On Jan. 8, 2024, the U.S. Food and Drug Administration (FDA) rolled out Structured Product Labeling (SPL) Xforms, a digital tool to register cosmetic product facilities and list products, as mandated by MoCRA.
See related: A Modernization of Cosmetics Regulation Act (MoCRA) Compliance Checklist
Xforms is just one digital option available for creating an SPL file with cosmetic product facility registration and product listing information. Two additional electronic options are available:
- Cosmetics Direct, an FDA Structured Product Labeling SPL authoring tool and electronic submission portal and
- SPL-formatted submissions through the Electronic Submissions Gateway (ESG).
Furthermore, the agency is providing downloadable PDF forms for "paper" submissions. These include Form FDA 5066 (to register facilities) and Form FDA 5067 (to list products).
Completed paper forms can be emailed to [email protected] or physically mailed to the FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program at:
Food and Drug Administration
Office of Cosmetics and Colors
Registration and Listing of Cosmetic Product Facilities and Products Program
5001 Campus Drive, CPK1, Room 1B-046, College Park, MD 20740-3835
While electronic submissions are not required, the FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management.
For more information about submissions and MoCRA mandates, see the FDA website.
See also: FDA Delays MoCRA Enforcement by 6 Months
