Document v6GadNJ5QvKRME7arOvQx8aoE

BABY PRODUCTS COMPANY N E W B R U N S W I C K , N. J. 0 8 9 0 3 November 15, 1974 Robert M. Schaffner, Ph.D. Associate Director for Technology 'v Bureau of Foods Food and Drug Administration Department of Health, Education, and Welfare 200 "C" Street, S.W. Washington, D.C. 20204 Dear Dr. Schaffnerj My colleagues and I at Johnson & Johnson would like to thank you and your staff for the meeting last Wednesday. I have always believed that face-to-face discussion leads to a better understanding and interpretation of different points of view. As Dr. Hildick-Smith indicated, we have received the Italian version of the paper presented by Dr. Rubino. Currently, it is undergoing translation and we would hope to have both the Italian and the translation to you by the end of the month. We believe this study addresses the direct question of the safety of talc inhalation over long term exposure periods in humans. Thank you again for the opportunity to meet you, and please extend our appreciation to your staff as well. Very truly yours, D. R. Petterson BABY PRODUCTS COMPANY N E W B R U N S W IC K , N. J. 0 8 9 0 3 April 3, 1975 CERTIFIED MAIL Robert M. Schaffner, PhD HFF-400 Bureau of Foods Food and Drug Administration 200 "C" Street, S. W. Washington, DC 20204 Dear Dr. Schaffner: In coni' inued cooperation with the Food and Drug Administration on informal ional exchange regarding the talc question, we have learned th^t a paper on Dr. G. F. Rubino's epidemiological study with Itali^n cosmetic talc miners and millers will be presented on April lfw 1975 at the San Francisco Hilton *during the American Industrial Health Conference. As soon as a copy of the paper, Tt1_ rnnftiins the main epidemiological data, is made available to us, we will forward it for your review. We also note that during the same conference Dr. L. J. Fine of Harvard will be presenting a paper, "Respiratory Morbidity in Talc Workers", providing data on pulmonary function of industrial rubber worKons who have been exposed to a combination of industrial arade talc n(3 organic solvents. Discussions with the Harvard roue e n a b ) ^ us to have a sample of the mineral powder analyzed and this w?*3 shown to contain only 42 percent talc. C o n c e r r h n<9 these studies we point out the vast differences in ^he nature of material, to which the populations of each, respectively L From the program there appear to be no other talc WrSel?aced ^paI^.vvrs other than the two described above. We trust this informatics W1H be useful. Respectfully yours, JOHNSON & JOHNSON Baby Products Company ttAt.C* ------- Wm. C. Waggoner, PhD Administrator Medical and Regulatory Affairs ~- / Certified Mail Return Receipt Requested BABY PRODUCTS COMPANY N E W B R U N S W I C K , N. J. 0 8 9 0 3 July 22, 1975 Robert M. Schaffner, PhD Hff-400 Bureau of Foods Food and Drug Administration 200 "C" Street, S.W. Washington, DC 20204 Dear Dr. Schaffner: On July 9, 1975, representatives of Johnson and Johnson participated in an industry presentation under the auspices of the Cosmetic, Toiletry & Fragrance Association at an open session of the FDA OTC Antiperspirant Advisory Panel. Data attesting to the safety of cosmetic talc was presented. In support of the presentation, the appended volume, containing relevant information on the safety of cosmetic grade talc in both dusting powder and aerosols, was given to the panel. You will note that the volume contains copies of several letters written to you on prior occasions. These letters were included because they gave appropriate explanation and identification to several of the accompanying documents and to other material previously submitted to your office. This information is forwarded in a spirit of continuing cooperation. Respectfully yours, JOHNSON & JOHNSON Enclosure Wm. C. Waggoner, PhD Administrator Medical & Regulatory Affairs 3 Y PRODUCTS COMPANY Ji January 8, 1976 N E W B R U N S W IC K . N. J O S9 0 3 Robert Schaffner, PhD Bureau of Foods HFF-400 Food and Drug Administration 200 "C" Street Washington, D.C. 20204 Dear Dr. Schaffner: Pursuant to the June 25, 1974, letter from Johnson Johnson, a copy of the final report entitled, "Investigation of Effects of Inhaled Baby Powder in Hamsters", is transmitted to your office in continuing cooperation on informational exchange regarding the talc question. Respectfully yours Wm. C. Waggoner, PhD Manager Regulatory Affairs /-AT-7C