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EXHIBIT 19
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
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AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE
“Nondetected”: The Politics of Measurement of
Asbestos in Talc, 1971–1976
David Rosner, PhD, MPH, Gerald Markowitz, PhD, and Merlin Chowkwanyun, PhD, MPH
The recent lawsuits against Johnson & Johnson have raised the issue of what and when talcum These contests over method-
powder manufacturers knew about the presence of asbestos in their products and what they did ology were enormously impor-
tant. They should be seen as part
or did not do to protect the public. Low-level exposure to asbestos in talc is said to result in either
of parallel battles over opera-
mesothelioma or ovarian cancer. Johnson & Johnson has claimed that there was “no detectable asbes-
tionalization of regulatory terms.
tos” in their products and that any possible incidental presence was too small to act as a carcinogen.
Since 1958, the FDA had been
But what exactly does “nondetected” mean? Here, we examine the historical development of the embroiled in controversy over
argument that asbestos in talcum powder was “nondetected.” We use a unique set of historical docu- proper interpretation of the so-
ments from the early 1970s, when low-level pollution of talc with asbestos consumed the cosmetics called “Delaney clause,” which
industry. We trace the debate over the Food and Drug Administration’s efforts to guarantee that talc banned approval of food addi-
was up to 99.99% free of chrysotile and 99.9% free of amphibole asbestos. Cosmetic talc powder tives that were carcinogenic. But
manufacturers, through their trade association, pressed for a less stringent methodology and adopted how exactly to “define zero,”
the term “nondetected” rather than “asbestos-free” as a term of art. (Am J Public Health. 2019;109: as historian Sarah Vogel puts it,
969–974. doi: 10.2105/AJPH.2019.305085) was far from self-evident and
resulted in decades of debates
over the clause’s interpretation.3
See also Aaltonen, p. 949;
Morabia, p. 955; T he recent lawsuits against
Johnson & Johnson, and
particularly the $4.8 billion ver-
raised concerns over findings of
low level pollution of talc with
asbestos. We trace the debate
When the controversy over talc
began, the National Institute for
Occupational Safety and Health
Michaels, p. 975;
Samet, p. 976; dict against the company, have over the FDA’s efforts to guar- (NIOSH) was arguing that only
Vineis, p. 978; raised the issue of what and antee that talc was up to 99.99% an asbestos exposure approach-
Rodenberg, p. 980; and when talcum powder manufac- free of chrysotile and 99.9% free ing zero could ensure workers’
Singla et al., p. 982. turers knew about the presence of amphibole asbestos. Talc pow- protection against cancers.4 If as-
of asbestos in their products and der companies’ counterproposals bestos could cause cancer among
what they did or did not do to were less stringent; they pro- workers even at minimal levels of
protect the public.1 posed methodologies that were exposure, then consumer advo-
Since the mid-1960s, asbestos, capable of detecting asbestos cates and federal officials worried
even at low levels, has been up to 99.5%. The difference in that everyday users of products
recognized as a cause of lung these methodologies meant that with asbestos were at risk, too.
cancer and mesothelioma. Since potentially billions of asbestos In earlier articles, we have traced
the early 1970s, the cosmetics fibers could be released into the how two other trade associations
industry, as represented by the air when babies were powdered representing manufacturers of
Cosmetic, Toiletry, and Fragrance or adults powdered themselves. asbestos products reacted to the
Association (CTFA), has claimed Cosmetic talc powder changing political, scientific, and
that there was either no asbestos manufacturers pressed for the regulatory efforts to control as-
or that any residual asbestos less stringent methodology and bestos exposure.5 Here, we look
in their products was “nonde- adopted the term “nondetected” at a third, the CTFA, represent-
tected.” But what exactly does asbestos, rather than “asbestos- ing an industry whose market
“nondetected” mean? Here, we free” as a term of art. The CTFA, was the broad public: men and
examine the historical devel- the industry trade association, women, mothers and fathers, and
opment of the argument that which represented companies even babies.
asbestos in talcum powder was such as Johnson & Johnson, Col-
nondetectable. gate, Pfizer, Mennen, Avon, and
We use a unique set of other manufacturers of cosmetic ORIGINS OF THE
historical documents from the talc products, spearheaded the CONCERN OVER TALC
early 1970s,2 when the Food efforts to define how to measure The suspicion that asbestos
and Drug Administration (FDA) asbestos in talc. was a dangerous pollutant in
July 2019, Vol 109, No. 7 AJPH Rosner et al. Peer Reviewed Public Health Then and Now 969
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talc can be traced back to the diseases “[produce] changes in the problem.” The meeting brought
1930s, when a number of clini- lungs and symptoms similar to together a number of parties:
cal reports appeared indicating those of asbestosis.”9 talc manufacturers, including
that talc workers were suffering By the mid-1960s, miners Johnson & Johnson and Pfizer;
from a pneumoconiosis whose of talc had been identified by government officials from the
symptoms resembled asbestosis, occupational health research- FDA, the Bureau of Mines,
the insidious lung disease that ers as at increased risk for lung NIOSH, and the US Geological
was of major concern at the cancer. Morris Kleinfeld and his Survey; physicians and scientists
time. For example,Waldemar colleagues conducted a study such as Irving Selikoff, William
Dreessen published a study of “to ascertain the health hazards Nicholson, and Arthur Langer
workers in two mills in 1933 associated with exposure to of Mt. Sinai School of Medicine
and concluded that “[t]he silicate dust in talc mining and milling.” and Seymour Lewin of New
dusts of tremolite talc [i.e., talc They concluded that “the data York University; and representa-
mixed with tremolite, one of the on carcinoma of the lung and tives of Johns Manville and the
six major forms of asbestos] and pleura shows an overall mortal- Consumers Union.14 At the
slate induce a fine, diffuse bilat- ity from carcinoma of the lung meeting, as reported by Pfizer
eral fibrosis of the lungs which and pleura to be approximately researchers, attendees discussed
is definitely demonstrable in the four times that expected.”10 The a number of different methods
X-ray.”6 In 1942, F.W. Porro and asbestos manufacturers identi- for identifying asbestos in talc,
his associates presented 15 cases fied tremolite in some “body including light microscopy, x-ray
of talc miners and millers with talcum powders.”11 In addition, diffraction, electron microscopy,
pneumoconiosis.They wrote: “It researchers identified tremo- and electron diffraction.15 The
would appear from a consid- lite in samples of cosmetic talc meeting laid out the evolving
eration of Dreessen’s analysis products. Louis Cralley and his concerns of industry, consumers,
that the dust responsible for the colleagues analyzed 22 talcum researchers, and the FDA regard-
disabling pneumoconiosis must products and found that all of ing how to evaluate the dangers
be the talc itself in the form of them had “an appreciable fiber from asbestos contamination
tremolite or soapstone or both.” content, ranging from 8 to 30%. in their products in light of the
They also commented that . . . The fibrous material was growing evidence that even the
“common to all cases is moder- predominantly talc but prob- smallest exposures to asbestos
ately frequent presence of asbes- ably contained minor amounts could prove carcinogenic.
