SPL XForms New FDA Regulations

SPL XForms are now an additional option for cosmetic companies to submit their information, in addition to using the Cosmetic Direct portal, FDA Electronic Submission Gateway (ESG), and paper forms FDA 5066 and FDA 5067.

This week, the U.S. Food and Drug Administration (FDA) announced that Structured Product Labeling (SPL) XForms are now available for cosmetic product facility registration and product listings under the Modernization of Cosmetics Registration Act MoCRA . XForms are an additional authoring tool option for Structured Product Labelling (SPL) . This means that cosmetic companies now have a new way to register their facilities and list their products with the FDA.

What is SPL?

SPL submissions refer to a document markup standard that has been approved by Health Level Seven (HL7) and adopted by the FDA. This standard is used as a mechanism for exchanging product and facility information. 

SPL XForms are now an additional option for cosmetic companies for submission along with the Cosmetic Direct portal, FDA Electronic Submission Gateway (ESG), as well as paper Form FDA 5066 and Form FDA 5067. 

For question or issues submitting cosmetic product, listing or facility registration information, users can email: 

[email protected]

More information about SPL submissions can be found on the FDA website

Published: 24 Jan 2024 


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