Document 5kL3wLNZ515vLdZNGEQ4ryYDD

FILE NAME: Johnson & Johnson (JAJ) DATE: 2019 July DOC#: JAJ 102 DOCUMENT DESCRIPTION: Journal Article - "Nondetected": The Politics of Measurement of Asbestos in Talc, 1971-1976 PUBLIC HEALTH THEN AND NOW "Nondetected": The Politics of Measurement of Asbestos in Talc, 1971-1976 David Rosner, PhD, MPH, Gerald Markowitz, PhD, and Merlin Chowkwanyun, PhD, M PH The recent lawsuits against Johnson & Johnson have raised the issue o f what and when talcum powder manufacturers knew about the presence o f asbestos in their products and what they did or did not do to protect the public. Low-level exposure to asbestos in talc is said to result in either mesothelioma or ovarian cancer. Johnson & Johnson has claimed that there was "no detectable asbes tos" in their products and that any possible incidental presence was too small to act as a carcinogen. But what exactly does "nondetected" mean? Here, we examine the historical development of the argument that asbestos in talcum powder was "nondetected." We use a unique set of historical docu ments from the early 1970s, when low-level pollution o f talc with asbestos consumed the cosmetics industry. We trace the debate over the Food and Drug Administration's efforts to guarantee that talc was up to 99.99% free o f chrysotile and 99.9% free o f amphibole asbestos. Cosmetic talc powder manufacturers, through their trade association, pressed for a less stringent methodology and adopted the term "nondetected" rather than "asbestos-free" as a term of art. Am J Public Health. Published online ahead of print May 16, 2019; e1-e6. doi: 10.2105/AJPH.2019.305085) The recent lawsuits against Johnson & Johnson, and particularly the $4.8 billion ver dict against the company, have raised the issue of w hat and when talcum powder manufac turers knew about the presence o f asbestos in their products and what they did or did not do to protect the public.1 Since the mid-1960s, asbestos, even at low levels, has been recognized as a cause o f lung cancer and mesothelioma. Since the early 1970s, the cosmetics industry, as represented by the Cosmetic, Toiletry, and Fragrance Association (CTFA), has claimed that there was either no asbestos or that any residual asbestos in their products was "nonde tected." But w hat exactly does "nondetected" mean? Here, we examine the historical devel opment of the argument that asbestos in talcum powder was nondetectable. We use a unique set of historical documents from the early 1970s,2w hen the Food and D rug Administration (FDA) raised concerns over findings of low level pollution o f talc with asbestos. We trace the debate over the FDA's efforts to guar antee that talc was up to 99.99% free of chrysotile and 99.9% free o f amphibole asbestos. Talc pow der companies'counterproposals were less stringent; they pro posed methodologies that were capable of detecting asbestos up to 99.5%. The difference in these methodologies meant that potentially billions o f asbestos fibers could be released into the air w hen babies were powdered or adults powdered themselves. Cosmetic talc powder manufacturers pressed for the less stringent methodology and adopted the term "nondetected" asbestos, rather than "asbestosfree" as a term o f art. The CTFA, the industry trade association, which represented companies such as Johnson & Johnson, Col gate, Pfizer, M ennen, Avon, and other manufacturers of cosmetic talc products, spearheaded the efforts to define how to measure asbestos in talc. These contests over m ethod ology were enormously impor tant. They should be seen as part o f parallel battles over opera tionalization of regulatory terms. Since 1958, the FDA had been embroiled in controversy over proper interpretation of the socalled "Delaney clause," w hich banned approval o f food addi tives that were carcinogenic. But how exactly to "define zero," as historian SarahVogel puts it, was far from self-evident and resulted in decades of debates over the clause's interpretation.3 W hen the controversy over talc began, the National