21592. Adulteration and misbranding of- tincture of aconite root, fluid- 
extract of ergot, and fluidextract of belladonna leaves. IT. S. v. 
Standard Pharmaceutical Corporation. Flea of guilty. Fine, $40 
and costs.    (F. & D. no. 28167.    I.S. nos. 39503, 46101. 46102, 46104.)
This case was based on interstate shipments of tincture of aconite root, 
fluidextract of ergot, and fluidextract of belladonna leaves, which were rep- ' 
resented to be pharmacopoeial products but which fell below the standard laid 
down in the United States Pharmacopoeia for such products.
On September 20, 1933, the United States attorney for the District of Mary- 
land, acting; upon a report by the Secretary of Agriculture, filed in the district 
court an information against the Standard Pharmaceutical Corporation, Bal- 
timore, Md., alleging shipment by said company in violation of the Food and 
Drugs Act, on or about October 28, November 20, and November 30, 1931, from 
the State of Maryland into the State of Georgia, of quantities of fluidextract of 
belladonna leaves, tincture of aconite root, and fluidextract of ergot, and on 
or about February 9, 1932, from the State of Maryland into the District of 
Columbia, of a quantity of tincture of aconite root, which products were adul- 
terated and misbranded. The articles were labeled in part: " Tincture Aconite 
Boot (Tinctura Aconiti) U.S.P."; Fluidextract Ergot (Fluidextractum Ergotae) 
U.S.P. Physiologically Tested"; "Fluidextract Belladonna Leaves (Atropi 
Belladonna) * * * One hundred mils contains 0.3 gm. Alkaloids. * * * 
Standard Pharmaceutical Corp. Baltimore, Md."
Analyses of samples of the articles by this Department showed that the tinc- 
ture of aconite root possessed approximately one-third the potency required by 
the United States Pharmacopoeia, that the fluidextract of ergot was less than 
one-third as potent as required by the pharmacopoeia; and that the fluidextract 
of belladonna leaves contained 8 percent more alkaloid than the maximum per- 
mitted by the pharmacopoeia.
It was alleged in the information that the articles were adulterated in that 
they were sold under names recognized in the United States Pharmacopoeia 
and differed from the standard of strength, quality, and purity as determined! 
by the tests laid down in the said pharmacopoeia in the following respects, 
and their own standard of strength, quality, and purity were not declared on the 
container:
The tincture of aconite root, when administered subcutaneously to guinea 
pigs, had a minimum lethal dose of more than 0.00045 cubic centimeter for 
each gram of body weight of guinea pig (the two lots requiring 0.0017 cubic 
centimeter and 0.0013 cubic centimeter, respectively, per gram of guinea pig 
for a lethal dose), whereas the pharmacopoeia required that tincture of aconite 
root, when administered subcutaneously to guinea pigs, shall have a minimum 
lethal dose of not more than 0.00045 cubic centimeter for each gram of body 
weight of guinea pig;
The fluidextract of ergot, when administered by intramuscular injection to 
single-comb white Leghorn cocks required more than 0.5 cubic centimeter for 
each kilogram of body weight of cock to produce a darkening of the comb 
corresponding in intensity to that caused by the same dose of the standard 
fluidextract of ergot, whereas the pharmacopoeia provides that fluidextract of 
ergot, when administered by intramuscular injection to a single-comb white 
Leghorn cock in doses not exceeding 0.5 cubic centimeter for each kilogram of 
body weight of cock, shall produce a darkening of the comb corresponding in 
intensity to that caused by the same dose of the standard fluidextract of 
ergot;
The fluidextract of belladonna leaves yielded not less than 0.356 gram of the 
total alkaloids of belladonna leaves per 100 cubic centimeters, whereas the 
pharmacopoeia provides that fluidextract of belladonna leaves shall yield not 
more than 0.33 gram of the total alkaloids of belladonna leaves per 100 cubic 
centimeters. Adulteration was alleged for the further reason that the strength 
and purity of the articles fell below the professed standard and quality under 
which they were sold.
Misbranding was alleged for the reason that the statements appearing on 
the labels of the respective products, " Tincture Aconite Root (Tinctura Aconiti)
U.S.P.", " Fluidextract Ergot * * * U.S.P. Physiologically Tested", " Flu- 
idextract Belladonna leaves * * * One hundred mils, contains 0.3 gm. 
alkaloids ", were false and misleading, since the said statements represented 
that the tincture of aconite root and the fluidextract of ergot conformed to the 
standard prescribed in the United States Pharmacopoeia, and that the fluidex- 
tract of belladonna leaves contained 0.3 gram of alkaloids in each 100 mils, 
whereas the said tincture of aconite root and the fluidextract of ergot did not 
conform to the standard prescribed in the United States Pharmacopoeia, and 
the fluidextract of belladonna leaves contained more than 0.3 gram of the alka- 
loids, namely, not less than 0.356 gram of alkaloids per 100 mils.
On September 22, 1933, a plea of guilty to the information was entered on 
behalf of the defendant company, and the court imposed a fine of $40 and 
costs.
M. L. WILSON, Acting Secretary of Agriculture.