Today the U.S. Food and Drug Administration (FDA) announced the launch of its Cosmetics Direct electronic submission portal for registration and listing of cosmetic product facilities and products, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The Cosmetics Direct portal, now available for industry, is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. Cosmetics Direct is accessed at https://direct.fda.gov/.
Cosmetics Direct is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, with user-friendly data entry forms that creates, validates, saves, submits, processes, and automatically transmits the SPL submission to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).
FDA is also accepting cosmetic product facility registration and cosmetic product listing submissions via SPL-formatted submissions through the ESG. In addition, FDA is also developing SPL-X forms that is anticipated to be available soon.
FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.
FDA is also developing paper forms for cosmetic product registration and cosmetic product listing as an alternative submission tool that are anticipated to be available soon.
On November 8, 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.