This week, the U.S. Food and Drug Administration (FDA) released a Cosmetics Constituent Update announcing that Structured Product Labeling (SPL) XForms are now available for cosmetic product facility registration and cosmetic product listings under the Modernization of Cosmetics Registration Act (MoCRA). XForms are an additional authoring tool option for Structured Product Labeling (SPL).
About SPL XForms
As previously reported by CosmeticsDesign last month, SPL submissions are “a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information,” as detailed on the FDA website. SPL XForms can be accessed here, and there are separate options for Cosmetic Facility Registration and Cosmetic Product Listings.
SPL XForms are web-based, require no downloads, and can be accessed on Mac or PCs. They are compatible with Mozilla Firefox (recommended) (6 and higher), Microsoft Edge Chromium (110 and higher), Google chrome (8 and higher) and Apple Safari (4 and higher) and contain a built-in validator to detect up to 95% of errors, according to the FDA’s website.
For questions or to receive updates on SPL XForms, users can email SPL@fda.hhs.gov for more information.
Other electronic submission options
Other submission options for cosmetic product listings and cosmetic product facility registrations include Cosmetics Direct, a free SPL tool that will “provide information to FDA/Office of Cosmetics and Colors (OCAC) about cosmetic product manufacturers/processors and cosmetic products on the market,” according to the website.
In addition to Cosmetics Direct, which went live last month, there is also FDA’s Electronic Submissions Gateway (ESG), which also accepts SPL-formatted submissions. The FDA ESG is “an Agency-wide solution for accepting majority of electronic regulatory submissions,” and it “enables the secure submission of premarket and postmarket regulatory information for review,” according to the organization’s website.
“The FDA ESG is the central transmission point for sending information electronically to the FDA,” according to its landing page, and “within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office.”
For questions or issues submitting cosmetic product listings or facility registration information via the FDA ESG, users can email ESGHelpDesk@fda.hhs.gov for assistance. FDA also maintains an ESG Center Submission Type page for more information.
Paper submission option
Under MoCRA, companies can also choose to submit product listing or facility registration information via paper forms, and in its most recent Cosmetic Constituent Update, FDA announced “the availability of Form FDA 5066 and Form FDA 5067 as an additional submission tool” option.
These forms are now available for download here, and can be submitted either by mail to: 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, or by email at RLC-PaperSubmissions@fda.hhs.gov.
In its update, FDA noted that while electronic submissions are not a requirement, they are strongly encouraged in order “to facilitate efficiency and timeliness of data submission and management for the agency.”