Institute for Occupational Safety and Health (NIOSH) was arguing that only an asbestos exposure approach ing zero could ensure workers' protection against cancers.4 If as bestos could cause cancer among workers even at minimal levels of exposure, then consumer advo cates and federal officials worried that everyday users o f products with asbestos were at risk, too. In earlier articles, we have traced how two other trade associations representing manufacturers of asbestos products reacted to the changing political, scientific, and regulatory efforts to control as bestos exposure.5 Here, we look at a third, the CTFA, represent ing an industry whose market was the broad public: m en and women, mothers and fathers, and even babies. ORIGINS OF THE CONCERN OVER TALC The suspicion that asbestos was a dangerous pollutant in el Public Health Then and Now Peer Reviewed Rosner e t al. AJPH July 2019, Vol 109, No.7 PUBLIC HEALTH THEN AND NOW talc can be traced back to the 1930s, w hen a number of clini cal reports appeared indicating that talc workers were suffering from a pneumoconiosis whose symptoms resembled asbestosis, the insidious lung disease that was of major concern at the time. For example,Waldemar Dreessen published a study of workers in two mills in 1933 and concluded that " [t]he silicate dusts of tremolite talc [i.e., talc mixed w ith tremolite, one o f the six major forms of asbestos] and slate induce a fine, diffuse bilat eral fibrosis o f the lungs which is definitely demonstrable in the X-ray."6 In 1942, FW Porro and his associates presented 15 cases of talc miners and millers with pneumoconiosis. They wrote: "It would appear from a consid eration of Dreessen's analysis that the dust responsible for the disabling pneumoconiosis must be the talc itself in the form of tremolite or soapstone or both." They also commented that "common to all cases is moder ately frequent presence of asbes tos bodies in the lesions. . . .The presence of asbestos bodies in fibrotic areas implies a degree of similarity between asbestosis and pneumoconiosis due to talc."7 In 1956,A. C. Hunt, publishing in Thorax, wrote that "commer cial talc is a mixture of the pure mineral talc (hydrated magnesium silicate) with related minerals such as dolomite, serpentine, anthophyllite and tremolite. The amount of pure talc in commer cial specimens is very variable."8 In 1963, the National Safety Council, an historically manage ment-friendly group, founded in 1912 by industry to inform com panies about--and help them ad dress-- ongoing health and safety problems in their plants, issued a pamphlet that stated: "Talcosis is usually associated with tremolite talc."The council noted that the diseases " [produce] changes in the lungs and symptoms similar to those of asbestosis."9 By the mid-1960s, miners o f talc had been identified by occupational health research ers as at increased risk for lung cancer. Morris Kleinfeld and his colleagues conducted a study "to ascertain the health hazards associated with exposure to dust in talc mining and milling." They concluded that "the data on carcinoma of the lung and pleura shows an overall mortal ity from carcinoma of the lung and pleura to be approximately four times that expected."10The asbestos manufacturers identi fied tremolite in some "body talcum powders."11 In addition, researchers identified tremolite in samples o f cosmetic talc products. Louis Cralley and his colleagues analyzed 22 talcum products and found that all of them had "an appreciable fiber content, ranging from 8 to 30%. . . .The fibrous material was predominantly talc but prob ably contained m inor amounts of tremolite, anthophyllite and chrysotile as these are often present in fibrous talc mineral deposits."12 Some went even far ther, arguing that cosmetic prod ucts were a threat to consumers: "It is difficult to conceive of a better way of having fibers inhaled than the use o f cosmetic talcum powders."13 In light of growing suspicion that asbestos, even at minimal levels, was carcinogenic, the FDA called