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FILE NAME: Talc (TALC) DATE: 2018 Jan 16 DOC#: TALC182 DOCUMENT DESCRIPTION: Website Article - Baby Powder Battles - J&J Internal Documents Reveal Asbestos Worries  HCoonmtaect Us Donate TFhaiurrWsdaaryn,inJganuary 18,2018 News of safety, health and corporate conduct FAIRW ARNING news ofsafety, health and corporate conduct HFaoimrWe arning Investigates FairWarning Reports DAobnoautteFairWarning Commentary Archive Home C Browse: Home > 2018 > January > Baby Powder Battles: Johnson & Johnson Internal Documents Reveal Asbestos Worries Search this site. Search Baby Powder Battles: Johnson & Johnson Internal Documents Reveal Asbestos Worries By Myron Levin on January 16,2018 OWWENT 239 28 348 In the early 1970s, a Johnson & Johnson official posed a question that haunts the company today. If Johnson's Baby Powder contained asbestos at a level of, say, 1percent, how much of the cancer-causing substance would a baby inhale when dusted with the powder? Tfahreleesxsetchuatnivteh'es lheagnadlwlirmitittenfomr aenmaosbreeasctohsedmwinheart,,tahtetmheaitnimseta,nmdaayrdhtahveensienempleadcea. comforting conclusion: The baby's exposure would be nBeuvtetrhecomnteaminoedantdheocthaercriinnotegrenna,lwcohmy pthaennydriedcoorfdfiscicaalsstbdootuhbetr otoneJs&timJ'sataesstehretipoontsenthtiaatl ietsxppooswudreerfsohraavbeaablyw?ays been asbestos-free. II' they pDhraarwmnafcreoumticaaltraonvde coofnasbuomuet r1p7r5o,d00u0ctspaggieasnto. fTJh&eJladwoscuuimtseanrtes,btyhevricetvimeaslinogf mmeesmotohsehliaovmeah,ealpraerdetaonidgnleittehaal bfourrmst oofflaitsibgeasttioosn-raeglaatiendst the cwahnectehrerth, aatftteyrpyiceaalrlsyosftrriokuetsindeelcyadspesrinakftleinrginoitniatlheexppoowsudreer.sA, ptliasisnuteiffiss wunhwetihtteinrgtalylcipnohawledderesnwouergehcoofntthaemminiactreodscboyptircacfiebserosftaosbcoesnttoras,ctanthde deadly illness Want more stories like this? Sign up here to get news alerts. X Subscribe to receive occasional alerts in your inbox Email Address (required) First Name Last Name pFraoircWeeadrinnmgsgarsevwieewlleads tmhoatuesraianldosbotfaipnaegdesunodfedrotchuemFerneetsdoinmproefpIanrfionrgmtahtiisosntoAryc,t;inmcolusdt ionfgthinistemrnaatlercioaml hpaasnynomt bemeeonsparnedvitoruanslsycrriepptsorotefdl.egal Ttahlce intriguing documents don't settle the safety issue. But they raise questions about J&J's candor on the incendiary topic of asbestos and J&J, which declined interview requests, has said its powders are perfectly safe, and could not have caused mesothelioma. In November, the company won a big victory in its first mesothelioma trial, when a Los Angeles Superior Court jury found J&J and co defendant lmerys Talc America were not responsible for the mesothelioma of Tina Herford, 61. Herford, of Camarillo, Calif., said she had used the company's talc powders for about 35 years. J&J settled a second case, and faces at least several dozen more lawsuits. Similar lawsuits are targeting other companies, including Colgate-Palmolive, which used to produce Cashmere Bouquet powder. OCopuenrtining NaregwumBernutnsswarieckse,tNf.oJr. JTahne. 2su2itincothnetennedxsttthraiatlSatgeapihnesnt JL&aJnzaondIIIa,gfrroomuptohef ttaimlcesuopfphliiserbsi,rtthhiisno1n9e7i2n,Mfreidqduleenstelyx CusoeudnatysbSeustpoesr-ior contaminated powder, causing him to contract mesothelioma. TMhoerHe acrodveTrraugthe:About the Softest Mineral A Win for Johnson & Johnson in Baby Powder-Mesothelioma Case The documents show that in contrast to their public assurances, J&J officials privately acknowledged decades ago that they had an asbestos problem. They tried to persuade federal regulators that no one would be harmed if talc powder had up to 1 percent asbestos. Moreover, J&J and its industry allies successfully lobbied for a test protocol -- still on the books today -- that is too crude to detect trace amounts of the carcinogen in talc powders and cosmetics. Talc, the softest known mineral, has a wide range of uses in