3693. Misbranding of Ceride solution and Eamide aqueous suspension.   U. S. v.
1,975 Ampuls of Ceride solution, etc    (F. D. C. No. 30868.   Sample Nos.
93124-K to 93127-K, incl.)
LIBEL FILED:   March 23, 1951, Western District of North Carolina.
ALLEGED SHIPMENT : On or about February 13 and April 23, 1950, from Decatur,
III., and New York, N. Y.
PRODUCT: 21,950 ampuls of Ceride solution and 23,950 ampuls of Kamide
aqueous suspension at Andrews, N. C, in possession of Swan's Enterprises,
Inc., and a number of 1-page leaflets entitled "Ceride and Kamide" and a num-
ber of 2-page leaflets entitled "Suggestions for the use of Ceride and Kamide."
RESULTS OF INVESTIGATION: The leaflets accompanying the products had been
prepared locally for the consignee, Swan's Enterprises, Inc.
*See also Nos. 3689-3691.
LABEL, IN PABT: . Portion of Ceride solution. (Ampul) "Ceride * * * 2 cc.
Sterile Ampule Bach cc. contains: Elemental Iodine, .00173 gm.; Cerium
Iodide (Cel?), .004125 gm.; Dextrose, .00767 gm. In distilled water" and
(carton) "For intravenous Use."
Remainder of Ceride solution. (Ampul) "2 cc. Size Ceride" and (carton)
"Ceride * * * Bach cc. contains: Elemental Iodine 0.00158 Gm. Cerium
Iodide 0.00457 Gm. Dextrose 0.0075 Gm. In distilled water * * * For
Intravenous use."
Portion of Kamide aqueous suspension. (Ampul) "Kamide * * * 2 cc.
Sterile Ampule Each cc. contains: Elemental Iodine, 0.00091 gm.; Potas-
sium Iodide 0.00184 gm.; Starch, 0.0142 gm. In distilled water. Dose 2 cc.
intramuscularly."
Remainder of Kamide aqueous suspension (Ampul) "2 cc. Kamide" and
(carton) "Kamide * * * Each cc. contains:. Elemental Iodine 0.001
Gm. Potassium Iodide 0.002 Gm. Starch 0.015 Gm. In distilled water
*    *   *   For Intramusular use."
INATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
labeling, namely, in the leaflets entitled "Ceride and Kamide" and "Sug-
gestions for the use of Ceride and Kamide," were false and misleading.
These statements represented and suggested that the Ceride solution was an
adequate and effective treatment for arthritis, virus infections, toxemias of
pregnancy, hay fever, asthma, hypertension, Buerger's disease, Raynaud's
disease, coronary thrombosis, diabetes, encephalitis, herpes zoster, primary
glaucoma, cerebral embolism, paralysis due to cerebral hemorrhage, meno-
pause, malaria, poliomyelitis, gastric ulcer, phlebitis, rheumatic fever, and
sinus infection; and that the Kamide aqueous suspension was an adequate
and effective treatment for diseases of the nervous system and circulatory
system, infections of the mucous membrane, arthritis, coronary thrombosis,
edema of the brain, herpes zoster and other virus infections, hypertension,
paralysis due to cerebral hemorrhage, cerebral embolism, poliomyelitis, rheu-
matic fever, and sinus infection. The articles were not adequate and effec-
tive treatments for such diseases and conditions. '
The articles were misbranded while held for sale after shipment in inter-
state commerce.
DISPOSITION: April 1, 1952. Swan's Enterprises, Inc., claimant, having con-
sented to the entry of a decree, judgment of condemnation was entered and
the court ordered that the products be released under bond, conditioned that
they be relabeled under the supervision of a representative of the Federal
Security Administrator.