Document by5evaaL3KO0eNKa6907q1721

mivn S A F Y PROCUCT^ COM 'ANY PLAINTIFFS E X H IB IT WCD-225 For CTfA Talc Meeting March 11# 1976 March 8, 976 COSMETIC TALC STATUS Th safety of.consumer talcum products has been ,undi.r continued attack# primarily 13d by th Mt. Sinai group, because of three alleged concerns. Th^se allegations are as follows : ' . . .; 1 ..' Commercial talcs often contain asbestos as naturally occurring contaminants. ' .',.: 2. Talc contains other impurities, m o r a l s and metals which may have potential biological, significance. 3* Talc s a mineral itself may be hazardous. 1 . FACTS OH TA&C A. Asbestos and Cosmetic Talcs _ ehrysotile asbestos has never been detected in cosmetic talcs or finished talcum products. - amphibole asbestos, e.g . tremolite and anthophyllile, has been found in a few . S. ccnsumar talcum prt- ducts (by Mt. Sinai and confirmed by a very reliable expert consultant). .. .; - disagreement existed between Sinai scientist .and an expert consultant in recent analyses for*asbestos . in British OTC talcum products. This resulted in withdrawal of highly controversial allegations oi . asbestos in British talcum products intended far presentation .at the 4th international Symposium oh inhaled Particles & Vapours, - Mt. Sinai disclosed statements in February '7b dtd-iug private interview with the Con tdian Broadcasting Corporation that their analysis of U. S. products hoe found asbestos. -I- . MarchC, 1976 B, Biological testing of Cosmetic talcs ^ extensive animal, testing data is only available for Windsor 66 talc and Italian 00000 talc. . - Battelle hamster inhalation testing on-Windsor talc with chronic exposures up to 1S5 times median baby dosage has demonstrated no exposure-related pathology. .. ' ' .. v . - . _ m r c (British Medical Research Council), testing with Italian 00000 taic indicated no turnouts resulted rrom intrapleural inoculation or ingestion. .- ^ - MRC testing with .Italian talc showed fibrosis at high and very long exposures (up to 1000 times median baby dosage) ,C. Hitman Medical Studies - Eubino Mortality Study indicated no excess deaths dae to cancer amongst talc miners and millers excused to Italian cosmetic talc. ;. \' . - Green prospective pulmonary Study with Wirdscr. talc . miners and millers have shown no respiratory disease. - Kleinfeld has published that deaths were due to cancer o f ;lung and pleura amongst talc workers receiving high exposure to industrial talcs mixed with appreciable amounts of tremolite, anthophyllite and small amount of silica. Dl Conclusions .` ' - all of the data which argues strongly that cos actio tai.es are not a hazard to health under.normal-use . conditions are based on studies with W m d c o r .-6 end Italian 00000 talcs, both of. u'hich hav a talc purity of better than 90%, and no asbestos content. . - aitvphibole asbestos contaminants have been observed in_ finished talcum products. Tight speci.xcatioris should be written to preclude sources which ard m^rgviai as to potential contaminants. : - 3- Marcht 3 , 197$ II. FDA/OTC PANEL EEV'IBMB OF TALC FDA - LEWIN PRODUCT ANALYSES - Professor Levin1a rais-identificati on. of chrysotile 3n store shelf talcum products highlighted to FDA the need to develop analytical methodology for talc. OTC CONTKACEPTIVES & VAGINAL PRODUCTS PANEL - After a brief look at the safety of talc, the September 18 19, 1975 meeting decided to defer definitive action on talc to the OTC Antiperspirant Panel. OTC SEDATIVE PRODUCTS PANEL - This panel originally proposed that talc, a non-essential ingredient be banned from OTC products that are meant to be ingested. Because of a J & J response, this Panel altered its position to urge that talc containing asbestos not be permitted to be formulated in OTC products meant to be ingested. OTC ANTIPEPS PIRMfT PRODUCTS PANEL - Talc was cleared for use in ant iperspirants only on tic basis of the law exposure in use. This panel has stated that it has not cleared talc for other uses. OTC MISCELLANEOUS EXTERNAL DRUG PRODUCTS PANEL - Because all three Of the above Panels have not issued an unequivocal conclusion in the safety of talc, this fourth Panel will be required to provide an ultima? e and definitive safety review on talc, tfith the previous history of attacks in the public media and the erosion of consumer confidence, all means should be taken to obtain a Category I for cosmetic grade talc. The publicity of category lil would do irreparable harm to talc's already tarnished imago. ~ PRESENT PROBLEM FOR CTFA & INDUSTRY - Present allegations from Sinai that the'.' ha-' analyzed and found asbestos in a substantial number or U. S. talcum products is particularly damaging to CTiA's Panel presentation testimony ?"hat msans are presently being taken by industry to seif--regulate. . - 4- March 8, 1976 Unless this Sinai data is refuted, it will adversely influence th Miscellaneous External Panel's forthcoming safety review for.talc and undermine the tenet that oafs cosmtic grad tlcs are now being responsibly utili-ei Ttythe industry. III. RECOMMENDAT IONS FOR CTPA ACT IQM . - CTPA should immediately providerefuting data by organizing a test of current talcum products and conduct examination for asbestos by the best method through independent experts. These same product samples should b e offered to the FDA and the Mt. Sinai Laboratory for verification of analyses. . - to support an effective and persuasive presentation to the OC Miscellaneous External Panel, CTPA should issue a strict revised talc standard which would very clearly distinguish cosmetic from industrial grades of talc. Such a specification will be credible to the consumer 1st advocates only if it fulfills the following requirements : 1. it must specify the absence of asbestos constituents by the most sensitive method, 2. It must adhere to a talc purity level ^hich is closely1similar to that.already used in toxi cological studies; namely, at least 9054 talc. - CTPA should identify conforming sources of talc as CTPA Cosmetic Grade Talcs and encourage manufacturers using this grade to label their finished products with this designation. m