Document 2JyGKqEKEBGwO7jwzBjronGZ6

DEC 1982 Raymond d. Russell 121 Riveredge Road Lincoln Park* Hew Jersey 07035 Dear Hr. R u sse ll: This rep lies to your le tte r dated October 15, concerning the presence o f needle-like p a rticle s 1n ta lc containing baby powder and face powder which you believe ay present a hazard sim ila r to one which exists from the in halation o f asbestos fib e r s . You indicated 1n your le tte r that a micro scopic examination o f ta lc revealed that approximately 5 to 10 percent o f the p a rticle s have a 10 to 20 micron, n eed le-lik e stru ctu re, sim ilar to that o f asbestos. The matter o f contamination o f ta lc with fibrous asbestos was exten sively studied by both the Food and Drug Administration and industry in the mide to la te 1970*s. Ve have no knowledge o f any cosmetic ta lc product on the market that contains fibrous asbestos. Hor do we have Information or data which indicates that presently marketed cosmetic t a lc preparations are un safe when used as d irected. While we are well aware th&t t a lc is chem ically, clo se ly related to asbestos, we believe th at the needle-like p a rticle s that you have b r ie fly described in your le tte r are ta lc needles, not fibrous asbestos. Talc needles are not known to cause harm or to present a hazard to health when t a l c containing baby powder and face powder are used under customary conditions o f use or as directed on th e ir la b e l. I f you have any, s c i e n t i f i c evidence that the p a r tic le s are not ta lc needles or th at a hazard e x is t s , we would appreciate receiving such Information* For your p e r u s a lw e are enclosing a number o f documents which revfewstthe current s ta te o f or knowledge r e la tin g to the health e ffe c ts o f t a l c and asbestos. These 'documents' are as - fo llo w s: L/1. L e tte r dated 1/11/79 Kennedy/Hoife .; - ;/2 - "S a fe ty o f Consumer Cosmetic Talc Products* Journal o f Toxicology and Environmental Health 2:1221-1222 1977, ; /3. *H1nera1og1cal Characterization o f Cosmetic Talc Products* Journal o f v. T o x i c o l o g y and Environmental Health 2:1223-1226, 1977. 4. 21 CFR 73.1550 - Talc f ra. Federal R egister document o f A pril 4 , 1975 Part 8, ace c - Russell He thank you for your comments since i t is often through observations rads by concerned citizen s such as yourself that potential areas of concern are brought to our attention. You can be assured that i f any cosmetic product offered for sale in th is country is found to be inherently in ju rio u s, the FDA w ill take appropriate regulatory action to remove such products from consumer channels. I f we can be o f any further assistance, please feel free to contact us. Sincerely yours, Allen R. Hal per A ssistant to the Director Division o f Regulatory Guidance Bureau o f Foods Enclosures: as stated above cc: HFC-1 r / f HFF-300 r / f HFF-314 r / f HFF-1 with copy o f control card HFY-1 (Nighingale) HFF-440 (Eiemann) HFF-441 (Henninger) R/D Init:JAWenninger:12/3/82 ARHalperrbdh: 12/3/82:245-1505 i:;. . .. . Optical Microscopy: To determine fibrous tremolite, anthophyllite, and chrysotile. Health Hazards ' Asbestos: diffuse, nonmalignant scaring-of lungs. Bronchogenic carcinoma:. malignancy of interior of lungs. Mesothelioma: malignancy of lining of chest cavity (pleural) or abdomen (peritoneal). Cancer of stomach, colon, rectum. 5-7 fold increase in lung cancer in asbestos workers, beginning 10-14 years after first exposure and significant after 20 years. Vi