Document b60mJJ8NJ5NQVvBN5mRZeY7k

FILE NAME: CTFA (CTFA) DATE: 1974 Sept 6 DOC#: CTFA035 DOCUM ENT DESCRIPTION: Letter from J&J SEP 9 19/4 G. LEE /i/vmm N E W B R U N S W IC K . N. J. 0 8 9 0 3 Septem ber 6, 1974 Robert M. Schaffner, Ph. D. A ssociate D irector for TechnologyBureau of Foods Food and Drug Adm inistration Departm ent of Health, Education, and W elfare 200 "C" S treet, S. W. Washington, D. C. 20204 Dear Dr. Schaffner: Johnson Sc Johnson has been cooperating with the C osm etic, TToalicle. tryInaannd eFfrfaogrtraton caensAwsesor ctihaetiqouneSstuiobncoambmouittttehee orne qAusibreesdtodseginree of sensitivity of the method of assay for asbestos in talc, our statistical group has made an estim ation of a theoretical safe level of asbestos fiber in a baby powder utilizing the official TLV for asbestos and the data on dusting of baby powder. The calculation shows that a substantial safety factor can be expected with talc containing 1% w /w asb esto s fib e rs. T h erefo re, m ethods capable of determ in ing le ss than 1% asbesto s in talc a re not n e c e ssa ry to assure the safety of cosm etic talc. The report is attached herewith. Since I have been assigned a new function at our R esearch Center, I will be turning over my responsibility in the talc/asbestos area to the R esearch Division of our Baby Products Company. I would appreciate your giving me the opportunity to personally present them to you and your staff to assure a continuation of the cooperative efforts of Johnson & Johnson in this difficult problem . The following individuals from our Baby Products Company will be Dr. R. Schaffner -2- September 6, 1974 available for a m eeting to be set at your convenience: D.R. Petterson, Ph. D ., V ice-President, R esearch B. Semple, M. D. , D irector of Medical and Regulatory Affairs G. Lee, M anager of Applied R esearch W. C. W aggoner, Ph. D. , A dm inistrator of M edical and Regulatory A ffairs. I hope to hear from you soon. Very truly yours, JOHNSON & JOHNSON Vjvj M by: W. Nashed, Ph. D. Associate D irector of Research Domestic Operating Company w n/cw Attach. bcc: Dr. A. Goudie Dr. G. HLldick-Smith M r. G. ---------------4BSC Mr. J. Melton DDrr.. DR.. PReotlltee rso n Dr. T. Shelley Mr. G. M iller M r. R. M iller, "Windsor M inerals M r. W. Dean, J&J G reat B ritain Dr, B. Semple Dr. W. Waggoner A ttachC ount B e g A tta c h C o n fid en tiality C u stod ian D ateM od DocExt E ndA ttach FHeNam e FileS ize PgCount P ro d V o l T e x t 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 RIG INAL O RIG INAL O RIG INAL ORIG INAL O RIG INAL O RIG INAL O RIG INAL O RIG INAL O RIG INAL O RIG INAL ORIG INAL