The U.S. Food and Drug Administration (FDA) has postponed the implementation of the Modernization of Cosmetics Regulation Act (MoCRA) Good Manufacturing Practices (GMPs) until October 2025.
Originally scheduled for December 29, 2024, this delay offers businesses additional time to prepare for compliance. Here’s what this means for companies navigating MoCRA compliance and how to leverage the extension to stay ahead.
MoCRA, signed into law in December 2022, marked a historic shift in cosmetics regulation by the FDA. Among its key provisions is the requirement for companies to adhere to Good Manufacturing Practices (GMP), ensuring product safety and quality throughout the manufacturing process. The aim is to modernize the cosmetics industry, offering enhanced consumer protections while aligning with global standards.
Why the delay and how it impacts cosmetics companies?
The FDA’s decision to delay MoCRA GMP until October 2025 stems from the need for more detailed regulatory guidance and industry feedback. While the agency works on refining these rules, businesses must still adhere to other MoCRA mandates, such as registration, product listing, and fragrance allergen labeling, which take effect sooner. Key deadlines to watch include the following:
- Fragrance allergen labeling: Targeted for January 2026.
- Registration and listing requirements: Enforcement begins mid-2024.
The postponement provides a critical window for companies to:
- Assess current practices: Conduct internal audits to evaluate compliance gaps in manufacturing processes.
- Develop compliance strategies: Create or update Standard Operating Procedures (SOPs) aligned with anticipated MoCRA GMP requirements.
- Invest in training: Educate teams on MoCRA compliance to ensure readiness when enforcement begins.
Steps to Take Now
While the delay grants more time, proactive measures can set your company up for success:
1. Register and List Products Early
Stay ahead by completing your MoCRA registration and product listings before the mid-2024 deadline. These foundational steps are critical to maintaining compliance.
2. Strengthen Documentation
Ensure meticulous record-keeping of manufacturing practices, ingredient sourcing, and testing protocols. These records will be vital once GMP enforcement begins.
3. Monitor FDA Updates
Keep an eye on the FDA’s announcements for the finalized GMP guidelines and adjust your strategies accordingly. Complying with MoCRA GMP standards ahead of schedule not only ensures regulatory readiness but also enhances brand trust and reputation. Companies that prioritize safety and transparency will likely gain a competitive edge in an increasingly regulated market.
Don’t Delay. Prepare Today
The FDA’s extension of the MoCRA GMP deadline provides an invaluable opportunity to get your processes in order. Use this time to ensure your business not only meets regulatory standards but also positions itself as a leader in product safety and quality.
If you’re unsure where to start, Quality Smart Solutions is here to help. Our team of compliance experts specializes in guiding businesses through MoCRA compliance, from registration to certification. Contact us today to ensure your business is prepared to thrive in this new era of cosmetics regulation.
