tev-regulatory-framework-33

Talc Evidence Atlas — release-gated evidence record. Status: verified · Track: regulatory · Modified 2026-08-13

The record

FDA's 2009-2010 talc survey found no asbestos in any sample, with PLM limits of detection around 0.19-0.23 percent and TEM limits of detection around 0.021-0.044 ppm — but only four of nine talc suppliers submitted samples, and FDA stated the results did not prove products were asbestos-free.

Claim scope

The published data table quantifies the survey's detection limits per supplier block, verbatim: PLM average limit of quantitation and limit of detection = 0.23% ± 0.01, 0.22% ± 0.01, 0.22% ± 0.01, 0.23% ± 0.01 and 0.19% ± 0.04; TEM average limit of detection = 0.021 ppm ± 0.001, 0.021 ppm ± 0.003, 0.022 ppm ± 0.002, 0.021 ppm ± 0.002 and 0.044 ppm ± 0.018; TEM average limit of quantitation = 0.46% ± 0.01, 0.43% ± 0.02, 0.43% ± 0.01, 0.46% ± 0.01 and 0.39% ± 0.08. Every result is reported as 'NAD' (no asbestos detected) — 122 NAD entries across 61 result rows, comprising 27 cosmetic-grade raw material talc samples from four suppliers (Rio Tinto Minerals/Luzenac America, Presperse, Sensient Cosmetic Technologies, Brenntag Specialties) and 34 talc-containing cosmetic product rows.

What this source does not establish

Does NOT establish that talc was asbestos-free in 2009-2010 — FDA says so itself in the quoted limitation. Note the gap between the TEM limit of DETECTION (~0.021 ppm) and the TEM limit of QUANTITATION (~0.43-0.46%), roughly seven orders of magnitude apart: this is exactly the LOD-versus-LOQ distinction FDA proposed to change in 2024, when it moved to make the single-fiber LOD the positivity criterion. A result reported as 'NAD' under an LOQ-based criterion is not the same as a negative under an LOD-based one.

Limitations

Report the detection limits verbatim with their ± values; do not average or round them. The counts (27 raw-material rows, 34 product rows) are derived by AsbestosAtlas from the published table, not stated by FDA. This survey is the historical baseline the FY2019 positives should be read against.

Source

Gov Report — FDA, 'Summary of Results from Testing of Official Samples of Talc-Containing Cosmetics of Asbestiform Fibers by AMA Laboratories During 2009-2010'; FDA Talc page, 'FDA's Talc Survey of 2009-2010'

Read the primary source