MoCRA Compliance Guide: Key FDA Requirements, Deadlines, and What Brands Must Do

4 min read

The Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant update to U.S. cosmetic regulation in decades. If you manufacture, package, or sell cosmetic products in the United States, MoCRA compliance is no longer optional, it is mandatory.

This guide explains what MoCRA requires, the key FDA deadlines, who must register, and how brands can stay compliant, either independently or with expert support.

What Is MoCRA?

MoCRA (Modernization of Cosmetics Regulation Act) is a federal law that expands the FDA’s authority over cosmetic products sold in the U.S. It introduces new requirements for:

  • Facility registration
  • Product listing
  • Adverse event reporting
  • Labeling for professional-use products
  • Recordkeeping and enforcement

MoCRA applies to most cosmetic brands, including skincare, haircare, and personal care products.

Key MoCRA Deadlines You Must Know

1. Facility Registration

Deadline: July 1, 2024

Cosmetic manufacturing and processing facilities must register with the FDA.

You may need to register your own facility if:

  • You package or process cosmetic products in-house
  • You purchase bulk cosmetic products and fill final packaging yourself
  • You do not qualify for the small business exemption

2. Product Listing

Deadline: July 1, 2024

All cosmetic products marketed in the U.S. must be listed with the FDA unless a small business exemption applies.

Key requirements:

  • Listings must be renewed annually
  • Existing products: must be listed within one year of MoCRA enactment
  • New products: must be listed within 120 days of entering the U.S. market

Each individual cosmetic product requires its own listing.

3. Adverse Event Reporting

Effective Date: December 29, 2023

Brands must report serious adverse events associated with cosmetic products.

Requirements include:

  • Reporting to the FDA within 15 business days of receiving the complaint
  • Maintaining adverse event records for six years

Failure to report can result in enforcement action.

4. Labeling for Professional-Use Products

Effective Date: December 29, 2023

All professional-use cosmetic products must clearly state:

“For Licensed Professional Use Only”

This applies to products sold exclusively to medical professionals, estheticians, or licensed providers.

Do You Need to Register Your Facility or Products?

Facility Registration: Who Is Required?

You must register a facility if:

  • You package or process cosmetic products yourself
  • You do not qualify for the small business exemption

Product Listing: Who Is Required?

You must list your cosmetic products with the FDA if:

  • Your average annual U.S. cosmetic revenue exceeds $1,000,000 over the past three years

If you meet this threshold, every cosmetic product sold in the U.S. must be listed, regardless of where it is manufactured.

How to Comply With MoCRA: Two Paths Forward

Option 1: Handle MoCRA Registration Yourself

Brands may complete registration and product listing directly through the FDA’s Cosmetics Direct electronic submission portal.

This approach requires:

  • Accurate facility and product data
  • Ongoing renewals and updates
  • Proper documentation and recordkeeping

It is feasible, but time-consuming and detail-sensitive.

Option 2: Let Next Beauty Labs Handle Compliance for You

If you want to reduce risk and save time, Next Beauty Labs offers MoCRA registration and product listing services, starting at $500 per product.

Our services include:

  • Full management of facility and product submissions
  • Accurate, FDA-aligned documentation
  • Secure access to your registration credentials
  • Ongoing compliance support

This allows you to focus on building and scaling your brand, not navigating regulatory complexity.

Frequently Asked Questions

What is MoCRA?

MoCRA is the Modernization of Cosmetics Regulation Act, a U.S. law that expands FDA oversight of cosmetic products.

Who must comply with MoCRA?

Most cosmetic brands selling products in the U.S., including skincare brands, private label brands, and professional-use product companies.

Do private label brands need MoCRA registration?

Yes. Even if a product is manufactured by a third party, the brand owner may still be responsible for product listing and adverse event reporting.

What happens if I don’t comply with MoCRA?

Noncompliance can result in FDA enforcement actions, including product recalls, warnings, or removal from the market.

Does MoCRA apply to small businesses?

Some small businesses may qualify for exemptions, but many MoCRA requirements still apply depending on revenue and activity.

Can a manufacturer handle MoCRA compliance for me?

Yes. Some manufacturers, including Next Beauty Labs, offer registration and compliance support services.

Stay Compliant With Confidence

MoCRA compliance is complex, but it doesn’t have to be stressful.

If you want expert guidance, accurate filings, and peace of mind, Next Beauty Labs is here to help.

We support brands with:

  • MoCRA facility registration and product listing
  • FDA-aligned documentation
  • Professional-grade manufacturing and compliance support
  • Turnkey solutions from formulation to regulatory readiness

Ready to ensure your brand is MoCRA compliant?

Contact Next Beauty Labs today to get started.