Document YGBkVmd9ge8er2L6GKB8V67dV

DISTRIBUTION Dr. Mr. Dr. Mr. Mr. Dr. Mr. Mr. -Mr Mr. Mr. Mr. ~ Mr. Mr. Mr. Dr. Dr. Mr. Mr. Mr Mr. Mr. Dr. Mr. Dr. Mr. Mr. Dr. Mr. B. Appino - McNeil H. Ashton A. Braun - Ortho M. Deavenport Heinze Hildick J. Huetteman D. Johnston Personal Products R. Jones - McNeil T. L Kelly F. Kniffen Kramer Marks K. Mesek N. Miller - Windsor Minerals L. Minier Murray W. Nashed R. Petterson L. Radeke P. Rhodes E. Runnells| R. G. Schoel F. to to Schwenker ~ Personal Products K. Morbey P. Seiden Semple L. Steelman - McNeil C. Stites L. Vassar C. Waggoner West 0097658 JNJ 000037293 Johnson Johnson BABY PRODUCTS COMPANY RARITAN N.J. 08869 May 13 1977 SUBJECT TALC NEWSLETTER TO J & J Affiliates The United States has served as an arena for considerable discussion and controversy over answer issues raised J & J has the safety of talc dedicated concerted To effort towards the sponsorship of relevant studies and the communication of relevant information to concerned regulatory and scientific groups These going talc activities are coordinated by the Baby Products Company's Research Department and we hope that this newsletter will provide a useful information summary for our overseas affiliated companies TALC DATA SUPPORTING SAFETY FOR CONSUMER USE 1 & has conducted studies to measure how much talc an infant would inhale during powdering of the diapering area 2 Long term animal inhalation studies have been completed on hamsters with exposures to JOHNSON'S Baby Powder of up to 1700 times the dose received by infants during powdering No effects from these exposures were noted 3 Animal studies also on hamsters show that inhaled talc is cleared from the lung and does not translocate to other body organs 4 A study of of causes deaths amongst Italian talc workers show that even with long duration working exposures to cosmetic grade talc there is no evidence of increase in deaths from cancer TALC STANDARDS & QUALITY 1. The Cosmetics Toiletries & Fragrance Association CTFA the largest toiletry industry trade association in the U.S. - has published a revised raw material standard for 0097659 JNJ 000037294 ot ~ TALC NEWSLETTER cosmetic grade talc which fibrous asbestos minerals of 90 mineral talc specifies no detectable and a typical purity level J has continued to furnish to the U.S. Food & Drug Administration FDA relevant data to support the view .that normal consumer use of JOHNSON'S Baby Powder for body powdering is free from hazard However the FDA has not issued regulations to cover tales used in foods drugs and cosmetics Four advisory panels to the FDA have completed their review of the safety and efficacy of talc as an ingredient in various counter product categories They have all recommended that talcs which do not contain asbestos minerals should be regardeads safe These panels are . Antiperspirant Panel - cosmetic grade talc free of asbestiform fibers in an aerosolized form in anti- perspirant products was regarded as safe Nighttime Sleep Daytime Sedative & Stimulant Panel talc containing asbestos should not be permitted as an inactive ingredient in nighttime sleep daytime sedatives and stimulants Microbial II Panel detectable asbestos was in fungal infections of fungal powder - cosmetic grade talc free of concluded to be safe for use groin the foot and as an anti- Miscellaneous External OTC Drug Products free of asbestos fibers was judged to be lubricant and adsorbent on intact skin Panel safe as talc a The U.S. Food and Drug Administration's Bureau of Foods has concluded that there is safety data supporting the but continued use of talc - has delayed issuance of free of asbestos - in foods regulations pending acceptance of analytical methods for determining the presence of asbestos The Consumer Product Safety Commission has declared household products containing asbestos as a hazard to the public It has banned spackling compounds wall patching mixtures imitation fireplace logs and ashes which contain asbestos Talc containing tremolite was 0097660 JNJ 000037295 mn TALC NEWSLETTER also banned for use in putties and spackling compounds ONGOING REGULATORY STUDII N E U.S S. 1 The U.S. Food and Drug Administration has a sponsored animal study underway to evaluate the inhalation effects of aerosolized tale 2 The National Institute For Occupational Safety and Health NIOSH has been conducting an environmental exposure morbidity and mortality study amongst talc workers in the State of Vermont 3 The Occupational Safety and Health Administration OSHA has contracted the National Bureau of Standards NBS to determine the presence or absence of asbestos in some 88 talc samples TALC SCIENTIFIC PUBLICATIONS The following are important supporting talc scientific papers published in prominent scientific journals Copies may be obtained on request from my office Mortality Studies of Talc Miners & Millers Rubino et al ; Journal of Occupational Medicine Vol 18 1975 The Characterization Rolle et al American Industrial p 295-304 of Talc & Associated Minerals Hygiene Association Journal May 1976 The Biology of Talc G.Y. Hildick British Journal of Industrial Medicine 1976 33 p 217-229 Inhalation Study of Talc Baby Powder by Hamsters Journal Food & Cosmetics Tox No. 2 Vol 15 p Webner et al 121 April We expect several more papers to be published in the next twelve months and will keep you informed by cc Distribution George Lee Director Applied Research 0097661 JNJ 000037296