cosmetic, pharmaceutical and food products, but talc deposits are sometimes contaminated by naturally-occurring asbestos. Damage control The documents echo an asbestos scare that rocked the cosmetics industry in the 1970s. The uproar began when researchers at New York University and Mount Sinai Hospital separately reported finding asbestos in a number of popular talc-based powders and cosmetics. For bmoamkebrssheolflsfuincdhinugpscwloesreeaandthpreeartsotonailtspwrohdoulcetsso,mneo ismtigamgeaacnodultdo abne iwcoonrsiec,parnodduthcet tihnadtuastcryomscpuarnryiedmteomcoonctaalilnedth"ethdeacmoargnee.rsFtoonreJ&ofJ,otuhre baby products franchise." aItsbtuersntoeds ionuttatlhcawt tehree reevpoolrvtisnogf--consotammeitnimateiosnyiweeldreinsgofmaleswehnaetgeaxtiavgegseorartfeadl.seAptothsietitvimese.,Oatnhaelrytliacbasl cmoeutlhdondostfcoorndfeirtmectcinergtalionwolfetvheelsreosfults, and the NYU and Mount Sinai researchers wound up retracting some of their positive findings. Celeste Monforton, a former U.S. Department of Labor official and an adjunct professor of occupational and environmental health, at left speaking with a labor activist last year in Morganton, N.C. (Photo courtesy of Oxfam America). iFtsorpirtosdpuacrtts,.J.&..JOsvoeurghfitfttyo yreeaasrssuorferceosneasurcmhearsndinkanoJwunleed2g9e, i1n9t7h1isparreesas linedleiacasete.s"Jthoahtntshoenre&isJonhonassobnestatoksescognretaaitnceadreintothaesspuorwedtheer purity of manufactured by Johnson & Johnson." wBuotulidnssiedeemthme cooremtphaannya,papdriofpferiraetnet tchoantvweersuatpigornadweatshteakqiunaglitpylaccoen.tSroolononafotuerr ttahlecparnedssbraeblyeapsoew, adceor,mppaartnicyuolaffrilcyiaalsdteoctlhaerepdoitnenatimaleamsboe:s"tIots content." Athnatot'h'merigchotmbpeacnlyasmsifeimedoaisnaAsbperislt,o1s9f7ib3e,rn."oted that ''occasionally, sub-trace quantities" of minerals were found iri Johnson's Baby Powder Records show that J&J ran experiments aimed at finding ways to destroy or remove asbestos from talc ores. In a May, 1974, memo. Vernon Zeitz, head of research and development for Windsor Minerals, J&J's talc mining operation, said that puisuing such methods "is strongly urged by this writer to provide the protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time." The asbestos scare revealed a general lack of rigor in screening cosmetic talc for low levels of asbestos. Talc suppliers and manufacturers weren't doing much and the U.S. Food and Drug Administration, which has limited authority over cosmetic safety, was doing even less To assuage public concern, they had to come up with a test procedure that would allow them to confirm their talc was asbestos-free Bseuntsiwtihveenennoouagshbetsotofsinids ifto.und in screening tests, it can mean one of two things: Either there is no asbestos, or the test method is not wReocuoldrdrsessuhlotwinthhaigthJ&anJaalnydticiatsl aclolisetss asundccdeissscfouvlleyrypuosfhterdacfeorasabreesltaotsivtehlayt pcoerumldisrseiqvueirteestthpermototocodli,scfeaardrintaglcthsautpmploieres.sTenhseiytivaelsoprfoecneddeudieosff acnaldlsFfroargFraDnAcerAegsusolactiiaotnio,nsu(cscinecsesfruelnlyamloebdbythinegPfeorsroannalinCdaursetrPy-raoddmucitnsisCteoruendctiel)s.t developed by their trade group-the Cosmetics, Toiletries Deploying a small army J&J rallied a small army to press these objectives. In a December, 1973 FDA memo that FairWarning obtained under the Freedom of Information Act, an agency official marveled that "in one meeting that we had with them [Johnson & Johnson], 16 technical people from United States and Europe presented a seminar covering analytical methods, toxicology and mining technology." This story aMlscoCplautcbhlivshDeCd by: TMhieamKiaHnsearsalCdity Star TThhee CSahcairalmotetentOobBseerever TFohret FWreosrntho SBtaeer-Telegram The Modesto Bee Durham Herald-Sun Idaho Statesman Bellingham Herald Tri-City Herald (Kennewick. Washington) Ledger-Enqurer (Columbus. Georgia) TWhaeuTsaruib(uWnexs(.S) aPniloLtuaisndORbiesvpioe.wCa.) Industrial Safety & Hygiene