disturbances at- 
tending final cessation of the menstrual functions. One capsule two or three 
times a day is advised."
On October 11, 1933, the American Pharmaceutical Co., Inc., claimant, having 
admitted the allegations of the libels and having consented to the entry! of 
decrees, judgments of condemnation and forfeiture were entered with a pro- 
vision that the product might be released under bond conditioned that it be 
correctly labeled. On February 2, 1934, the claimant having filed bonds but 
having failed to comply with the provisions of the decrees, the court ordered 
that the product be destroyed by the United States marshal, and that judgments 
be entered on the bonds for costs.
M. L. WILSON, Acting Secretary of Agriculture.