Document NG5xbRDNDJqvvgob3d94b566E

FILE NAME: CTFA (CTFA) DATE: 1976 Mar 15 DOC#: CTFA029 DOCUMENT DESCRIPTION: Letters between CTFA & J&J The Cosmetic, Toiletry arid Fragrance Association, Inc. 1133 16th STREET. N.W.; WASHINGTON. O.C. 20005 502/331-1770 * TELEX 63-2671 JjmKr H KonM Pns.titM Noirnan F, Fstrin. *h.D. Pri*it 'e.: March 15th, 1976 Mr. Heinz J* Eiermann Food and Drug Administration 20 C Street, S.W. . Washington, D,C. 20204 On March 11th, 1976, Mr. Eiermann - t-- the CTFA Talc Subcommittee met to discuss the current sta tus of talc. It was recognized that a need exists co bring to your attention a profile of the analyses for asbestos form materials in talc used in the U.S. production of cosmetics and toiletry products. Th attached letters demonstrate responsibility of industry in.monitoring its talcs. We re certain that, th summary will give, you assurance as to. the freedom from con temintimi by asbestos form materials of cosmetic talo products. Individual companies are more, than willing to discuss the detailed data with you at your convenience. Norman F. Estrin, Fh.D. Vice President - Science NFE jj Attachments BABY PRODUCTS COMPANY NEW BRUNSWICK. N J 081X03 March 15, 1976 Dr. Norman f . Estrin Vice President Sdiene Cdsmetic, Tdiifetrj.es', and Fragrance Association 1133. 15th St r e e t , fi.WWashington, D.C. 20005 Re: Examiriation for Asbestos In Talc Dear Dr. Estrin: The talc which is used by Johnson & Johnson is solely derived from its own mine in Vermont, where the ore i,e mined selectively and t h e n beneficiated by the process of flotation. Shipments of this highly purified talc are routinely examined by our own laboratory to verify the absence of asbestos minerals* Historically* Johnson & Johnson has always been concerned about the mineralogical integrity of its. talcs and even its earliest s p e d - , fications have required the examination for acieuJLar .particulates.; When it was erroneously reported in 1971 that our powder contained asbestos, we. sponsored a scientific seminar of mineralcgical and analytical experts for the FDA to. prove that our talc is not con taminated with asbestos. At that time humerous samples were analyzed by experienced consultants s.uch as McCrone Associates. Colorado School of Mines, Professor B*. D. Pooley (.of the University College, Cardiff); Professor G. Brown (of Pri nee ton 1 and Professor M-i Buerger (of These examinations incJuded X^-ray diffrac tion analysis, differential thermal analysis, and transmission electron microscopy.- . During, the period December 1972 to October 1973, 03 lots were indi vidually sampled and.examined by X-ray diffractometry for the presence of asbestos minerals. No amphiboles or serpentine minerals were* detected in any sample. Dr. N. F, Estrin C.T.F'.A. ;i -2- March 15, 1976 Beginning in October 1973, differential .thermal analysis was added to our specified requirement; Both, differential thermal analysis, and X-ray diffraetometry were instituted for the routine exarninatibn of sequential lotis. A further 100 lots have since been examined," applying both methods to. eadh sample. Again, no Arnpfaibole or ser pentine minerals have been detected, I would like t advise that vieare. continuing to employ differen thermal analysis and X-ray diffractoftietry in the examination of sequential lots for the detection of amphibole and serpentine min erals. . It should be pointed out that we also maintain a worldwide monitoring of talcs used by our Johnson & Johnson affiliates, employing those same techniques. Fihally, lefriie add that periodically, we. also submit sub-samples for Transmission Elctron Microscope examination and these have always verified the absence of asbestiform minerals. It is our understanding that you would wish to submit this information to the FDAi Plea& regard this letter as. lion-confidential. Sincerely yours., GL/mm George Lee Director of Applied Research