News Tunhdisetiescwtehde,rienttohecobsambieetsi-ctso-amndinpeorswcdoemrsp, anroisoonnes wcaomueldinb.eJh&aJrmsoeudg, hbtetcoaucsoentvhienceexpthoesuFrDesAwthoautldevbeenaiftisnmy aflrlacatmioonunotfsoocfcuaspbaetisotonsalslipped, standards in place at that time. "aOmuerevtienrgy wpriethlimthienaFrDyAcailncuJalantuioanryi,n1d9ic7a4t.eTs htheamt seumbostannottieadl athsabtesatnosFDcaAn obfefiaclilaolw"eadppseaaferelyd isnkeapbtaicbayl"paonwdd"eirm,"paliJe&d Jtheaxtewcuhtaivt eiswsarofetefoarftaer miner may not be safe for a baby." The company then pressed the argument m a letter to Dr. Robert Schaffner, a senior FDA official. "The calculation shows that a substantial safety factor can be expected with talc containing 1% ... asbestos fibers. Therefore, methods capable of determining less than 1 % asbestos in talc are not necessary to assure the safety of cosmetic talc." At a meeting in February, 1975, however, Schaffner dismissed the argument as ''foolish since no mother was going to powder her baby with 1% of a known carcinogen irregardless of the large safety factor," a memo said. "oIftfisceiaelmwshluodtiecarcohuesstoocmcueptahtaiot nyaoluawndouelndveirvoennmbeentmalakhienaglththaatt TcaelxcauslaSttiaotne,"UsnaiivderCseitlye.stAecMcoorndfionrgtoton,MaofonrfmoretornU,.wS.hLoarbeovrieDweepdarstommeentot the documents at the request of FairWarning, "In this time period of the 1970s it was well established that asbestos was a carcinogen, and the notion that some amount is OK as long as it's just a little ... is unconscionable." There is consensus among experts that a safe level of asbestos exposure has not been determined. In an article published in 2014, an expert panel of USP, a nonprofit scientific standards group, noted that asbestos concentrations "well below 1 percent by weight ... can generate potentially hazardous exposures." This issue "may be particularly relevant for talc used in powders and cosmetics," the article said. For a while it appeared that the FDA might impose test standards by federal regulation, rather than let the industry police itself. An FDA official complained in a memo that the companies weren't moving quickly enough to address the problem. "If this is all that can be expected from the cosmetic industry in the form of analytical effort in the light of the asbestos in talc publicity in 1971," he wrote, "we have not much choice but to move as speedily as possible with a proposal of a regulation on asbestos." Critical timing For their part, the companies pressed for agency buy-in on their proposed test protocol. "We believe it is critical ... to now recommend these methods to the FDA before the art advances to more sophisticated techniques with higher levels of sensitization," according to a memo by a J&J executive. AUlltthimouagtehlya, dtheeteFcDtioAnblaimckiet dofof1fpaenrdceanctcaespbteedstothsewinasdussctrrayppteesdt --meitthwoads,sweht iacth0w.5a%s aindsotpetaedd--inm1a9n7y6e. xperts say the test does not assure that potentially hazardous levels of asbestos will be detected. Jin&dJusatnrdy ahtavleeasctristoicmizeedo.thAesr caonmexpeacnuietisvseuopfptlheme teanlct tmheinminegthfoirdmwLituhzeandadciti(onnoawl tceasltlse,dbIumt tehroysse) saariedn'itnraenqueimreadil-atofathctetFhDatAevinen20so01me"iInththinek we all recognize" that standard test methods "are simply not sensitive enough to provide complete assurance that the talc is free of detectable asbestos." SHOWER SHOWER' powder Johnson & Johnson is battling litigation asserting that people contracted mesothelioma, an asbestos-related cancer, from years of using the company's talc powders-Johnson's Baby Powder and Shower to Shower, a product J&J sold to another company in 2012. J&J says the powders are perfectly safe and do not contain asbestos. FwDarAnionfgfiocnialtsalccopnrcolduudcetds,thsatattitnheg iinndausletrtytertetshtahtatdheaqpuoasliittiyveofimcopsamcte.tIicn t1a9lc86h,atdhe"ysigrenjiefcicteadntalyciimtizperno'vsepde.ti.t.i.oYnotuorrpeqetuiitrioenanhaassbneosttos persuaded