Document Y9G1J5gxQeRdkpXbBajp2p0OD
FILE NAME: Johnson & Johnson (JAJ) DATE: 1973 Jan 29 DOC#: JAJ064 DOCUMENT DESCRIPTION: Memo RE Talc/Asbestos
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1/ 29/73
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EXHIBIT
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JN JA Z K J)00004172
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New Brunswick, N.l.
Jan u ary 29i 1973
Or. R. A. Fuller
M r. Stites told m e on F rid a y th at CTFA rece iv ed in q u iries fro m a M r. Spivak, a Wall Street Journal rep o rte r, who told them that FDA is about to issue regulations governing asbestos in talc and asked them what is industry doing about it.
CTFA also told M r. Stites that they understand FDA is going to issu e such regulations based on "no detectable asbestos in talc by x -ray " and that they w ill also release D r. Lew in's rep o rt (updated).
On F rid a y , I tr ie d to get in touch w ith D r. S chaffner, D r. W e issle r, and M r. W enninger at the FDA but it w as too late in the day. 1 learn ed that D r. Schaffner is in a m eeting on the W est C oast and is due back Tuesday.
Today I called M r. W enninger, Chief} C osm etics B ranch, who rep o rts to D r, W eissler. I asked him if FDA is about to issue ta lc/a sb e sto s regulations. He said to the best of his knowledge, his reco rd s show that they plan to have a regulation w ritten by M arch 19, 1973. H owever, he w ill confirm this inform ation to m e. I told him that it is my understanding that Dr. Lew in's report w ill also be released a t that tim e and that our la te st information fro m D r. Schaffner is that Dr. Lewin found J&J products to be free of a s b e s to s w ith f r * H l j ftl1 of one m ed icated pow der sajaaple -- w hich showed " tr a ^ e a o f a a b e ste a . 11 1 said th a t t r a c e ^ of aab e a tg y m ean s th a t it is pro b ab ly le ss than 1%, i. e . , not d etectab le h y x -ra y . I pointed out that if the Lewin report is released sim ultaneously with the regulation requiring no detectable asbestos by x -ra y , there w ill be an inconsistency between the findings of the Lew in re p o rt and the regulation. T herefore, it would be advisable if a ll of Lewin's rep o rts w ill be based on x -ra y scan rath e r than other m eans. Zadded that we had examined our M edicated Powder by x -ra y and find no detect able asbestos.
M r. W enninger said that he understands the problem and that he w ill make a point of bringing it up with D r. W eissler. and Dr. Schaffner as soon as possible.
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fis y . 73 JNJAZ55_Q00004173
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Dr. R. A. Fuller
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Jan u ary 29 1973
I also added that we had talked to D r. Schaffner and gone on reco rd in w ritin g th a t we w ill be read y to d isc u ss the an im al and c lin ica l data on ta lc and we have had no resp o n se so fa r . He suggested fixt I d iscu ss this with Dr. Schaffner when he comes back.
Two h o u rs la te r , he called m e and confirm ed th a t fixe M arch date is still th eir targ et dat for regulations and he is even doubtful that they can m eet it.
' I reported this inform ation to both M r. Stites and M r. F o ster. .
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cc: M r. D. D. Johnston M r. J. Dettre M r. H. R. Callum Dr. D. F e tte rs on M r. S. Sxnoyer M r. H. Stolzar Dr. G. Hildick-Smith Dr* T . H . Shelley
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W. Hashed
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JMJAZSSJKM004174