Beyond the existing electronic submission portal, Cosmetic Direct, the U.S. Food and Drug Administration (FDA) officially launched additional submission tools on January 8, 2024, providing stakeholders with more flexibility for meeting their specific needs in cosmetic facility registration and product listing. These tools include:
Structured Product Labeling (SPL) Xforms: This tool serves as an SPL authoring tool, facilitating the creation of SPL file containing information on cosmetic product facility registration and product listing.
Form FDA 5066 and Form FDA 5067: These forms are designated for paper submissions. Form FDA 5066 is used for cosmetic facility registration, while Form FDA 5067 directs at cosmetic product listing. These forms are editable online. Stakeholders shall complete these paper forms and submit them via mail to FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program at the provided address: 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. Alternatively, they can opt to email the completed forms to RLC-PaperSubmissions@fda.hhs.gov.
At present, the FDA offers four options for stakeholders to submit cosmetic product facility registration and product listing information, covering both electronic and paper submissions. The details are outlined below. FDA encourages stakeholders to leverage electronic submissions whenever possible, given the associated efficiency and timely data management benefits.
No. | Submission Way | Detailed Requirements |
1 | Submit via electronic portal | Fill out and submit SPL documents on Cosmetics Direct electronic submission portal |
2 | Fill out and submit SPL documents via FDA’s Electronic Submissions Gateway (ESG) or any SPL authoring software, including SPL Xforms. | |
3 | Submit via electronic form | Email the completed Form FDA 5066 and Form FDA 5067 to the provided mailbox. |
4 | Submit via paper form | Mail the completed Form FDA 5066 and Form FDA 5067 to the provided address. |
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