Document 6B5MxeMXozzyqjv1BLR8GJdk4

FILE NAME: Talc (TALC) DATE: 1973 June 4 DOC#: TALC074 DOCUMENT DESCRIPTION: Letter to the FDA from Barry Castleman /> ^ -r (202) 332-6000 CENTER FOR SCIENCE IN THE PUBLIC INTEREST 1779 Church Street, N.W. Washington, D.C. 20036 June it, 1973 Food and Drug Administration Bureau of Drugs ,+ 0TC Drugs Products Evaluation Staff 56OO Fishers Lane, Rockville, MD 20852 ino) (BD-iuy; OTC Drug Review Information-Contraceptives and Other Vaginal Drug Products ' IV. Human Safety Data on Talc A. Individual Active Components 5 , Pertinent Medical and Scientific Literature, a. Henderson, W.J. et al, "Talc and Carcinoma of the Ovary and Cervix," J. Oustet. Gyn, Brit. Comm,, 1 971 b. Bleier, H.P. and Arlon, R., T_alc t a, Possible Occupational and Environmenxal Carcinogen*" J Occup. Med,, JLl* i-ffj* VI. qummarv Statement-- Talc is commonly used in the manufacture and packaging of condoms and diaphragms. Henderson- s study revealed the presence o f n imbedded in the majority of primary malignant o/arian and cervical tumors examined. ihe fact tnat researchers could not find talc in nf a secondary tumor, and the fac 0 that no 'q s foSnd in L y of the tissue studied support ,the hypothesis that talc per se naa a roie in u u o i 6 malignancies to develop. Bleier and Arlon develop the hypothesis of talc carcinogenicity in their recent literature review, citing the strong chemical similarity between eaxe ana certain asbestiform minerals (which have been proven to be carcinogenic agents). One problem inprying to i-nlate the effects of pure talc is the fact that most talc deposits and tale produets con^in traces to large fractions of tremolite asbestos. On august 12, 1972 the FDA proposed to ban the use of aspe^tos containing talcs in the preparation and packaging of foods (Federal Register v, 37 no. 157) woul OTC Drugs Products Evaluation Staff--Page 2 certainly be appropriate to ban the use of asbestOo-- contaminated talcs in contraceptives, other vaginal drug products, and cosmetics immediately In view of Henderson's report and some points made by Blejer and Arlon there is clearly reason to consider that talc per se is a "possible carcinogen. In view of this it would be prudent to minimize the introduction of talc-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 asbestos-contaminated talc) in contra ceptives will have direct implications for talc m cosmetics Sincerely yours, Barry Castleman Michael Jacobson