The record
In March 1975 the FDA declined to finalise its talc regulation, stating it had examined numerous talc samples using the proposed methodology and found approximately two-thirds within the proposed limits, but deciding to delay any final regulation until an acceptable determination method could be developed.
Claim scope
The decisive regulatory event: the FDA abandoned the stricter standard on methodological grounds, and its own notice recorded that approximately two-thirds of samples met the limits — the paper notes the implication that possibly one third did not. The paper also quotes the Commissioner concluding the limits “would not impose an unreasonable burden on manufacturers.” PMID 31095409's endnote 30 identifies the document as “Asbestos-Form Particles in Drugs for Parenteral Injection,” Federal Register 40, no. 51 (March 14, 1975): 11865-66.
What this source does not establish
Not independently retrieved from govinfo here. NOTE a substantive caveat the endnote reveals: the March 1975 document's title concerns DRUGS FOR PARENTERAL INJECTION, not cosmetics — so the talc-regulation delay is recorded inside a parenteral-drug notice. Do not describe it as a cosmetics rulemaking. The paper further states that by 1977 the FDA “essentially gave up its efforts to regulate asbestos in talc”, which is the authors' historical characterisation rather than a documented agency action.
Limitations
MANDATORY DISCLOSURE whenever this paper is cited: its own conflict-of-interest statement reads “David Rosner and Gerald Markowitz wrote a 2017 Report to the Court in a legal case that formed the original basis of this article. They received funding from plaintiffs' law firms for research and writing.” Its documentary base is litigation-discovery material hosted on toxicdocs.org. It is peer-reviewed and PubMed-indexed, which satisfies house citation standards, but it is not a neutral archival study. The FR title/scope mismatch is important and easy to get wrong. Verify 40 Fed. Reg. 11865 on govinfo.
Source
Pmid — 31095409