AHPA exec outlines ‘need to know info’ for MoCRA compliance in 2024



Per its previously issued guidance in November of last year, FDA will be delaying enforcement of the requirements for cosmetic product facility registration and product listings under MoCRA until July 1, 2024. There is still time for cosmetic and personal care product companies to implement compliance efforts, but that window is rapidly closing.

For more insight into what indie beauty companies need to know about MoCRA in 2024, including important considerations to address prior to the first upcoming deadline, implementations that might be overlooked when addressing compliance measures, and suggestions for support to ensure MoCRA regulatory compliance, we spoke with Robert Marriott, Director of Regulatory Affairs at the American Herbal Products Association (AHPA).

Need to know info

One aspect of MoCRA enforcement that is important to note, said Marriott, is that “in 2024, cosmetics companies should be ready to comply with serious adverse event reporting (SAER) requirements, including the requirement that cosmetic products bear a domestic contact address.”

While not currently available, FDA “has signaled that the agency’s electronic SAER system will go online in the coming months,” he explained, and therefore, “companies need to maintain product safety substantiation and ensure that cosmetics intended only for professional use are appropriately labeled.”

Although the previous statutory date of December 29, 2023 for compliance regulation enforcement has been delayed until July 1, 2024, “compliance with these requirements may be labor-intensive for smaller companies that don’t fall under its size exemption,” said Marriott.



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