13/14 March 2024
The FDA announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This follows the recently announced launch of Cosmetics Direct, FDA's electronic submission portal.
Xforms is one option of creating an SPL file with cosmetic product facility registration and cosmetic product listing information. However, the agency is also accepting facility registrations and product listings via Cosmetics Direct and SPL-formatted submissions through the Electronic Submissions Gateway (ESG).
Furthermore, the FDA also announced the availability of Form FDA 5066 and Form FDA 5067 as an additional submission tool for providing cosmetic product facility registration and cosmetic product listing information to the agency. These paper forms are available at Registration & Listing of Cosmetic Product Facilities and Products.
While electronic submission is not required, the agency strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.