Landmark Cosmetic Law Adopted that Significantly Changes how Cosmetics Are Regulated by FDA - Steptoe
The Modernization of Cosmetics Regulation Act (MoCRA) introduces mandatory FDA facility registration, product listing, safety substantiation, adverse event reporting, and GMP compliance for all cosmetic manufacturers and distributors.
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. All businesses manufacturing, packaging, distributing, or importing cosmetics in the U.S., including indie brands, contract manufacturers, private-label makers, and importers. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Facility registration and product listing due by December 29, 2023; GMP compliance by December 29, 2024; other provisions phased in.. 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
Cosmetics are now subject to mandatory FDA facility registration, product listing, safety substantiation, adverse event reporting, GMP requirements, and labeling updates (fragrance allergens, PFAS, talc).
Who it affects
All businesses manufacturing, packaging, distributing, or importing cosmetics in the U.S., including indie brands, contract manufacturers, private-label makers, and importers.
What you must do
Register facilities with FDA, list products, establish safety substantiation files, implement adverse event reporting systems, and update labels to comply with new requirements.
Deadline
Facility registration and product listing due by December 29, 2023; GMP compliance by December 29, 2024; other provisions phased in.
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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.
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- FDA Final Guidance on Cosmetic Facility Registration and Product Listing: Take Two - ArentFox Schiff
- FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA - Crowell & Moring LLP
- Cosmetics Under the Microscope: FDA’s Expanding Regulatory Reach Under MoCRA - retailconsumerproductslaw.com
- FDA drops proposed rule on asbestos testing in cosmetics - ConsumerAffairs
- FDA Withdraws Talc Asbestos Rule for Cosmetics - Environment+Energy Leader