Document daqnxK1vYBO98VbZEQnmGL2ob

FILE NAME: Johnson & Johnson (JAJ) DATE: 1971 Aug 13 DOC#: JAJ026 DOCUMENT DESCRIPTION: Confidential Memo RE Talc * c. - . V Subject; Talc CONFIDENTIAL #503 New Brunswick, N.J. August 13, 1971 Dr. R. A. Fuller At the risk of over-summarizing the asbestos-talc situation, perhaps the following will put certain facets in perspective: A. We have analyzed seven separate and distinct samples of talc from Windsor Minerals and two separate samples of baby powder. None were found to contain asbestos. This information was verbally submitted to the FDA in the recent meeting and will be forwarded in writing by Dr. Nashed as soon as all written reports are received. B. Analysis of Grantham talc, the feminine deodorant talc, SHOWER-TO-SHOWER* Powder, and Medicated Powder are underway and should be available very soon. We have recommended that laboratory work be instituted, directed to the removal of Microcel from the latter. G,, The Bureau of Mines expert who testified at the behest of the FDA commented on the pure grade talc in our Windsor mine but mentioned the ore next to the outlying rock could contain asbestos. It is imperative that careful selection of the ore be maintained at the mine. It is always possible that the FDA may inspect the mines and our records. D. Quality Control should bd upgraded and the possible presence of asbestos be determined'on periodic samples. E. We owe the FDA detailed analytical procedures for the presence of asbestos in talc. These should be expedited as we appear to have a good relationship with the FDA, which we wish to continue. F. Dr. Cralley of the U. S. Public Health Service has published his concern, which he stated at the FDA meeting, re metal 'content of talc, particularly nickel: this as a possible carcino gen. We have an unusually high content of nickel in Vermont talc which does not appear amenable to removal, We must delve into this subject, which we thus far have ignored. Protected Document-Subject to Protective Order I EXHIBIT V JNJAZ55_000004804 Dr. R. A. Fuller CU W JiJU JiW TIA L, August 13, 197J G. It is generally accepted that the lung-damaging particles of minerals are below 10 microns. Roughly, we have about 58% of such in our talc. Most of this can probably be removed based on experiments by B ill Ashton and the Colorado School of Mines. Such will affect the character of the finished powder and perhaps alter perfume stability. It is probable that some fines may be regenerated on shipping but such would probably be minimal. Of more concern are our different blending methods in the plants,. Removal of fines would raise production costs! H. Selikoff et al, as Dr. Hildick-Smith has described, raised the bugaboo of talc per se in the lungs. This should and will be studied in animal models as Dr. Hildick-Smith indicated. An attempt must be made to make the test realistic; e . g . , we are , not particularly concerned about constant exposure such as that of talc miners, but rather normal consumer exposure. i i It is probable that all inorganic minerals in small particle size can produce lung fibrosis with massive exposure. Our tests should be realistic--and should probably compare'regular powder with that from wHch the fines are removed since such . fines are generally assumed to be the physiologically active fractions, I. A facet of the situation not yet considered is that of the efficacy of body powder. A considered approach to all "health products" is that of benefit versus risk. While it has generally beep believed that baby powder provides lubricity, thus reducing chaffing, may absorb moisture, etc. , this has not been proven insofar as we know. There have been certain friction tests and water holding tests carried out by various people in R&D in the past but none are really scientifically rigoro.us. What should be considered are studies such as have been carried out on adhesive bandages where it was scientifically and ethically demonstrated that they do aid in healing. Such studies are part of the program Dr. Hildick-Smith alluded to in the fifth . paragraph of his memo of August 10 and must be further discussed. A major objective of the formation of the Central Research Laboratories of the DOC was the carrying out of such basic research. J. Present and incomplete information indicates Grantham talc may contain tremolite. If this is the asbestos-form variety, we may have to reconsider our plans in this mine, The search Protected Document-Subject to Protective Order JNJAZ66_000004906 I 'i ` * - A.- . . CONFIDENTIAL Dr. R. A. Fuller _ -3- 1 August 13, 1971 i for new sources of talc then should be reactivated or at least rsconsidfered. Mr. Ashton is planning this and will need the decision shortly. K. Analysis of our overseas talc will be undertaken by Prof. . Pooley at the University of Wales and the results submitted to Mr. E. Stewart. L. J & J Great Britain has'instituted tracer studies of talc migration in the body at the British Atomic Energy Com mission Laboratories. This was in response to the Tenovus publicity. We will follow this and keep them informed of our work. . M. Finally, now that we have apparently won the first battle, I should like, to acknbwledge the effort of some of those who assisted Dr. Nashed, Dr. 'Hildick-Smith and m yself during the past month. We essentially began from ground zero. , The turning period came from Dr. Sundberg's acquaintance ship with Dr. Puhdsacfc, V ice-President of Research and Development at Johns-Manvil'le. We were given'extensive briefing by Dr, Pundsack and his associates, numerous reports and the names of the experts who- later helped us. Particular recognition should go to Dr. Goudie and Dr. .Rolle and their associates in the Analytical Laboratory, who worked nights and weekends and whose scientific competence provided the basis for the effort. me cc: Mr. W. Ashton Mr. D. R. Clare Mr. J . *T. Dettre Dr. E,. R. L. Gaughran Dr, A. J. Goudie . * Dr. G. Hildick-Smith '.Dr. G. H. Lord Mr. R. Miller - Vermont. Mr. R. T. Mortimer Dr. W, Nashed Dr. F. R. Rolle Mr. W. N. Steinberg Mr. E. 'W. Stewart Mr. H. G. Stolzer Dr. R. L. Sundberg Mr. J. C. Walcott Protected Document-Subject to Protective Order