Document q32VpkQBJGnygDknqm4ozn2Xn

Normart F, Estrin, Ph.D, V/c# President---Science TALC SUBCOMMITTEE MINUTES A meeting of the Talc 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 John Facq, Colgate-Palmolive Allan Harvey, R.T. Vanderbilt Co., Inc. George Lee, Johnson fi Johnson Ray Krammes, Whittaker, Clark & Daniels Roderick Mundy, Sterling Drug Inc. ' Louis Murino, Cyprus Industrial Minerals Fred Roesch, Whittaker, Clark & Daniels Robert Rolle, Johnson fi Johnson Joseph Simko, Colgate-Palmolive Trry Smith, Faberge Harold Stanley, Charles Pfi2 er Co. Ian Stewart, Walter C, McCrone Assoc., Inc, Robert Suffis, Mennen Co. John Travers, Avon Products, Inc. Ronald Yakupcin, Kolmar Labs. Norman Estrin, CTFA ' Mr, Sandland opened the meeting and proceeded with the agenda. 1. Collaborative Study 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. Danger's results when applied to their specific products. E X H IB IT WCD-393 Goodhue WCD 000162 -2 - The advantages and disadvantages were discussed in detail of_ engaging in a collaborative study. It was generally felt the study could not be successful if there are restrictions on which talcs can be gathered. Many members favored engaging a collabora tive study. Dr. Estrin suggested a. proposal be put together to be presented to the CTFA 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 . of Mr. Suffis, Mr. Lee and chaired by Mr.. .Sandland. ' 2. Periodic Reporting : The Subcommittee agreed on the success of the presentation of summary reports given to the EDA. Dr. Estrin suggested the Subcommittee should not obligate itself to give periodic reports to FDA 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 FDA with an update on industry analysis. 3. Review of Talc , The planned review of talc by the Miscellaneous OTC Drug Panel was noted. It was suggested CTFA 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 Miscellaenous 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 Dr. Gressel and Dr. Finkelstein to investigate this possibility. 6. Sampling The Subcommittee agreed CTFA should not address the issue raised by Mr. Eiermann and Dr. Schaffner further with the FDA, There being no further business, the meeting adjourned. Norman F. Estrin, Ph.D. Vice President - Science NFEimp Goodhue WCD 000163