MoCRA Compliance Services for Cosmetic Brands

MoCRA Compliance: Is Your Cosmetic Brand Ready for the July 2026 Deadline?

🔹 Understanding MoCRA: Why It Matters?

The Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant change to U.S. cosmetic regulations in decades. Under MoCRA, many activities that were previously voluntary are now mandatory and subject to active enforcement.

Cosmetic manufacturers and responsible persons must now comply with strict FDA requirements, including facility registration, product listing, adverse event reporting, and recordkeeping.

Failure to comply may result in:

❌ Import detentions
❌ Product removal from U.S. marketplaces
❌ Retail delisting
❌ Regulatory warning notices
❌ Reputational damage

MoCRA compliance is no longer optional—it is essential for market access.

Our Comprehensive MoCRA Solutions

Facility Registration & Biennial Renewal: We manage your initial filing and the critical 2026 renewal cycle via the Cosmetics Direct portal, ensuring your FDA Establishment Identifier (FEI) remains active.

Mandatory Product Listing: Detailed ingredient cataloging for every SKU, including fragrance allergen disclosures and annually required updates.

Safety Substantiation Dossiers: We help “Responsible Persons” compile the necessary tests, studies, and research to meet the legal standard of “reasonable certainty” of safety.

U.S. Agent Representation: For foreign manufacturers, we serve as your official, Maryland-based point of contact for all FDA communications.

Adverse Event Intake Systems: We help you set up Standard Operating Procedures (SOPs) for tracking and reporting serious health-related events to the FDA within the 15-day window.

Fragrance Allergen Disclosure: Helping you navigate the expanded list of allergens that must now be explicitly declared on your packaging.

Talc & PFAS Compliance: Strategic guidance on standardized testing for asbestos in talc-containing products and the new PFAS reporting requirements.

Professional Use Labeling: Ensuring salon-only products meet the new mandatory labeling standards for professionals.

🔹 Who This Service Is For

Our MoCRA Compliance service is designed for:

✔ Cosmetic manufacturers outside the U.S.
✔ Private-label beauty brands
✔ Skincare and personal care exporters
✔ Contract manufacturers
✔ Indie beauty brands entering the U.S.
✔ Established brands updating compliance

If you sell cosmetics in the U.S., MoCRA applies to your business.

🔹 Facility Registration

Under MoCRA, cosmetic manufacturing and processing facilities must be registered with the FDA.

We assist with:

✔ Facility identification and classification
✔ FDA account setup
✔ Registration through Cosmetics Direct
✔ Ownership and operational data verification
✔ Submission and confirmation records

We ensure your facility is registered accurately and on time.

🔹 Cosmetic Product Listing

Each cosmetic product must be listed with detailed formulation and labeling information.

We support:

✔ Product cataloging
✔ Ingredient disclosure review
✔ Label content verification
✔ Product category classification
✔ Submission through FDA systems

This process helps ensure transparency and regulatory alignment.

🔹Adverse Event Reporting Systems

MoCRA requires manufacturers to monitor and report serious adverse events.

We help you establish:

✔ Internal reporting procedures
✔ Incident documentation systems
✔ Regulatory notification workflows
✔ Record retention protocols
✔ Staff compliance guidance

These systems protect both consumers and your brand.

🔹Our Advantage

Why Choose FDA Consults for MoCRA Compliance?

✔ U.S.-Based Regulatory Consultants
✔ Experience with Cosmetics Direct Portal
✔ International Export Expertise
✔ Technical Submission Accuracy
✔ Ethical, Transparent Guidance
✔ Personalized Support

We specialize in helping global cosmetic brands adapt to the new regulatory environment.

🔹Industries & Products We Support

We assist cosmetic brands offering:

Skincare products
Hair care products
Beauty creams and lotions
Soaps and cleansers
Makeup and cosmetics
Fragrance products

Each product category has unique compliance requirements.

Let’s Work Together

If you are preparing to enter the U.S. market or need reliable FDA registration and U.S. Agent support, our team is ready to assist you. Contact FDA Consults today to discuss your compliance needs.

Get Started

🔹 Our MoCRA Compliance Process

We follow a structured, proactive approach to help cosmetic brands achieve and maintain full compliance under the Modernization of Cosmetics Regulation Act (MoCRA). Our process is designed to minimize risk, prevent errors, and support long-term regulatory readiness.

Step 1 — MoCRA Readiness Assessment

We begin with a comprehensive review of your current compliance status, including existing facility registrations, product listings, and internal regulatory practices. We assess your product portfolio, manufacturing structure, and distribution model. This initial assessment helps identify compliance gaps and prioritize required actions before regulatory deadlines.

Step 2 — Regulatory Mapping

Based on your assessment results, we map all applicable MoCRA obligations to your specific business operations. Different manufacturers, private-label brands, and responsible persons have varying compliance requirements. We create a customized regulatory roadmap that outlines facility registration, product listing, reporting, and recordkeeping responsibilities.

Step 3 — System Setup

We assist with the setup and configuration of your FDA accounts and access to the Cosmetics Direct portal. This includes user permissions, security settings, and system verification. Proper system setup ensures smooth submission processes and reduces technical errors that can delay compliance.

Step 4 — Facility & Product Submissions

Our team prepares and submits your facility registration and cosmetic product listings through official FDA systems. We carefully review ingredient disclosures, labeling elements, and product classifications before submission. All entries are validated for completeness and accuracy to minimize rejection or follow-up inquiries.

Step 5 — Documentation & Records

We organize and maintain your MoCRA-related documentation, including registration confirmations, product listings, adverse event records, and correspondence. Well maintained records support regulatory inspections, audits, and internal reviews while ensuring long-term compliance continuity.

Step 6 — Monitoring & Renewals

We actively monitor regulatory updates, FDA guidance, and system notifications related to cosmetic compliance. Our team tracks renewal deadlines and reporting requirements. You receive timely reminders and proactive support to prevent missed obligations.

Step 7 — Ongoing Advisory Support

We provide continuous regulatory guidance as MoCRA requirements evolve and enforcement practices mature. When you launch new products, change formulations, or expand operations, we help update your compliance framework accordingly. Our advisory support ensures your business remains aligned with regulatory expectations over time.

Our Commitment to Cosmetic Compliance Excellence

This structured process helps cosmetic brands maintain accuracy, transparency, and regulatory readiness. By partnering with FDA Consults, you gain a dedicated compliance team focused on protecting your brand and U.S. market access.

🔹 Compliance Disclaimer

FDA Consults is an independent consulting firm and is not affiliated with or endorsed by the U.S. Food and Drug Administration. Our services do not constitute approval, certification, or legal representation.