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The Cosmetic, Toiletry and Fragrance Association, Inc. -- i,;/- t13316th STREET, N.W .. - .. H. Merritt

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Norman F. Estrin. Ph.O. Via, I',ffidenr_'.n.,

TALC ,SUBCOMMITTEE MINUTES,

A meeting of the Talc Subcommittee was held on 15, 1976 at CTFA Headquarters. Those in were:

George Sandland, Bristol-Myers Berdick, Chesebrough-pond's, ' Inc.

Christopher Costello, Colgate-Palmolive George Lee, 'Johnson & Johnson Roderidk Mundy, Sterling Drug Inc. Fred Roesch, Whittaker, Clark & Daniels Joseph Simko, Jr., Terry Smith, Faberge Ian Stewart, Walter C. McCrone Associ'ates I Inc. John Travers, Avon Products, Inc. Norman Estrin, CTFA Anita Curry, CTFA

The meeting opened by critically reviewing submissions made by members of the

Mr.Sandland highlighted the results of the Friday meeting with the Food and Drug Administration. 'Mr. Lee also summarize4 his letter descrxbing Dr. results.

The meeting adjourned to reconvene at FDA.

The Talc Subcommittee reconvened at FDA On March 15,. at HOO p.m. Those in attendance from industry were:

George Sandland, Bristol-Myers Murray Berdick, Chesebrough-Pond's Christopher' Costello, Colgate-Palmolive George Lee, Johnson & Roderick Mundy, Sterling Drug Inc. Fred Roesch, Whittaker, Clark & Daniels

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Joseph Simko, Jr., Colgate-palmolive Terry Smith, Faherge . Ian Stewart, Walter C. McCrone Associates, Inc. John Travers, Avon Products, Inc. Norman

Those in attendance from FDA .were:

Henry Davis Heinz Eiermann Martin Greif Robert Schaffner John Wenninger Ronald Yates

The meeting opened with a brief description of the purpose of the meeting. A letter and attachments. prepared by .cosmetic manufacturers and suppliers submitted to FDA.· Sandland asked each member to summarize verbally the content of his letter.

Mr. Eiermann·reported samples have not yet been received by FDA and noted that FDA plans t9 provide Dr. Lang'er with samples collected by FDA in 1975.

Dr. Estrin requested code numbers be identified to '.ensure th,? samples collected represent current· production. Mr •. Eiermann read the code numbers for products from Avon, Chesebrough-Pond, Colgate-Palmolive, Helena Rubinstein and Sterling Drug. He af·terwards provided the code numbers for The Mennen Company.

Dr. schaffner advised inclusion of .a chrysotile method in the CTFA Standards. Dr. Stewart responded he ha·s not. found· chrysotile with ins-q:-umen·tation having a sensitivity.of 2%. It was noted with instumentation having a sentivitity of a half· a percent chrysotile also had not been found. .

Mr.- Eiermann reported on FDA's analysis of 76 samples of talc products; no dete.ctable findings of·chrysotile by optical microscopy· or tremolite by DTA were · reported.. .

Mr. Sand land noted the expected publication in the near future. of a revised standar.d for talc. ·The possibility was suggested that suppliers would afix a tag noting that their talc was CTFA grade.

Mr. Eiermann discussed the prQblems involved in deVeloping a statistically significant sampling plan for talc.· Mr. Roesch noted the history of the mine source is very importa·nt and he was confident in the sources used to provide talc· to the cosmetic industry. Mr. Eiermann agreed the data provided today gives the

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FDA assurance of the purity talc, but he needed information as to what universe these results represent. He how one could, be assured that the results would represent tomorrow's tales or those produced a year from now. He asked rhetorically, how do'you control tales. ·' By 'regulation. How many samples 'would be , required. What would be the, frequency of sampling. Would compositEls be , ,desirable. Dr. Berdick stated categorically it was not; . feasible to develop a statisticaliy valid samplinq plan for 'talc. Dr. Estrin expressed that after ' reviewing nearly 4,000 analyses provided at this meeting,. FDA would need

Dr. Schaffner echoed Mr. Eiermann's recommendations that an adequate sampling plan be developed for quality assurance for talc. Mr. Sandland suggested if FDA considered all the tales tested as being in one lot, .the fact becomes apparent that no sa'!Jlpie 11a5 , given positive results Dnd this is a fact of very great statistical signif'icance. . Dr. Schaffner ' and Mr. Eiermann noted the oversight hearings taking plaoe 'today and t he fact :that talc would be dis,oussed , at those meetings and the pressures that they are under to develop such an approach. In addition. Dr. Schaffner gave as analogies the speCifications f or botulism in food and pesticides in food. Dl!'. Berdick responded those very exatnples show ' that , FDA relies on reports from industry on their praotices rather. than .r equiring statistical sampling of food products. Dr., Schaffner suggested the possibility of having industry report periodically on the results of ,its analy.ses to the FDA. Dr. Estrin responded the subcommittee would give serious consideration to this suggestion. Dr. Schaffner noted the FDA is considering using the information SUbmitted by industry together with its own data to prepare, a press release. .

There being no further business, the meeting adjourned.

Norman Estrin, Ph.D. Vice President - Soience

NFE:MP March 18, 1976