Cosmetics Under the Microscope: FDA’s Expanding Regulatory Reach Under MoCRA - Crowell & Moring LLP
FDA's MoCRA enforcement is expanding, with new requirements for facility registration, product listing, safety substantiation, adverse event reporting, and compliance with GMP, PFAS, talc, and fragrance allergen rules. Small businesses must act now to avoid penalties.
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Indie beauty brands, contract manufacturers, private-label makers, importers/distributors should confirm how it applies to their specific situation before acting. There is a time constraint attached: Facility registration and product listing deadlines have passed (Dec 2023 for registration, ongoing for listing); GMP compliance by 2025; other rules effective now.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA is actively enforcing MoCRA, requiring facility registration, product listing, safety substantiation, adverse event reporting, and compliance with new rules on GMP, PFAS, talc, and fragrance allergens.
Who it affects
Indie beauty brands, contract manufacturers, private-label makers, importers/distributors
What you must do
Register facilities and list products with FDA, ensure safety substantiation, set up adverse event reporting, and comply with GMP and ingredient restrictions.
Deadline
Facility registration and product listing deadlines have passed (Dec 2023 for registration, ongoing for listing); GMP compliance by 2025; other rules effective now.
Never miss a change like this again
Aforeworn watches Cosmetics & Personal-Care (MoCRA) around the clock and alerts you the moment a rule moves — with a plain-English brief on what to do.
Start your free trialRelated changes in Cosmetics & Personal-Care (MoCRA)
- New Jersey bans some products with toxic PFAS chemicals. Here’s what to know - WHYY
- Implementing MoCRA: FDA Releases New Draft Guidances on Insanitary Conditions for Tattoo Ink and Cosmetic Product Registration & Listing - Food and Drug Law Institute (FDLI)
- France bans PFAS in cosmetics – COSlaw.eu - Guiding through EU Cosmetics Regulations - COSlaw.eu
- Illinois Governor Signs Bill Banning Intentionally Added PFAS in Certain Consumer Products and Requiring IEPA to Prepare Report on Fluoropolymers by August 1, 2027 - Bergeson & Campbell
- FDA Final Guidance on Cosmetic Facility Registration and Product Listing: Take Two - ArentFox Schiff