On 11 February 2026, U.S. Food and Drug Administration (FDA) announced updates to its Cosmetics Direct electronic submission portal, user guide, and supporting materials to help cosmetic facilities prepare for biennial registration renewal under the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA).
Cosmetics Direct now displays two new fields on the cosmetic product facility registration homepage: REGISTRATION STATUS and RENEWAL DATE. Automated email reminders will be sent before the renewal date to the facility contact, FDA Direct account contact, U.S. agent, additional contact, and paper submitter (as applicable).
Additional Key Details Renewal is required every two years (section 607(a)(2) of the FD&C Act) based on the initial registration date (e.g., initial registration received February 20, 2024, renewal due by February 20, 2026). Facilities may submit renewals earlier if needed.
Two renewal options are now available in the latest Structured Product Labelling (SPL) version:
1. COSMETIC PRODUCT FACILITY REGISTRATION – BIENNIAL RENEWAL (for registrations with changes)
2. COSMETIC PRODUCT FACILITY REGISTRATION – ABBREVIATED RENEWAL (for registrations with no changes, as permitted under section 607(a)(5))
Important Notes
1. Cosmetic facility registration and product listing are not an approval or promotional tool; FDA does not issue certificates.
2. Responsible persons must list every marketed cosmetic product (including ingredients) and update annually.
3. Small business exemptions from registration/listing do not apply to eye-area, injectable, internally used, or long-wear appearance-altering products.
4. Exemptions also exist for certain drug/device-regulated products and facilities.
5. FDA may suspend a facility’s registration if there is a reasonable probability of serious adverse health consequences.