996. Misbranding: of double strength solution of posterior pituitary. IT. S. v.
1 Litre and 2 Bottles of Double Strength Solution of Posterior Pituitary.
One  lot  tried  to the  court.    Decrees  of condemnation  and destruction.
(F. D. C. Nos. 7807, 7815.   Sample Nos. 89506-E, 89507-E).
On June 26 and 29,1942, the United States attorneys for the Southern and East-
ern Districts of New York filed libels against 1 litre, at Brooklyn, N. Y.,
and 2 bottles, each containing 1 litre, of double strength solution of posterier
pituitary, at New York, N. Y., alleging that the article had been shipped on or
about November 18, 1941, by Armour and Co., Chicago, 111.; and charging that
it was misbranded.
The article was alleged to be misbranded in that the statements on its label,
"Double Strength Solution of Posterior [or "Post"] Pituitary U. S. P XI," and
"20 I. U. per cc." were false and misleading since the strength of the article was
not double that of solution of posterior pituitary, as defined in the eleventh re-
vision of the United States Pharmacopoeia, and was not 20 International Units
per cc.
On February-5, 1943, Armour and Co. of Delaware, having appeared as claim-
ant for the lot at New York and having denied the allegation in the libel with
respect to misbranding and the case having come on for trial, the court, after
hearing the evidence and the arguments of counsel, handed down the following
memorandum opinion:
WHJJAM BONDY, District Judge: "Assuming that there was sufficient evidence
of identity of the contents of the exhibits 1 and 3 in evidence, and of samples
from which the tests were made by the claimant; and assuming that all the
tests as to which evidence was given were properly made, as to which there is
a very serious question, there is no proof that any of the tests disclosed more
than 18.5 International Units. The Court believes that what might be called
the tolerance of 20 percent either way was a tolerance allowed in determining
whether the product complies with the requirements of the Food and Drug Act
and whether it may be transported in interstate commerce. The Act does not
authorize anyone to represent the strength of the solution in International
Units in the absence of reasonable certainty on the part of the person making
the representation.
two bottles that were seized was 'Double Strength Solution Posterior Pituitary
U. S. P. XI 20 I. U. per CC. For Manufacturing Use. Expiration date Sep-
tember 1948.'
"The Court understands that to be a representation that the solution had a
strength of 20 International Units. The evidence of the experts on behalf of
the government, whom the Court believes to be very well qualified, testified that
it never was a double strength solution of 20 International Units, or, in other
words, that it never exceeded at any time 16.2 Units. The claimant's experts,
also men of unquestionable competence, testified that by the methods used by
them in making their assays which they claim were used in compliance with
the Pure Food and Drug Act, it at most equalled 18.5 Units.
"The only issue is whether the solution was properly labeled or branded. The
evidence in the case shows that the solution never was a solution of 20 Inter-
national Units.
"The Court is convinced that the claimant believed it was authorized to label
the solution containing 18.5 as a 20 International Units solution, in view of
the tolerance allowed by the Pharmacopoeia.
"The claimant was mistaken in believing that it was entitled to use that
tolerance in making an absolute representation that the solution was one of
20 International Units.
"The label or representation was not correct The two bottles were properly
seized and must be condemned.
"There accordingly should be a decree in favor of the libellant, with costs."
,   On March 4,1943, the court made the following findings of facts and conclusions
of law:
WILLIAM: BONDT, District Judge:
FINDINGS OF FACT
"1. That the two bottles, each containing one litre of an article labeled in part
'Double Strength Solution of Posterior Pituitary U. S. P. XI 20 I. U. per CC con-
tained a solution of posterior pituitary the strength of which was not double the
strength of solution of posterior pituitary U. S. P.
"2. That the two bottles described in finding No. 1 contained a solution of
posterior pituitary which did not contain more than 18.2 International Units
per cubic centimeter.
"3. That at no time since its manufacture by the claimant herein did the two
bottles of solution of posterior pituitary herein contain 20 international units
per cubic centimeter.
"4. The statement on the label of the product, 'Double Strength Solution of
Posterior Pituitary, U. S. P. XI 20 I. U. per cc.' was false and misleading."
CONCLUSIONS OF LAW
"1. The product was misbranded while in interstate commerce.
"2. The product must be condemned."
On March 9, 1943, judgment of condemnation was entered against the lot at
New York and it was ordered destroyed. On May 24, 1943, Pro-Medico Labora-
tories, Inc., Brooklyn, N. Y., claimant for the lot at Brooklyn, having filed an
answer denying the allegation in the libel with respect to misbranding and sub-
sequently having withdrawn its answer, judgment of condemnation was entered
and the lot was ordered destroyed.