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The US Food and Drug Administration will consider a newly published white paper from a federal interagency working group it formed in 2018 as it considers drafting guidance or initiating rulemaking on testing methods for asbestos in cosmetic talc and talc-containing cosmetic products.

Published on 13 January, the white paper hews closely to recommendations released by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) in advance of a February 2020 public meeting on the topic.

“We have become aware that methods employed by some industry members to test for asbestos in talc-containing cosmetic products may not always detect the presence of asbestos,” says Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, in a same-day release.

The IWGACP – which includes the FDA, Environmental Protection Agency, and National Institutes for Health – believes asbestos in cosmetic talc and talc-containing products is under-reported at present due to shortcomings in existing testing standards.

Those include the J4-1 method that has been used voluntarily by the cosmetics industry since 1976.

A United States Pharmacopeia (USP) method for certifying asbestos-free talc for use in drug products is similarly problematic, according to the working group.

Both approaches call for x-ray diffraction or infrared spectroscopy to screen for potential asbestos content, followed by polarized light microscopy (PLM) only if the screening results are positive.

Neither incorporates transmission electron microscopy (TEM), which the IWGACP characterizes as superior at detecting smaller, thinner particles, with “a limit of detection that is several orders of magnitude lower than PLM.”

That’s important insofar as the IWGACP has concerns about amphibole and other mineral particles that have elongate structures which could pose respiratory risks, ie, those with length ≥ 0.5 micrometer and aspect ratio ≥ 3:1, in addition to particles historically characterized – inconsistently, the working group says – as asbestos based on unusual fibrous (asbestiform) crystal growth habit.

The Personal Care Products Council took issue with that point in 2020. Tom Myers, the trade association’s executive vice president, legal, and general counsel, stated in an interview, “I don’t think the science is necessarily there to say these are all biologically active.”

He added, “My concern is that if you suddenly expand the scope of what constitutes asbestos or [elongate mineral particles] or whatever they’re going to call them, that could create additional liability for companies.” (FDAProposed Talc Testing Methods Likely Would Find Particles Of Concern Then What)

Myers said PCPC is less concerned about an updated methodology that requires TEM, though TEM’s greater specificity and sensitivity compared with PLM and other imaging techniques could result in increased findings of asbestos or EMP-contaminated talc and talc-containing cosmetics.

The IWGACP notes that in 2019, “tremolite and/or chrysotile asbestos was reported in nine cosmetic products analyzed by TEM [on behalf of the FDA]; however, seven of the nine products were reported as ‘not detected’ by PLM.”

The FDA’s 2019 survey of the cosmetic talc landscape targeted products already suspected of asbestos contamination following highly publicized third-party investigations, including into powder makeup products available to kids through Claire’s Stores, Inc. (FDA Final Report Asbestos Detected In 17 Of TalcContaining Cosmetics Including Products Previous)

In an October 2021 analysis of samples likely more representative of the cosmetics marketplace, the FDA found no traces of asbestos in all 50 talc-based cosmetics products it had tested by Lanham, MD-based AMA Analytical Services, Inc. (50 For 50 All Talc-Containing Cosmetic Samples Found Asbestos-Free In Latest US FDA Tests)

Which could suggest that industry already has the asbestos-tainted talc issue well in hand.

But Is It Doing This?

The IWGACP white paper puts forth the following scientific opinions and advice:

  1. Use both PLM and TEM methods to identify/report, at minimum, the presence of asbestos, other amphibole minerals, and talc particles exhibiting non-platy morphology;

  2. Tabulate, at minimum, all amphibole and chrysotile particles having a length ≥ 0.5 micrometer (µm) (500 nanometer (nm)) and a ratio of length to width, i.e., aspect ratio (AR), ≥ 3:1 in talc-containing cosmetic products and talc intended for use in cosmetics, and avoid categorizing such particles as non-asbestiform when there is ambiguity as to habit of growth;

  3. Scanning electron microscopy (SEM) can be used as a complementary method to TEM, but has certain limitations at this time;

  4. TEM results should be reported by tabulating each particle6 to facilitate an estimate of the number of particles per unit mass of sample analyzed (i.e., particles/gram of talc, particles/gram cosmetic product), rather than as weight percent;

  5. An adequate number of TEM images that show the morphology of representative particles in each category described in #1 and an adequate number of energy dispersive spectroscopy (EDS) spectra and selected area electron diffraction analysis (SAED) patterns to support mineral identification should be provided.

  6. Samples should be prepared to mitigate interference from the sample matrix using techniques similar to those used for the testing of bulk materials for asbestos;

  7. Content and format of analytical reports should facilitate consistent and comprehensive reporting of particles (as described in #1 and 2), in conjunction with adequate documentation of findings; and

  8. Policies and procedures covering rigorous training, quality assurance, and quality control should accompany the implementation of these methods to maintain intra- and interlaboratory consistency and to ensure laboratories are qualified and their qualifications are reviewed regularly.

In its release, the FDA says, “The scientific opinions set forth in the white paper could potentially be used to support regulatory policy developments on a definition of particles of interest and standardized testing methods for asbestos and other mineral particles that could potentially affect talc-containing cosmetic product safety.”

The agency adds, “Should the FDA decide to develop recommendations with respect to standards or testing methods for asbestos in talc, it would issue draft guidance for public comment. Likewise, the FDA would propose any related regulations through a public notice and comment process.”

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