representatives of a wide range of cosmetics manufactur ers and scientists to Washington in August 1971 to "discuss in detail analytical methods for the determination of minor amounts o f `asbestos like'materials in talc with particular reference to cosmetic grade talcs," or, as one m ember o f the CTFA called it, "the asbestos in talc problem." The meeting brought together a number o f parties: talc manufacturers, including Johnson & Johnson and Pfizer; government officials from the FDA, the Bureau of Mines, NIOSH, and the US Geological Survey; physicians and scientists such as Irving Selikoff,William Nicholson, and Arthur Langer of Mt. Sinai School of Medicine and Seymour Lewin of New York University; and representa tives ofJohns Manville and the Consumers U nion.14At the meeting, as reported by Pfizer researchers, attendees discussed a number of different methods for identifying asbestos in talc, including light microscopy, x-ray diffraction, electron microscopy, and electron diffraction.15The meeting laid out the evolving concerns o f industry, consumers, researchers, and the FDA regard ing how to evaluate the dangers from asbestos contamination in their products in light of the growing evidence that even the smallest exposures to asbestos could prove carcinogenic. By August 1972, some results had begun to come in from both inside and outside N IO SH indicating that there was a prob lem. N IO SH had independently been testing "nine commercially available baby powders" by using electron microscopy. Its study indicated "possible asbestos fiber contamination of commercial baby powders."16A m onth later, Seymour Lewin, under contract w ith the FDA, began reporting his findings of the contamination of talcum powders. O f the 102 samples "o f standard, commercial products containing talc" that he tested, x-ray diffraction showed "that 59 of the products [had] no detectable amounts o f any asbestiform minerals.. ."17;"20 had small but definite percentages of both tremolite and chrysotile," and "7 had substantial percentages AJPH July 2019, Vol 109, No.7 Rosner e t al. Peer Reviewed Public Health Then and Now e2 PUBLIC HEALTH THEN AND NOW o f one or both of these asbestiform minerals."18 In a memo, CTFA representatives noted Lewin's conclusion that "over 40 percent of the samples may con tain asbestiform minerals such as chrysotile or tremolite."19 There was a lot at stake for both the industry and consumers.The Wall StreetJournal, in February 1973, gave a detailed summary of Lewin's findings, telling its readers that " 10% [of the 200 talcum powders tested] contain 2% to 4% asbestos impu rities, with a handful running as high as 10% to 20%." The impact was expected to fall primarily on "manufacturers of dusting pow ders, baby powders, after shave products and the talc-containing cosmetics."The Journal reported that the FDA would "impose stringent limits" on these prod ucts but optimistically predicted that manufacturers would likely support these changes. "Most cosmetic concerns agree that asbestos must be eliminated from their products and some have already moved to do so, partly under FDA pressure."20 Apart from economic con siderations, the political milieu o f the time also gave both the manufacturers and the FDA reason to worry. Skepticism of large institutions was burgeon ing, w ith activist ire aimed at everything from major research universities to the military to large corporations. Advocacy for the interests of the everyday consumer, particularly around health and safety concerns, was exemplified by the attorney Ralph Nader, who became the public face o f a revived con sumer movement that thrived from the early 1960s into the 1980s. Nader had made his mark with a scorching investigation of automobiles, entitled Unsafe at Any Speed, which had shaken the entire industry and led to sweep ing legislative reforms.21 He subsequently led young investi gative teams-- dubbed "N ader's Raiders"-- that wrote critical and detailed reports on other targets, including government agencies like the Federal