tos bodies in the lesions. . . .The of tremolite, anthophyllite and By August 1972, some results
presence of asbestos bodies in chrysotile as these are often had begun to come in from
fibrotic areas implies a degree of present in fibrous talc mineral both inside and outside NIOSH
similarity between asbestosis and deposits.”12 Some went even far- indicating that there was a prob-
pneumoconiosis due to talc.”7 ther, arguing that cosmetic prod- lem. NIOSH had independently
In 1956, A.C. Hunt, publishing ucts were a threat to consumers: been testing “nine commercially
in Thorax, wrote that “commer- “It is difficult to conceive of available baby powders” by using
cial talc is a mixture of the pure a better way of having fibers electron microscopy. Its study
mineral talc (hydrated magnesium inhaled than the use of cosmetic indicated “possible asbestos fiber
silicate) with related minerals talcum powders.”13 contamination of commercial
such as dolomite, serpentine, In light of growing suspicion baby powders.”16 A month later,
anthophyllite and tremolite.The that asbestos, even at minimal Seymour Lewin, under contract
amount of pure talc in commer- levels, was carcinogenic, the FDA with the FDA, began reporting
cial specimens is very variable.”8 called representatives of a wide his findings of the contamination
In 1963, the National Safety range of cosmetics manufactur- of talcum powders. Of the 102
Council, an historically manage- ers and scientists to Washington samples “of standard, commercial
ment-friendly group, founded in in August 1971 to “discuss in products containing talc” that he
1912 by industry to inform com- detail analytical methods for the tested, x-ray diffraction showed
panies about—and help them ad- determination of minor amounts “that 59 of the products [had] no
dress—ongoing health and safety of ‘asbestos like’ materials in detectable amounts of any
problems in their plants, issued a talc with particular reference asbestiform minerals…”17;
pamphlet that stated: “Talcosis is to cosmetic grade talcs,” or, “20 had small but definite per-
usually associated with tremolite as one member of the CTFA centages of tremolite,” and
talc.”The council noted that the called it, “the asbestos in talc “7 had substantial percentages
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of one or both of these asbes- ing legislative reforms.21 He of talc at least 99.9 percent free
tiform minerals.”18 In a memo, subsequently led young investi- of amphibole types of asbestos
CTFA representatives noted gative teams—dubbed “Nader’s fibers and at least 99.99 percent
Lewin’s conclusion that “over 40 Raiders”—that wrote critical free of chrysotile asbestos
percent of the samples may con- and detailed reports on other fibers.”25
tain asbestiform minerals such as targets, including government The industry reacted im-
chrysotile or tremolite.”19 agencies like the Federal Trade mediately and negatively to the
There was a lot at stake for Commission and Department of proposed rule. Two weeks after
both the industry and consum- Veterans Affairs.22 the announcement in the Federal
ers. The Wall Street Journal, in The FDA was no exception Register, the CTFA Subcommit-
February 1973, gave a detailed to this muckraking. One Nader- tee of Scientific Advisory Com-
summary of Lewin’s findings, spawned entity, Public Citizen, mittee on Asbestos in Talc met
telling its readers that “10% [of created a Health Research and attacked the FDA’s method-
the 200 talcum powders tested] Group, headed by the physi- ology as “not completely reliable
contain 2% to 4% asbestos impu- cian Sidney Wolfe. It focused and discriminatory,” arguing it
rities, with a handful running as on pharmaceutical safety and was not clear that the methods
high as 10% to 20%.” The impact transparency in the approval used really measured true asbes-
was expected to fall primarily on process, taking advantage of tos fibers. The CTFA suggested
“manufacturers of dusting pow- new laws like the Freedom that the methods could actu-
ders, baby powders, after shave of Information Act to request ally be finding nonfibrous or
products and the talc-containing previously classified material.23 nontoxic materials. “[C]hrysotile
cosmetics.” The Journal reported Other groups, most notably might fall within the critical
that the FDA would “impose activists in the women’s health range of refractive indices used,”
stringent limits” on these prod- movement, set their sights on the CTFA contended. Further,
ucts but optimistically predicted the safety of synthetic hormones committee members claimed
that manufacturers would likely and contraceptives.24 Corpora- that the counting, even if ac-
support these changes. “Most tions and the FDA both faced curate, would take an inordinate
cosmetic concerns agree that a new culture of accountability: amount of time—perhaps six
asbestos must be eliminated from for corporations, over the safety hours—for a technician to reach
their products and some have of their products; for the FDA, a “tentative identification” of the
already moved to do so, partly over the ability to ensure that asbestos content. “The tedium
under FDA pressure.”20 safety if corporations themselves effect on the person count-
Apart from economic con- could not provide it. It is in ing is obvious,” the committee
siderations, the political milieu this context that the exchanges maintained.26
of the time also gave both the on methodology between the The CTFA organized a
manufacturers and the FDA CTFA and the FDA occurred. “round robin” test to determine
reason to worry. Skepticism of the reliability of the method-
large institutions was burgeon- ologies proposed by the FDA.
ing, with activist ire aimed at THE INDUSTRY GOES ON After distributing samples of talc
everything from major research THE OFFENSIVE from a variety of mines from a
universities to the military to In the fall of 1973, the FDA number of states, it asked various
large corporations. Advocacy announced its proposed rule in companies to have their experts
for the interests of the everyday the Federal Register: “Any drug, determine whether the samples
consumer, particularly around drug ingredient, or drug packag- contained chrysotile or amphi-
health and safety concerns, was ing material containing talc that bole asbestos. The CTFA had
exemplified by the attorney fails to meet the specifications . . . provided samples that they had
Ralph Nader, who became the as determined by the method “spiked” with known amounts
public face of a revived con- set out . . . shall be deemed to be of different asbestos fibers to see
sumer movement that thrived adulterated in violation of … the how accurately or inaccurately
from the early 1960s into the Act” and thus not a substance the methodologies performed.
1980s. Nader had made his mark “generally recognized as safe.” The round robin test revealed
with a scorching investigation of The standard was exacting: The “strong inconsistency” among
automobiles, entitled Unsafe at FDA proposed using a polarizing “the different scientists applying
Any Speed, which had shaken the microscope that they believed the method to the same group of
entire industry and led to sweep- could accurately ensure “a purity coded talc samples.” The CTFA
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“concluded that the method FDA, MESA [Mine Enforce- as compared with the FDA’s
published in the Federal Register ment Safety Administration], methodology, which claimed ac-
does not provide a truly reliable etc. are based on something less curacy to 0.01%. This meant that
means for the detection of asbes- than the truth.”29 future cosmetic talc products
tos in talc.” Given that the meth- This struggle between the might, in fact, contain asbestos
odology was “tedious and may government and industry over below the 0.5% detectable limit.
