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Background: In 1973, the FDA proposed regulation to assure that cosmetic products containing talc were at

least 99.9% asbestos-free. The talc companies objected, the FDA withdrew the regulation and allowed

industry to self-regulate. In 1976, the talc industry proposed voluntary testing for asbestos in talc and adopted

a “zero tolerance” standard for asbestos in talc. Talc mining and manufacturing companies have since

claimed that their pharmaceutical and cosmetic grade talc is asbestos-free.

Objective: Evaluate the claim that consumer talc is “asbestos-free” by reviewing records produced by talc

mining and manufacturing companies and by other laboratories.

Methods: The authors employed systematic search techniques and a grounded theory approach to review

corporate documents. Talc-related documents were initially searched for asbestos-related terms. The authors

conducted additional searches, focusing on terms associated with testing protocols, quality control measures,

and specific talc mines and mills. The authors also reviewed depositions of individuals connected to talc

litigation. Results: Industry tests indicate that talc used in cosmetics contained asbestos. The test methods

adopted by the industry had a high limit of detection and therefore could never assure that talc was asbestos-

free. Even with insensitive methods, company tests identified asbestos in talc mines and in talc products.

Discussion: Talc-based cosmetics and powders contain asbestos. Talc companies cannot assure a “zero

tolerance” standard for asbestos in talc. IARC has classified inhaled asbestos as a Group 1 ovarian

carcinogen and epidemiologic studies have shown an association between talc use and ovarian cancer. The

presence of asbestos in talc provides a causal explanation for this association.

Disclosures: David Egilman MD, MPH is a medical consultant to patients who have developed cancer as a

result of exposures to asbestos. In some cases, he has also served as an expert witness in related litigation.

Joan Steffen and Triet Tran are researchers for Dr. Egilman. Ella Fassler is a consulting researcher on the

same talc and asbestos litigation. Lawyers did not provide financial support for this research or input into this

research.

Abstract

Talc-based cosmetics and powders contain asbestos. Talc companies cannot assure that talc used in

cosmetics is asbestos-free. There are no known test methods with a limit of detection of zero. Despite

having high limits of detection, some tests have found asbestos in cosmetic talc products. IARC has

classified asbestos as an ovarian carcinogen and epidemiologic studies have shown as association

between talc use and ovarian cancer. The inhalation of fibers from expected use of talc containing

cosmetics provides evidence that this association is causal.

Study limitations: Historic testing of talc for asbestos is limited in methodology and scope. Courts and

plaintiff lawyers have agreed, without the knowledge or permission of their clients, to keep secret some of

the documents reported here; these documents became public during court proceedings over the

objections of J&J and Imerys. Many documents remain sealed.

.

As early as 1898, Dana’s Textbook of Mineralogy, a standard

mineralogy textbook, mentioned that asbestos was one of the minerals

associated with talc formations.1 The following asbestiform minerals

have since been found in association with talc: actinolite, anthophyllite,

chesterite, chrysotile, clinojimthompsonite, jimthompsonite, tremolite,

and winchite.2,3,4,5,6,7 Fibrous (asbestiform) talc has also been found in

talc deposits.29 Van Gosen et al. 2004 found that “the talc-forming

environment directly influenced the amphibole and amphibole-asbestos

content of the talc deposit” and reported “consistent associations of

amphibole-rich talc deposits with contact metamorphism versus

amphibole-poor talc with hydrothermal processes.”8

Geology of Asbestos in TalcAsbestos Test Results

Total of 686 publicly available positive asbestos test results in talcs used in cosmetics from 1948 – 2017:

Inadequate Testing Methods

Reports of Asbestos in Cosmetic Talc Products

Anti-WarningsTalc advertisements encouraged inhaled asbestos exposure

In 1973, Walter C. McCrone Associates, a lab that industry used to test for asbestos in talc, stated that XRD

was “less sensitive” than transmission electron microscopy (TEM), but that the “sensitivity can be increased

from 0.5 - 1% to 0.1- 0.5%” asbestos (level of detection) by step-scanning. 16 Dr. Lewin of NYU

recommended the same step-scanning methods and the use of an internal standard to improve the level of

detection by XRD. 17

XRD Analysis

Testing

Method

Tests for

Chrysotile?

