US MoCRA for SME cosmetic brands
MoCRA expanded FDA’s cosmetics authority: facility and product listing, safety substantiation, serious adverse event reporting, and a still-moving rulemaking calendar.
MoCRA expanded FDA’s cosmetics authority: facility and product listing, safety substantiation, serious adverse event reporting, and a still-moving rulemaking calendar.
December 2025 FDA report ≠ permission. Illinois HB 3409 is the 2026 reminder that the calendar is state-by-state.
Illinois moved HB 3409 as a Cosmetic Products Act restricting listed chemicals, including PFAS, with a 1 July 2028 horizon in contemporary bill text. Confirm the Public Act before you brief retailers.
A “new INCI” is not one global project. China wants No. 59. The EU wants an annex path or a documented history. The US wants safety substantiation and a listing that matches the label.
Listing and serious AE reporting are live. GMP, allergen labeling and the asbestos method are still a calendar. Brief the board with two columns.
FDA’s May 2026 Voices post walks listing, PFAS report, and leftover rulemakings. Useful as a checklist against the MoCRA statute page.
Facility and product listing are live MoCRA duties. Rulemakings can slip; listing updates cannot wait for a perfect GMP rule.
FDA’s MoCRA-mandated PFAS report found evidence too thin for safety determinations on most intentionally added PFAS. State bans can still apply.
“Salon only” is not a MoCRA off-ramp. Adverse-event contact and other required statements still need a home on the pack or the mandated alternative.
The December 2024 proposed rule on standardized asbestos testing in talc cosmetics was withdrawn. MoCRA still directs FDA to work this problem — a withdrawal is not a permission slip.