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Monday, October 23, 2023Regulation

MoCRA: the US FDA publishes a guide for labelling and registrations

MoCRA : la US FDA publie un guide pour l'étiquetage et les enregistrements

On 13 October 2023, the US FDA published a Structured Product Labeling (SPL) Implementation Guide with validation procedures for cosmetic facility and product registrations required by the Modernization of Cosmetics Regulation Act (MoCRA).

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Facility and cosmetic product registrations are now included in the SPL framework, says the FDA.
In the near future, when the FDA begins accepting data, users will be able to transmit their submissions in SPL format via the FDA’s Electronic Submissions Gateway (ESG) or via SPL creation software such as Xforms.

The FDA is also unveiling the address of the next electronic submission portal, Cosmetics Direct (https://direct.fda.gov/), indicating that it will be a tool for creating SPLs containing data entry forms, with initial validations, the creation and registration of SPL submissions, making it possible not to use the ESG.

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