Document NxwxxRqV9nn792VMpz25o4nV

y !'i ttySs. (j Vj'U> J jIL u jh e Cosmetic, Toiletry and Fragrance Association, Inc. 133 15lh STREET, N.W., WASHINGTON, D.C. 20Q0S- 202/33M770 TELEX 89-2673 James H. Merrill P ietltienl Norman F. Eslrln, Ph.D. Vico P ret/dont--Seienco TALC SUBCOMMITTEE MINUTES 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 John Facq, Colgate-Palmolive Allan Harvey, R.T. Vanderbilt Co., Inc. George Lee, Johnson & Johnson Ray Krammes, Whittaker, Clark s Daniels Roderick Mundy, Sterling Drug Inc. Louis Murino,'Cyprus Industrial,Minerals Fred Roesch, Whittaker, Clark & Daniels Robert Rolle, Johnson & Johnson Joseph Simko, Colgate-Palmolive Terry Smith, Faberge . Harold Stanley, Charles Pfizer 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. Langer's results when applied to their specific products. CONFIDENTIAL PFI MO 00001785 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 FDA.. 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 Th 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