FDA Guidance: Cosmetics Direct – PharSafer® – Global Clinical and Post Marketing Drug Safety

FDA Guidance: Cosmetics Direct

Navigating the FDA's Cosmetics Direct for Enhanced Compliance

In a recent notification, the FDA has communicated the introduction of the Cosmetics Direct, a pivotal tool within FDA Direct that facilitates the registration and listing of cosmetic product facilities and products via an electronic submissions portal. This user-friendly tool simplifies the submission process, ensuring compliance with the latest regulatory standards.

Within this communication, Companies have been urged to consider the structured product labelling (SPL) requirements, the necessity of comprehensive data submission, and the need for adherence to regulatory standards including Section 508 for EIT accessibility.

This initiative significantly impacts manufacturers by streamlining the compliance process, reducing administrative burdens, and enhancing product safety and transparency in the cosmetics industry.

In order to ensure the highest levels of compliance, those impacted should review the Structured Product Labelling (SPL) Implementation Guide and familiarise yourself with the Cosmetics Direct tool – and ensure all submissions comply with the FDA's standards and guidelines.

For assistance or more information on navigating the new system, please do not hesitate to contact us directly.

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