FDA Updates Portal and Materials to Aid Cosmetic Facilities in Biennial Registration Renewal

In February, the U.S. Food and Drug Administration (FDA) announced updates to the Cosmetics Direct electronic submission portal, along with the user guide and other materials, to assist in the biennial registration renewal of cosmetic product facilities as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Overview of the Updated Content

The updates include new Cosmetics Direct | FDA features that display facility registration status and renewal date, automated facility registration renewal reminders to registered facilities, and updated facility registration and renewal instructions, including the user guide and tutorial(s).

These updates are being announced in light of the two-year anniversary of the launch of the Cosmetics Direct portal in December 2023, when cosmetic product facilities began registering with the FDA. Currently, over 14,000 cosmetic product facilities are registered with the FDA.

Cosmetics Direct electronic facility registration renewal submission options include:

• Biennial Renewal (for facility registration renewals with changes)
• Abbreviated Renewal (for facility registration renewals without changes)
• Paper facility registration renewal submission options are also available.

Renewal of Registration 

In a recent update, the U.S. FDA reminded all individuals and entities required to register their facilities that they must renew their registrations biennially, in accordance with section 607(a)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

To streamline the process, the FDA is introducing an abbreviated renewal option for facilities that have not made any changes to their registration information since their last submission, as stipulated in section 607(a)(5) of the FD&C Act.

It is important to note that the renewal timeline and requirements for cosmetic product facility registrations may differ from those of other FDA-regulated products, which may also necessitate facility registration. Stakeholders are encouraged to review their registration status and ensure compliance with the renewal process.

Renewal Dates

A cosmetic product facility must renew its registration every two years from the date of initial registration.

• Renewal dates are determined by the initial registration date. For instance, if the FDA received your initial registration on February 20, 2024, the renewal date would be February 20, 2026.
• Facilities can submit renewals earlier than the two-year period. For example, an early renewal for your cosmetic facility registration can be submitted along with your CDER annual establishment registration renewal when it is due.

Our Services

• The United States Agent
• The United States FDA Cosmetic Facility Registration
• The United States FDA Cosmetic Product Listing
• The United States FDA OTC Drug Registration
• The United States Color Additive Batch Certification
• The United States Cosmetic/OTC Drug Labeling Review
• International Cosmetic Ingredient Name (INCI) Application

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

FDA