Trade Commission and Department of Veterans Affairs.22 The FDA was no exception to this muckraking. O ne Naderspawned entity, Public Citizen, created a Health Research Group, headed by the physi cian Sidney Wolfe. It focused o n pharmaceutical safety and transparency in the approval process, taking advantage of new laws like the Freedom of Information Act to request previously classified material.23 O ther groups, most notably activists in the w om en's health movement, set their sights on the safety o f synthetic hormones and contraceptives.24 Corpora tions and the FDA both faced a new culture of accountability: for corporations, over the safety o f their products; for the FDA, over the ability to ensure that safety if corporations themselves could not provide it. It is in this context that the exchanges on methodology between the CTFA and the FDA occurred. THE INDUSTRY GOES ON THE OFFENSIVE In the fall o f 1973, the FDA announced its proposed rule in the Federal Register. "Any drug, drug ingredient, or drug packag ing material containing talc that fails to m eet the specifications . . . as determined by the method set out . . . shall be deemed to be adulterated in violation of ... the A ct" and thus not a substance "generally recognized as safe." The standard was exacting. The FDA proposed using a polarizing microscope that they believed could accurately ensure "a purity of talc at least 99.9 percent free of amphibole types o f asbestos fibers and at least 99.99 percent free of chrysotile asbestos fibers."25 The industry reacted im mediately and negatively to the proposed rule. Two weeks after the announcement in the Federal Register, the CTFA Subcommit tee of Scientific Advisory Com mittee on Asbestos in Talc met and attacked the FDA's method ology as "not completely reliable and discriminatory," arguing it was not clear that the methods used really measured true asbes tos fibers. The CTFA suggested that the methods could actu ally be finding nonfibrous or nontoxic materials. " [C]hrysotile might fall w ithin the critical range o f refractive indices used," the CTFA contended. Further, committee members claimed that the counting, even if ac curate, would take an inordinate amount of time-- perhaps six hours-- for a technician to reach a "tentative identification" of the asbestos content. "The tedium effect on the person count ing is obvious," the committee maintained.26 The CTFA organized a "round robin" test to determine the reliability of the m ethod ologies proposed by the FDA. After distributing samples of talc from a variety o f mines from a number o f states, it asked various companies to have their experts determine whether the samples contained chrysotile or amphi bole asbestos. The CTFA had provided samples that they had "spiked" w ith know n amounts of different asbestos fibers to see how accurately or inaccurately the methodologies performed. The round robin test revealed "strong inconsistency" among "the different scientists applying the method to the same group of coded talc samples."The CTFA e3 Public Health Then and Now Peer Reviewed Rosner e t al. AJPH July 2019, Vol 109, No.7 PUBLIC HEALTH THEN AND NOW "concluded that the method published in the Federal Register does not provide a truly reliable means for the detection o f asbes tos in talc." Given that the meth odology was "tedious and may consume as much as one half day per sample," the "subcommittee urge[d] that the Food and Drug Administration defer finalizing the proposed optical microscopic method and proceed [to a] program which would combine FDA and Industry in a strong effort to develop a truly reliable method." The CTFA subcom mittee estimated "that a satisfac tory method will take at least six months to a year to develop" if industry and the FDA worked together.27The industry was willing to challenge the FDA since some privately believed that the "FDA is reluctant to take any legal action in any problems with industry." The CTFA had been told that the FDA had "neither the money nor the manpower to pursue matters so