Starting July 2024, compliance with the Modernization of Cosmetics Regulation Act (MoCRA) becomes mandatory for all cosmetic products distributed in the United States. While the registration process may appear straightforward, many businesses face rejection due to avoidable errors. As an exporter of U.S. cosmetics, understanding these pitfalls is crucial to ensuring a smooth entry into the market.
At FDC Corp., we specialize in helping international businesses navigate FDA regulations, including MoCRA compliance. Below, we highlight the top three reasons why MoCRA registrations fail—and how you can avoid them.
1. Errors in Ingredient Listings: INCI Naming Standards
One of the most common reasons for MoCRA registration rejection is inaccuracies in ingredient labeling. MoCRA mandates that all ingredients comply with International Nomenclature Cosmetic Ingredient (INCI) naming standards. Domestic ingredient formats or outdated nomenclature are not acceptable. Additionally, businesses must ensure the following:
- Proper Sequencing: Ingredients must be listed in descending order of concentration.
- Banned Substances: Verify that none of the ingredients are prohibited under FDA regulations.
- Functional Descriptions: Clearly indicate the purpose of each ingredient.
FDC Corp. Tip: Use reliable databases or consult with regulatory professionals to validate your ingredient list before submission. Proper validation can save time and prevent costly delays.
2. Facility Registration Errors: Accurate Facility Information
Another frequent issue arises from inaccuracies in facility registration details. MoCRA requires precise information about the manufacturing or processing facility, including:
- Address and Contact Details: Ensure these are complete and match official records.
- Responsible Personnel: Clearly identify the individual or entity responsible for compliance.
- Consistency: All information must align with other submitted documents.
Errors in Facility ID registration often stem from miscommunication between exporters and domestic manufacturers.
FDC Corp. Tip: Collaborate closely with your manufacturing partners and double-check English-language business details to ensure accuracy. A small oversight can lead to rejection or compliance delays.
3. Incomplete Product Labeling: Adhering to FDA Standards
Labeling compliance is another critical aspect of MoCRA registration. Cosmetic products destined for the U.S. market must meet FDA labeling requirements, which include:
- Product Name: Clearly display the name of the cosmetic product.
- Usage Instructions and Warnings: Provide detailed directions for use and any necessary safety warnings.
- Exporter or Distributor Information: Include contact details for the company responsible for distribution in the U.S.
Many businesses make the mistake of using domestic labels without modification, leading to missing or incorrect information.
FDC Corp. Tip: Review your labels thoroughly and ensure they meet FDA standards. Consider consulting with compliance experts to avoid common pitfalls.
Preparation Is Key to Successful MoCRA Registration
Navigating MoCRA compliance requires meticulous attention to detail, from ingredient validation to facility coordination and labeling adherence. The good news? With proper preparation and expert guidance, you can avoid these common mistakes and ensure a successful registration.
At FDC Corp., we offer tailored support to help international businesses succeed in the U.S. cosmetics market. Our team of professionals can assist with:
- Ingredient verification and compliance checks.
- Facility registration and documentation.
- FDA-compliant labeling solutions.
Why Choose FDC Corp. for MoCRA Compliance?
As a trusted partner for international exporters, FDC Corp. is committed to simplifying the complexities of FDA regulations. Whether you’re new to MoCRA or seeking to refine your compliance processes, we’re here to help. Contact us today to learn more about our services and take the next step toward MoCRA success.
By avoiding these common errors and leveraging expert guidance, your business can confidently navigate MoCRA registration and thrive in the U.S. cosmetics market. Let FDC Corp. be your partner in compliance and growth!
