Cosmetics Direct

Electronic Submission Portal

What’s New?

September 9, 2026 - Today, the U.S. Food and Drug Administration is informing cosmetic product facilities, retailers, and industry responsible persons that it does not provide certificates or other documents to verify compliance for cosmetic product facility registration.

February 11, 2026 - Today, the U.S. Food and Drug Administration announced updates to its Cosmetics Direct electronic submission portal, its user guide, and other materials, to assist in the biennial registration of cosmetic product facilities as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Cosmetics Direct now displays two new fields, REGISTRATION STATUS and RENEWAL DATE, in the latest version of the cosmetic product facility registration homepage.

Every person who is required to register a facility must renew such registration biennially (i.e., every two years) (section 607(a)(2) of the FD&C Act). For each registered facility, the facility contact, the FDA Direct account contact (Cosmetics Direct or Combined CDER Direct and Cosmetics Direct), U.S. agent, additional contact and paper submitter (as applicable) will receive automated email reminders before the facility registration renewal date.

Cosmetics Direct is an electronic submissions portal for the registration & listing of cosmetic product facilities and products. It is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to the FDA for internal processing without having to use the Electronic Submissions Gateway Next Generation (ESG NextGen).

SPL, an established document sanctioned by health level seven (HL7) for the exchange of product and facility-related information, serves as a foundational reference for regulatory guidance documents and product labeling content exchange. It enforces control over crucial product information, resulting in a standard for product labeling. The FDA has adopted SPL to enhance patient/customer safety and product usability within its consumer base. Beginning in 2005, the FDA stated that SPL in extensible markup language (XML) format is the only electronic format for certain electronic submissions. This standard defines the content and structure of product labeling required for submission to the FDA. Consistent structure and standard terminology are employed to enhance the accuracy and reliability of product information. For additional information, see the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures.

Launch Cosmetics Direct

Download the User Guide (February 2026)

Cosmetics Direct - Facility Registration Tutorial (February 2026)

Cosmetics Direct - Product Listing Tutorial (February 2026)

Important Notes

The FDA does not issue certificates or other documents to verify compliance for cosmetic product facility registration or cosmetic product listing, including but not limited to:

a certificate as proof of cosmetic product facility registration or cosmetic product listing,
a verification document, such as a letter or email, stating a facility is registered or a cosmetic product is listed, or
a document (e.g., certificate, letter, or email) confirming a facility or responsible person is not required to register or list cosmetic products with the FDA.

Cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool. The assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its products.

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Announcements

2026

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2023