What is MoCRA compliance?

MoCRA (Modernization of Cosmetics Regulation Act) is a 2022 US law requiring all cosmetic facilities to register with the FDA, list their products, designate a Responsible Person, and report serious adverse events. Registration and product listing deadlines passed in December 2023.

Do foreign cosmetic brands need to comply with MoCRA?

Yes. MoCRA applies to all facilities that manufacture or process cosmetics for US distribution, regardless of where the facility is located. Foreign cosmetic manufacturers, importers, and private label brands are all within scope.

What is the MoCRA registration deadline?

The FDA cosmetic facility registration deadline for existing facilities was December 29, 2023. These deadlines have passed. Facilities that have not yet registered are non-compliant and face FDA enforcement risk.

What is a Responsible Person under MoCRA?

Under MoCRA, a Responsible Person is the US-based manufacturer, packer, or distributor whose name appears on the cosmetic product label. For foreign manufacturers without a US presence, a qualified US FDA Agent or US distributor typically serves as the Responsible Person.

Comprehensive MoCRA Compliance Services for U.S. Cosmetics

Axentra Global Pharma Compliance LLC offers vital support for businesses navigating MoCRA regulations. From FDA registration to U.S. Agent responsibilities for FDA, our services ensure seamless compliance. By partnering with us, brands can focus on growth while we handle regulatory complexities. With Axentra, you gain a trusted ally to streamline operations and meet all compliance requirements effortlessly.

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The Modernization of Cosmetics Regulation Act (MoCRA)

The Modernization of Cosmetics Regulation Act (MoCRA) has fundamentally changed how cosmetic products are regulated in the United States. For U.S. brands and global manufacturers alike, MoCRA introduces mandatory facility registration, product listing, adverse event reporting, and increased FDA oversight.

Axentra Global Pharma Compliance LLC supports cosmetic companies with structured, audit-ready MoCRA compliance, allowing sales and marketing teams to launch, expand, and rebrand products without regulatory surprises.

Who This Service Is Designed For

MoCRA compliance impacts more than regulatory teams — it directly affects commercialization timelines, product launches, and brand continuity.

Sales and marketing directors managing cosmetic product launches impacted by MoCRA compliance requirements

Sales & Marketing Directors

Leading U.S. cosmetic and OTC launches while managing new package sizes, refreshed artwork, label changes, and claim updates — often under tight deadlines.
Frequently searching for fast, reliable support for label compliance review, packaging updates, MoCRA requirements, or FDA regulatory advice to avoid launch delays, reprints, or retail pushback

Brand Owners & Founders

Scaling cosmetic brands in the U.S. market and needing FDA cosmetic compliance support without hiring a full-time regulatory team.
Often looking for MoCRA consultants, U.S. Agent services, cosmetic labeling help, or regulatory support for new SKUs and package sizes to stay compliant while focusing on growth.

Regulatory and quality assurance managers reviewing cosmetic safety documentation under MoCRA regulations

Regulatory & QA Managers

Managing FDA and MoCRA compliance internally while supporting commercial teams with product listing updates, artwork changes, adverse event reporting, and inspection readiness.
Typically searching for on-demand regulatory support, cosmetic compliance expertise, FDA guidance, or external regulatory partners to supplement internal resources during peak workload periods.

What MoCRA Now Requires — and Where Brands Are Exposed

MoCRA is not a one-time filing. It establishes an ongoing compliance framework that FDA is actively enforcing.

Axentra helps you operationalize MoCRA compliance so regulatory requirements do not block commercial execution.

Cosmetic facility registration with FDA

Mandatory FDA registration for all owners and contract manufacturers.

Cosmetic product listing and updates

Detailed ingredient and labeling submission for every SKU.

Adverse event reporting and record retention

Strict 15-day reporting window for serious safety events.

Maintenance of safety substantiation

Documented proof of safety for every formula on the market.

Labeling and claims compliance

Updated contact info and professional-use disclosures to avoid "Misbranding."

MoCRA Facility Registration

We prepare and submit cosmetic facility registration and manage updates/renewals.

Labeling & Claims Compliance Review

Fast review of cosmetic + OTC-style claims, label panels, and marketing language to reduce enforcement and retailer risk.

MoCRA Product Listing

Structured product listing support, updates for formula/label/size changes, and portfolio maintenance.

U.S. Agent Representation for Cosmetics

A reliable U.S. point-of-contact for compliance communications—aligned with your existing U.S. Agent positioning

Adverse Event Management

Setup of intake, documentation, follow-up workflow, and regulatory reporting to meet MoCRA expectations.

“Launch Control” for New Sizes & Rebrands

A rapid review path for packaging changes, new SKUs, and refreshed branding so launches don’t stall at the finish line.

Serious Adverse Event Reporting & Post-Market Safety Requirements

Under the Modernization of Cosmetics Regulation Act (MoCRA), Responsible Persons must report Serious Adverse Events (SAEs) to the FDA within 15 business days and maintain supporting documentation for up to six years.

Compliance requires more than policy statements. Companies must implement structured intake procedures, seriousness assessment criteria, regulatory submission workflows, and documented record retention systems.

For companies marketing in both the United States and the European Union, SAE (US) and SUE (EU) reporting obligations must be aligned within a defensible compliance framework.

Learn more about MoCRA adverse event reporting requirements and global cosmetovigilance expectations in our detailed guide:

MoCRA Adverse Event Reporting Guide (2026)

Your In-House Compliance Engine — Without the Overhead

Building an internal regulatory department is expensive... Axentra operates as an extension of your team

Comparison table showing Axentra’s MoCRA compliance services versus in-house regulatory teams and traditional consultants