Document NMobzvy63LXmpQ4k02yX87Q

FILE NAME: Talc (TALC) DATE: 0000 DOC#: TALC059 DOCUMENT DESCRIPTION: Unpublished Report - FDA & Talc Cosmetic Use of Talc It has long been known that talc minerals are commonly contaminated with asbestos. "Fibrous" talc miners in New York state were reported as having fibrosis of the lungs m 1943, an excessive rate of lung cancer in 1967, and cases o f pleural mesothelioma more recently. Early reports raised concern about talc itself as well as talc with asbestos minerals in it. U.S. governmental researchers called attention to "Fibrous and Mineral Content of Cosmetic Talc Products" (LJ Cralley et al., Amer. Indust. Hyg. Assoc. J. pp. 350-354, 1968), which contained 8 to 30 percent o f fibrous materials. The use o f talc on surgical gloves was no longer recommended after that year {Merck Index 1968, p. 1011, cited in Blejer and Arlon). "Talc and Carcinoma of the Ovary and Cervix" (WJ Henderson et al., J Obstet. Gynaec. Brit. Comm. 78: 266-272,1971) was a concern raised by consumer exposure to talc. A paper presented in 1971 reported that the Kaiser Foundation Hospital in Los Angeles had discontinued the use o f talcum powders for any inpatient use (H Blejer and R. Arlon, "Talc: A Possible Occupational and Environmental Carcinogen,"J Occup. Med. 15; 92-97,1973). This report also referred to a 1971 study by researchers at the Mt. Sinai School o f Medicine in New York, in which "significant amounts of asbestos were present in two brands o f commercial, household-use fibrous talc dusting ('talcum') powder." In August of 1971, FDA official Alfred Weissler organized a "discussion section at FDA on asbestos in talc, which was attended by almost 50 representatives o f industry, universities, and govemment."(letter to L Adamson and S Lang, Environmental Defense Fund, Mar. 2,1973). I worked at the Baltimore County Department of Health at this time and received a letter from Congressman Paul Sarbanes observing, "Apparently the FDA should be taking a greater interest in [the suspected carcinogenicity of talcs and the labeling of products containing asbestos]."(Apr. 19, 1972) The U.S. Food and Drug Administration proposed on August 12,1972 {Federal Register) to issue new regulations to require that talc used as a food additive and in food packaging be free of "asbestos-form particles." The next year, two environmental groups petitioned FDA to take action on asbestos foods and drugs arising from talc use and asbestos filtration o f drugs. The asbestos-talc issue thus received widespread publicity ("FDA Asked to Ban Asbestos Filters," New York Times, June 29,1973). The National Enquirer ran a story "Talcum Powder Can Cause Cancer" (Nov. 5, 1974) in which the world authority on asbestos at Mt. Sinai, Dr. Irving Selikoff, was ' quoted as saying, "We're really worried about the use of talc in the home" because of talc s asbestos content. Selikoffs team published a lengthy report in which the presence o f asbestiform minerals and quartz was cited as establishing a "need for a regulatory standard for cosmetic talc." (AN Rohl et al., "Consumer Talcums and Powders: Mineral and Chemical Characterization," J. Tox. Envir. Health 2: 255-284,1976). Selikoffs associate Arthur Langer said they found 2-20 percent asbestos in 9 o f 19 products tested (M Burros, "Asbestos Fibers Found in Baby Powder," Washington Post, Mar. 8, 1976). Some products tested were asbestos-free, and one was composed o f cornstarch instead of talc. The products were formulated prior to June, 1973. Given the widespread concern over asbestos in talc by health scientists, government, and the media, companies using talc in consumer "talcum" products after 1971 should have been aware o f the potential mortal hazard of asbestos in such products to miants, cosmeticians, and other users and consumers of these products.