[D. D. N. J.
1502. Misbranding: of Pancreas Cell Compound.   U. S. v. 4 Bottles of Pancreas Cell
Compound.    Default decree of condemnation and destruction.     (F. D. C.
No. 15281.    Sample No. 29384-H.) 
On February 23, 1945, the United States attorney for the Northern District
of California filed a libel against 4 bottles of Pancreas Cell Compound at San
Francisco, Calif., alleging that the article had been shipped on or about Novem-
ber 27, 1944, from South Bend, Ind., by the Oak Balm Co., Inc. The article was
labeled in part: "Directions Take one or two tablets just before eating, three
times daily, or according to special directions from your doctor."
Examination of a sample showed that the article contained glandular material
including pancreatin and insulin.
The article was alleged to be misbranded (1) in that it was a tirug composed
partly of insulin that was not from a batch for which a certificate or release had
been issued; and (2) in that the statement on the bottle label, "A pluri-endocrine
compound of carefully selected endocrine substances designed to act as a gland-
ular stimulant," was false and misleading since the article would not act as a
glandular stimulant. The article was alleged to be misbranded further in that
the label statement, "Pancreas Cell Compound Each Tablet Contains Pancreas
Substance. ... 1 Grain Islets of Langerhans ... 2 Grains Parathyroid
Substance . . . ?o Grain And small amounts of Orchic, Spleen, Parotid and
Submaxillary Substances," was misleading in the absence of a revelation of
the fact, material in the light of such representation and material with respect
to the consequences which might result under the conditions of use prescribed in
the labeling, that none of the ingredients listed nor the combination of them
would have any therapeutic effect if consumed in accordance with the directions
stated upon the bottle label.
On March 31, 1945, no claimant having appeared, judgment of condemnation
was entered and the product was ordered destroyed.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS