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  • Writer's pictureDaniel Jiménez

FDA - Delays MoCRA Compliance

In a recent release, the Food and Drug Administration (FDA) has announced a delay in the launch of the facility registration and product listing platform, providing additional leeway for compliance with established requirements.

FDA - Delays MoCRA Compliance
FDA - Delays MoCRA Compliance

FDA's Grace Period: Compliance Policy Shift for Cosmetic Product Facilities

This move comes in the wake of the FDA's recent publication of the "Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing." Under this guidance, the agency will not impose penalties for noncompliance with cosmetic product facility registration and listing requirements until six months after the statutory deadline, which was originally set for December 29, 2023, or until July 1, 2024. The main purpose of this extension is to provide the regulated industry with additional time to comply with such requirements.

FDA's Comprehensive Approach: Changes in Cosmetic Product Regulations and Deadlines

In addition, FDA has also decided not to require facility registration for those owners or operators who began manufacturing or processing cosmetic products after December 29, 2022, or the listing of cosmetic products that are first marketed after this same date, until July 1, 2024. This measure seeks to facilitate the adaptation of industry players to the new requirements without imposing additional burdens in the transition.

However, FDA has not officially communicated whether it intends to delay the implementation of the professional product labeling requirements as set forth in MoCRA, whose effective date is December 29, 2023. Also, it has not been reported whether the delay in implementation will alter the December 29, 2023 deadline for companies to maintain adverse event records, report serious adverse events to FDA, or retain adequate safety justification records.

In summary

FDA has decided to extend the deadlines for compliance with facility registration and listing requirements for cosmetic products, granting an additional six months to the regulated industry. This measure is intended to promote a smooth and effective transition to the new regulatory framework, allowing industry operators to adjust to the new regulations in an appropriate manner and without undue pressure.

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