Last week, the FDA published a guidance update extending MoCRA’s product listing and cosmetic manufacturing facility registration compliance statutory deadline from December 29, 2023, to July 1, 2024. This update is the latest in a series of actions by the FDA to prepare for MoCRA’s enactment over the past year, including the suspension of the Voluntary Cosmetics Registration Program (VCRP) in March and the launch of an open commentary period for its replacement, draft electronic submission portal Cosmetics Direct in September.
The FDA intends to “provide regulated industry additional time to comply” with MoCRA’s regulations by delaying enforcement of facility registration and listing requirements for cosmetic products and manufacturers. To learn more about how this extension is being received by beauty brand decision-makers, including the most significant challenges to MoCRA compliance and proposed solutions to these challenges, CosmeticsDesign spoke with Erin Delatorre, Regulatory Compliance Manager, and Chad Conger, Senior Vice President of Technology at cosmetics manufacturing company Cohere Beauty. Delatorre is a member of the Independent Beauty Association’s Technical Regulatory Committee and MoCRA subcommittee, placing her at the forefront of MoCRA developments.
CDU: What are the implications of the FDA’s guidance on extending the deadline for cosmetics and personal care product manufacturers to comply with facility registration and product listing requirements under MoCRA for beauty brand decision-makers?
Erin Delatorre (ED): This is a much-needed relief to the industry as it provides a more reasonable timeline for navigating the new portal and successfully submitting the required information – especially for emerging brand decision-makers who may not have the regulatory expertise that more prominent brands do.
CDU: What are some of the best ways to navigate misinformation and red flags when outsourcing MoCRA compliance efforts?
ED: Regulatory expertise on MoCRA is vital for emerging and established brands. Ignorance of the law does not exempt anyone from it, which holds true for both large and small brands.
For example, someone may request payment for registration or product listing — however, the FDA does not charge fees for these services. Additionally, product listings with the FDA do not include confidential formulas.
Regulatory knowledge is non-negotiable, as a brand must understand and comply with these regulations. Cohere Beauty’s mission is to ensure that our current and potential customers are fully informed to protect themselves from potential wrongdoers and liabilities, and we’ve continually built up our regulatory expertise to do so.
CDU: What are beauty brand decision-makers’ expectations for future MoCRA regulation announcements under the FDA?
ED: The first thing that Beauty brand decision-makers can expect is more information on the electronic submission portal that will be used for facility registration and product listing. The timing of industry testing and feedback, which will lead to the ultimate timing of opening the portal, is still unknown.
We also await information on fragrance allergen labeling and cosmetic Good Manufacturing Practices (GMP). Although not specifically announced, the FDA may provide additional guidance on safety substantiation methods for cosmetic products.
FDA will publish the proposed rulemaking for fragrance allergen labeling no later than June 2024, and the final rulemaking will be 180 days after the comment period closes. FDA will issue proposed rulemaking for Good Manufacturing Practices for cosmetic facilities on or before December 2024 and the final rulemaking on or before December 2025.
CDU: What are some of the most critical considerations for cosmetics and personal care product ingredient manufacturers and suppliers in the “post-MoCRA” world?
Chad Conger (CC): Manufacturers and suppliers of cosmetic ingredients should expect greater scrutiny over their products, especially regarding safety substantiation. Beauty brand decision-makers will be fielding new consumer questions and need contract manufacturing partners with strong technical and regulatory expertise to support their needs.
For example, consumer questions will follow once fragrance allergens start appearing on product labels. At Cohere Beauty, we maintain relationships with cosmetic ingredient suppliers and require substantial regulatory documentation on every cosmetic ingredient we use.
We will continue to drive the conversation forward with our customers by disclosing the Cohere Beauty approach in each of these areas to ensure transparency in what we do as part of our standard process. We also partner with our customers to discuss requirements in great detail to help them understand where and how they can improve their processes. This will help customers to make informed decisions.
CDU: What are some of the biggest concerns or challenges facing beauty brand decision-makers regarding product ingredient and formulation compliance under MoCRA?
ED: The biggest challenge for beauty brand decision-makers under MoCRA will be aligning themselves with knowledgeable and experienced partners and developing processes and systems to manage the changes and incremental data required for MoCRA compliance. For example, over the next two years, every label will need to change to align with the updated fragrance allergen requirements.
The spotlight will be on the brands, as the MoCRA Responsible Person, to comply with all elements of MoCRA. Are you informing your contract manufacturer about MoCRA, or are they informing you? And MoCRA is just one of many regulations applicable to cosmetic products. A knowledgeable and experienced partner should help guide you through regulatory changes.
CDU: What solutions can address these concerns or challenges?
ED: Don’t wait to ask questions. Engage your contract manufacturers and other business partners early to discuss the specifics of MoCRA compliance. Ask your contract manufacturers for FEI numbers, what kind of raw material documentation they maintain, and their plan for issuing updated ingredient listings.
With upcoming changes to cosmetic product labeling requirements under MoCRA, beauty brand decision-makers should use this opportunity to consider other labeling updates they might want to make.
CDU: Anything else to add?
ED: A wealth of MoCRA information is available, but unfortunately, not all of it is accurate or helpful. Check the source of the information and consider their qualifications. Reach out to the FDA directly, if need be, to verify information. Work with partners that value your success.