A M VI    \S 
FOOD AND DRUG ADMINISTRATIONIf     "? -
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
1151-1200
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district courts
by the United States attorneys acting upon reports submitted by direction of the
Federal Security Administrator.
WATSON B. MILTER, Acting Administrator, Federal Security Agency.
Washington, D. C, April 5,1945.
CONTENTS*
Page
Page
Drugs actionable because of potential danger
when used according to directions     303
New drug shipped without effective applica-
tion 
       305
Drugs actionable because of failure to bear
adequate directions or warning statements.    305
Drugs actionable because of contamination
with filth        315
Drugs and devices actionable because of devia-
tion from official or own standards..  317
Drugs actionable because of false and mislead-
ing claims 
  322
Drugs for human use..  
.. 322
Drugs for veterinary use ..   330
DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
1151. Adulteration and misbranding of Eli-606 Capsules and misbranding of
Stero-Uteroids. U. S. v. Charles A. Ainsworth (Ainsworth Specialty
Co.). Plea of guilty. Fine, $350. (F. D. C. No. 10542. Sample Nos.
3311-F, 37824-F.)
On September 17, 1943, th? United States attorney for the Western District
of Missouri filed an information against Charles A. Ainsworth, trading as the
Ainsworth Specialty Co., Kansas City, Mo., alleging shipment from the State
of Missouri into the State of Oklahoma, on or about January 21, 1943, of a
quantity of Eli-606 Capsules, and into the State of Illinois from on or about July
24, 1941, to October 17, 1942, of quantities of Stero-Uteroids.
Analysis of the Eli-606 Capsules disclosed that the article contained per
capsule 0.154 grain of sodium cacodylate, and not more than 0.89 grain of
methenamine, 0.386 grain of acetanilid, 0.49 grain of calcium phosphate, and
0.476 grain of sodium phosphate.
The article was alleged to be adulterated in that its strength differed from
that which it purported and was represented to possess since it was represented
to contain in each capsule ? grain of sodium cacodylate, 2 grains of methenamine,
and 1 grain each of acetanilid, calcium phosphate, and sodium phosphate, whereas
it contained smaller amounts of those substances. It was alleged to be misbranded
in that the statements on its label, "Formula: Soda Cacodylate y2 Gtr.   *   *    *
?For presence of a habit-forming narcotic without warning statement, see Nos. 1152,1163; deceptive pack;
aging, No. 1155; failure to bear accurate statement of quantity of contents, Nos. 1156,1182,1190,1191,1196-
omission of, or unsatisfactory, ingredients statement, Nos. 1157; 1188, 1196; inconspicuousness of, or un-
satisfactory, required label information, Nos. 1158, 1160; imitation of another drug, No. 1190; cosmetics,
subject to the drug provisions of the Act, Nos. 1193,1194.
641299-45 1 
303
Methenamine 2 Grs.   *   *   * . Acetanilide. Calc. Phosphate.   Sodium Phosphate
aa.   1    Gr.   *   *   *,"  were false  and  misleading;   and  in  that  the  state-
ments "Formula   *   *   *   to make one 10 grain capsule,"  appearing on its (
label, and "FORMULA   *   *   *   for each 10 gr. capsule," appearing /n/ the
circular accompanying the article, were false and misleading since they r^pre-f".
sented and suggested that each of the capsules contained 10 grains of the articfie,' I
whereas, each capsule contained a smaller amount.   It was alleged to be misj| j
branded further because of false and misleading statements in its labeling whicn
represented and suggested that the article would be efficacious as an anti-
lnetic, urinary antiseptic, alterative, blood cleanser, blood tonic, and as a sub-
stitute for or supplement to intravenous medication in luetic-syphilitic cases;
and that it would be efficacious in the cure, mitigation, treatment, or prevention
of gonorrhea, venereal discharges and infections, blood dyscrasias, malarial
poisoning, anemias, lowered blood count, hepatic (liver) torpor, gallstones, and
urinary infections, generally.
Analysis of the Stero-Uteroids disclosed that they consisted essentially of
small proportions of zinc sulfate, plant material including an alkaloid-bearing
drug, ichthammol, and a minute amount of iodine incorporated in lanolin.
The Stero-Uteroids were alleged to be misbranded in that the article would
be dangerous to health when used in the dosage or with the frequency or dura-
tion prescribed, recommended, and suggested in the labeling, since the name of
the article, "Stero-Uteroids," the manner of packaging, i.e., collapsible metal
tube with key, and the directions of a portion, "Apply with catheter under
aseptic conditions," suggested the introduction of the article into the uterus,
whereas the article, when introduced into the uterus, would be dangerous. It
was alleged to be misbranded further in that the statements (portion), "Stero-
Uteroids * * * to be used only by or on the prescription of a physician," and
(remainder) "Stero-Uteroids * * * Directions: Apply with catheter under
aseptic conditions. For administration by physician only," appearing in the
labeling, were false and misleading since they represented and suggested that
the article was a safe medicament for introduction into the uterus, whereas it
was not a safe medicament for introduction into the uterus.
On October 11, 1943, the defendant entered a plea of guilty and the court im-
posed a fine of $50 on each of the 7 counts, a total fine of $350.