consume as much as one half day the FDA recommendation was Furthermore, the CFTA pro-
per sample,” the “subcommittee highly consequential. In March mulgated its own definition of
urge[d] that the Food and Drug 1975, the objections of industry talc’s purity by avoiding precise
Administration defer finalizing to the earlier FDA notice of rule- statements in favor of vaguer
the proposed optical microscopic making in the Federal Register had language in its description of the
method and proceed [to a] undermined the FDA’s efforts asbestos content of the manufac-
program which would combine to adopt stricter standards. “The turers’ products. “After extensive
FDA and Industry in a strong Food and Drug Administration discussions of advantages and
effort to develop a truly reliable has . . . examined numerous talc disadvantages of listing a 0.5%
method.” The CTFA subcom- samples of undefined grade in maximum limit as opposed to
mittee estimated “that a satisfac- the past two years, using the pro- ‘nondetected’ terminology, the
tory method will take at least six posed methodology,” the Federal Standards Committee voted for
months to a year to develop” if Register had announced, “and the use of . . . ‘nondetected.’”31
industry and the FDA worked finds that approximately two- One industry representative,
together.27 The industry was thirds of such samples are within however, acknowledged the
willing to challenge the FDA these limitations” of 99.9% dishonesty in using “nonde-
since some privately believed amphibole free and 99.99% tected” as the definition for
that the “FDA is reluctant to take chrysotile free.The implication safety of cosmetic talc products:
any legal action in any problems of this was that possibly one “You will notice that a talc
with industry.” The CTFA had third were not free of asbestos. standard definition for cosmetic
been told that the FDA had “The Commissioner therefore talc was adopted unanimously,”
“neither the money nor the concludes that the proposed H.D. Stanley of Pfizer wrote to
manpower to pursue matters so limitations would not impose an R.E. Norwood following a July
that they will have airtight cases unreasonable burden on manu- 8, 1976 meeting of the CTFA.
in scientific matters.”28 facturers of talc if these limita- “Had I been there I would have
The CTFA also challenged tions were adopted.” But industry objected to their definition. I
the government even though was objecting and, hence, “The particularly object to the section
one representative of Johns Commissioner . . . decided to . . . that reads – containing no
Manville reported that some delay any final regulation for talc detectable asbestos minerals.”
talc suppliers were distributing until an acceptable method for Stanley pointed out the irony
products with high amounts of determining the presence of as- that a “nondetected” level de-
three of the major forms of as- bestos particles can be developed pended on the adequacy—or in-
bestos—chrysotile, tremolite, and for this substance.”30 adequacy—of the methods used
anthophyllite—and might be The industry had won a to detect it. Using an insensitive
lying to the government about major battle, and it proceeded to method would allow manufac-
it. R.S. Lamar of Johns Manville promulgate its own methodol- turers to claim that asbestos had
was specifically referring to ogy, referred to as J4-1, and its not been detected but would
“R.T. Vanderbilt Company talc own definition of talc: “Cos- simultaneously lead to “serious
products,” which “always have metic talc is a white, essentially breaks in communication be-
and continue to contain chryso- odorless, fine powder, ground tween the buyer and the seller,”
tile as a significant mineral from naturally occurring rock who would believe that the
component (in addition to ore, consisting mainly of mag- product was truly asbestos-free.32
tremolite and anthophyllite).” He nesium silicate . . . with lesser This observation was not trivial
concluded his private correspon- amounts of naturally associated and got to the heart of the prob-
dence with another Manville minerals . . . and containing no lem the cosmetics industry faced.
executive: “It is apparent that the detectable fibrous asbestos miner- As Arthur Rohl, a researcher in
R.T. Vanderbilt presentation to als [emphasis added].” J4-1 was Irving Selikoff ’s department at
OSHA [Occupational Safety and less stringent than the FDA stan- Mt. Sinai School of Medicine,
Health Administration], NIOSH, dard; it was only reliable to 0.5% pointed out, if the wrong
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methodology was used, billions CONCLUSION: LEGACY that such warnings were “not
of particles of asbestos could OF THE CTFA CAMPAIGN necessary to protect the health
escape detection. He wrote that By 1977, the FDA essentially of consumers and would un-
“Even at the lowest level of gave up its efforts to regulate necessarily alarm consumers re-
detection by x-ray diffraction, asbestos in talc, as the J4-1 garding the use of safe cosmetic
i.e., 0.25%, there would be about method created by the CTFA products.”37 The FDA did not act
109 fibers/mg. Cosmetic talcum had been adopted by the on the petitioners’ appeal.
powder, for example, which had industry despite the CTFA’s The recent lawsuits against
been step-scanned and chrysotile own acknowledgment that its various talc manufacturers have
not found might contain billions methodology was inadequate to once again brought the issue
of fibers released during dusting the task. John Schelz of Johnson of asbestos in talc to public
with a half-gram dose.”33 How & Johnson, who was chair of attention. The consequences
dangerous talc products were, the CTFA Taskforce on Round of industry’s actions and inac-
then, depended on what one Robin Testing of Consumer tions—and of its knowledge or
used to measure risk. Talcum Products, reported on lack thereof—that were identi-
Industry objections to a round robin test of samples fied a half century ago are still
research that found asbestos in of talc and found that J4-1 with us.
talc was noted by researchers had failed its test for identify-
themselves. In 1976, follow- ing “asbestiform amphibole ABOUT THE AUTHORS
ing publications by Mt. Sinai contaminants” with accuracy, David Rosner, Gerald Markowitz, and Mer-
lin Chowkwanyun are with the Department
researchers of the presence of reliability, and practicality. “These
of Sociomedical Sciences, Mailman School of
asbestos in commercial talcum objectives have not yet been Public Health, Columbia University, New
powders bought off the shelf achieved [emphasis in original],” York, NY. Gerald Markowitz is also with the
John Jay College and Graduate Center, City
in local stores, representatives he wrote, and suggested a partial
University of New York, New York, NY.
of the CTFA visited Mt. Sinai retest.36 Despite this, the J4-1 Correspondence should be sent to David
in an apparent effort to get the method, one that the industry Rosner, PhD, Mailman School of Public
Health, Columbia University, 722 West
institution and the researchers to itself acknowledged is incapable
168th St, Room 935, New York, NY
qualify, if not retract, their find- of determining low-level pollu- 10032. Reprints can be ordered at http://
ings. In one such meeting, the tion, is still the standard within www.ajph.org by clicking the “Reprints” link.
This article was accepted March 10, 2019.
primary authors of the Mt. Sinai industry.
doi: 10.2105/AJPH.2019.305085
studies informed the industry The industry methodology
group that they had found asbes- was no more capable of deter- CONTRIBUTORS
tos in 10 samples by using x-ray mining low-level exposures than D. Rosner and G. Markowitz wrote the
first drafts of the article. M. Chowk-
diffraction and transmission was the methodology the FDA wanyun edited and added substantive
electron microscopy. In a memo, first proposed, and may have historical context and additional docu-
the Mt. Sinai authors wrote: “Dr. been less accurate than were the mentation.
