Document 53KM6b71x8rekLkQ967Y2mV0

FILE NAME: Johnson & Johnson (JAJ) DATE: 1974 Sept 6 DOC#: JAJ008 DOCUMENT DESCRIPTION: Letter from J&J to the FDA SEP 9 19f4 G. LEE 'V M c n N E W B R U N S W IC K . N. J. 0 6 9 0 3 S eptem ber 6, 1974 R obert M. S chaffner, Ph. D. A ssociate D ire c to r for Technology Bureau of Foods Food and Drug A dm inistration D epartm ent of H ealth, Education, and 200 "C " S tr e e t, S. W. W ashington, D. C. 20204 W elfare D ear D r. Schaffner: Johnson & Johnson has been cooperating with the C osm etic, T o iletry and F ra g ra n c e A sso ciatio n Subcom m ittee on A sbestos in T alc. In an e ffo rt to an sw er the question about the re q u ire d degree of sen sitiv ity of the m ethod of a ssa y fo r asb esto s in ta lc , our sta tistic a l group has m ade an estim ation of a th e o re tic al safe level of a sb e sto s fib e r in a baby pow der utilizing the o fficial TLV for asb esto s and the data on dusting of baby pow der. The calculation shows th at a su b stan tial safety factor can be expected w ith talc c o n ta in in g 1% w /w a s b e s to s f i b e r s . T h e r e f o r e , m e th o d s c a p a b le of d e te r m in in g l e s s th a n 1% a s b e s to s in ta lc a r e n o t n e c e s s a r y to a ssu re the safety of cosm etic talc. The re p o rt is attached herew ith. Since I have been assig n ed a new function at o u r R e se a rc h C enter, I w ill be tu rn in g o v er m y resp o n sib ility in the ta lc /a s b e sto s a re a to the R e s e a rc h D ivision of o u r Baby P ro d u cts C om pany. I would a p p re c ia te y o u r giving m e the o p p o rtu n ity to p e rs o n a lly p re s e n t th em to you and y o u r s ta ff to a s s u re a co n tin u atio n of the co o p erativ e effo rts of Joh n so n & Johnson in this difficult p ro b lem . The follow ing individuals fro m our Baby P ro d u cts Com pany w ill be Dr. R. Schaffner - 2- Septem ber 6, 1974 a v ailab le fo r a m eetin g to be s e t a t y o u r convenience: D .R . P etterso n , Ph. D. , V ice-P resid en t, R esearch B. Sem ple, M. D. , D irecto r of M edical and R egulatory A ffairs G. L ee, M anager of A pplied R esearch W. C. W aggoner, Ph. D. , A dm inistrator of M edical and R egulatory A ffairs. I hope to h e a r fro m you soon. V ery truly yours, JOHNSON & JOHNSON vra/cw A ttach. . Ni '.- 'V by: W. N ashed, Ph. D. A ssociate D irector of R esearch D om estic O perating Company bcc: D r. A. Goudie D r. G. K ildicli-Sm ith M r. G. L e o ^ - --- -4SSC M r. J . M elton D r. D. P etterso n D r. R. Rolle D r. T. Shelley M r. G. M iller M r. R. M iller, W indsor M inerals M r. W. D ean, J& J G re a t B rita in D r. B. Sem ple D r. W. W aggoner AttachCount BegAttach Confidentiality Custodian DateMod DocExt EndAttach F ile N a m e FileSize PgCount ProdVol Text Path JNJ000240291 Metadata 1 JNJ 000240291 N Legacy 1 09/06/1974 12-00 AM T IF JNJ 000240296 K 000076563.TIF - K000076564.TIF 0 00 2 TALC_GLOBAL_002 TEXT\0235\JN J 000240291.txt O RIG INAL O R IG IN AL O R IG IN AL O RIG INAL O R IG IN AL O R IG IN AL O R IG IN AL O R IG IN AL O R IG IN AL O R IG IN AL O R IG IN AL O RIG INAL