Proposed Rule on Talc-Testing for Asbestos

FDA Proposed Rule on

Talc-Testing for Asbestos

On December 26, 2024, The Food and Drug Administration (FDA) issued a proposed rule for cosmetic manufacturers as it pertains to talc-testing methods and detecting asbestos in talc-containing products. If finalized, the proposed rule will establish and require standardized talc-testing methods, require record keeping, and enforce compliance to ensure public safety. Issuance of the proposed ruling falls under The Modernization of Cosmetics Regulation Act of 2022, to reduce cosmetic product recalls and promote consumers' public health from fewer asbestos exposures.

Requirements Overview:

Testing of talc-containing cosmetic products for detecting and identifying asbestos using the following methods:
- Polarized Light Microscopy (PLM) (with dispersion straining) and
- Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED)
Maintaining asbestos testing records for at least 3 years after the date the record was created.
Records availability must be made within 1 business day for inspection and copying upon request.
Effective Date: 30 days after publication of final rule in the Federal Register.

Insights:

Rule would apply to all manufacturers of talc-containing cosmetic products.
If asbestos is detected while using either microscopy testing methods (PLM or TEM/EDS/SAED), then the sample is considered positive for asbestos.
Manufacturers may either test each batch or lot of the talc cosmetic ingredient, or rely on a certificate of analysis for each batch or lot from a qualified talc supplier prior to using talc for manufacturing.
Talc tests would need to occur upon receipt of supplier's initial certificate of analysis and annually, thereafter.
Record maintenance requirements for manufacturer testing for asbestos include:
- Raw data (microscopy images, spectra, diffraction patterns and bench sheets)
- In-depth description of how the samples were tested
Record maintenance requirements for manufacturers relying on Certificate of Analysis include:
- Certificates of analysis from supplier for testing of talc
- Maintaining reliablily of supplier's certifiate of analysis through verification of test results
All records maintained would be required to be written in English or an English Translation made available.
FDA is accepting public comments by 11:59 p.m. (EST) at the end of March 27, 2025.