Langer was somewhat disgusted time-consuming methods they ACKNOWLEDGMENTS
by the talc industry’s attitude. He critiqued. For the following half We thank Colleen Lanier Christiansen,
said the results of his work ha[d] century, the debate over the Sadie Bergen, and Valentina Parisi for
their assistance.
been known to the industry for presence or absence of asbestos in
several years but nothing was talc has continued.The implica- CONFLICTS OF INTEREST
done until the . . . results became tions of this for science, regula- David Rosner and Gerald Markowitz
wrote a 2017 Report to the Court in a
public.”34 A few days after that tion, and consumer safety have legal case that formed the original basis
meeting, the industry was par- resulted in conferences, symposia, of this article. They received funding
tially mollified when the dean and many scientific papers ever from plaintiffs’ law firms for research and
writing. Merlin Chowkwanyun has no
of Mt. Sinai, Thomas Chalm- since. But it is no mere scholastic potential conflict of interest.
ers, was quoted in the media as issue. In 1995, for example,
qualifying news reports claim- Edward Kavanaugh, president of ENDNOTES
ing that “most of the talcum the CTFA, responded to a peti- 1. See, for example, Tina Bellon, “J & J
Loses Bid to Have $4.7 Billion Talc
powder currently on the market tion by a citizen advocacy group,
Verdict Set Aside,Vows to Appeal,” Re-
contain[ed] asbestos.” “It is the the Cancer Prevention Coali- uters, December 19, 2018, https://www.
opinion of Mount Sinai’s De- tion, that asked the FDA to label reuters.com/article/us-johnson-johnson-
cancer/jj-loses-bid-to-have-4-7-billion-
partment of Pediatrics that baby cosmetic talc products as potential
talc-verdict-set-aside-vows-to-appeal-
talc is a useful and safe product,” carcinogens. He reiterated the idUSKCN1OI27P (accessed January 17,
he stated to WCBS.35 industry’s long-standing position 2019); Lisa Girion, “Johnson & Johnson
July 2019, Vol 109, No. 7 AJPH Rosner et al. Peer Reviewed Public Health Then and Now 973
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Knew for Decades That Asbestos Lurked gbq4wMVNy39gQpYQoRr0EpBE3/ Cosmetics,” Wall Street Journal, February gbq4wMVNy39gQpYQoRr0EpBE3.pdf
in Its Baby Powder,” A Reuters Investiga- gbq4wMVNy39gQpYQoRr0EpBE3.pdf 26, 1973, 16. (accessed March 15, 2019).
tion, December 14, 2018, https://www. (accessed February 25, 2019). 30. “Asbestos-Form Particles in Drugs
21. Ralph Nader, Unsafe at Any
reuters.com/investigates/special-report/ for Parenteral Injection,” Federal
12. L.J. Cralley, M.M. Key, D.H. Groth, Speed: The Designed-In Dangers of the
johnsonandjohnson-cancer (accessed Register 40, no. 51 (March 14, 1975):
W.S. Lainhart, and R.M. Ligo, “Fibrous American Automobile (New York, NY:
January 13, 2019). 11865-66, https://cdn.toxicdocs.org/By/
and Mineral Content of Cosmetic Grossman Publishers, 1965); Justin
2. These documents have been released Talcum Products,” American Industrial Martin, Nader: Crusader, Spoiler, Icon By4GYmaDEJ4wNRExn4Z1DpBp8/
through the discovery process of a num- Hygiene Association Journal 29 (1968): (New York, NY: Perseus/Merloyd By4GYmaDEJ4wNRExn4Z1DpBp8.pdf
ber of lawsuits against talc manufacturers 350–354, quote on p. 353. Lawrence, 2002). (accessed February 25, 2019).
and producers of baby and body pow- 31. CTFA Standards Committee, Minutes,
13. G.W. Wright, “Asbestos and Health 22. Edward F. Cox, Robert C. Fellmeth,
ders. The primary documents used here August 21, 1975, https://cdn.toxicdocs.org/
in 1969,” American Review of Respiratory and John E. Schultz, “The Nader Report”
are available on toxicdocs.org as identi- V3/V3pEx8RX2wqVY3BQXJMGqrq08/
Disease 100 (1969): 467–479, quote on on the Federal Trade Commission (New
fied in the references. V3pEx8RX2wqVY3BQXJMGqrq08.pdf
p. 476. York, NY: R.W. Baron, 1969); Paul Starr
3. Sarah Vogel, Is It Safe? BPA and the (with assistance from James F. Henry (accessed February 25, 2019).
14. “Asbestos in Talc Methodology Con-
Struggle to Define the Safety of Chemicals and Raymond P. Bonner), The Discarded 32. H.D. Stanley to R.E. Norwood, July
ference at FDA, Washington, DC,” Pfizer
(Berkeley, CA: University of California Army: Veterans After Vietnam; The Nader 27, 1976, https://cdn.toxicdocs.org/zb/
Memo on [August 3] Meeting, August
Press, 2013), 47. Report on Vietnam Veterans and the Veterans zb02zbxnMgamYQzjoGgY1DMb6/
10, 1971, https://cdn.toxicdocs.org/
4. National Institute for Occupational Administration (New York, NY: Charter- zb02zbxnMgamYQzjoGgY1DMb6.pdf
Rj/RjqZD73bLJ2LRDzpaZeKexZb7/
Safety and Health (NIOSH), “Criteria house, 1973). (accessed February 25, 2019).
RjqZD73bLJ2LRDzpaZeKexZb7.pdf
for a Recommended Standard . . . Oc- (accessed March 15, 2019); [Johns 23. On Health Research Group, see Ava 33. A.N. Rohl, “Asbestos in Talc,” En-
cupational Exposure to Asbestos,” 1972, Manville] Research and Engineering Alkon, “Late 20th-Century Consumer vironmental Health Perspectives 9 (1974):
https://cdn.toxicdocs.org/2R/2RxDB Center, “Memo for File: FDA [Food Advocacy, Pharmaceuticals, and Public 129–132, quote on p. 130.
b5zErM1pYGanagm843Gr/2RxDBb5 and Drug Administration] Meeting - Health: Public Citizen’s Health Research
zErM1pYGanagm843Gr.pdf (accessed Asbestos in Cosmetic Talcs, August 3, Group in Historical Perspective,” PhD 34. “Memorandum of Meeting” at Mt.
March 15, 2019). 1971—Washington, DC,” August 11, dissertation (New York, NY: Columbia Sinai between Arthur Langer and
1971, https://cdn.toxicdocs.org/GJ/ University, 2012); Nancy Tomes, Remak- Arthur Rohl and Clifton Wilson
5. See David Rosner and Gerald Mar- and Ronald Yates, March 22, 1976,
kowitz, “‘Ain’t Necessarily So!’ The GJ48dMXmZpZ3qj8Mpg3v7xY7/ ing the American Patient: How Madison
GJ48dMXmZpZ3qj8Mpg3v7xY7.pdf Avenue and Modern Medicine Turned Pa- https://cdn.toxicdocs.org/ba/
Brake Industry’s Impact on Asbestos baxK5KjeY8EaoDzVQv6dkZ333/
Regulation in the 1970s,” American (accessed April 3, 2019). tients Into Consumers (Chapel Hill, NC:
University of North Carolina Press, baxK5KjeY8EaoDzVQv6dkZ333.pdf
Journal of Public Health 107 (2017): 15. See also FDA, “Memorandum of a (accessed February 25, 2019).
1395–1399; David Rosner and Gerald 2016), 314–317; Wendy Kline, Bodies of
Symposium, ‘Asbestos and Talc,’” August
Markowitz, “‘Educate the Individual to Knowledge: Sexuality, Reproduction, and 35. Tony Biesada to Bill Stephenson,
3, 1971, https://cdn.toxicdocs.org/DM/
a Sane Appreciation of the Risk’: A His- Women’s Health (Chicago, IL: University “Re: Media Coverage—Talcs,” March
DMV5eMX50wdQMQv0LVNEw7myO/
tory of Industry’s Responsibility to Warn of Chicago Press, 2010), 106–107. 25, 1976, https://cdn.toxicdocs.org/
DMV5eMX50wdQMQv0LVNEw7myO.
