Understand the New FDA Law & Ensure Full Compliance

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, represents the most significant overhaul of U.S. cosmetic regulation since 1938. It introduces mandatory requirements for manufacturers, distributors, and importers of cosmetic products in the United States. 

Whether you’re a U.S. brand, a foreign manufacturer, or an Amazon seller, MoCRA compliance is now a legal obligation. This guide outlines everything you need to know to comply with the new FDA cosmetic rules. 

At Cosmereg, we support cosmetic brands, manufacturers, and private labelers in achieving full regulatory compliance for the U.S. market. Whether you're launching a new product, reviewing your labeling, or need a MoCRA-compliant US Agent, this guide will walk you through the essential steps and requirements to legally market cosmetics in the United States.

MORE INFORMATION ABOUT MOCRA COSMETICS

What Is MoCRA?

MoCRA is part of the Consolidated Appropriations Act, 2023 and expands the FDA's authority to regulate cosmetics.

Key Objectives:

  • Improve product safety transparency
  • Enforce standardized manufacturing practices
  • Enable FDA recalls of dangerous cosmetic products
  • Ensure accurate ingredient and facility disclosures

Who Must Comply With MoCRA Cosmetics?

MoCRA applies to all cosmetic products marketed in the United States, including:

  • U.S.-based manufacturers and private labelers
  • Foreign manufacturers exporting to the U.S.
  • Amazon and eCommerce sellers
  • Importers and distributors of cosmetic goods
Appoint Cosmereg as you US Agent

If you're based outside the U.S., you are now legally required to appoint a US Agent to interact with the FDA on your behalf. 

MoCRA Cosmetics Compliance Checklist

Here’s what your company must do to stay compliant:

Facility Registration

  • Mandatory for all domestic and foreign manufacturers
  • Must include facility name, address, and contact info
  • Requires US Agent designation for foreign sites
  • Must be renewed every two years
  • Deadline: December 31, 2023 (first registration)

Cosmetic Product Listing

  • Each product must be listed with the FDA
  • Required details include:
  • Product name
  • Category (e.g., shampoo, skin cream)
  • Ingredient list
  • Must be updated annually or after formula changes
  • Deadline: July 1, 2024

Safety Substantiation

  • You must maintain scientific evidence showing that each cosmetic product is safe for its intended use
  • This includes toxicological assessments and/or documented product safety reports

Serious Adverse Event Reporting

  • Any serious adverse events (e.g., hospitalization, infection, disfigurement) must be reported to the FDA within 15 business days
  • Requires clear procedures for post-market surveillance

Labeling Changes

  • Labels must now include:
  • Contact information of the responsible person
  • Disclosure of fragrance allergens (expected future rule)
  • Professional-use-only declarations, where applicable

Good Manufacturing Practices (GMP)

  • The FDA will enforce GMP rules specific to cosmetics
  • Expect inspections, documentation checks, and hygiene controls
  • Final GMP rule expected by end of 2025
REGISTER YOUR COSMETIC FACILITY

What’s the Role of a US Agent Under MoCRA?

Foreign facilities must designate a US Agent, who will:

  • Serve as the official contact with the FDA
  • Assist with facility registration and product listings
  • Communicate adverse event reports
  • Respond to FDA inquiries during inspections or alerts
Learn more about our US Agent services

MoCRA Cosmetics Compliance Checklist

  • Registration
  • Listing
  • Documentation
  • Label updates
  • Reporting systems

How Cosmereg Assists

  • Facility & Product Listing with FDA
  • US Agent Service (registered FDA facility)
  • Labeling compliance reviews
  • Safety dossier support
  • Guidance on GMP implementation

We help cosmetic brands and manufacturers meet FDA requirements quickly and efficiently.

Ready to Get Compliant?

Let our regulatory experts manage your MoCRA compliance — so you can focus on your brand.

Request MoCRA Support

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

Prepare for the upcoming changes mandated by the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA Cosmetics),
as it significantly transforms the regulatory landscape
for cosmetic companies in the United States.
The MoCRA cosmetics regulations, which comes into full effect in 2023,
represents a substantial expansion of the FDA’s authority
over the cosmetics industry.

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

START NOW

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

START NOW

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.

WHY CHOOSE US

We offer you peace of mind
by assuming responsibility for compliance activities,
allowing you to focus exclusively on the task
of marketing your cosmetics.
With a wealth of experience spanning over a decade
in the field of cosmetic compliance, our agency has
a team of seasoned Safety Assessors and dedication to
exceptional customer support and US Mocra Agent for Cosmetics.

Trust us to guide you through these
regulatory changes with the highest levels of
expertise and professionalism.

CONTACT US

US FDA Regulations

Health Canada Regulations

EU/UK Regulations

CONTACTS

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