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.
Further, he added, “the agency released a final guidance on these new requirements in December 2023; cosmetics companies subject to these requirements should begin gathering information to perform facility registration and product listing well in advance of that date.”
Noteworthy implementations to keep in mind
Additionally, Marriott shared that “FDA is required to issue a proposed rule on labeling of fragrance allergens by mid-2024.” This is important for indie companies to keep in mind, he explained, because “depending on its provisions, this rule may require major industry label or manufacturing changes.”
Regarding safety substantiation, he added, while “FDA does not currently plan to issue additional regulations, this is a good time for cosmetics companies to ensure they maintain appropriate product safety records.”
Overall, most companies are currently focusing on their efforts to comply with MoCRA’s outlined cosmetic facility registration requirements. To be in compliance, “cosmetics facilities subject to registration will need to have already obtained an FDA Establishment Identifier (FEI) number, and foreign cosmetic facilities will need a U.S. agent to comply with registration,” Marriott said.
Additionally, he added that “FDA has taken the position in its most recent guidance on the matter that laboratories performing cosmetic batch release testing are subject to registration requirements.” He further clarified that “this also means these facilities are identified in the product listing for cosmetics which they test.”
Best ways to ensure compliance
Marriott emphasized that companies should do their best to stay up to date on the latest information to help ensure compliance with FDA regulations for MoCRA enforcement to ensure compliance in the upcoming year. “FDA maintains a core website that provides information and updates on MoCRA regulatory implementation,” he advised, and “cosmetics companies should monitor this site and work with their trade associations to provide feedback on new proposed regulations and learn more about what compliance will require.”
Regarding software or other means of electronic support for companies seeking clarification on regulatory requirements, “FDA’s online platform that handles cosmetic facility registration and product listing, FDA Direct, also fulfills the same functions for drugs, and shares a standardized data format between both product classes,” Marriott shared.
While this may be sufficient for companies with small to mid-sized product catalogues, “for companies with especially large product libraries, we anticipate third party software may eventually become available to help manage product listing and facility registration compliance,” he added.