July 1, 2024—A Pivotal Date for U.S. Cosmetics
The cosmetics industry in the U.S. is undergoing a significant transformation as the Modernization of Cosmetics Regulation Act (MoCRA) approaches full implementation on July 1, 2024. This landmark legislation introduces mandatory compliance requirements that will reshape the industry, impacting manufacturers, distributors, and exporters alike.
With over 184,000 businesses and a market size exceeding $45 billion, the stakes are high for companies that must adapt to MoCRA’s rigorous standards.
Key Milestones: What Has Changed So Far?
- Facility Registration Deadline
By December 29, 2023, all cosmetic manufacturing and processing facilities were required to register with the FDA. This includes international facilities exporting to the U.S. - Product Listing Deadline
Cosmetic products currently sold in the U.S. also needed to be listed with the FDA by December 29, 2023. New products entering the market must complete their listing within 120 days of launch.
What’s on July 1, 2024?
Full Implementation of MoCRA
The July 2024 deadline marks the full enforcement of MoCRA’s provisions, including:
- Mandatory Compliance with GMP Standards: Facilities must adhere to Good Manufacturing Practices, ensuring consistency with international regulations.
- FDA Recall Authority: The FDA gains authority to mandate recalls for unsafe products.
- Expanded Labeling Requirements: Fragrance allergens and professional-use disclaimers must appear on product labels.
- Adverse Event Reporting: Companies must report serious adverse events within 15 days and maintain detailed records.
Impact on the Cosmetics Industry
MoCRA represents a seismic shift in how cosmetics are regulated in the U.S.:
- Increased Oversight: The FDA now has greater authority to monitor facilities and enforce compliance.
- Higher Costs: Compliance with GMP, labeling, and registration requirements may increase operational costs, particularly for small businesses.
- Consumer Trust: Enhanced transparency and safety measures are expected to boost consumer confidence in the cosmetics industry.
Distinction Between Cosmetics and Drugs
Under MoCRA, understanding the classification of products is crucial:
- Cosmetics: Products designed for cleansing, beautifying, or altering appearance (e.g., makeup, nail polish).
- Drugs: Products intended for therapeutic purposes (e.g., sunscreen, anti-dandruff shampoo).
- Cosmetic/Drug Combinations: Products with both cosmetic and therapeutic claims (e.g., lipstick with SPF).
Preparing for the Future
As July 1, 2024 approaches, businesses must prioritize compliance with MoCRA’s requirements to avoid penalties and protect consumer trust. The full implementation of MoCRA is not just a regulatory update—it’s a transformative initiative that will define the future of cosmetics safety in the U.S.
At FDC Corp., we provide expert guidance to help businesses navigate these changes. Contact us today to ensure your business is MoCRA-ready.