Preview
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 EXHIBIT 19 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE “Nondetected”: The Politics of Measurement of Asbestos in Talc, 1971–1976 David Rosner, PhD, MPH, Gerald Markowitz, PhD, and Merlin Chowkwanyun, PhD, MPH The recent lawsuits against Johnson & Johnson have raised the issue of what and when talcum These contests over method- powder manufacturers knew about the presence of asbestos in their products and what they did ology were enormously impor- tant. They should be seen as part or did not do to protect the public. Low-level exposure to asbestos in talc is said to result in either of parallel battles over opera- mesothelioma or ovarian cancer. Johnson & Johnson has claimed that there was “no detectable asbes- tionalization of regulatory terms. tos” in their products and that any possible incidental presence was too small to act as a carcinogen. Since 1958, the FDA had been But what exactly does “nondetected” mean? Here, we examine the historical development of the embroiled in controversy over argument that asbestos in talcum powder was “nondetected.” We use a unique set of historical docu- proper interpretation of the so- ments from the early 1970s, when low-level pollution of talc with asbestos consumed the cosmetics called “Delaney clause,” which industry. We trace the debate over the Food and Drug Administration’s efforts to guarantee that talc banned approval of food addi- was up to 99.99% free of chrysotile and 99.9% free of amphibole asbestos. Cosmetic talc powder tives that were carcinogenic. But manufacturers, through their trade association, pressed for a less stringent methodology and adopted how exactly to “define zero,” the term “nondetected” rather than “asbestos-free” as a term of art. (Am J Public Health. 2019;109: as historian Sarah Vogel puts it, 969–974. doi: 10.2105/AJPH.2019.305085) was far from self-evident and resulted in decades of debates over the clause’s interpretation.3 See also Aaltonen, p. 949; Morabia, p. 955; T he recent lawsuits against Johnson & Johnson, and particularly the $4.8 billion ver- raised concerns over findings of low level pollution of talc with asbestos. We trace the debate When the controversy over talc began, the National Institute for Occupational Safety and Health Michaels, p. 975; Samet, p. 976; dict against the company, have over the FDA’s efforts to guar- (NIOSH) was arguing that only Vineis, p. 978; raised the issue of what and antee that talc was up to 99.99% an asbestos exposure approach- Rodenberg, p. 980; and when talcum powder manufac- free of chrysotile and 99.9% free ing zero could ensure workers’ Singla et al., p. 982. turers knew about the presence of amphibole asbestos. Talc pow- protection against cancers.4 If as- of asbestos in their products and der companies’ counterproposals bestos could cause cancer among what they did or did not do to were less stringent; they pro- workers even at minimal levels of protect the public.1 posed methodologies that were exposure, then consumer advo- Since the mid-1960s, asbestos, capable of detecting asbestos cates and federal officials worried even at low levels, has been up to 99.5%. The difference in that everyday users of products recognized as a cause of lung these methodologies meant that with asbestos were at risk, too. cancer and mesothelioma. Since potentially billions of asbestos In earlier articles, we have traced the early 1970s, the cosmetics fibers could be released into the how two other trade associations industry, as represented by the air when babies were powdered representing manufacturers of Cosmetic, Toiletry, and Fragrance or adults powdered themselves. asbestos products reacted to the Association (CTFA), has claimed Cosmetic talc powder changing political, scientific, and that there was either no asbestos manufacturers pressed for the regulatory efforts to control as- or that any residual asbestos less stringent methodology and bestos exposure.5 Here, we look in their products was “nonde- adopted the term “nondetected” at a third, the CTFA, represent- tected.” But what exactly does asbestos, rather than “asbestos- ing an industry whose market “nondetected” mean? Here, we free” as a term of art. The CTFA, was the broad public: men and examine the historical devel- the industry trade association, women, mothers and fathers, and opment of the argument that which represented companies even babies. asbestos in talcum powder was such as Johnson & Johnson, Col- nondetectable. gate, Pfizer, Mennen, Avon, and We use a unique set of other manufacturers of cosmetic ORIGINS OF THE historical documents from the talc products, spearheaded the CONCERN OVER TALC early 1970s,2 when the Food efforts to define how to measure The suspicion that asbestos and Drug Administration (FDA) asbestos in talc. was a dangerous pollutant in July 2019, Vol 109, No. 7 AJPH Rosner et al. Peer Reviewed Public Health Then and Now 969 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE talc can be traced back to the diseases “[produce] changes in the problem.” The meeting brought 1930s, when a number of clini- lungs and symptoms similar to together a number of parties: cal reports appeared indicating those of asbestosis.”9 talc manufacturers, including that talc workers were suffering By the mid-1960s, miners Johnson & Johnson and Pfizer; from a pneumoconiosis whose of talc had been identified by government officials from the symptoms resembled asbestosis, occupational health research- FDA, the Bureau of Mines, the insidious lung disease that ers as at increased risk for lung NIOSH, and the US Geological was of major concern at the cancer. Morris Kleinfeld and his Survey; physicians and scientists time. For example,Waldemar colleagues conducted a study such as Irving Selikoff, William Dreessen published a study of “to ascertain the health hazards Nicholson, and Arthur Langer workers in two mills in 1933 associated with exposure to of Mt. Sinai School of Medicine and concluded that “[t]he silicate dust in talc mining and milling.” and Seymour Lewin of New dusts of tremolite talc [i.e., talc They concluded that “the data York University; and representa- mixed with tremolite, one of the on carcinoma of the lung and tives of Johns Manville and the six major forms of asbestos] and pleura shows an overall mortal- Consumers Union.14 At the slate induce a fine, diffuse bilat- ity from carcinoma of the lung meeting, as reported by Pfizer eral fibrosis of the lungs which and pleura to be approximately researchers, attendees discussed is definitely demonstrable in the four times that expected.”10 The a number of different methods X-ray.”6 In 1942, F.W. Porro and asbestos manufacturers identi- for identifying asbestos in talc, his associates presented 15 cases fied tremolite in some “body including light microscopy, x-ray of talc miners and millers with talcum powders.”11 In addition, diffraction, electron microscopy, pneumoconiosis.They wrote: “It researchers identified tremo- and electron diffraction.15 The would appear from a consid- lite in samples of cosmetic talc meeting laid out the evolving eration of Dreessen’s analysis products. Louis Cralley and his concerns of industry, consumers, that the dust responsible for the colleagues analyzed 22 talcum researchers, and the FDA regard- disabling pneumoconiosis must products and found that all of ing how to evaluate the dangers be the talc itself in the form of them had “an appreciable fiber from asbestos contamination tremolite or soapstone or both.” content, ranging from 8 to 30%. in their products in light of the They also commented that . . . The fibrous material was growing evidence that even the “common to all cases is moder- predominantly talc but prob- smallest exposures to asbestos ately frequent presence of asbes- ably contained minor amounts could prove carcinogenic. tos bodies in the lesions. . . .The of tremolite, anthophyllite and By August 1972, some results presence of asbestos bodies in chrysotile as these are often had begun to come in from fibrotic areas implies a degree of present in fibrous talc mineral both inside and outside NIOSH similarity between asbestosis and deposits.”12 Some went even far- indicating that there was a prob- pneumoconiosis due to talc.”7 ther, arguing that cosmetic prod- lem. NIOSH had independently In 1956, A.C. Hunt, publishing ucts were a threat to consumers: been testing “nine commercially in Thorax, wrote that “commer- “It is difficult to conceive of available baby powders” by using cial talc is a mixture of the pure a better way of having fibers electron microscopy. Its study mineral talc (hydrated magnesium inhaled than the use of cosmetic indicated “possible asbestos fiber silicate) with related minerals talcum powders.”13 contamination of commercial such as dolomite, serpentine, In light of growing suspicion baby powders.”16 A month later, anthophyllite and tremolite.The that asbestos, even at minimal Seymour Lewin, under contract amount of pure talc in commer- levels, was carcinogenic, the FDA with the FDA, began reporting cial specimens is very variable.”8 called representatives of a wide his findings of the contamination In 1963, the National Safety range of cosmetics manufactur- of talcum powders. Of the 102 Council, an historically manage- ers and scientists to Washington samples “of standard, commercial ment-friendly group, founded in in August 1971 to “discuss in products containing talc” that he 1912 by industry to inform com- detail analytical methods for the tested, x-ray diffraction showed panies about—and help them ad- determination of minor amounts “that 59 of the products [had] no dress—ongoing health and safety of ‘asbestos like’ materials in detectable amounts of any problems in their plants, issued a talc with particular reference asbestiform minerals…”17; pamphlet that stated: “Talcosis is to cosmetic grade talcs,” or, “20 had small but definite per- usually associated with tremolite as one member of the CTFA centages of tremolite,” and talc.”The council noted that the called it, “the asbestos in talc “7 had substantial percentages 970 Public Health Then and Now Peer Reviewed Rosner et al. AJPH July 2019, Vol 109, No.7 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE of one or both of these asbes- ing legislative reforms.21 He of talc at least 99.9 percent free tiform minerals.”18 In a memo, subsequently led young investi- of amphibole types of asbestos CTFA representatives noted gative teams—dubbed “Nader’s fibers and at least 99.99 percent Lewin’s conclusion that “over 40 Raiders”—that wrote critical free of chrysotile asbestos percent of the samples may con- and detailed reports on other fibers.”25 tain asbestiform minerals such as targets, including government The industry reacted im- chrysotile or tremolite.”19 agencies like the Federal Trade mediately and negatively to the There was a lot at stake for Commission and Department of proposed rule. Two weeks after both the industry and consum- Veterans Affairs.22 the announcement in the Federal ers. The Wall Street Journal, in The FDA was no exception Register, the CTFA Subcommit- February 1973, gave a detailed to this muckraking. One Nader- tee of Scientific Advisory Com- summary of Lewin’s findings, spawned entity, Public Citizen, mittee on Asbestos in Talc met telling its readers that “10% [of created a Health Research and attacked the FDA’s method- the 200 talcum powders tested] Group, headed by the physi- ology as “not completely reliable contain 2% to 4% asbestos impu- cian Sidney Wolfe. It focused and discriminatory,” arguing it rities, with a handful running as on pharmaceutical safety and was not clear that the methods high as 10% to 20%.” The impact transparency in the approval used really measured true asbes- was expected to fall primarily on process, taking advantage of tos fibers. The CTFA suggested “manufacturers of dusting pow- new laws like the Freedom that the methods could actu- ders, baby powders, after shave of Information Act to request ally be finding nonfibrous or products and the talc-containing previously classified material.23 nontoxic materials. “[C]hrysotile cosmetics.” The Journal reported Other groups, most notably might fall within the critical that the FDA would “impose activists in the women’s health range of refractive indices used,” stringent limits” on these prod- movement, set their sights on the CTFA contended. Further, ucts but optimistically predicted the safety of synthetic hormones committee members claimed that manufacturers would likely and contraceptives.24 Corpora- that the counting, even if ac- support these changes. “Most tions and the FDA both faced curate, would take an inordinate cosmetic concerns agree that a new culture of accountability: amount of time—perhaps six asbestos must be eliminated from for corporations, over the safety hours—for a technician to reach their products and some have of their products; for the FDA, a “tentative identification” of the already moved to do so, partly over the ability to ensure that asbestos content. “The tedium under FDA pressure.”20 safety if corporations themselves effect on the person count- Apart from economic con- could not provide it. It is in ing is obvious,” the committee siderations, the political milieu this context that the exchanges maintained.26 of the time also gave both the on methodology between the The CTFA organized a manufacturers and the FDA CTFA and the FDA occurred. “round robin” test to determine reason to worry. Skepticism of the reliability of the method- large institutions was burgeon- ologies proposed by the FDA. ing, with activist ire aimed at THE INDUSTRY GOES ON After distributing samples of talc everything from major research THE OFFENSIVE from a variety of mines from a universities to the military to In the fall of 1973, the FDA number of states, it asked various large corporations. Advocacy announced its proposed rule in companies to have their experts for the interests of the everyday the Federal Register: “Any drug, determine whether the samples consumer, particularly around drug ingredient, or drug packag- contained chrysotile or amphi- health and safety concerns, was ing material containing talc that bole asbestos. The CTFA had exemplified by the attorney fails to meet the specifications . . . provided samples that they had Ralph Nader, who became the as determined by the method “spiked” with known amounts public face of a revived con- set out . . . shall be deemed to be of different asbestos fibers to see sumer movement that thrived adulterated in violation of … the how accurately or inaccurately from the early 1960s into the Act” and thus not a substance the methodologies performed. 