FDA Cosmetics Registration System Officially Opened

Release time:

2023-12-20 14:46

On December 18, 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Cosmetic Direct Electronic Submission Portal (cosmetics direct) for the registration and product listing of cosmetics factories under the Cosmetic Regulatory Modernization Act of 2022 (MoCRA).

The Cosmetics Direct portal is now open to industry and is dedicated to cosmetic facility registrations and electronic submissions of cosmetic listings to the FDA.

Cosmetics Direct 可通过https://direct.fda.gov/Visit.

Cosmetics Direct is an FDA Structured Product Label (SPL) authoring tool for cosmetic factory registration and cosmetic listings with user-friendly data entry forms that create, validate, save, submit, process, and automatically transmit SPL submissions to the FDA for internal processing without the use of an Electronic Submission Gateway (ESG).

FDA also accepts submission of cosmetic factory registration and product listing in SPL format through ESG (Electronic Submission Gateway). In addition, the FDA is developing a SPL-X form, which is expected to be available soon.

FDA strongly encourages electronic submissions to improve the efficiency and timeliness of the agency's data submission and management.

The FDA is also developing paper forms for cosmetic registrations and cosmetic listings as an alternative submission tool, which is expected to be available soon.

MoCRA Implementation Time Point

On November 8, 2023, the FDA issued guidance stating its intention to delay the implementation of the cosmetic facility registration and cosmetic listing requirements under the MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

The FDA has postponed the requirements related to cosmetic factory registration and cosmetic marketing until July 1, 2024, to provide additional time for regulated industries to comply with these requirements.

In addition, before July 1, 2024, FDA does not intend to enforce registration requirements for owners or operators of facilities that first engage in the production or processing of cosmetic products after December 29, 2022, nor does it intend to enforce listing requirements for cosmetic products that are first marketed after December 29, 2022.

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