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FILE NAME: Talc (TALC) DATE: 1976 Mar 11 DOC#: TALC199 DOCUMENT DESCRIPTION: Newspaper Article - Talc Tests Wanting, FDA Experts Admit ' x. March 11, 1976 RECORD Bergen Cunty, N. J. John Walcott TALC TESTS WANTING, FDA EXPERTS ADMIT \y, 4-Vir'*Vb*Vv.* -Vv 7 7 ^ 3 - A 7 - 7c Washing ton-Baby powders that are found to contain asbestos should not be allowed on the market, the Food & Drug Adm inistration's top cosmetic expert said yesterday. However, H. E ierm ann, D irector of the FD A 's division of cosm etic technology, said the government so far has found no evidence that some baby and bath powders are contaminated with the cancer-causing mineral. Researchers at New York Mt. Sinai Hospital have reported finding asbestos in c o n c e n t r a t i o n s ranging f r o m 2-20% in 10 of the 20 b a b y p o w d e r s a m p l e s that they have tested. tw T h e F D A and the Mt. S inai r e s e a r cV h e r s u s e d d if f e r e n t m e t h o d s to identify asbestos in talc, the m ain ingredient in m ost powders, E ierm ann said, and there is considerable disagreement in scientific circles about how best to analyze the complex minderals. Nevertheless, he said, the FDA has agreed to test the Mt. Sinai samples and to compare its results with those obtained by the New York scientists. Eiermann also said the Mt. Sinai tests, which were conducted on powders purchased in 1973, m ay not accurately reflect the com position of the pow ders on the m arket today. Many m anufacturers, he said, recently have become concerned about the. asbestos content of their product, and have switched to talc supplies which are relatively free of asbestos contam ination, SAYS HANDS ARE TIED N evertheless, said Eierm ann, the FDA lacks the legal authority, the m an power, and the money to adequately protect the public for potentially hazardous cosm etics ranging from hair dyes to contaminated m ascara. E very cosmetic that goes on the m arket should be test, " he said. The law today m erely prevents m anufacturers from introducing adulterated or m is branded products. "The entire cosmetics budget, is only 2-1/2 million, and we have only 8 chemists. There are 250, 000 different cosm etic products on the m a r k e t and 4000-5000 m a n u fa c tu re rs . We have 1% of the total FDA budget. " Eiermann made his comments at a 2-1/2 hour meeting yesterday with Rep, Andrew Maguire, D-NJ. Maguire , concerned about published reports of asbestos contamination in baby powders, walked in on E ierm ann un. announced after lunch, with his staff health expert, his press secretary, two house investigation sub-com m lttce staffers, ancka. r e p o r te r in tow. Protected Document--Subject to protective order JNJ 000030476 Maguire asked Eierm ann to produce his files on baby powders and to explain w hat the FDA has been doing aboi.it the rep o rts of contam ination. A t one point, M aguire asked whether the FDA considers any level of asbestos in pow ders,-no m atter how low, to be safe. Eierm ann replied that no safe exposure to asbestos had been found, and later said that talc which is found to contain asbestos should not be used to make baby or body powder. CALLS TESTING DIFFICULT He said, how ever, that sophisticaled and tim e-consum ing techniques that are need to find asbestos fibers can test only minute amounts of talc. Because talc and asbestos often are mixed together in infinitely variable concentrations, tests on such sm all sam ples do not accurately reflect asb estos lev els in larger sample-s of talc, he told M aguire. The FDA, Eiermann said, wants a new law tightening government control on all cosmetics. The agency, he said, supports a bill sponsored by Senator Thomas Eagleton, D-Mo, , which would require cosmetic manufacturers to safely test their products and to submit the test results to the FDA for approval before the products could be sold. A FDA study conducted last year indicates that cosmetics may be responsible fo r as m an y as 140, 000 injuries to A m e ric a n c o n su m e r s' each y e a r, ranging from minor skin irritations to prolonged medical problems requiring professional attention. Testimony before the Senate has placed the number of cosmetic related injuries anywhere from 29,000 to 60, 000 per year. Eiermann said the FDA now is studying, among other things, hair dyes, antiperspirants, and m ascara for evidence of danger. F o r example, he said, there is some evidence that mascara can become contaminated from contact with the skin and may cause ulcers on the cornea, the transparent cover over the lens of the eye. If the brush used to apply m ascara accidentially scratches the cornea, he said, it can deposit germ s which can cause corneal ulcers, which can lead to blindness. The FDA, said Eierm ann, is studying the use of preservatives in m a sc a ra to prevent the spread of such germ s, and may issue regulations mi the composition of mascara. There is no evidence, on the other hand, that baby powder is a potential health hazard, Eiermann said. Johnson & Johnson in New Brunswick, the nation's leading m anufacturer of baby powders, has tested its talc on ham sters and has found no evidence that talc inhaled into the lungs is hazardous, he said. Protected Document--Subject to Protective Order UND 000030477 V -3 - "When questioned, how ever, Eierm ann acknowledged that Johnson & Johnson talc, which com es from the com pany's own m ines in Verm ont, has been found to be virtually free of asbestos. No tests have been conducted pn anim als using talc from New York State, which is used in Some powders and which generally contains m ore asbestos than Vermonj) talc. The FDA, he said, has no plans for such tests. "Let me go to the housewife in my d istrict, " Macguire replied. "She g o es into the store and she se e s 9 types of talc lined up on. the sh e lv e s. How is she to know which ones are safe?" "We cannot test every sam ple, "Eierm ann replied. ini 1i1r # Protected Document--Subject to Protective order UNJ 000030478