1980s. Nader had made his mark “generally recognized as safe.” The round robin test revealed with a scorching investigation of The standard was exacting: The “strong inconsistency” among automobiles, entitled Unsafe at FDA proposed using a polarizing “the different scientists applying Any Speed, which had shaken the microscope that they believed the method to the same group of entire industry and led to sweep- could accurately ensure “a purity coded talc samples.” The CTFA July 2019, Vol 109, No. 7 AJPH Rosner et al. Peer Reviewed Public Health Then and Now 971 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE “concluded that the method FDA, MESA [Mine Enforce- as compared with the FDA’s published in the Federal Register ment Safety Administration], methodology, which claimed ac- does not provide a truly reliable etc. are based on something less curacy to 0.01%. This meant that means for the detection of asbes- than the truth.”29 future cosmetic talc products tos in talc.” Given that the meth- This struggle between the might, in fact, contain asbestos odology was “tedious and may government and industry over below the 0.5% detectable limit. consume as much as one half day the FDA recommendation was Furthermore, the CFTA pro- per sample,” the “subcommittee highly consequential. In March mulgated its own definition of urge[d] that the Food and Drug 1975, the objections of industry talc’s purity by avoiding precise Administration defer finalizing to the earlier FDA notice of rule- statements in favor of vaguer the proposed optical microscopic making in the Federal Register had language in its description of the method and proceed [to a] undermined the FDA’s efforts asbestos content of the manufac- program which would combine to adopt stricter standards. “The turers’ products. “After extensive FDA and Industry in a strong Food and Drug Administration discussions of advantages and effort to develop a truly reliable has . . . examined numerous talc disadvantages of listing a 0.5% method.” The CTFA subcom- samples of undefined grade in maximum limit as opposed to mittee estimated “that a satisfac- the past two years, using the pro- ‘nondetected’ terminology, the tory method will take at least six posed methodology,” the Federal Standards Committee voted for months to a year to develop” if Register had announced, “and the use of . . . ‘nondetected.’”31 industry and the FDA worked finds that approximately two- One industry representative, together.27 The industry was thirds of such samples are within however, acknowledged the willing to challenge the FDA these limitations” of 99.9% dishonesty in using “nonde- since some privately believed amphibole free and 99.99% tected” as the definition for that the “FDA is reluctant to take chrysotile free.The implication safety of cosmetic talc products: any legal action in any problems of this was that possibly one “You will notice that a talc with industry.” The CTFA had third were not free of asbestos. standard definition for cosmetic been told that the FDA had “The Commissioner therefore talc was adopted unanimously,” “neither the money nor the concludes that the proposed H.D. Stanley of Pfizer wrote to manpower to pursue matters so limitations would not impose an R.E. Norwood following a July that they will have airtight cases unreasonable burden on manu- 8, 1976 meeting of the CTFA. in scientific matters.”28 facturers of talc if these limita- “Had I been there I would have The CTFA also challenged tions were adopted.” But industry objected to their definition. I the government even though was objecting and, hence, “The particularly object to the section one representative of Johns Commissioner . . . decided to . . . that reads – containing no Manville reported that some delay any final regulation for talc detectable asbestos minerals.” talc suppliers were distributing until an acceptable method for Stanley pointed out the irony products with high amounts of determining the presence of as- that a “nondetected” level de- three of the major forms of as- bestos particles can be developed pended on the adequacy—or in- bestos—chrysotile, tremolite, and for this substance.”30 adequacy—of the methods used anthophyllite—and might be The industry had won a to detect it. Using an insensitive lying to the government about major battle, and it proceeded to method would allow manufac- it. R.S. Lamar of Johns Manville promulgate its own methodol- turers to claim that asbestos had was specifically referring to ogy, referred to as J4-1, and its not been detected but would “R.T. Vanderbilt Company talc own definition of talc: “Cos- simultaneously lead to “serious products,” which “always have metic talc is a white, essentially breaks in communication be- and continue to contain chryso- odorless, fine powder, ground tween the buyer and the seller,” tile as a significant mineral from naturally occurring rock who would believe that the component (in addition to ore, consisting mainly of mag- product was truly asbestos-free.32 tremolite and anthophyllite).” He nesium silicate . . . with lesser This observation was not trivial concluded his private correspon- amounts of naturally associated and got to the heart of the prob- dence with another Manville minerals . . . and containing no lem the cosmetics industry faced. executive: “It is apparent that the detectable fibrous asbestos miner- As Arthur Rohl, a researcher in R.T. Vanderbilt presentation to als [emphasis added].” J4-1 was Irving Selikoff ’s department at OSHA [Occupational Safety and less stringent than the FDA stan- Mt. Sinai School of Medicine, Health Administration], NIOSH, dard; it was only reliable to 0.5% pointed out, if the wrong 972 Public Health Then and Now Peer Reviewed Rosner et al. AJPH July 2019, Vol 109, No.7 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE methodology was used, billions CONCLUSION: LEGACY that such warnings were “not of particles of asbestos could OF THE CTFA CAMPAIGN necessary to protect the health escape detection. He wrote that By 1977, the FDA essentially of consumers and would un- “Even at the lowest level of gave up its efforts to regulate necessarily alarm consumers re- detection by x-ray diffraction, asbestos in talc, as the J4-1 garding the use of safe cosmetic i.e., 0.25%, there would be about method created by the CTFA products.”37 The FDA did not act 109 fibers/mg. Cosmetic talcum had been adopted by the on the petitioners’ appeal. powder, for example, which had industry despite the CTFA’s The recent lawsuits against been step-scanned and chrysotile own acknowledgment that its various talc manufacturers have not found might contain billions methodology was inadequate to once again brought the issue of fibers released during dusting the task. John Schelz of Johnson of asbestos in talc to public with a half-gram dose.”33 How & Johnson, who was chair of attention. The consequences dangerous talc products were, the CTFA Taskforce on Round of industry’s actions and inac- then, depended on what one Robin Testing of Consumer tions—and of its knowledge or used to measure risk. Talcum Products, reported on lack thereof—that were identi- Industry objections to a round robin test of samples fied a half century ago are still research that found asbestos in of talc and found that J4-1 with us. talc was noted by researchers had failed its test for identify- themselves. In 1976, follow- ing “asbestiform amphibole ABOUT THE AUTHORS ing publications by Mt. Sinai contaminants” with accuracy, David Rosner, Gerald Markowitz, and Mer- lin Chowkwanyun are with the Department researchers of the presence of reliability, and practicality. “These of Sociomedical Sciences, Mailman School of asbestos in commercial talcum objectives have not yet been Public Health, Columbia University, New powders bought off the shelf achieved [emphasis in original],” York, NY. Gerald Markowitz is also with the John Jay College and Graduate Center, City in local stores, representatives he wrote, and suggested a partial University of New York, New York, NY. of the CTFA visited Mt. Sinai retest.36 Despite this, the J4-1 Correspondence should be sent to David in an apparent effort to get the method, one that the industry Rosner, PhD, Mailman School of Public Health, Columbia University, 722 West institution and the researchers to itself acknowledged is incapable 168th St, Room 935, New