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.
Five things that actually moved a calendar in Q2: SCCS triage, China method packs, mercury date approaching, FDA Voices, leftover MoCRA rules.
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.
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The December 2024 proposed rule on standardized asbestos testing in talc cosmetics was withdrawn.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.
Statutory target dates for some MoCRA rules have slipped. Track FDA’s MoCRA page. Do not implement a draft you cannot cite.