Document ZJp6ZO0qOVExYyQNQmDkV2Q48

FILE NAME Talc TALC DATE 1973 June 4 DOC TALC074 DOCUMENT DESCRIPTION Letter to the FDA from Barry Castleman 202 332-6000 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1779 Church Street N.W. Washington D.C. 20036 June 4 1973 Food and Drug Administration Bureau of Drugs OTC Drugs Products Evaluation 5600 Fishers Lane Rockville MD 20852 Staff 109 OTC Drug Review Contraceptives Vaginal Drug Products and Other IV Human Safety Data on Talc VI A. Individual Active Components 5. Pertinent Medical and Scientific Literature 2 Henderson W.J. et al Talc and Carcinoma of the Ovary and Cervix J. Obstet Gyn Brit Comm 78 266 1971 b Blejer H.P. and Arlon R. Tale a Possible Occupational and Environmental Carcinogen J. Occup Med 15 92 1973 Summary Statement is commonly used in the manufacture and packaging of condoms and diaphragms Henderson's study revealed the presence of talc deeply imbedded in the majority of primary malignant ovarian and cervical tumors examined The fact that these researchers could not find talc in thorough studies of a secondary tumor and the fact that no asbestos was found in any of the tissue studied support the hypothesis that talc per se nad a role in causing malignancies to develop Blejer and Arlon develop the hypothesis of tale carcinogenicity in their recseinmtilalriitteyratbuerteweernevtiaelwc and citing the strong chemical certain asbestiform minerals which have been proven to be carcinogenic agents One problem in trying to isolate the effects of pure talc is the fact that most talc deposits and talc products contain traces to large fractions of tremolite asbestos On August 12 1972 the FDA proposed to ban the use of asbestoscontaining talcs in the preparation and packaging of foods Federal Register v 37 no 157 It would OTC Drugs Products Evaluation Staff 2 certainly be appropriate to ban the use of asbestoscontaminated talcs in contraceptives other vaginal drug products and cosmetics immediately In view of Henderson's report and some points made by Blejer and consider that talc Arlon there per se is a is clearly reason to possible carcinogen In view of this it would be prudent to minimize the introduction of bearing contraceptives into the vagina where the talc may easily find its way to prime cancer sites As talcum cosmetic powders when used by females and males and vaginal sprays are additional sources of talc insult to the female genital tract it is obvious that FDA's findings and actions on talc both pure talc and contaminated talc in contra- ceptives will have direct implications for talc in cosmetics Sincerely yours Barry Castleman Michael Jacobson