Document rx4zw3Gg2jLKJvaEDRjVNEBQv

FILE NAME: CTFA (CTFA) DATE: 1976 March 15 DOC#: CTFA029 DOCUMENT DESCRIPTION: Letters between CTFA & J&J The Cosmetic, Toiletry and Fragrance Association, Inc. 1133 16th ST R E T . N.W.; W ASHINGTO N, D C. 2Q05 -202/331-1770 - T E L E X 69-2673 h Klnrtsn Pns.d-.-at Norman F. FNtrin. ph.p, W ee Prcst le.: -- 5 l * vicc- 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. Eierniann -- --- 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. The 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 .contamination by asbestos form materials of cosmetic talc products. Individual companies are more, than willing to discuss the detailed data with you at your convenience. Cordially, NFE:jj '' Attachments I BABY PRODUCTS COMPANY ' NEW BRUNSW ICK. N J 0 S 0 3 March 15, 1976 Dr. Norman F. Estrtn Vice President - Science Cosmetic, Toiletries, and Fragrance Association 1133. 15th Street, .W. Washington, D.O. 20005 Re: Examination for Asbestos In Talc Dear Dr. Estrin: The taic which is used by Johnson s Johnson is solely derived from its own min in Vermont, where the ore i,s mined selectively and thenbeneficiated 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.j Johnson & Johnson has always bren concerned about the mineralgica! integrity of its talcs and even its earliest sped-, fications have required the examination for acicular .particulates,; When it was erroneously reported in 1971 that our powder contained asbestos, we-sponsored a scientific seminar of mineralogical and analytical experts for the FDA to. prove that our talc is not con taminated with asbestos. At that time numerous funnies were analyzed b y .experienced Consultants such as McCrone Associates. Colorado School of Mines, Professor F. D. Pooler (of the University College, Cardif f),, Professor G. Brown (of Pri neeton 1 and Professor M-i Buerger (of M.-I.T.). These examinations incJuded X-ray diffrac tion analysis, differential thermal analysis, and transmission electron microscopy.- During the period December 1972 to October 1973, 93 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, Estuili C.T.F.A. 2- March 15, 1976 Beginning in October 1973, differential thermal, analysis was added to our1 s'pec.ified requirement. Both, differential thermal analysis and X-ray diffraefometry were instituted for the routine examination of sequential lots. A further 100 lots have since been examined;' applying both methods to eadh sample. Again, no amphibole or ser pentine minerals have been detected, I would like t6 advise that we are.continuing to employ differential. ' thermal. analysis'and X-ray dif fraetofiietry 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 oiir Johnson & Johnson affiliates, employing these same techniques. Fihally, let me add that periodically, we also submit sub-samples for Transmission Electron Microscope examination and these have always verified the absence of asbestiforin minerals. It is oiir understanding that'you would wish to submit this information to the FDA. Please regard this letter as. non-confidential. Sincerely yours. GL/mm George Lee Director of Applied 'Research