FDA Introduces SPL XForms for Cosmetic Product Registration and Listing

24 January 2024

The U.S. Food and Drug Administration (FDA) has announced the availability of Structured Product Labeling (SPL) XForms for cosmetic product facility registration and cosmetic product listings under the Modernization of Cosmetics Registration Act (MoCRA). This new tool aims to streamline the submission process and improve efficiency for cosmetic manufacturers.

In a bid to modernize the registration and listing process for cosmetic products, the FDA has introduced SPL XForms as an additional authoring tool option. The FDA’s announcement comes as part of its ongoing efforts to enhance regulatory oversight and ensure the safety of cosmetics in the market. With the of SPL XForms, cosmetic manufacturers now have a web-based tool that simplifies the submission process, making it more accessible and user-friendly.

SPL XForms: A Convenient and Efficient Solution
SPL XForms offer several advantages for cosmetic manufacturers seeking to register their facilities and list their products. These web-based forms eliminate the need for downloads and are compatible with popular web browsers such as Mozilla Firefox, Microsoft Edge Chromium, Google Chrome, and Apple Safari. Additionally, SPL XForms include a built-in validator, which helps detect errors in submissions, ensuring accuracy and compliance with FDA guidelines. With these features, cosmetic manufacturers can easily navigate the registration and listing process, saving time and resources.

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Other Electronic Submission Options
Apart from SPL XForms, the FDA provides alternative electronic submission options for cosmetic product listings and facility registrations. Cosmetics Direct, a free SPL tool, allows manufacturers to provide information about their products and facilities directly to the FDA’s Office of Cosmetics and Colors (OCAC). This tool, launched last month, aims to simplify the submission process for manufacturers and enhance communication with regulatory authorities.

Another electronic submission option is the FDA’s Electronic Submissions Gateway (ESG), which accepts SPL-formatted submissions. The ESG serves as a secure platform for the submission of premarket and postmarket regulatory information. It acts as a conduit for submissions to reach the appropriate FDA center or office. With the ESG, manufacturers can ensure the secure and timely submission of their data to the FDA.

Paper Submission Option
In addition to electronic submission options, MoCRA allows companies to submit product listing and facility registration information via paper forms. The FDA has made Form FDA 5066 and Form FDA 5067 available for download, which can be submitted either by mail or email. While electronic submissions are not mandatory, the FDA strongly encourages their use to streamline data submission and management for the agency.

Conclusion:

The of SPL XForms by the FDA marks a significant step forward in streamlining the registration and listing process for cosmetic manufacturers. With user-friendly web-based forms, built-in validation, and compatibility with popular web browsers, SPL XForms offer a convenient and efficient solution for submitting facility registration and product listing information. Alongside other electronic submission options like Cosmetics Direct and the FDA’s Electronic Submissions Gateway, the FDA aims to enhance regulatory oversight and ensure the safety of cosmetic products in the market. While paper submissions remain an option, electronic submissions are encouraged to improve efficiency and timeliness in data management. As the cosmetics industry continues to evolve, these advancements in regulatory processes will play a crucial role in safeguarding consumer health and well-being.

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