MoCRA compliance is a pivotal milestone for every beauty brand looking to thrive in the US market.
As the founder of H. Honeycup and the Quality Control Manager at Raintree Labs, I can interpret the details of MoCRA (the Modernization of Cosmetics Regulation Act). I'd like to share insider insights and time-sensitive strategies to help you navigate this regulatory maze.
Here's a breakdown of key deadlines and the essential documents you'll need:
Safety Substantiation (Deadline: 12/29/23)
- Even though the deadline has passed, ensure your manufacturer possesses necessary data to support the safety of your cosmetic products.
- Request vital documents such as manufacturer Certificate of Analysis (COA) for each batch and Safety Data Sheets (SDS) from ingredient suppliers.
Adverse Event Reporting (Deadline: 12/29/23)
- Verify that your manufacturer has established a robust system for preparing reports on serious adverse events, which you must submit to the FDA within 15 days of occurrence.
- Request copies of manufacturer's Standard Operating Procedures (SOP) on adverse event reporting, plus sample reports.
Adverse Event Recordkeeping (Deadline: 12/29/23)
- Ensure your manufacturer maintains comprehensive records of production, ingredient sourcing, and safety testing for a minimum of two years, as needed for adverse event reporting.
- Request samples of batch records for your products, test results, and supplier information by ingredient.
Facility Registration (Enforcement Deadline: 07/01/24)
- If your manufacturer is required to register online, ensure they comply with the deadline. See small business exemption.
Product Listing (Enforcement Deadline: 07/01/24)
- Register your products online, providing detailed information such as the list of ingredients, specific product category, and manufacturer FEI Number. See small business exemption.
GMP Guidance (Deadline: 12/29/24) & Final (Deadline: 12/29/25)
- Ensure your manufacturer is prepared to comply with Good Manufacturing Practices (GMP), adjusting their processes as necessary to meet requirements. See small business exemption.
New Labeling Requirements
- Incorporate contact information on product labels for questions or adverse events. (Deadline: December 29, 2024)
- Add fragrance allergen information to labels once published by the FDA, following the specified format. (Deadline: Est February, 2025)
Important Definitions and Notes
- Understand criteria for small business exemptions and the definition of adverse events.
- Recognize role of the Responsible Person and significance of including contact information on product labels.
- A "small business" is generally defined as an entity whose average gross annual sales of cosmetic products in the United States for the previous three years do not exceed $1,000,000, adjusted for inflation.
- MoCRA Regulation
Consult with legal experts for comprehensive MoCRA guidance tailored to your specific situation.