"Nondetected": The Politics of Measurement of Asbestos in Talc, 1971-1976

Our plain-English summary of "Nondetected": The Politics of Measurement of Asbestos in Talc, 1971-1976, by D. Rosner, G. Markowitz, M. Chowkwanyun (American Journal of Public Health, 2019).

The study

• Authors: D. Rosner, G. Markowitz, M. Chowkwanyun
• Journal: American Journal of Public Health
• Published: 2019;109(7):969-974
• Cited by: 10 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

The recent lawsuits against Johnson & Johnson have raised the issue of what and when talcum powder manufacturers knew about the presence of 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 asbestos" 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 We use a unique set of historical documents from the early 1970s, when low-level pollution of talc with asbestos consumed the cosmetics industry.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 of chrysotile and 99.9% free of 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.

In plain English

This is a history article, not a study of disease. The authors examined industry and government documents, released through lawsuits, about how asbestos in cosmetic talc was measured in the 1970s. Two of the authors wrote a 2017 report for a court case that formed the basis of the article, and they received funding from plaintiffs' law firms. In 1973 the Food and Drug Administration (FDA) proposed a microscope method intended to ensure talc was at least 99.9 percent free of amphibole asbestos and 99.99 percent free of chrysotile. The cosmetics trade association, the CTFA, ran its own round robin test and reported strong inconsistency among scientists using the method. In 1975 the FDA delayed a final rule. The industry adopted its own method, J4-1. The authors describe it as reliable only to 0.5 percent, compared with 0.01 percent claimed for the FDA method. A CTFA committee chose the term "nondetected" over a 0.5 percent limit, and a Pfizer representative objected to that wording. A 1977 industry test found that the method's objectives had not yet been achieved. The authors concluded that by 1977 the FDA had essentially given up regulating asbestos in talc.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Historical analysis of archival documents (not a study of health outcomes). The article grew out of a 2017 court report written by two of the authors, who were funded by plaintiffs' law firms.
• Who was studied: Industry, trade association (CTFA), and government (FDA) documents, mainly from 1971 to 1977, released through the discovery process in lawsuits against talc manufacturers and makers of baby and body powders
• Exposure: Asbestos contamination of cosmetic talc: chrysotile and amphibole asbestos (including tremolite and anthophyllite), and the laboratory methods used to detect it
• Main results:
  • Seymour Lewin, working under FDA contract in 1972, tested 102 samples of commercial talc-containing products. By x-ray diffraction, 59 showed no detectable asbestiform minerals.
  • In 1973 the FDA proposed a polarizing-microscope method intended to ensure talc was at least 99.9 percent free of amphibole asbestos fibers and at least 99.99 percent free of chrysotile asbestos fibers
  • The CTFA's round robin test of the FDA method, using coded talc samples, found strong inconsistency among scientists
  • In March 1975 the FDA Commissioner delayed a final talc regulation until an acceptable detection method could be developed
  • The industry's own method, J4-1, was reliable only to 0.5 percent, compared with the 0.01 percent accuracy claimed for the FDA's method
  • The CTFA Standards Committee chose the term 'nondetected' rather than a stated 0.5 percent maximum limit
  • In 1976 H. D. Stanley of Pfizer wrote that he objected to the definition's wording 'containing no detectable asbestos minerals'
  • A 1974 article by Arthur Rohl, quoted by the authors, stated that cosmetic talcum powder in which chrysotile was not found by x-ray diffraction might still contain billions of fibers released during dusting with a half-gram dose
  • In 1977 the chair of a CTFA round robin task force (John Schelz of Johnson & Johnson) reported that the J4-1 method's objectives had not yet been achieved
• The authors' conclusion: The authors concluded that by 1977 the FDA had essentially given up its efforts to regulate asbestos in talc. In their account, this happened because the industry had adopted its own J4-1 method even though the CTFA itself acknowledged the method was inadequate.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Talc and vermiculite.

Medical terms in this study, explained in our Lexicon: Talc, Mesothelioma, Ovarian Cancer, Chrysotile, Amphibole Asbestos, Cosmetic Talc.

Related studies

• Cosmetic talc and ovarian cancer — D.L. Longo, R.C. Young (1979)
• Mesothelioma Associated With the Use of Cosmetic Talc — J. Moline, K. Bevilacqua, et al. (2020)
• Cosmetic talc as a risk factor for pleural mesothelioma: a weight of evidence evaluation of the epidemiology — B.L. Finley, S.M. Benson, et al. (2017)
• Serous Ovarian Cancer Caused by Exposure to Asbestos and Fibrous Talc in Cosmetic Talc Powders-A Case Series — J.E. Steffen, T. Tran, et al. (2020)
• Talc, Asbestos, and Epidemiology: Corporate Influence and Scientific Incognizance — T.H. Tran, J.E. Steffen, et al. (2019)
• Evaluation by electron microscopy techniques of asbestos contamination in industrial, cosmetic, and pharmaceutical talcs — L. Paoletti, S. Caiazza, et al. (1984)

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