us that the cosmetic talc that is presently being produced contains significant amounts of asbestiform minerals." Concern has flickered over the years, however. In a paper published in 1991. Alice M. Blount, a Rutgers University researcher, said she had found asbestos fibers in some talc samples, including in a sample of Johnson's Baby Powder. Following reports of asbestos contamination in some consumer products, the FDA in 2009-2010 conducted a survey. purchasing 34 talcbased cosmetics and powders, including Johnson's Baby Powder, from retailers in the Washington, D.C. area. The agency also asked nine suppliers to provide samples of raw talc, though only four complied. The samples were analyzed by a sophisticated method called transmission electron microscopy, which uses electron beams to achieve a high level of magnification. No asbestos was detected in any of the products or samples. "The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested." the FDA cautioned in its report. Accordingly, the results "do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United State are likely to be free of asbestos contamination." Targeting the deep pockets Mhaevseohthaedliiodmenatisftiraibkleeswanorakvpelraacgeeeoxfpoabsuoruets3, b.2u0t0oUth.eSr.sraepsipdeeanrtstophearvyeeahra,dmloitstltedoyrinngowcoitnhtianctawcoituhpalesboefsytoesa-raspoafrtdfiarogmnoasilsle.gMedosetxvpiocstiumres through years of using talc-based powders and cosmetics. As a result, asbestos lawyers are now targeting deep-pocketed makers of these products. Separately, J&J faces thousands of lawsuits contending that use of its talc powders for feminine hygiene caused ovarian cancer. In the mesothelioma case won by J&J last year, Flerford's lawyers showed jurors test reports, mostly from the 1970s, appearing to show contamination of talc ore and even finished powders. William Longo, a materials scientist and plaintiff expert, testified that he had caonnaltyazineedrtsaolcldcaosntraeicneenrtslypuarsc2h0a1se6d. from collectors on eBay, and found trace levels of asbestos in 17 of 30 containers-including in a "They knew it had asbestos in it ... They were reckless with peoples' lives," Chris Panatier, a lawyer for Herford, told the jury. Jte&stJslwaweryeerlsataenrddewbiutnneksesdesindfisoplluotwed-uapllafninadlyinsgess--ofaarsebseusltto,sthceoynstaamidi,noaftisounc.hTthheiyngpsreasselnatbedcodnotcaummineanttisonthoatr tahneaylyssatisdmshisotwakeidngthnaot npositive asbestos particles for asbestos. Rexeepcourttisveo.f asbestos contamination have ''never been proven to be correct," declared John Hopkins, a toxicologist and former J&J Defense lawyers made a plausible case for a different cause of Herford's mesothelioma: the aggressive radiation treatments she received for breast cancer in 1998. Therapeutic radiation is one of the only suspected causes of mesothelioma other than asbestos. Following its victory, J&J blasted the "baseless theory" that its powders could be harmful. "Johnson's Baby Powder has been around since 1894 and it does not contain asbestos or cause mesothelioma," according to the company's statement. WBuitttimnaDne, caenmdbheerr, haussabasencdoJnodhtnr.iaIlninthLatocsaAsen,gteoloe,sawpalsaianbtoifuft'stoexsptaerrtt,hJa&dJraegproereteddtofinadsientgtletrmaceenst owfitahsbmesetsoosthineliaocmoantvaiicnteimr oBf aSrhboawraer to Shower, another J&J powder. Posted in Air Pollution/Toxic Exposure. Environmental Safety and Health. Product Hazards and Recalls, Uncategorized ILeave a comment Print 1 ^ g i ^ j P 239 346 About the author Myron Levin is editor of FairWarning. Read more Leave a comment Comment' Name * Email * Website Post Comment Previous FairWarning's stories and op-eds have appeared in... CThBeSDNaellwass Morning News Newsweek The Kansas City Star Los Angeles Times Mother Jones NBCNews.com The Oregonian The Philadelphia Inquirer Salon San Francisco Chronicle The Washington Post See more Amid Rush to Deploy Driverless Cars. 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