that they will have airtight cases in scientific matters."28 The CTFA also challenged the government even though one representative ofJohns Manville reported that some talc suppliers were distributing products with high amounts of three o f the major forms of as bestos-- chrysotile, tremolite, and anthophyllite-- and might be lying to the government about it. R . S. Lamar ofJohns Manville was specifically referring to "R.T. Vanderbilt Company talc products," which "always have and continue to contain chrysotile as a significant mineral component (in addition to tremolite and anthophyllite)." He concluded his private correspon dence with another Manville executive: "It is apparent that the R.T. Vanderbilt presentation to OSHA [Occupational Safety and Health Administration], NIOSH, FDA, MESA [Mine Enforce m ent Safety Administration], etc. are based on something less than the truth."29 This struggle between the government and industry over the FDA recommendation was highly consequential. In March 1975, the objections o f industry to the earlier FDA notice of rule making in the Federal Register had undermined the FDA's efforts to adopt stricter standards. " The Food and Drug Administration has . . . examined numerous talc samples of undefined grade in the past two years, using the pro posed methodology," the Federal Register had announced, "and finds that approximately twothirds of such samples are within these limitations" o f 99.9% amphibole free and 99.99% chrysotile free. The implication of this was that possibly one third were not free of asbestos. "The Commissioner therefore concludes that the proposed limitations would not impose an unreasonable burden on manu facturers of talc if these limita tions were adopted." B ut industry was objecting and, hence, "The Commissioner . . . decided to delay any final regulation for talc until an acceptable m ethod for determining the presence of as bestos particles can be developed for this substance."30 The industry had won a major battle, and it proceeded to promulgate its own methodol ogy, referred to as J4-1, and its own definition of talc: "Cos metic talc is a white, essentially odorless, fine powder, ground from naturally occurring rock ore, consisting mainly o f mag nesium silicate . . . with lesser amounts of naturally associated minerals . . . and containing no detectable fibrous asbestos miner als [emphasis added]."J4-1 was less stringent than the FDA stan dard; it was only reliable to 0.5% as compared with the FDA's methodology, which claimed ac curacy to 0.01%. This meant that future cosmetic talc products might, in fact, contain asbestos below the 0.5% detectable limit. Furthermore, the CFTA pro mulgated its own definition of talc's purity by avoiding precise statements in favor o f vaguer language in its description of the asbestos content o f the manufac turers'products. "After extensive discussions of advantages and disadvantages o f listing a 0.5% maximum limit as opposed to `nondetected'terminology, the Standards Com mittee voted for the use o f . . . `nondetected.'"31 O ne industry representative, however, acknowledged the dishonesty in using "nonde tected" as the definition for safety of cosmetic talc products: "You will notice that a talc standard definition for cosmetic talc was adopted unanimously," H. D. Stanley of Pfizer wrote to R . E. N orw ood following a July 8, 1976 meeting of the CTFA. "Had I been there I would have objected to their definition. I particularly object to the section . . . that reads --containing no detectable asbestos minerals." Stanley pointed out the irony that a " nondetected" level de pended on the adequacy-- or inadequacy-- of the methods used to detect it. Using an insensitive m ethod would allow manufac turers to claim that asbestos had not been detected but would simultaneously lead to "serious breaks in communication be tween the buyer and the seller," w ho would believe that the product was truly asbestos-free.32 This observation was not trivial and got to the heart of the prob lem the cosmetics