Document XR16KzYmdKJxOnQm50jRQV7qR

~~ BABY PRODUCTS COMPANY RARITAN, N.J. 08869 June 15, 1977 SUBJECT: Talc Advisory .TO: Distribution Review Meeting The Talc Advisory Group met on June 8th in the J & J East Research Conference Room with the following in attendance: Mr. w. H. Ashton Mr. G. Heinze -Dr. G. Hildick-Smith Mr. A. J. Huetteman Dr. L. L. Kaplan Mr. G. Lee Dr. G. H. Lord Dr. J. R. Marshall Dr. w. Nashed Dr. F. R. Rolle Dr. J. P. Schelz Dr. B. Semple Dr. w. C. Waggoner 1. Lovelace Study Update Dr. Waggoner reported that Dr. G. Thompson of the FDA agreed to exchange copies of all the Lovelace Progress Reports for a copy of our Battelle Deposition Study final report. These reports have since been furnished to Dr. Waggoner by June 14th. Bill Waggoner summarized the status of this study as coin6iding with the Mokler summary to G. Lee. Dr. Rolle expressed doubts as to the accuracy of the talc quantitation methodology which relies on magnesium determination. 2. Battelle Macrophage Study Dr. Semple informed the group that the budget of this project has been increased by a few thousand dollars. A full review report is e.xpected shortly. 3. OTC Mi~c. External -Talc Panel Dr, Semple had no further developments cerning the Panel's preparation to FDA. of its to report conformal submission 7W-10 JNJ 0002CI0462 -2Talc Advisory Review Meeting 4. NIOSHMorbidity Study No further information has been received from NIOSH concerning the final report of the Mortality Study. Dr. Hildick-Smith has not learned any new information from Drs. Peter or Weigman on the Morbidity study and will check with Dr. Kleinfeld whether there have been any further developments. G. Lee will follow up on Vernon Zeitz and his analysis pulmonary data. of the Windsor 5. OSHA/NBSAsbestos-in-Talc Status Mr. Ashton brought the group up to date on the NBS testing which concluded that the OSHA/NIOSHprocedure for examination is useful only for determining "fiber" content and not rasbestos" content. No J & J affiliated consumer products were included in the sampling. NBS is organizing a Workshop in Washington July 18-20/77 on "Asbestos: Definitions and Measurement Methods". The program will include a session on "Relationship between Chemical & Physical Properties and Health Effects" with Selikoff-Langer and Stanton as speakers. Krause and Ashton will- deliver a paper on "Misidentification of Asbestos in Talc". G. Lee will convene a task group consisting of HildickSmith, Rolle, Ashton and Lee to plan and organize coverage, fact presentation during discussions, etc. MRCtremolite data needs to be surfaced. G. Lee will contact Dr. N. Estrin and coordinate. representation under the banner of the CTFA. J & J will maintain low visibility on asbestos discussions. 6. CTFA Talcum Product Round Robin Dr. Schelz outlined the status wherein Mt. Sinai has refused to use the CTFA methods. Their written report using Sinai methods has not been received. A retest has been agreed to amongst the company participants and samples will be mailed on or around June 10th. Elaborations of the step II procedure have been prepared for th~s retest. JNJ 000250463 ,I -3Talc Advisory Review Meeting 7. JBP Communication Literature Dr. Waggoner reported on: a) al page Talc White Paper has been prepared for the CTFA at their request. b) the draft of the professional brochure has been restylized and is being held in readiness for publication after the FDA OTC talc monograph has been ;issued. Photographs are in the process of preparation. c) the desirability of providing FDA with a package of safety data for JOHNSON1 S Baby Powder was unanimously supported. Dr. Waggoner will talk to FDA on the concept of providing a data package which th~y can furnish to inquirers on request. This packet will consist of published papers and a,rticles, d) Dr, Waggoner will be sending to the FDA, copy of the Langer ''Consumer Talcuin Products'' paper with the two rebuttals from Dr, Hildick-Smith and Dr. Krause 8, JBP Baby & Adult Exposure Study The Advisory group agreed that this published, but needs to appear as an to the Battelle Inhalation Study for establishing multiples of safety. study should be adjunct study the purpose of G, Lee will coordinate prep~ration of this paper. 9, Francis Roe Editorial Dr. Hildick-Smith discussed Dr, Francis Roe's proposed talc editorial for the L~ncet, Suggestions for amend- ments were to be presented through Dr. Hildick-Smith. George /by JNJ 000250464 .. DI S TR I BUT I ON Dr. J.B. Appino - McNeil Mr; W. H. Ashton Dr. G. A. Braun - Ortho Mr. W.R. Dean - J&J England Mr. S. P. Falk Mr. G. Heinze Dr. G. Hildick-Smith Mr. A. J. Huetteman - Personal Products Mr. D. D. Johnston Mr. W.R. Jones - McNeil Dr. L. L. Kaplan Mr. C. E. La Rosa Dr. G. H. Lord Dr. J. R. Marshall Mr. R. N. Miller - Windsor Minerals Mr. J. Murray Dr. W. Nashed Dr. D.R. Petterson Dr. F. R. Rolle Mr. A. P. Ruffo - J&J Canada Mr. R. F. Schwenker to Dr. G. K. Morbey - Personal Products Dr. B. Semple Dr. T. H. Shelley Mr. R. L. Steelman - McNeil Mr. R. C. Stites Dr. W. C. Waggoner JNJ 000250465