Concentration

step?

Step

Scan?

Internal

Standard?

Reported

Level of Detection?

CTFA J4-1 NO NO NO NO 0.5% and above

USP Yes NO NO NO Not Reported

Moreover, neither the CTFA J4-1 nor the USP

method specified the magnification power used for

Optical Microscopy Analysis. Colgate-Palmolive

stated that they used 125x power to test the talc. 22

Standard phase contrast microscopy (PCM) power

is 450x. 125x cannot detect thinner asbestos fibers,

and would generate false negative results. 23

In 1976, the CTFA performed a round robin test to evaluate the J4-1 method. They sent spiked amphibole

samples to the FDA, Avon, Chesebrough-Ponds, McCrone, Colgate-Palmolive, Cyprus, Mennen and Johnson

& Johnson. Only one lab (the FDA’s) was able to detect 0.5% tremolite by CTFA J4-1; the round robin results

demonstrate a false negative rate of ~86%. 24 Despite this, CTFA never changed the method and they rely on

it to this day. 20

A bathroom scale would not register any weight and a

report would state “No feather detected”

In 1973, Dr. Pooley developed “two techniques for preconcentration of chrysotile and tremolite

in talc followed by X-ray diffraction [XRD] analysis.” Dr. Pooley found 0.05% tremolite in J&J

Vermont talc. J&J disapproved of this method because “it may be too sensitive:” 15

In a 2004 submission to the National Toxicology Program regarding the question of talc’s carcinogenicity, the

CTFA claimed that their talc products have been asbestos-free since the creation of CTFA method J4-1:12

Talc Industry Claims “Zero Tolerance” for Asbestos

Johnson and Johnson reiterated this position on their website in 2016:26

Talc company corporate representatives testify that they have a “zero tolerance” policy for asbestos in talc:

Johnson and Johnson28Colgate Palmolive27

In 1968, Cralley et al. published two papers on the asbestos content of cosmetic talcum powders: “The 22

talcum products analyzed showed fiber contents ranging from 8 to 30% by count of the total talcum

particulates with an average of 19%.”9,10 In 1971, Harold Romer, the assistant commissioner of Air Resources

for New York City raised the alarm with Johnson and Johnson (J&J) and with the FDA that Dr. Selikoff’s group

at Mount Sinai Hospital had found a significant amount of asbestos in J&J talc. Through the 1970s, Drs. Rohl,

Langer, Selikoff and others at Mt. Sinai continued to publish analyses finding asbestos in cosmetic talc

products.5,6

In 1972, the FDA proposed regulation of asbestos in talc, requiring a 99.9% purity for tremolite and 99.99%

purity for chrysotile.11 The Cosmetic, Toiletry, and Fragrance Association (CTFA) objected, and the FDA

withdrew the proposed regulation. In 1976, the FDA allowed the industry to establish voluntary procedures for

asbestos in talc used in cosmetics. In a 2004 submission to the National Toxicology Program, the CTFA

admitted that talc products manufactured before they developed this test (but sold and used after) contained

asbestos:12

In March 1976, the CTFA sent the FDA a packet of eleven letters from talc mining and manufacturing

companies and laboratories that tested their talc. These letters urged the FDA not to regulate asbestos in

talc and assured the agency that cosmetic talc products were asbestos-free. McCrone – who tested talc for

Avon, Bristol-Myers, Chesebrough-Ponds, Colgate-Palmolive, Faberge, Johnson & Johnson, Windsor

Minerals, and Whittaker Clark and Daniels – claimed that cosmetic talc had never contained chrysotile and

no longer contained other asbestos minerals, in contradiction to their test result records. 19

McCrone found chrysotile in 22 tests for cosmetic talc companies by March 1976 and reported asbestos in

124 tests for cosmetic talc companies from 1973 to 1976. In 1972, for example, TEM tests on Shower to

Shower (performed at the U. of Minnesota Space Science Center and commissioned by McCrone and

