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Mr. fl * Lee bcc: Mr. G. Lee oefi Dr. D. R. Petters .. Dr.. B. Semple Johnson & Johnson BABY PRODUCTS COMPANY '; August 26, 1977 The viny viny. RARITAN, N. J. 08869 Se! Mr. Gordon K. Wurster:- ane UniteCdo n|v eSnttaitone,s IPnhca.rmacopeial 12601 Twinbrook Parkway - Rockville, Maryland 20852 Dear Mr. Wurster: Thank you for the information on the USP XIX Talc Monograph. We understand that the statement, " Do not inhale ", under dispensing information for , talc was placed there only as a suggested precautione a e in case the talc contained asbestos. _ ete Current information does not indicate that the warning. is needed for- talc, and we feel strongly that the statement should be removed. However; we do support a standard for cosmetic talc (CTFA Cosmetic Talc Specification, Rev. 10/7/76), which specifies no detec- table fibrous asbestos minerals and a typical purity level of 90% mineral talc. We encourage that this attached standard be perpetuated because the data certainly indicates that normal exposure to cosmetic talc presents no inhalation hazard. Appended for your review is a tale safety summary and supporting literature. Thank you for your consideration. Respectfully yours, clj clj Attachments .. ... 08 Wm. C. Waggoner, PhD Manager Medical and Regulatory Affairs . RECE RECE RECE 24 1977 1977 AUG Protected Document -- Subject to Protective Order JNJNL61 000020359 SAFETY OF TALC ~- 1 Rubino, et al., conducted a retrospective epidemiological . _ study of talc mine employees to determine whether the causes of death were different compared with a control population of agricultural workers not involved in dusty industries Res | piratory deaths in the talc miners exposed to mixed mineral dusts were significantly higher than controls, although the incidence of pulmonary cancer, all cancers and cardiovascular disease was statistically sw igne ifi cant tlyt lom wer foe r te he mine erse Pores pee eee owe to ote h= aenn eet hacee tceeo:n tte rpooel t agr raaotuenpe eHseo w- evov eTorte,n -t h~ e millers who wa ere exposed only to the high grade cosmetic talc had a similar deaths of from respiratory disease cancer, lung and incidence all cancers, but a statistically lower incidence of cardiovascular deaths. The data indicates that prolonged exposure to cosmetic grade talc at the current threshold limit value (TLV) for talc (20 million particles per cubic foot) did not increase deaths from | pulmonary disease compared with the control group. Wehner, et al., 2 studied the effect of inhalation of a commercially available cosmetic talc baby powder in Syrian golden hamsters for as long as 300 days. The talc dust consisted of 97% mineral talc in platy form free of detectable asbestos and silica. The highest dose corresponded to 1700 times the dose to which an infant is exposed when it is dusted with it. From the data there was no difference in viability or body weight between treated hamsters and the untreated control animals. In addition, histological examination and the incidence of tumors of lungs, heart stomach, liver, kidney, testes, and ovaries showed no difference between treated and control animals. Protected Document -- Subject to Protective Order JNJNL61_000020360 JNJNL61_000020360 , To determine pulmonary deposition, translocation, and ( clearance of inhaled talc, 10 week - - old hamsters received a single 2 hour - nose only - large exposure to neutron activated - talc. 3 An estimated 6% to 8% of the inhaled talc was deposited in the alveoli. The biological half life - of the alveolar deposited talc was 7 to 10 days. Alveolar clearance > was ee. Par a Le ns __ essentially complete 4 months post - exposure. No translocation- of talc talc to liver, kidneys kidneys kidneys kidneys kidneys kidneys; ovaries ovaries ovaries ovaries, or other parts of the body body body aane was found. The Food and Drug Administration commissioned teratologic me - ~ anndumber mutoafg eanbinco rsmtauldiiteise so ns eteanl ci.n Isno ftth eo rt esrkaetloeltoagli ct isstsuudeys "o ft htehe test groups did not differ from the number occurring spontaneously. in the sham - treated controls. " Mutagenic testing in 3 systems abe wee ED en! soeeree _: Peden ee re ete se * Paed ony igs "ee = (1) host mediated assay, 2 () cytogenetics, and (3) dominant lethal, produced no adverse results. Subsequent evaluation 6 of the talc used in these studies showed that it conformed to USP requirements and was free from asbestos minerals. Finally, a recent editorial? from Lancet reviewed the subject of talc inhalation and concluded " there is no reason to believe that normal consumer exposure to cosmetic talc has in the past led either to cancer at any site or to measurable loss of lung function. It seems unlikely that future exposure to cosmetic talc of the specifications now agreed to by major manufacturers will present a health hazard. " Protected Document -- Subject to Protective Order ***** ren erent me errr TER en rernneene " JNJNL61 JNJNL61 000020361 a t ' REFERENCES - 1. Rubino, G., Scansetti, G., Piolatto, G., and Romano, C.: ~" ~- Mortality Studies of Talc Miners and Millers. Journal of Occupational Medicine 18: 186-193, 1976. 2. Wehner, A.P., Zwicker, G.M., Cannon, W.C., Watson, C.R. wre and Carlton, W.W.: Inhalation of Talc Baby Powder by 7 Hams.. ters: Food and - Cosmetic Toxicology 15: 12111143 -129, 1977 3 = oBf WaIethntnheearll,le deA . N PePa ucPtuirlofmnio nc-a rNAyo cDtreitpvhoaswtieetsdi toTn. a DlLecpa obisnoi trSiayotnro,irani eGsoT,lr daRnesnil coHhcaalmtasintoend r,as n WdW aaCsslhheiainrnaggntctoeonn. July, 1976. 4. Teratologic Evaluation of FDA 71-43 (Talc), PB 221 - 804, Food and Drug Research Labs., Inc., January, 1973. 5. 458 Mutagenic Evaluation of Compound FDA 71-43, Talc. 7P7B0 1- e2t4t5 Shen 458, Litton - Biometrics, Incorporated, 9 Defecn epom ebeee rm8 B1IR9 7el4 ".ae -- 6 Characterization of Talc, type 141, Lot 11-16-17, Johnson & Johnson Research Department, May 14, 1976. 30 EJduinteo 2r5i,a l1,9 7C7o.smetic - Talc Powder The LancBeeetn. .p aawg oers e e1s 3b4om8.- "1 3"n4a9e inven Protected Document Protective -- Subiect to Protective Order Order er annie rooms rooms, rooms oe ce a an aa EE LER CHa e CH