The record
In the proposed cosmetic-talc testing rule (89 FR 105490), FDA rejected X-ray diffraction and infrared methods and named the J4-1 method, noting its 0.5% limit of detection.
Claim scope
FDA's stated method preferences and its on-the-record characterization of J4-1's detection limit in the 2024 proposal.
What this source does not establish
The proposal was withdrawn in 2025 — every requirement described from 89 FR 105490 must be written in the conditional or past voice of a proposal that never took effect.
Limitations
Cite as 'the withdrawn proposed rule'; none of its requirements are or were binding.
Source
Federal Register — 89 FR 105490 at 105496-105497 (Dec. 27, 2024), FR Doc. 2024-30544