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Dr. A. V. Downes Union Carbide plasties Company Room 1103 30 East 42nd Street Dr. V. B. Ackart Dr. H. P. Smyth, Jr. Mr. V. C. Qulnby Mr. 0. T. Soriba
May 22, 1959 "Pood Crude" Cast Vinyl Films
Dear Dr. Downest Ve are In receipt of the formulations of these films.
A copy of your letter Is being sent to Henry Smyth for his comment* also.
X think the time has oome when we shall need extrac tion studies done on the majority of suoh films In order to have proper data to present to the Pood and Drug Administration.
Ve would comment as follows on these filmst (4) VBAC-9123
Although there Is only 0.2Q of sine stearate in this, the Food and Drug Adminis tration would Insist on extraction studies stowing that less than 50 parts per million of sine is extracted, they have done this In the past. X am not particularly concerned about the other constituents. (*) TBAA-91B4
Same comments as for #1. (3) VBAC-1142
The only questionable product In the mixture Is fareerll CV which Is a butadiene acrylonitrile rubber. The question Is raised because we understand it has an unacceptable
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Dr. A. . Downes
-2-
Kay 22, 1959
antioxidant In It, Z believe Dr. Aokart tracked thla down.
In 1943 we did get a letter of accept ance from the Food and Drug Administration for a similar formulation containing Ferbunaa 35HS90 - 38 Instead of the Faraorll CV.
(4) VBAA-913
Same remarks would apply as for #3.
(5) VBA~3Q2I
There would appear to be no objection to this formulation.
Very truly yours.
Thomas W, Male, N. D. mh
MEDICAL DIRECTOR
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