2453. Action to enjoin and restrain the interstate shipment of a drug: sometimes
designated as "The Old Famous Sillard Cancer Remedy." IT. S. v. Mrs.
Bertha  Stephens.    Consent  decree  granting injunction.     (Inj.  No.   199.)
COMPLAINT TILED : Between September 24 and October 15, 1948, Eastern Dis-
trict of Tennessee, against Mrs. Bertha Stephens, North Chattanooga, Tenn.
NATURE OF CHARGE : That the defendant had been from time to time intro-
ducing and delivering for introduction into interstate commerce consignments
of a drug consisting of a liquid containing small proportions of tincture of iron
and potassium iodide, and sometimes designated by the name The Old Famous
Sillard Cancer Remedy; that prior to about March 12, 1948, the drug was
labeled as follows "The Old Famous Sillard Cancer Kemedy Designed for the
cure of Cancers or Ulcers and Stomach trouble of any kind. Directions One
Tablespoonful before each meal. Made by Mrs. Bertha Stephens (North)
Chattanooga, Tennessee"; that on or about March 12, 1948, the defendant
caused the drug to be introduced into interstate commerce without any labeling;
that the drug for many years past had been and was still intended for use in the
treatment of cancers, ulcers, and stomach troubles of all kinds, but that
labeling statements revealing its intended uses would be false and misleading,
in that the drug was not efflcaceous in the cure, mitigation, or treatment of
such diseases;' that any labeling statement representing or suggesting the use of
the article as a drug would be false and misleading, in that it was without
value in the cure, mitigation, treatment, or prevention of disease, or in bene-
ficially affecting any function of the human body.
The complaint alleged further that prior to March 12, 1948, the drug was
misbranded as follows:
Section 502 (a), the name "Cancer Remedy" and the statement "Designed for
the cure of Cancers or Ulcers and Stomach trouble of any kind" were false
and misleading, since the article would not be efflcaceous in the cure of such
diseases and conditions;
Section 502 (e) (2), the article was not designated solely by a name recog-
nized in an official compendium and was fabricated from two or more ingredi-
ents, and its label failed to bear the common or usual name of each active
ingredient;
Section 502 (f) (2), the labeling of the article failed to bear warnings against
use in those pathological conditions where its use may be dangerous to health,
in such manner and form as are necessary for the protection of users, in that
the use of the article might be dangerous to the health of persons suffering from
lung disease, chronic coughs, or goiter (thyroid diseases) ; and the labeling of
the article failed to bear any warning against unsafe duration of administra-
tion, since it failed to bear a warning to discontinue the use of the article if a
skin rash appeared.
The complaint alleged also that the article when introduced into inter-
state commerce on or about March 12, 1948, was misbranded as follows:
Section 502 (f) (1), the article failed to bear adequate directions for use
for the purposes for which it was intended;
Section 502 (f) (2), the labeling of the article failed to bear adequate warn-
ings against use in pathological conditions where its use may be dangerous to
health, and warnings against unsafe duration of administration, in such
manner and form as are necessary for the protection of users;
Section 502 (b) (1), the article failed to bear a label containing the name and
place of business of the manufacturer, packer, or distributor;
Section 502 (b) (2), the article failed to bear a label containing an accurate
statement of the quantity of the contents in terms of weight, measure, or
numerical count;
Section 502 (e) (2), the article failed to bear a label declaring the common
or usual name of each active ingredient.
PBATEB OF COMPLAINT: That the defendant be restrained and enjoined during
the pendency of the action, and permanently, from shipping the above-mentioned
drug in interstate commerce.
?See also No. 2452.
DISPOSITION :   October 15,1948.   The defendant having consented to the entry of
a decree, an order was entered enjoining the defendant from directly or indi-
rectly introducing or delivering for introduction into interstate commerce the    I
above-mentioned product, which was misbranded within the meaning of Sec-
tions 502 (a),502 (f) (1) and (2), 502 (e) (2), and 502 (b) (1) and (2).