26736. Iodine preparation.    (F.D.O. No. 43937.   S. No. 77-694 P.)
QUANTITY: 2 5-gal. containers aud 1 fluid oz. btl. at Cleveland, Ohio, in pos- 
session of Inorganic Bioelements, Inc.
SHIPPED :   3-6-59 and 8-27-59, from Oak Ridge, Tenn., by Martin Anderson Co.
LABEL IN PART: (5-gal. containers) "Amidal An Iodine Preparation Active 
Ingredients: Edible Proteins consisting of Gelatin, Extract of Algae and 
Pepsin, and 5% of Iodine in the form of Sodium Compounds, including 
Sodium Iodide, Sodium Iodate, and Sodium Hypoiodite. Indicated as a source 
of iodine for nutritional purposes and for the prevention of goiter, in animals. 
Directions: * * * y2 Fluid Gallon Distributed By Inorganic Bioelements, 
Inc. * * * Cleveland 10, Ohio"; and (btl.) "Amio 5% Nutritional Iodine Prep- 
aration for Human Use * * * Inorganic Bioelements, Inc., Cleveland 10, Ohio 
Distributor."
ACCOMPANYING LABELING : Literature and leaflets entitled "The Importance of 
Iodine in the Nutrition of Farm Animals," and "The Importance of Iodine 
in Nutrition" and a number of loose "Amino" and "Amidal" labels.
RESULTS OF INVESTIGATION: Analysis showed that the article of (5-gal. con- 
tainers) contained 1.42 percent free iodine and a total iodine content of 5.20 
percent, and (btl.) 0.68 percent free iodine and a total iodine content of 5.82 
percent. The bottle was repacked and labeled by the dealer from the 5-gal. 
containers shipped as described above.
LIBELED :   12-4-59, N. Dist. Ohio.
CHARGE: 403(a)—when shipped and while held for sale, the label statement 
of the article (btl.) "5% Nutritional Iodine" and "One Drop of Amino con- 
tains 3.5 milligrams Iodine, equivalent to seven times the minimum daily 
requirement for adults and children," was false and misleading since the 
article contained more than 5 percent iodine and 3.5 milligrams iodine will 
supply 35 times the minimum daily requirement for iodine; and 403(e) (2) — 
the article (5-gal. container) failed to bear an accurate statement of the 
quantity of contents since the label statement "% Fluid Gallon" was 
inaccurate.
The libel charged also that the article was misbranded under the provisions 
of the law applicable to drugs and devices as reported in notices of judgment 
on drugs and devices, No. 6060.
DISPOSITION :   1-18-60.   Default—destruction.