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emerging, established, and international beauty brands
adapting to U.S. regulations.
Navigating MOCRA Compliance with Colella Legal Studio
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In December 2022, the Modernization of Cosmetics Regulation Act (MoCRA) transformed the regulatory landscape for cosmetics in the United States. As part of the Consolidated Appropriations Act, MoCRA is the first major update to the Food, Drug, and Cosmetic Act since 1938, imposing new compliance obligations on beauty and personal care brands. Whether you're a small indie label or an established global company, understanding MoCRA is essential to ensure your products meet the latest standards.
Modernization of Cosmetics Regulation Act (MoCRA):
Modernization of Cosmetics Regulation Act (MoCRA):
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What Is the Modernization of Cosmetics Regulation Act?
MoCRA enhances the Food and Drug Administration's (FDA) oversight of cosmetics. This law aims to improve consumer safety by holding cosmetic manufacturers accountable for their products' ingredients, manufacturing practices, and labeling.
Key provisions include:
Mandatory Facility Registration
Product Listing Requirements
Adverse Event Reporting:
Good Manufacturing Practices (GMP):
Label Transparency
FDA Recall Authority
Cosmetic manufacturing facilities must register with the FDA.
Mandatory Facility Registration
Product Listing Requirements
Adverse Event Reporting:
Good Manufacturing Practices (GMP):
Label Transparency
FDA Recall Authority
Brands must report product details and ingredient lists to the FDA.
Mandatory Facility Registration
Product Listing Requirements
Adverse Event Reporting:
Good Manufacturing Practices (GMP):
Label Transparency
FDA Recall Authority
Serious adverse health events associated with cosmetic use must be reported promptly.
Mandatory Facility Registration
Product Listing Requirements
Adverse Event Reporting:
Good Manufacturing Practices (GMP):
Label Transparency
FDA Recall Authority
The FDA will establish uniform standards to ensure product safety and consistency.
Mandatory Facility Registration
Product Listing Requirements
Adverse Event Reporting:
Good Manufacturing Practices (GMP):
Label Transparency
FDA Recall Authority
The FDA can now order product recalls if a product is deemed unsafe.
Mandatory Facility Registration
Product Listing Requirements
Adverse Event Reporting:
Good Manufacturing Practices (GMP):
Label Transparency
FDA Recall Authority
Specific allergens must be disclosed on cosmetic labels.
- Gap Analysis: We conduct a thorough review of your current operations to identify areas that require alignment with MOCRA standards.
- Risk Evaluation: Assess potential compliance risks and develop strategies to mitigate them effectively.
- Label Compliance: Ensure all product labels meet MOCRA requirements, including proper ingredient listing and warning statements.
- Ingredient Verification: Analyze product formulations to confirm all ingredients are permitted and disclosed appropriately.
- SOP Development: Create comprehensive procedures for mandatory adverse event reporting under MOCRA.
- Staff Training: Educate your team on proper reporting protocols and compliance requirements.
- Ongoing Compliance Support: Update SOPs as regulations evolve to maintain compliance.
- FDA Product Listings: Facilitate the submission of required product listings to the FDA.
- Ingredient Verification: Review all product ingredients for compliance with U.S. regulations.
- Formulation Analysis: Assess formulations to ensure they meet safety and regulatory standards.
- Marketing Claims Evaluation: Analyze product claims to ensure they are truthful, substantiated, and compliant.
- Advertising Compliance: Review promotional materials across all platforms for regulatory adherence.
- Risk Mitigation: Identify and address potential compliance issues before they become liabilities.
mocra
offerings
Claims and Formulation Reviews
Product Labeling and Ingredient Review
Product Listings and Ingredients Review
Regulatory Compliance Assessment
Standard Operating Procedures for Adverse Event Reporting
- Gap Analysis: We conduct a thorough review of your current operations to identify areas that require alignment with MOCRA standards.
- Risk Evaluation: Assess potential compliance risks and develop strategies to mitigate them effectively.
- Label Compliance: Ensure all product labels meet MOCRA requirements, including proper ingredient listing and warning statements.
- Ingredient Verification: Analyze product formulations to confirm all ingredients are permitted and disclosed appropriately.
- SOP Development: Create comprehensive procedures for mandatory adverse event reporting under MOCRA.
- Staff Training: Educate your team on proper reporting protocols and compliance requirements.
- Ongoing Compliance Support: Update SOPs as regulations evolve to maintain compliance.
- FDA Product Listings: Facilitate the submission of required product listings to the FDA.
- Ingredient Verification: Review all product ingredients for compliance with U.S. regulations.
- Formulation Analysis: Assess formulations to ensure they meet safety and regulatory standards.
- Marketing Claims Evaluation: Analyze product claims to ensure they are truthful, substantiated, and compliant.
- Advertising Compliance: Review promotional materials across all platforms for regulatory adherence.
- Risk Mitigation: Identify and address potential compliance issues before they become liabilities.
mocra
offerings
BOOK YOUR CONSULTATION TODAY BOOK YOUR CONSULTATION TODAY BOOK YOUR CONSULTATION TODAY BOOK YOUR CONSULTATION TODAY
Customized Legal Solutions
Long-Term Growth Support
Industry-Specific Expertise
Why Choose Colella Legal Studio?
Product Listings and Ingredients Review
Claims and Formulation Reviews
- Gap Analysis: We conduct a thorough review of your current operations to identify areas that require alignment with MOCRA standards.
- Risk Evaluation: Assess potential compliance risks and develop strategies to mitigate them effectively.
Regulatory Compliance Assessment
Regulatory Compliance Assessment
Product Labeling and Ingredient Review
Product Listings and Ingredients Review
Claims and Formulation Reviews
- Label Compliance: Ensure all product labels meet MOCRA requirements, including proper ingredient listing and warning statements.
- Ingredient Verification: Analyze product formulations to confirm all ingredients are permitted and disclosed appropriately.
Regulatory Compliance Assessment
Product Labeling and Ingredient Review
Product Listings and Ingredients Review
- FDA Product Listings: Facilitate the submission of required product listings to the FDA.
- Ingredient Verification: Review all product ingredients for compliance with U.S. regulations.
- Formulation Analysis: Assess formulations to ensure they meet safety and regulatory standards.
Regulatory Compliance Assessment
Product Labeling and Ingredient Review
Claims and Formulation Reviews
- Marketing Claims Evaluation: Analyze product claims to ensure they are truthful, substantiated, and compliant.
- Advertising Compliance: Review promotional materials across all platforms for regulatory adherence.
- Risk Mitigation: Identify and address potential compliance issues before they become liabilities.
MOCRA Compliance:
a new era for beauty brands
