Modernization of Cosmetics Regulation Act of 2022 (MoCRA) - fda.gov
MoCRA introduces new FDA requirements for cosmetics, including facility registration, product listing, GMP compliance, and adverse event reporting. While primarily targeting cosmetics, the law also impacts pharmaceutical manufacturers that produce cosmetic products or use cosmetic ingredients.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 16, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Pharmaceutical manufacturers that also produce cosmetics (e.g., over-the-counter drugs with cosmetic claims, or contract manufacturers handling both) and API/contract manufacturers supplying cosmetic ingredients. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Facility registration and product listing due by July 1, 2024 for large businesses; small businesses have until July 1, 2025. GMP compliance required by July 1, 2024.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) 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 FDA oversight similar to drugs: mandatory facility registration, product listing, adherence to GMPs, and adverse event reporting. Enforcement begins July 1, 2024 for large companies, with staggered deadlines for small businesses.
Who it affects
Pharmaceutical manufacturers that also produce cosmetics (e.g., over-the-counter drugs with cosmetic claims, or contract manufacturers handling both) and API/contract manufacturers supplying cosmetic ingredients.
What you must do
Determine if your products meet the definition of 'cosmetic' under MoCRA. If yes, register facilities and list products with FDA, implement GMPs, and set up adverse event reporting systems.
Deadline
Facility registration and product listing due by July 1, 2024 for large businesses; small businesses have until July 1, 2025. GMP compliance required by July 1, 2024.
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