Johnson & Johnson) reported that “crysotile [sic] asbestos does exist in the specimens of [s]hower to

[s]hower.” 18

In 2014, a panel of experts met to evaluate the USP method for detecting asbestos in talc. The group

found that the “Limit of detection may be too high for public health and regulatory purposes” and that

the XRD step “may give false-negative result[s] if used as a screening method.” 25

Later in 1976, the CTFA created voluntary method CTFA J4-1 to test for tremolite asbestos in “cosmetic grade”

talc. 20 Having told the FDA that their talc never contained chrysotile, the J4-1 method did not test for chrysotile,

thereby assuring that chrysotile would never again be found in talc. The US Pharmacopeia later added a test

for asbestos to its monograph for “pharmaceutical grade” talc. 21 The USP and CTFA Methods both relied on a

screening step using XRD followed by a microscopy step to confirm the presence of asbestos. The USP

method also included an alternative screening step using infrared (IR) spectroscopy, which has also been

found unreliable.25

CTFA Method J4-1

In 1972, NIOSH studied fiber exposures to mothers and infants who used talc powders during diapering.

NIOSH found that J&J Baby Powder exposed mothers to 2.2 fibers/cc on average and babies to 1.8 f/cc on

average during diaper changing for about 3-4 hour/week. 13

Gordon et al. 2014 reported average airborne fiber concentrations of 4.8 f/cc during use of Cashmere

Bouquet talc powder. Gordon reported that 1.9 f/cc of the fibers were asbestos; the remaining 2.9 f/cc were

fibrous talc. 14

109

10768

64

48

259 7 1 1

1Anthophyllite

Tremolite

Unspecified fiber

Talc fiber

Chrysotile

Asbestos

Antigorite

Amphibole

Richterite

Sillicate

Serpentine

52

429

171

Positive tests by type of sample

Ore

Processed talc used inproducts

Consumer powder

105

10

92

5

1

2

2

2

37

58

4

13

6

43

2

2

1

2

43

15

44

87

3

2

4

9

86

15

0 50 100 150 200 250

Colgate

Cyprus/Luzenac…

Eastern Magnesia

J&J

Johns-Manville

Mennen

Pfizer

RTV

Sierra

WCD

Windsor, Inc.Asbestosfibers

Unspecifiedfiber

Unspecifiedasbestos form

Positive tests by companies

2

5

10

2

18

*103

19

8

5

1

1

15

11

2

12

2

3

21

7

7

9

11

4

7

27

11

17

9

6

0 10 20 30 40 50 60

Argonaut

California

Englehard

Gassets

Grantham

Hammondsville

Montana

Val Chisone

Vermont

West Windsor

Positive tests by mines & mills

*Rescaled for better illustration

Positive tests by mineral

References1.Dana, E., A Textbook of Mineralogy With an Extended Treatise on

Crystallography and Physical Mineralogy. 1898, New York: John Wiley &

Sons.

2. Veblen, D.R. and C.W. Burnham, New biopyriboles from Chester, Vermont;

I, Descriptive mineralogy. American Mineralogist, 1978. 63(9-10): p. 1000-9.

3. Veblen, D.R. and C.W. Burnham, New biopyriboles from Chester, Vermont:

II. The crystal chemistry of jimthompsonite, clinojimthompsonite, and chesterite,

and the amphibole-mica reaction. American Mineralogist, 1978. 63(9-10): p.

1053-1073.

4. Wylie, A. and C. Huggins, Characteristics of a Potassium Winchite-Asbestos

From the Allamore Talc District, Texas. Canadian Mineralogist, 1980. 18: p.

101-107.

5. Rohl, A., et al., Consumer Talcums and Powders: Mineral and Chemical

Characterization. Journal of Toxicology and Environmental Health, 1976. 2: p.

255-284.

6. Rohl, A. and A. Langer, Identification and Quantitation of Asbestos in Talc.

Environmental Health Perspectives, 1974. 9: p. 95-109.

7. Cralley, L., et al., Fibrous and Mineral Content of Cosmetic Talcum

Products. American Industrial Hygiene Association Journal, 1968. 29(4): p.

