The Modernization of Cosmetics Regulation Act (MoCRA) introduces significant regulatory changes for the cosmetics industry, aimed at enhancing consumer safety and product transparency. This article explores the essential MoCRA requirements, from new facility registration and labeling rules to adverse event reporting and Good Manufacturing Practices (GMP). By understanding and implementing these standards, cosmetic manufacturers and retailers can navigate compliance effectively and strengthen consumer trust.
MoCRA’s New Facility Registration and Product Listing Requirements
Under MoCRA, the FDA mandates rigorous facility registration and product listing requirements that impact cosmetic manufacturers globally. Some exemptions do apply.
As of December 29, 2023, all cosmetics marketed in the U.S. must be listed with the FDA, including detailed ingredient listings for each product type or variation, including fragrance and flavors. Each product variation, from seasonal kits to individual color shades, requires separate listings that must be updated annually. Facilities outside the U.S. must also appoint a U.S. agent to facilitate FDA communications, ensuring consistent oversight. These requirements underscore MoCRA’s focus on transparency, aligning cosmetics with other FDA-regulated industries like pharmaceuticals and food.
Adverse Event Reporting and Record-Keeping
MoCRA’s stringent adverse event reporting requirements place a new level of accountability on cosmetic brand owners. Serious adverse events — including severe reactions such as burns or significant disfigurement — must be reported to the FDA within 15 business days.
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Additionally, companies are required to maintain detailed records of all adverse events for six years (three years for small businesses). A well-organized record-keeping system is essential for MoCRA compliance and safeguarding consumer safety.
To facilitate transparency, primary and secondary packaging must now include consumer contact information for reporting. Cosmetic product labels are required to display the contact information for a Responsible Person (RP) to ensure consumers can easily report adverse events to the brand owner. This includes a U.S. address, phone number or electronic contact information, which should be prominently displayed on both the primary container and any outer packaging.
This clear, accessible contact information empowers consumers to report issues directly, aiding companies in maintaining transparency and complying with MoCRA’s adverse event reporting requirements.
Best Practices for Managing Adverse Events
Companies should strive to streamline the adverse event reporting process for consumers by establishing a central reporting system that protects personal and sensitive consumer information. Adverse event records should be organized and easily accessible, facilitating timely FDA submissions. Additionally, a trained response team is vital for quickly assessing incidents, ensuring accurate records and addressing potential consumer concerns, all while staying within MoCRA’s 15-day reporting requirement.
Alternatively, you can source a compliance partner to help handle Adverse Event Management and take care of everything from consumer intake to investigation to FDA reporting and records storage.
Labeling Requirements and Safety Substantiation
MoCRA enforces strict new standards for labeling and safety substantiation to ensure consumer protection. Cosmetic labels must now specify if products are for professional use only and disclose any FDA-recognized fragrance allergens, enhancing safety and addressing potential health concerns.
For safety substantiation, companies must maintain scientific evidence — tests, studies or expert assessments — proving product safety. The FDA may request these records at any time, not just during inspections, making documented proof of safety a vital part of consumer trust and compliance with cosmetic regulations.
Strategies for Manufacturers and Retailers to Stay Compliant
Compliance with FDA MoCRA requires proactive strategies across the production and distribution process. Manufacturers should implement strict GMP protocols and maintain transparent ingredient records. For retailers, sourcing only MoCRA-compliant products is essential, as non-compliance risks customer complaints and returns, inventory issues, negative media coverage and potential lawsuits.
Collaboration across the supply chain—ensuring partners meet MoCRA’s standards—can help avoid disruptions. Additionally, investing in ongoing compliance training and third-party audits and mock inspections can keep all stakeholders aligned with FDA MoCRA Regulations, safeguarding business continuity and consumer trust.
Looking Ahead: Compliance and Consumer Confidence Under MoCRA
The Modernization of Cosmetics Regulation Act represents a pivotal shift for the U.S. cosmetics industry, enhancing consumer safety through rigorous requirements for registration, labeling, adverse event reporting and Good Manufacturing Practices. Staying compliant demands proactive strategies, meticulous record-keeping and strong communication across the supply chain.
By aligning operations with the requirements of MoCRA, manufacturers and retailers can not only meet regulatory standards but also build consumer trust in a competitive market. Adapting early to these requirements will support a resilient, transparent and safe cosmetics landscape in the years to come.
David Lennarz is President at Registrar Corp., which he co-founded in 2003. He has worked for nearly 22 years in FDA-regulated industries in the U.S. and Europe, conducting seminars on FDA regulations for trade associations, trade shows, and governments around the world.