On 8 January 2024, the US Food and Drug Administration (FDA) rolled out a new authoring tool for cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which is known as SPL Xforms or Structured Product Labeling (SPL).
US FDA provides 3 options for submission of cosmetic product facility registrations and cosmetic product listings via electronic submission which are:
Xforms
Cosmetics Direct, can be submitted via the electronic submission portal
SPL-formatted submissions through the Electronic Submissions Gateway (ESG)
While FDA also provides manual methods by releasing Form FDA 5066 and Form FDA 5067 as submission tools in paper form for the cosmetic product facility registration and cosmetic product listing information to the FDA. However, FDA strongly suggests the submissions be made via electronic submissions for efficiency and timeliness of the data submission and management.
Manufacturers, stakeholders, or responsible persons should be alerted of the delayed enforcement date which has been postponed to 1 July 2024. Hence, all responsible persons, manufacturers, or stakeholders have sufficient time to prepare for the facility registration and cosmetic product listing submission to the FDA.
Contact us at info@arqon.com for more information.