29003. Adulteration of catgut ligatures. U. S. v. 1,000 Dozen Tubes of Catgut 
Ligatures. .Unsterlle portion condemned and destroyed. Remainder, 
with consent of claimant, retained by marshal and subsequently ordered 
destroyed.    (F. & D. No. 29736.   Sample No. 28829-A.)
This product consisted of ligatures identified by various control numbers. 
Ligatures were examined from four of the control numbers. Nine out of twenty- 
four examined from one of the control numbers were unsterile.
On January 10, 1933, the United States attorney for the District of Columbia, 
acting upon a report by the Secretary of Agriculture, filed in the Supreme Court
of the District of Columbia, holding a district court, a libel praying seizure and 
condemnation of 1,000 dozen tubes of catgut ligatures at Washington, D. C.; 
alleging that the article had been shipped in interstate commerce on various dates 
between June 22, 1931, and September 14, 1932, from Boston, Mass., by Jaeger- 
Bigelow Co.; and charging adulteration in violation of the Food and Drugs Act.
The article was alleged to be adulterated in that its purity fell below the 
professed standard or quality under which it was sold.
On June 29, 1933, F. W. Jaeger, having appeared as claimant, a demurrer and 
exceptions to the libel were filed upon the grounds that catgut ligatures were 
not within the purview of the Food and Drugs Act; that the plaintiff had not 
complied with the provisions of the Food and Drugs Act, section 11, pertaining 
to notice and hearing; and that the libel was indefinite, ambiguous, and uncer- 
tain in that it did not appear in what respect the ligatures were adulterated 
within the meaning and intent of the Food and Drugs Act.
On October 27, 1933, the court handed downthe following opinion:
ADKINS, Justice: "(1) The principal question in this case is whether the 
catgut ligatures come within the definition of a drug as set forth in the Pure 
Food and Drugs Act.
"The term 'drug' as used in that act is defined to include 'all medicines and!, 
preparations recognized in the United States Pharmacopoeia or National Formu- 
lary for internal or external use, and any substance or mixture of substances 
intended to be used for the cure, mitigation, or prevention of disease of either 
man or other animals.'
"Catgut ligatures are not recognized in either the United States Pharmacopoeia 
or National Formulary. Do they come within the remaining part of the defi- 
nition 
"Catgut ligatures are a substance. They are in fact used by physicians in 
stitching together parts of the body after operations. Such operations are free 
quently for the purpose of curing disease. I am unable to escape the conclusion, 
that these ligatures come strictly within the second part of the definition.
"(2) I think a notice and hearing under section 11 of the Food and Drugs 
Act is not a condition precedent to the jurisdiction of the court. U. S. v. Rawleigh 
Co., 57 Fed. (2d) 505. U. 8. v. Morgan, 222 U. S. 274. Therefore the first and 
second grounds of exception are overruled.
"(3) The statute provides that a drug shall be deemed adulterated—
"Second. If its strength or purity fall below the professed standard or quality 
under which it is sold.'
"The charge in the libel is in the above language. I think this is not a sufficient 
allegation, and that the third exception should be sustained.
"Plaintiff relies upon the rule that a purely statutory offense may be alleged 
in the words of the statute.
"This is not a criminal proceeding; if it were I doubt if the rule would be 
applicable under the facts of this case.
"In my judgment the owner of the property seized is entitled to have the libel 
state the professed standard or quality under which the ligatures were sold and 
the respects in which their strength or purity fell below that standard or quality.
"The third ground of exception will be sustained, with leave to amend."
On February 14,1934, an amended libel was filed, alleging that the article was 
adulterated in that its purity fell below the professed standard of quality under 
which it was sold, since it was sold under United States Government Master 
Specification No. 357, pertaining to ligatures, which specification provides that 
each strand of catgut ligatures shall be sterile; whereas a considerable number 
of ligatures delivered, which were the subject matter of the proceeding, were 
not sterile, that is to say, on such ligatures there were present viable aerobic 
Bpore-forming organisms.
On March 16, 1934, the claimant filed an answer to the amended libel. No 
further proceedings having been had and the claimant having consented thereto, 
on April 25, 1938, the court entered judgment of condemnation against the liga- 
tures which had been found to be unsterile, i. e., one control number, and they 
were ordered destroyed. Owing to the lapse of time and the perishable nature 
of the product, the remainder was ordered retained in the custody of the United 
States for such action as the court might deem appropriate, and on May 12, 1938* 
it was likewise ordered destroyed.
M
. L. WILSON, Acting Secretary of Agriculture.