20886. Adulteration of tincture digitalis and tincture aconite root. U.S. 
v. Smith, Kline & French Laboratories. Plea of guilty. Fine, 
$600.     (F. & D. no. 29356.    I.S. nos. 38094, 38097, 38098.)
This case was based on two shipments of tincture digitalis and one shipment 
of tincture aconite root that were represented to be of pharmacopoeial standard. 
Examination of the articles showed that the tincture digitalis had a potency 
of approximately three fifths of that required by the United States Pharma- 
copoeia, and that the tincture aconite root had a potency of approximately 
one third of that required by the pharmacopoeia.
On February 17, 1933, the United States attorney for the Eastern District 
of Pennsylvania, acting upon a report by the Secretary of Agriculture, filed in 
the District Court of the United States for the district aforesaid an information 
against Smith, Kline & French Laboratories, a corporation, Philadelphia, Pa., 
charging violation of the Food and Drugs Act. It was alleged in the informa- 
tion that the defendant company had delivered to Smith, Kline & French, Inc., 
Philadelphia, Pa., on or about September 2, 1931, September 22, 1931, and 
October 2, 1931, quantities of tincture digitalis and tincture aconite root; that 
the articles had been guaranteed by the defendant as complying with the 
Federal Food and Drugs Act; that they had been shipped by the said Smith, 
Kline & French, Inc., in the identical condition as when delivered and guaran- 
teed by the said defendant, or about September 26, and October 10, 1931, from 
the State of Pennsylvania into the State of New Jersey; and that they were 
adulterated in violation of the Food and Drugs Act. The articles were labeled 
in part: (Bottles) " S-K-F Tincture Digitalis U.S.P. * * * Tested physio- 
logically and found to be of full strength on 7/9/31"; and " S-K-F Tincture 
Aconite Boot U.S.P. * * * Physiologically and found to be of full strength 
on 1-16-31 * * * Smith, Kline & French Laboratories * * * Philadel- 
phia, Pa."
Adulteration of the tincture digitalis was alleged in the information for the 
reason that it was sold under a name recognized in the United States Pharma- 
copoeia, and differed from the standard of strength, quality, and purity as de- 
termined by the test laid down in the said pharmacopoeia official at the time; 
of the investigation, in that the pharmacopoeia provides that each cubic centi- 
meter of tincture of digitalis should correspond to 0.083 milligram of ouabain,
whereas each cubic centimeter of the article corresponded to 0.050 milligram 
of ouabain, approximately three fifths of the requirement of the pharmacopoeia, 
and the standard of strength, quality, and purity of the article was not stated 
on the container. Adulteration of the tincture aconite root was alleged for 
the reason that it was sold under a name recognized by the United! States 
Pharmacopoeia, and differed from the standard of strength, quality, and purity 
as determined by the test laid down in the said pharmacopoeia official at the 
time of investigation, in that the article, when administered subcutaneously to 
guinea pigs, had a minimum lethal dose of more than 0.00045 cubic centimeters 
for each gram of body weight of guinea pig, to wit, not less than 0.0013 cubic 
centimeter for each gram of body weight of guinea pig, whereas said pharma- 
copoeia provides that tincture of aconite, when administered subcutaneously to 
guinea pigs, should have a minimum lethal dose of not more than 0.00045 cubic 
centimeter for each gram of body weight of guinea pig; and the standard of 
strength, quality, and purity of the article was not declared on the container. 
Adulteration of the articles was alleged for the further reason that they fell 
below the professed standard of quality under which they were sold, since they 
were represented to conform to the United States Pharmacopoeia, whereas they 
did not.
Oh March 27, 1933, a plea of guilty to the information was entered on behalf 
of the defendant company, and the court imposed a fine of $600.
R. G. TuGWEii, Acting Secretary of Agriculture.