industry faced. As A rthur R ohl, a researcher in Irving Selikoff's department at Mt. Sinai School o f Medicine, pointed out, if the wrong AJPH July 2019, Vol 109, No.7 Rosner e t al. Peer Reviewed Public Health Then and Now e4 PUBLIC HEALTH THEN AND NOW methodology was used, billions o f particles o f asbestos could escape detection. H e wrote that "Even at the lowest level of detection by x-ray diffraction, i.e., 0.25%, there would be about 109fibers/mg. Cosmetic talcum powder, for example, which had been step-scanned and chrysotile not found might contain billions o f fibers released during dusting with a half-gram dose."33 How dangerous talc products were, then, depended on what one used to measure risk. Industry objections to research that found asbestos in talc was noted by researchers themselves. In 1976, follow ing publications by Mt. Sinai researchers o f the presence of asbestos in commercial talcum powders bought off the shelf in local stores, representatives o f the CTFA visited Mt. Sinai in an apparent effort to get the institution and the researchers to qualify, if not retract, their find ings. In one such meeting, the primary authors o f the Mt. Sinai studies informed the industry group that they had found asbes tos in 10 samples by using x-ray diffraction and transmission electron microscopy. In a memo, the Mt. Sinai authors wrote: "Dr. Langer was somewhat disgusted by the talc industry's attitude. He said the results o f his work ha[d] been known to the industry for several years but nothing was done until the . . . results became public."34A few days after that meeting, the industry was par tially mollified when the dean o f Mt. Sinai, Thomas Chalm ers, was quoted in the media as qualifying news reports claim ing that "most of the talcum powder currently on the market contain[ed] asbestos." "It is the opinion of M ount Sinai's D e partm ent o f Pediatrics that baby talc is a useful and safe product," he stated to WCBS.35 CONCLUSION: LEGACY OF THE CTFA CAMPAIGN By 1977, the FDA essentially gave up its efforts to regulate asbestos in talc, as the J4-1 method created by the CTFA had been adopted by the industry despite the CTFA's own acknowledgment that its methodology was inadequate to the task. John Schelz ofJohnson & Johnson, w ho was chair of the CTFA Taskforce on R ound R obin Testing o f Consumer Talcum Products, reported on a round robin test of samples o f talc and found that J4-1 had failed its test for identify ing "asbestiform amphibole contaminants" with accuracy, reliability, and practicality. "These objectives have not yet been achieved [emphasis in original]," he wrote, and suggested a partial retest.36 Despite this, th e J4-1 method, one that the industry itself acknowledged is incapable of determining low-level pollu tion, is still the standard within industry. The industry methodology was no more capable of deter mining low-level exposures than was the methodology the FDA first proposed, and may have been less accurate than were the time-consuming methods they critiqued. For the following half century, the debate over the presence or absence o f asbestos in talc has continued. The implica tions o f this for science, regula tion, and consumer safety have resulted in conferences, symposia, and many scientific papers ever since. But it is no mere scholastic issue. In 1995, for example, Edward Kavanaugh, president of the CTFA, responded to a peti tion by a citizen advocacy group, the Cancer Prevention Coali tion, that asked the FDA to label cosmetic talc products as potential carcinogens. H e reiterated the industry's long-standing position that such warnings were "not necessary to protect the health of consumers and would un necessarily alarm consumers re garding the use of safe cosmetic products."37The FDA did not act on the petitioners'appeal. The recent lawsuits against various talc manufacturers have once again brought the issue of asbestos in talc to public attention.The consequences of industry's actions and inac tions-- and o f its knowledge or lack thereof1--that