York, NY qualify, if not retract, their find- of determining low-level pollu- 10032. Reprints can be ordered at http:// ings. In one such meeting, the tion, is still the standard within www.ajph.org by clicking the “Reprints” link. This article was accepted March 10, 2019. primary authors of the Mt. Sinai industry. doi: 10.2105/AJPH.2019.305085 studies informed the industry The industry methodology group that they had found asbes- was no more capable of deter- CONTRIBUTORS tos in 10 samples by using x-ray mining low-level exposures than D. Rosner and G. Markowitz wrote the first drafts of the article. M. Chowk- diffraction and transmission was the methodology the FDA wanyun edited and added substantive electron microscopy. In a memo, first proposed, and may have historical context and additional docu- the Mt. Sinai authors wrote: “Dr. been less accurate than were the mentation. Langer was somewhat disgusted time-consuming methods they ACKNOWLEDGMENTS by the talc industry’s attitude. He critiqued. For the following half We thank Colleen Lanier Christiansen, said the results of his work ha[d] century, the debate over the Sadie Bergen, and Valentina Parisi for their assistance. been known to the industry for presence or absence of asbestos in several years but nothing was talc has continued.The implica- CONFLICTS OF INTEREST done until the . . . results became tions of this for science, regula- David Rosner and Gerald Markowitz wrote a 2017 Report to the Court in a public.”34 A few days after that tion, and consumer safety have legal case that formed the original basis meeting, the industry was par- resulted in conferences, symposia, of this article. They received funding tially mollified when the dean and many scientific papers ever from plaintiffs’ law firms for research and writing. Merlin Chowkwanyun has no of Mt. Sinai, Thomas Chalm- since. But it is no mere scholastic potential conflict of interest. ers, was quoted in the media as issue. In 1995, for example, qualifying news reports claim- Edward Kavanaugh, president of ENDNOTES ing that “most of the talcum the CTFA, responded to a peti- 1. See, for example, Tina Bellon, “J & J Loses Bid to Have $4.7 Billion Talc powder currently on the market tion by a citizen advocacy group, Verdict Set Aside,Vows to Appeal,” Re- contain[ed] asbestos.” “It is the the Cancer Prevention Coali- uters, December 19, 2018, https://www. opinion of Mount Sinai’s De- tion, that asked the FDA to label reuters.com/article/us-johnson-johnson- cancer/jj-loses-bid-to-have-4-7-billion- partment of Pediatrics that baby cosmetic talc products as potential talc-verdict-set-aside-vows-to-appeal- talc is a useful and safe product,” carcinogens. He reiterated the idUSKCN1OI27P (accessed January 17, he stated to WCBS.35 industry’s long-standing position 2019); Lisa Girion, “Johnson & Johnson July 2019, Vol 109, No. 7 AJPH Rosner et al. Peer Reviewed Public Health Then and Now 973 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 104 RECEIVED NYSCEF: 07/10/2023 AJPH SCIENCE & PUBLIC HEALTH CONSCIENCE Knew for Decades That Asbestos Lurked gbq4wMVNy39gQpYQoRr0EpBE3/ Cosmetics,” Wall Street Journal, February gbq4wMVNy39gQpYQoRr0EpBE3.pdf in Its Baby Powder,” A Reuters Investiga- gbq4wMVNy39gQpYQoRr0EpBE3.pdf 26, 1973, 16. (accessed March 15, 2019). tion, December 14, 2018, https://www. (accessed February 25, 2019). 30. “Asbestos-Form Particles in Drugs 21. Ralph Nader, Unsafe at Any reuters.com/investigates/special-report/ for Parenteral Injection,” Federal 12. L.J. Cralley, M.M. Key, D.H. Groth, Speed: The Designed-In Dangers of the johnsonandjohnson-cancer (accessed Register 40, no. 51 (March 14, 1975): W.S. Lainhart, and R.M. Ligo, “Fibrous American Automobile (New York, NY: January 13, 2019). 11865-66, https://cdn.toxicdocs.org/By/ and Mineral Content of Cosmetic Grossman Publishers, 1965); Justin 2. These documents have been released Talcum Products,” American Industrial Martin, Nader: Crusader, Spoiler, Icon By4GYmaDEJ4wNRExn4Z1DpBp8/ through the discovery process of a num- Hygiene Association Journal 29 (1968): (New York, NY: Perseus/Merloyd By4GYmaDEJ4wNRExn4Z1DpBp8.pdf ber of lawsuits against talc manufacturers 350–354, quote on p. 353. Lawrence, 2002). (accessed February 25, 2019). and producers of baby and body pow- 31. CTFA Standards Committee, Minutes, 13. G.W. Wright, “Asbestos and Health 22. Edward F. Cox, Robert C. Fellmeth, ders. The primary documents used here August 21, 1975, https://cdn.toxicdocs.org/ in 1969,” American Review of Respiratory and John E. Schultz, “The Nader Report” are available on toxicdocs.org as identi- V3/V3pEx8RX2wqVY3BQXJMGqrq08/ Disease 100 (1969): 467–479, quote on on the Federal Trade Commission (New fied in the references. V3pEx8RX2wqVY3BQXJMGqrq08.pdf p. 476. York, NY: R.W. Baron, 1969); Paul Starr 3. Sarah Vogel, Is It Safe? BPA and the (with assistance from James F. Henry (accessed February 25, 2019). 14. “Asbestos in Talc Methodology Con- Struggle to Define the Safety of Chemicals and Raymond P. Bonner), The Discarded 32. H.D. Stanley to R.E. Norwood, July ference at FDA, Washington, DC,” Pfizer (Berkeley, CA: University of California Army: Veterans After Vietnam; The Nader 27, 1976, https://cdn.toxicdocs.org/zb/ Memo on [August 3] Meeting, August Press, 2013), 47. Report on Vietnam Veterans and the Veterans zb02zbxnMgamYQzjoGgY1DMb6/ 10, 1971, https://cdn.toxicdocs.org/ 4. National Institute for Occupational Administration (New York, NY: Charter- zb02zbxnMgamYQzjoGgY1DMb6.pdf Rj/RjqZD73bLJ2LRDzpaZeKexZb7/ Safety and Health (NIOSH), “Criteria house, 1973). (accessed February 25, 2019). RjqZD73bLJ2LRDzpaZeKexZb7.pdf for a Recommended Standard . . . Oc- (accessed March 15, 2019); [Johns 23. On Health Research Group, see Ava 33. A.N. Rohl, “Asbestos in Talc,” En- cupational Exposure to Asbestos,” 1972, Manville] Research and Engineering Alkon, “Late 20th-Century Consumer vironmental Health Perspectives 9 (1974): https://cdn.toxicdocs.org/2R/2RxDB Center, “Memo for File: FDA [Food Advocacy, Pharmaceuticals, and Public 129–132, quote on p. 130. b5zErM1pYGanagm843Gr/2RxDBb5 and Drug Administration] Meeting - Health: Public Citizen’s Health Research zErM1pYGanagm843Gr.pdf (accessed Asbestos in Cosmetic Talcs, August 3, Group in Historical Perspective,” PhD 34. “Memorandum of Meeting” at Mt. March 15, 2019). 1971—Washington, DC,” August 11, dissertation (New York, NY: Columbia Sinai between Arthur Langer and 1971, https://cdn.toxicdocs.org/GJ/ University, 2012); Nancy Tomes, Remak- Arthur Rohl and Clifton Wilson 5. See David Rosner and Gerald Mar- and Ronald Yates, March 22, 1976, kowitz, “‘Ain’t Necessarily So!’ The GJ48dMXmZpZ3qj8Mpg3v7xY7/ ing the American Patient: How Madison GJ48dMXmZpZ3qj8Mpg3v7xY7.pdf Avenue and Modern Medicine Turned Pa- https://cdn.toxicdocs.org/ba/ Brake Industry’s Impact on Asbestos baxK5KjeY8EaoDzVQv6dkZ333/ Regulation in the 1970s,” American (accessed April 3, 2019). tients Into Consumers (Chapel Hill, NC: University of North Carolina Press, baxK5KjeY8EaoDzVQv6dkZ333.pdf Journal of Public Health 107 (2017): 15. See also FDA, “Memorandum of a (accessed February 25, 2019). 1395–1399; David Rosner and Gerald 2016), 314–317; Wendy Kline, Bodies of Symposium, ‘Asbestos and Talc,’” August Markowitz, “‘Educate the Individual to Knowledge: Sexuality, Reproduction, and 35. Tony Biesada to Bill Stephenson, 3, 1971, https://cdn.toxicdocs.org/DM/ a Sane Appreciation of the Risk’: A His- Women’s Health (Chicago, IL: University “Re: Media Coverage—Talcs,” March DMV5eMX50wdQMQv0LVNEw7myO/ tory of Industry’s Responsibility to Warn of Chicago Press, 2010), 106–107. 25, 1976, https://cdn.toxicdocs.org/ DMV5eMX50wdQMQv0LVNEw7myO.