350-354.

8. Van Gosen, B., Using the geologic setting of talc deposits as an indicator of

amphibole asbestos content. Environmental Geology, 2004. 45: p. 920-939.

9. Cralley, L., et al., Fibrous and Mineral Content of Cosmetic Talcum

Products. American Industrial Hygiene Association Journal, 1968. 29(4): p.

350-354.

10. Gross, P., et al., Pulmonary Ferruginous Bodies. Arch. Path., 1968. 85: p. 9.

11. FDA, Asbestos Particles in Food and Drug [21CFR Parts 121, 128, 133].

1973, Food and Drug Administration: Federal Register.

12. McEwen, G., Letter to Dr. C.W. Jameson, NTP RE: Call for Public

Comments on 21 Substances, Mixtures and Exposure Circumstances Proposed

for Listing in the Report on Carcinogens, Twelfth Edition (69 Federal Register

28940): Cosmetic Talc. 2004.

13. Dement, J., P. Shuler, and R. Zumwalde, Preliminary Report: Fiber

Exposure During Use of Baby Powders. 1972, NIOSH Environmental

Investigations Branch.

14. Gordon, R., S. Fitzgerald, and J. Millette, Asbestos in commercial cosmetic

talcum powder as a cause of mesothelioma in women. International Journal of

Occupational and Environmental Health, 2014. 20(4): p. 318-332.

15. Exhibit to Deposition of Dr. John Hopkins. August 15-18, 2017.

16. McCrone, W., Letter to FDA Hearing Clerk Re: Test Methods for Asbestos

in Talc. 1973.

17. Lewin, S., Letter to WCD, X-Ray Diffraction Analysis For Asbestos in Talc

No. 1621 Lo Micron. 1972. p. WCD002448 - WCD002465.

18. Hutchinson, T., INVESTIGATION OF POSSIBLE ASBESTOS

CONTAMINATIONS IN TALC SAMPLES. 1972.

19. Estrin, N., Letter to Eiermann, H. (FDA) March 15, 1976, CTFA,. 1976.

20. CTFA, CTFA Method J4-1: Asbestiform Amphibole Minerals in Cosmetic

Talc. 1976: p. QE-CPC00001142 - QE-CPC00001151.

21. USP, Talc Specifications. 2011, US Pharmocopeia Convention: USP

Revision Bulletin - Talc.

22. Deposition of Herbert Ohlmeyer. 2011.

23. Wylie, A.G., et al., The importance of width in asbestos fiber

carcinogenicity and its implications for public policy. Am Ind Hyg Assoc J,

1993. 54(5): p. 239-52.

24. CTFA, Minutes: CTFA Task Force on Round Robin Testing of Consumer

Talcim [sic] Products for Asbestiform Amphibole Minerals. 1977.

25. Block, L.H., et al. "Modernization of Asbestos Testing in USP Talc,” Stimuli

to the Revision Process. U.S. Pharmacopeia. 2014.

26. Johnson & Johnsons. 5 Important Facts about the Safety of our Talc.

https://www.jnj.com/our-products/5-important-facts-about-the-safety-of-talc

Accessed 11/1/2017.

27. Scala, D., Deposition in Polakow vs. Brenntag North America, Inc., et al. in

the Superior Court Of The State Of California For The County Of Los Angeles

pg. 341-342. 2016.

28. Hopkins, J., Deposition in Herford vs. AT&T et al. in the Superior Court Of

The State Of California For The County Of Los Angeles pg 42-57. 2017.

29. Virta, R. L. The Phase Relationship of Talc and Amphiboles in a Fibrous

Talc Sample. Bureau of Mines Report of Investigations. 1985.

Conclusions

Presence of asbestos in consumer talc products: Evaluating a “zero tolerance” policy

1Never Again Consulting; 2 Brown University, Providence, RI; 3Against Method Consulting; 4 Clinical Professor Family Medicine Alpert School of Medicine at Brown University, Attleboro, MA, degilman@egilman.com

Joan Steffen1, Triet Tran2, Ella Fassler3, David S. Egilman MD, MPH4