were identi fied a half century ago are still w ith us. /4jPH ABOUT THE AUTHORS David Rosner, Gerald Markowitz, and Mer lin Chowkwanyun are with the Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY. Gerald Markowitz is also with the John Jay College and Graduate Center, City University ofNewYork, NewYork, N Y Correspondence should be sent to David Rosner, PhD, Mailman School ofPublic Health, Columbia University, 722 West 168th St, Room 935, NewYork, N Y 10032. Reprints can be ordered at http:// www.ajph.org by clicking the "Reprints"link. This article was accepted March 10, 2019. doi: 10.2105/AJPH.2019.305085 CONTRIBUTORS D. Rosner and G. Markowitz wrote the first drafts of the article. M. Chowk wanyun edited and added substantive historical context and additional docu mentation. ACKNOWLEDGMENTS We thank Colleen Lanier Christiansen, Sadie Bergen, and Valentina Parisi for their assistance. CONFLICTS OF INTEREST David Rosner and Gerald Markowitz wrote a 2017 Report to the Court in a legal case that formed the original basis of this article.They received funding from plaintiffs'law firms for research and writing. Merlin Chowkwanyun has no potential conflict of interest. ENDNOTES 1. See, for example, Tina Bellon, "J &J Loses Bid to Have $4.7 Billion Talc Verdict Set Aside,Vows to Appeal," R e uters, December 19, 2018, https://www. reuters.com/article/us-johnson-johnsoncancer/jj-loses-bid-to-have-4-7-billiontalc-verdict-set-aside-vows-to-appealidUSKCN1OI27P (accessed January 17, 2019); Lisa Girion, "Johnson & Johnson e5 Public Health Then and Now Peer Reviewed Rosner e t al. AJPH July 2019, Vol 109, No.7 PUBLIC HEALTH THEN AND NOW Knew for Decades That Asbestos Lurked in Its Baby Powder," A Reuters Investiga tion, December 14, 2018, https://www. reuters.com/investigates/special-report/ johnsonandjohnson-cancer (accessed January 13, 2019). 2. These documents have been released through the discovery process of a num ber of lawsuits against talc manufacturers and producers o f baby and body pow ders. The primary documents used here are available on toxicdocs.org as identi fied in the references. 3. SarahVogel, Is It Safe? BPA and the Struggle to Define the Safety of Chemicals (Berkeley, CA: University of California Press, 2013), 47. 4. National Institute for Occupational Safety and Health (NIOSH), "Criteria for a Recommended Standard . . . Oc cupational Exposure to Asbestos" 1972, https://cdn.toxicdocs.org/2R/2RxDB b5zErM1pYGanagm843Gr/2RxDBb5 zErM1pYGanagm843Gr.pdf (accessed March 15, 2019). 5. See David Rosner and Gerald Mar kowitz, " `Ain't Necessarily So!'The Brake Industry's Impact on Asbestos Regulation in the 1970s" American Journal of Public Health 107 (2017): 1395-1399; David Rosner and Gerald Markowitz, "`Educate the Individual to a Sane Appreciation of the Risk':A His tory of Industry's Responsibility to Warn ofJob Dangers Before the Occupational Safety and Health Administration" Amer icanJournal of Public Health 106 (2016): 28-35; Gerald Markowitz and David Rosner, " `Unleashed on an Unsuspecting World':The Asbestos Information As sociation and Its Role in Perpetuating a National Epidemic," AmericanJournal of Public Health 106 (2016): 834-840. 6.Waldemar C. Dreessen, "Effects of Certain Silicate Dusts on the Lungs," Journal of Industrial Hygiene 15 (1933): 66-78, quote on p. 78. 7. FW Porro, J.R . Patton, and AA. Hobbs, Jr, "Pneumoconiosis in the Talc Industry," AmericanJournal ofRoentgenol ogy and Radium Therapy 47 (1942): 518. 8. A.C. Hunt, "Massive Pulmonary Fibro sis From the Inhalation of Talc," Thorax 11 (1956): 287-294. 9. National Safety Council, "Dusts, Fumes, and Mists in Industry," Data Sheet 531, 1963, p. 7, https://cdn.toxicdocs.org/wq/ wqy2qoZBDG0a2bYMGM9GX48KJ/ wqy2qoZBDG0a2bYMGM9GX48KJ.pdf (accessed March 15, 2019). 10. M. Kleinfeld, J. Messite, O. Kooyman, and M. H. Zaki, "Mortality Among Talc Miners and Millers in New York State," Archives of Environmental Health 14 (1967): 663-667, quote on p. 665. 