Document LKmXoKy9BqVvLKXZpDdzwDGGd

BABY PRODUCTS COMPANY Johnson . DRAFT CERTIFIED MAIL RETURN RECEIPT 2809 REQUESTED RARITAN N. J. 08869 June 29 1977 Robert M. Schaffner PhD Bureau of Foods 400 Food and Drug Administration 200 C Street Washington DC 20204 Dear Dr. Schaffner We enclose copies of an article and two commentaries respectively ' @ @ Rohl AN AM Langer IJ Selikoff A Tordini and Klimentidis Consumer Talcums and Powders Mineral and Chemical Characterization Toxicol Environ Health 255-294 1976 Hildick G Safety of Consumer Cosmetic Talc Products J Toxicol Environ Health 1221-1222 1977 e Krause JB Mineralogical Characterization of Cosmetic Talc Products J Toxicol Environ Health 1223-1226 1977 initial initial initial In the original article Rohl et al indicated that the disease potential of consumer talc products is . investigation Whereas review unknown and needs That states the available N data indicates normal usage of cosmetic grade talc by the consumer is not a hazard to health JNJ 000260274 2810 : initial initial In his commentary concerning the original article i Krause said it is therefore apparent that the stated major purpose of their paper namely to determine the mineralogical and chemical composition with particular emphasis on the quantitative determination of tremolite anthophyllite serpentine minerals and quartz has not been achieved Accordingly the results reported are without analytical basis and the conclusions drawn are invalid and misleading This information is forwarded in the continuing spirit of cooperation of Johnson & Johnson for helping to answer any questions on cosmetic talc Thank you Respectfully yours clj Wm C. Waggoner PhD Manager Medical and Regulatory Affairs JNJ 000260275