The record
The industry J4-1 test method was never codified and carried no compliance requirements, per the peer-reviewed review of the talc testing record (PMID 33641519); FDA's own characterization in 89 FR 105490 is similar but weaker.
Claim scope
That J4-1 functioned as a voluntary industry method without regulatory force, per a peer-reviewed review, with FDA's proposal as corroborating context.
What this source does not establish
The review author's characterization should be attributed as such — the author discloses litigation consulting work. J4-1's voluntary status does not by itself establish what any company's internal results showed.
Limitations
Attribute the 'never codified' finding to the review article; use the FDA proposal as independent context, not as the same claim.
Source
Gov Report — 89 FR 105490 at 105496-105497 (Dec. 27, 2024), FR Doc. 2024-30544; and PMID 33641519 (New Solut. 2021;31(2):152-169)