11. Johns Manville Research and Engineering Center, "Body Talcum Powders," October 31, 1968, pp. 1-2, https://cdn.toxicdocs.org/gb/ gbq4wMVNy39gQpYQoRr0EpBE3/ gbq4wMVNy39gQpYQoRr0EpBE3.pdf (accessed February 25, 2019). 12. L.J. Cralley, M.M. Key, D.H. Groth, W.S. Lainhart, and R . M. Ligo, "Fibrous and Mineral Content of Cosmetic Talcum Products," American Industrial Hygiene AssociationJournal 29 (1968): 350-354, quote on p. 353. 13. G.W Wright, "Asbestos and Health in 1969," American Review of Respiratory Disease 100 (1969): 467-479, quote on p. 476. 14. "Asbestos in Talc Methodology Con ference at FDA,Washington, DC," Pfizer Memo on [August 3] Meeting, August 10, 1971, https://cdn.toxicdocs.org/ Rj/RjqZD73bLJ2LRDzpaZeKexZb7/ RjqZD73bLJ2LRDzpaZeKexZb7.pdf (accessed March 15, 2019); [Johns Manville] Research and Engineering Center, "Memo for File: FDA [Food and Drug Administration] Meeting Asbestos in Cosmetic Talcs, August 3, 1971--Washington, DC," August 11, 1971, https://cdn.toxicdocs.org/GJ/ GJ48dMXmZpZ3qj8Mpg3v7xY7/ GJ48dMXmZpZ3qj8Mpg3v7xY7.pdf (accessed April 3, 2019). 15. See also FDA, "Memorandum of a Symposium,`Asbestos and Talc,'"August 3, 1971, https://cdn.toxicdocs.org/DM/ DMV5eMX50wdQMQv0LVNEw7myO/ DMV5eMX50wdQMQv0LVNEw7myO. pdf (accessed March 15, 2019). 16. NIOSH, "Fiber Exposure During Use of Baby Powders," Preliminary Report, July 1972, pp. ii, 6, https://cdn. toxicdocs.org/4v/4vw152B9nBVK34J5v BNa3ZZme/4vw152B9nBVK34J5vBNa 3ZZme.pdf (accessed March 15, 2019). 17. "The term asbestiform fibers includes fibers that possess great strength and flexibility, durability, a surface structure relatively free of defects, . . . . Commer cial quality asbestos is an example of an asbestiform fiber." See "Historical Back ground, Terminology, and Physiochemical Properties," in National Research Coun cil, Committee on Nonoccupational Health Risks ofAsbestiform Fibers, Asbestform Fibers: Nonoccupational Health Risks (Washington, DC: National Acad emies Press, 1984), 25. 18. Seymour Lewin, New York Univer sity, to Alfred Weissler, FDA, August 3, 1972, https://cdn.toxicdocs.org/85/85Jy ymOw7EB568x1mExoqRQVe/85Jyym Ow7EB568x1mExoqRQVe.pdf (accessed February 25, 2019). 19. Memorandum of meeting with FDA, companies, and CTFA [Cos metic, Toiletry, and Fragrance Associa tion], https://cdn.toxicdocs.org/rr/ rr5nNZexD4dQE8wEvyXZj28a/ rr5nNZexD4dQE8wEvyXZj28a.pdf (accessed February 24, 2019). 20. Jonathan Spivak, "FDA Plans to Impose Limits on Asbestos in Certain Cosmetics," Wall StreetJournal, February 26, 1973, 16. 21. Ralph Nader, Unsafe at Any Speed: The Designed-In Dangers of the American Automobile (New York, NY: Grossman Publishers, 1965); Justin Martin, Nader: Crusader, Spoiler, Icon (New York, NY: Perseus/Merloyd Lawrence, 2002). 22. Edward F. Cox, Robert C. Fellmeth, and John E. Schultz, "The Nader Report" on the Federal Trade Commission (New York, NY: R.W. Baron, 1969); Paul Starr (with assistance from James F. Henry and Raymond P. Bonner), The Discarded Army: Veterans After Vietnam; The Nader Report on Vietnam Veterans and the Veterans Administration (New York, NY: Charter house, 1973). 23. On Health Research Group, see Ava Alkon, "Late 20th-Century Consumer Advocacy, Pharmaceuticals, and Public Health: Public Citizen's Health Research Group in Historical Perspective," PhD dissertation (New York, NY: Columbia University, 2012); Nancy Tomes, Remak ing the American Patient: How Madison Avenue and Modern Medicine Turned Pa tients Into Consumers (Chapel Hill, NC: University of North Carolina Press, 2016), 314-317; Wendy Kline, Bodies of Knowledge: Sexuality, Reproduction, and Women's Health (Chicago, IL: University of Chicago Press, 2010), 106-107. 24. Kline, Bodies of Knowledge, 97-126; Vogel, Is It Safe? 50-63. 25. Department of Health, Education, and Welfare, FDA, "Asbestos Particles in Food and Drugs, Notice of Proposed Rulemaking," Federal Reg ister 38 (September 28, 1973): 27079 80, https://cdn.toxicdocs.org/R2/ R26RZ08ZMoL6YjvN5rNgneVZB/ R26RZ08ZMoL6YjvN5rNgneVZB.pdf (accessed February 24, 2019). 26. 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