Major Changes in Cosmetic Regulations Coming in 2025: What You Need to Know

Mandatory Good Manufacturing Practices (GMP)

To ensure product safety and quality, cosmetic manufacturers must now strictly follow GMP guidelines, where once they were voluntary. The Draft Guidance for Industry: cGMP for Cosmetics is currently in place to assist manufacturers in understanding the minimum requirements for product safety and quality. By December 29, 2025, this Guidance will be finalized, which will emphasize the importance of standardized manufacturing processes to minimizing risk to consumers.

Adverse Events Reporting

Another significant change is the requirement for cosmetic manufacturers to report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the FDA. In the past, reporting these events was voluntary, which often led to underreporting and limited data on the safety of cosmetic products. Now, manufacturers, distributors, and packers must report any serious adverse events within 15 business days of receiving the information.

Facility and Product Registration

MoCRA also mandated the registration of cosmetic manufacturing facilities and product listings with the FDA. All owners and operators of facilities that manufacture and process cosmetics distributed in the United States must have registered their facilities with the FDA, even if they had previously registered through the Voluntary Cosmetic Registration Program (VCRP). For new facilities, registration must occur within 60 days of beginning operations. For product listings, companies must submit their products to the FDA. This listing includes detailed information about the products, such as ingredients and intended use. The FDA has launched a new system to facilitate this process, replacing the VCRP.

Safety Substantiation

Cosmetic products must have adequate safety substantiation, evaluated by qualified experts. Companies should gather evidence of safety to comply with this requirement.

Mandatory Recalls

The FDA has the authority to mandate recalls of adulterated cosmetic products that pose serious health risks. An appeal process is in place for companies to challenge the FDA's decision.

How Lumanity uses QT9 QMS to Support MoCRA Initiatives

As cosmetic manufacturers face these stringent new regulations, leveraging Quality Management Systems (QMS) like QT9 QMS can provide significant support in ensuring compliance with MoCRA initiatives:

1. Streamlined GMP Compliance: QT9 QMS offers comprehensive tools to document, monitor, and manage GMP processes. Automated workflows and real-time tracking help ensure that all manufacturing steps adhere to the required standards, minimizing the risk of non-compliance.
2. Efficient Adverse Event Reporting: With QT9 QMS, manufacturers can automate the collection, analysis, and reporting of Adverse Events and Serious Adverse Events. This ensures timely submission to the FDA, reducing the administrative burden and enhancing data accuracy.
3. Simplified Facility and Product Registration: QT9 QMS can assist in managing the extensive data required for facility and product registration. It keeps all necessary documentation organized and easily accessible, facilitating a smoother registration process with the FDA's new system. Features include:
   • Centralized Data Repository: Store all facility and product data in one centralized location, making it easy to access and update information as required.
   • Automated Reminders and Alerts: Set up automated reminders for registration deadlines and alerts for missing or incomplete information to ensure timely and accurate submissions.
   • Customizable Templates: Use customizable templates to streamline the data entry process and ensure consistency in the information submitted to the FDA.
4. Comprehensive Safety Substantiation: The system supports the compilation and management of safety substantiation documents, making it easier to gather, evaluate, and store evidence of product safety as required by MoCRA. Features include:
   • Document Control: Manage all safety substantiation documents within a controlled environment, ensuring version control and easy retrieval.
   • Collaboration Tools: Facilitate collaboration among qualified experts by allowing multiple users to access, review, and comment on safety documents in real-time.
   • Audit Trails: Maintain detailed audit trails of all changes and updates to safety documents, providing transparency and accountability.
5. Recall Management: In the event of a mandatory recall, QT9 QMS provides tools for traceability and recall management. This ensures that affected products can be quickly identified and removed from the market, protecting consumer safety and maintaining regulatory compliance. Features include:
   • Traceability: Track products throughout the supply chain to quickly identify affected batches and their distribution history.
   • Recall Workflows: Implement predefined recall workflows to ensure a structured and efficient recall process, from initial notification to final resolution.
   • Communication Management: Manage communications with stakeholders, including regulatory bodies, customers, and suppliers, to ensure clear and consistent messaging throughout the recall process.

Conclusion

These regulatory changes mark a significant shift towards more rigorous oversight of the cosmetics industry, aiming to enhance consumer safety and product quality. Compliance with these new requirements is crucial for all cosmetics manufacturers, distributors, and packers. By adhering to GMP, reporting adverse events, and ensuring timely registration of facilities and products, companies can contribute to a safer and more transparent cosmetic market. Leveraging tools like QT9 QMS can significantly ease the transition, ensuring that all regulatory requirements are met efficiently and effectively.

Mandatory Good Manufacturing Practices (GMP)

Adverse Events Reporting

Facility and Product Registration

Safety Substantiation

Mandatory Recalls 

How Lumanity uses QT9 QMS to Support MoCRA Initiatives

Conclusion