Document KzezVG30adgLLXV0J0xY26B42
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| m j: m Cosmetic, Toiletry and Fragrance Association, Inc.
1133 15IH STREET, N.W.. WASHINGTON, D.C, 2000S- 203/331-1770 TELEX 80-2673
James H. Mori
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Mormon F. Eslrln, Ph.D.
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TALC SUBCOMMITTEE MINUTES
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A meeting of the Ta-lc Subcommittee was held on March 31, .1976, at Bristol-Myers, 225 Long. Avenue, Hillside, New Jersey. Those in attendance were:
-. George Sandland, Bristol-Myers (CHAIRMAN)
John Clements, -Pfizer, Inc.
'Christopher Costello, Colgate-Palmolive
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John Facq, Colgate-Palmolive
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Allan Harvey, R.T, Vanderbilt Co., Inc.
;.'Georgs Lee, Johnson 6 Johnson
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.*'' . Ray Kraranes, Whittaker, Clark Daniels
-*'Roderick Hundy, Sterling Drug Inc.
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Louis Marino;'-'Cyprus Industrial ..Minersls
. Fred Roesch, Whittaker, Clark s Daniels
. Robert Rolle, Johnson & Johnson
Joseph Simko, Colgate-Palmolive--
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, . Terry Smith, Faberge ,
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. -, .`"Harold Stanley, Charles Pfizer Co.
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' .'Ian- Stewart, -Walter C. McCrone Assoc., Inc,' >
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*Robert Suffis, Hennen Co, 5
-'.John Travers, Avon Products, Inc.
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i..-.Ronald akupcin, Kolmar Labs.
Norman Estrin,' CTFA.
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-;.<r.. SaiLdlandAopened, the meeting and proceeded with the agenda. .
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1. Collaborative Study,
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'Mr. Lee and Dr. Rolle updated the Subcommittee on reports of: recent gathering- of samples by the Mt. Sinai group. A " ' suggestion was made that individual companies write directly -to Mt. Sinai's, management on the lack of creditability of . ,,Dr. hanger's results when applied to their specific products.
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. ~D e p o n e n t : H; M U ^ V A ^ ' D ate:_ Shirley Q. Casilan, CSR No. 12361
CONFIDENTIAL
PLAINTIFF'S EXHIBIT
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P E L MO.. 00001785
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The advantages and disadvantages were discussed in detail of engaging in a collaborative study. 'It'was generally felt the Study could not be successful ii' there are restrictions on which talcs can be gathered. Many members favored engaging a collaborative- study'. Dr. Estrin suggested a proposal be put together to be presented to the CTPA Board of Directors (as was done in the case of the microbiological contents study several years ago). A subcommittee was organized to draw up this proposal consisting r, of Mr. Suffis,'Mr. Lee and chaired by Mr. Sandland.
2. Periodic Reporting
The Subcommittee agreed on the success o f the presentation of
, _ summary reports given to. the PDA.. Dr._ Es.trin suggested the
.. Subcommittee should not obligate -itself to give periodic
reports to PDA but urged members to build their data base so
, that at some time in the future the Subcommittee can decide
whether the time is right to present PDA with an update
on industry analysis.
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3, ' Review of Talc
Th planned* review of talc by the Miscellaneous OTG. Drug ..Panel'was noted'. It was suggested CTPA begin at once to plan , for a presentation to be made by a panel of experts, including independent experts, talc suppliers and manufacturers. The '. actual data.for consideration by the ftiscellaenous Panel of summary information on talc was not known.
5. Animal Studies
! -'Dr. Estrin suggested consideration be'given to planning animal .- studies.,,on .talc which may not-be covered adequately by
previous, studies. Dr. Travers, Mr.'Roesch and Mr.- Lee will coordinate activities involving Er. Gressal and Dr. Finkalstein to investigate this possibility.
6. Sampling . `The Subcommittee agreed CTFA should not address the issue . raised by Mr. Eiermann and Dr. Schaffo.er further with the FDA.
There being no further business, the meeting adjourned.
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;Norman F . .Estrin, Ph.D. Vice president - Science
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CONFIDENTIAL
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PFI MO 000017S6