27264. Misbranding of Kopp's. V. S. v. 292 Bottles and 96 Bottles of Kopp's 
(and another seizure action). Default decrees of condemnation and 
destruction.    (F. & D. nos. 37148, 37561.    Sample nos. 55862-B, 57008-B.)
The bottle labels and a circular accompanying this product contained false 
and fraudulent curative and therapeutic claims, and false and misleading rep- 
resentations which were indicative that the preparation was a safe and ap- 
propriate remedy for infants and young children; whereas it was not, since in- 
fants and young children are susceptible to poisoning from morphine, an 
ingredient of the article.
On February 3 and April 11, 1936, the United States attorney for the Eastern 
District of Michigan, acting upon reports by the Secretary of Agriculture, filed 
in the district court libels praying seizure and condemnation of 388 bottles and 
575 packages of various sizes of Kopp's at Detroit, Mich., alleging that it had 
been shipped in interstate commerce on or about December 28 and 30, 1935, and 
March 7, 1936, by C. Robert Kopp, Inc., from Hellam and York, Pa., and 
charging misbranding in violation of the Food and Drugs Act as amended.
Analysis of a sample of the article showed that it contained morphine sul- 
phate (one-eighth grain per fluid ounce), flavoring oils including anise oil, 
alcohol, sugar, and water.
It was alleged to be misbranded in that the following directions on the labeling 
detailing how it should be given to infants and young children, together with 
the picture in a circular accompanying certain sizes, of a baby, entitled 
"Kopp's Remedies for Babies and Children", were false and misleading, "Di- 
rections—Dose for a child 1 week old, 4 drops; 2 weeks, 6 drops; 1 month, 10 to 
12 drops; 2 months, 15 to 18 drops; 3 to 4 months, Ys teaspoonful; 4 to 6 months, 
y2 teaspoonful; 6 to 9 months, % teaspoonful; 12 months and over, 1 teaspoonful. 
Repeat in 3 or 4 hours if necessary"; (circular in German and other foreign 
languages accompanying certain sizes) "Directions—Dose for a child 1 week 
old, 6 drops; 2 weeks old, 8 drops; 1 month, 15 to 18 drops; 2 months, 20 to 
25 drops; 3 to 4 months, ^ [on some sizes "%"] teaspoonful; 4 to 6 months, %
teaspoonful; 6 to 9 months, 1 teaspoonful; twelve or more months, 1% teaspoon- 
ful. Repeat the dose every 3 to 4 hours if necessary", in that said statements 
were indicative that the preparation was a safe and appropriate remedy for 
infants and young children; whereas it was not since infants and young children 
are susceptible to poisoning from morphine, which was one of its ingredients. 
The article was alleged to be misbranded further in that the directions on the 
label and said circular, together with the picture on the circular of a baby, 
entitled "Kopp's Remedies for Babies and Children", were statements, designs, 
and devices regarding its curative or therapeutic effect and were false and 
fraudulent.
On April 9, 1937, no claimant having appeared, judgments of condemnation 
were entered and it was ordered that the product be destroyed.
H. A. WATT.ACE, Secretary of Agriculture.