Document QXMLaKYwZOjyYwV1NbMQbjqV4

DEPARTMENT OF HEALTH & HUMAN SERVICES 8 FEB 1983 Public Heaitn Service Foo and Drug A dm inistration W ashington DC 2 0 2 0 4 Joan M. Pankey Sup ervisor, Cancer Inform ation Service The John Hopkins Oncology Center Cancer Communications Network O ffice 550 North Broadway Baltim ore, Maryland 21205 Dear Ms. Pankey: This re p lie s to your le t t e r dated January 14, in which you request in fo r mation regarding the potential re la tio n sh ip of talcum powder to lung and ovarian cancer as well as inform ation we have on studies concerning the potential lung cancer hazard o f inh a lin g asbestos contaminated talcum powder. As you are probably aware, exposure to asbestos has been linked to cancer o f the lungs. The matter o f contamination o f ta lc with fib rous asbestos was e xte n siv e ly study . by both the Food and Drug Adm inistration (FDA) and in d u stry in the mid to la te 1 9 7 0 's. We have no knowledge o f any cosmetic talcum powder product on the market that contains fib ro u s asbestos. Nor do we have any inform ation or data which in d ic a te s that p resently marketed cosmetic t a lc preparations are unsafe when used as directed. While we are well aware that ta lc i s chem ically c lo se ly related to asbestos, ta lc needles are not known to cause harm or to present a hazard to health when ta lc containing baby powder and face powder are used under customary cond itions o f use or as directed on th e ir la b e ls. With regard to your question to the re la tio n s h ip between ta lc and ovarian cancer, our s c ie n t is t s in our D iv is io n o f Toxicology have reviewed th e ir f i l e s and do not fin d any lit e ra t u r e on t h is top ic. A statement was found in a chapter in "Chemical Carcinogens", C.E. Searle, ACS Monograph 173, Washington, DC (1976) that mentioned ovarian tumors and asbestos. It stated "P rospective surveys o f occupational groups exposed to asbestos have in general shown a small excess r is k o f some other types of cancers (in a d d itio n to bronchial and m so th lia l), e sp e c ia lly those of the g a s tro in te stin a l tr a c t and ovarian tumors. The excess o f these tumors i s r e la t iv e ly small compared with that fo r'b ro n c h ia l cancer". No reference was given fo r t h is statement, however. Page 2 - Joan M. Pankey The In te rn a tio n a l Agnecy fo r Research on Cancer evaluated asbestos in 1976 (IARC Monograph - V o l. 14). No reference was made to any re la tio n sh ip between ovarian cancer and asbestos exposure in th is report. A lit e ra t u r e search on asbestos was performed by the Environmental Protection Agency in 1978 and you may wish to purchase a copy from the National Technical In f o r mation Service (NTIS) 5285 Port Royal Road, S p rin g fie ld , V irg in ia 22161, phone number (.703) 487-4630; (order number PB-286-486 - Asbestos, a b ib lio g ra p h y). You may a lso wish to run another lite ra tu re search to id e n tify more recent a r t ic le s . For your perusal, we are enclosing a number o f documents which reviews the state o f our knowledge re la tin g to the health e ffe cts of ta lc and asbestos. These documents are as fo llo w s: 1. Letter dated 1/11/79 Kennedy/Wolfe 2. "S a fe ty o f Consumer Cosmetic Talc Products" Journal o f Toxicology and Environmental Health 2:1221-1222 1977. 3. "M in e ra lo g ica l C haracterization o f Cosmetic Talc Products" Journal of T oxicology and Environmental Health 2:1223-1226, 1977. 4. 21 CFR 73.1550 - Talc 5. Federal R e giste r document o f A p ril 4, 1975 Part 8. Many o f the references cite d in the above enclosures may provide you with add ition al useful inform ation concerning talcum powder, asbestos, and cancer. We hope that t h is inform ation i s he lp fu l. I f you have any further questions, please le t us know. Sincerely yours, Enclosures;, as stated above ^ , if u ce: H hv--l'r/f HFR-3240 r/ f A lle n R. Halper A ssista n t to the Director D iv is io n o f Regulatory Guidance Bureau o f Foods ^ - 3 0 r/f HFF-314 r/ f ARHalper:bdh:2/8/83:245-1505