MoCRA Compliance Checklist: Why Cosmetic Facility and FDA Registration Matter More Than Ever

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The Cosmetic Industry Faces a Compliance Overhaul 

With the signing of the Modernization of Cosmetics Regulation Act (MoCRA), the U.S. FDA has launched a new chapter in the oversight of cosmetic products. This legislative change significantly affects how businesses bring products to market and maintain consumer trust. At the center of these updates are Cosmetic Facility RegistrationFDA Cosmetic Registration and MoCRA Registration, each contributing to a unified standard of safety and compliance. 

Why MoCRA Matters to All Cosmetic Stakeholders 

Whether you're a brand owner, manufacturer, or distributor, MoCRA affects you. From ingredient transparency to adverse event tracking, the law introduces several new responsibilities that were not previously enforced. 

Cosmetic Facility Registration: Your First Compliance Step 

Mandatory for All Manufacturing Locations 

All U.S. and foreign facilities that produce, package, or process cosmetics for the U.S. market must complete Cosmetic Facility Registration. This is required even for small-batch producers or indie brands. Registration must be updated every two years and include: 

  • Facility name and address 

  • Contact information 

  • Brands or product lines associated with the site 

Foreign companies must also appoint a domestic U.S. agent. 

What Happens Without Registration? 

Non-compliance can result in: 

  • Product holds or refusal of import 

  • FDA enforcement letters 

  • Damage to brand reputation 

  • Market access delays 

Timely and accurate Cosmetic Facility Registration is essential to avoid such risks. 

FDA Cosmetic Registration: Keeping Products on the Market 

Listing Every Product is Now Mandatory 

Previously voluntary, FDA Cosmetic Registration is now compulsory under MoCRA. Each product must be listed with the FDA, including details such as: 

  • Intended use (e.g., skin moisturizer, lip gloss) 

  • Complete ingredient breakdown 

  • Packaging and usage directions 

  • Responsible person or distributor contact 

This product database helps regulators track market trends, evaluate safety, and streamline recall procedures when necessary. 

How Registration Promotes Brand Credibility 

By following FDA guidelines, brands communicate responsibility and transparency to their customers. A product that is properly listed signals quality, care, and legitimacy—critical values in today’s health-conscious market. 

Full MoCRA Registration: Beyond the Basics 

Adverse Event Monitoring and Labeling Accuracy 

MoCRA Registration, requires companies to report serious adverse events within 15 business days. It also enforces updated labeling requirements, including disclosure of allergens and usage warnings. Brands must: 

  • Maintain documented proof of product safety 

  • Keep updated labeling for all items 

  • Ensure marketing claims match the product’s intended function 

Ongoing Compliance for Long-Term Success 

Compliance doesn’t end with registration. MoCRA requires continuous diligence. Companies must implement internal systems for monitoring changes, training staff on regulations, and preparing for potential FDA inspections. 

Conclusion: MoCRA Registration is a Long-Term Investment in Success 

MoCRA has reshaped the U.S. cosmetics landscape. Companies that embrace the new standards—by completing Cosmetic Facility Registration, following FDA Cosmetic Registration protocols, and maintaining accurate MoCRA Registration—are building the foundation for a strong, reputable brand. In a marketplace that values transparency and trust, compliance is not just a necessity—it’s a competitive advantage. 

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