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FDA Facility Registration and Cosmetic Product Listing

To place cosmetic products on the United States market, manufacturers are required to register their facilities and list their products within the FDA system.

These obligations have become mandatory under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), covering both FDA cosmetic product listing and FDA facility registration processes.

With MoCRA, the FDA’s authority over cosmetic products has significantly expanded, making registration and compliance a legal requirement for both domestic and foreign companies operating in the US market.

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Legal Background

Why Are FDA Facility Registration and Product Listing Required?

Under MoCRA, FDA registration processes are essential for companies placing cosmetic products on the US market, ensuring that cosmetic products and manufacturing facilities are registered with the FDA, product and facility data are traceable and up to date, compliance with US regulatory requirements is demonstrated, and regulatory risks during inspections and audits are minimized; MoCRA-compliant FDA registration is therefore critical for sustainable access to the US market.

Failure to comply with FDA product listing and facility registration requirements may result in:

  • Delays or rejection of market entry in the US
  • Non-compliance findings during FDA inspections
  • Product recalls or restrictions on commercial activities
  • Damage to brand reputation and business credibility

For this reason, FDA registration processes must be managed carefully and in full alignment with MoCRA requirements.

Our services

How Obelis Türkiye Supports Your FDA and MoCRA Compliance

Obelis Türkiye provides comprehensive regulatory support for cosmetic companies entering the US market.

Our support includes:

  • Evaluation of product and facility requirements under MoCRA
  • Coordination of FDA product listing and facility registration processes
  • Verification of regulatory compliance of submitted information
  • Guidance for internal teams on FDA and MoCRA obligations
  • Support in minimizing regulatory risks in the US market

By partnering with Obelis Türkiye, you can establish a compliant, reliable, and sustainable regulatory framework for your cosmetic products in the US.

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FAQ

Frequently Asked Questions

Find answers to common concerns. If your query isn’t answered here, get in touch.

Yes. Under MoCRA, FDA product listing and facility registration are mandatory within defined scopes.

MoCRA expanded FDA’s authority, making product and facility registration legally required.

No. Information must be kept up to date, and changes in product or facility data require updates.

Yes. Obelis Türkiye provides regulatory support for both local and international companies entering the US market.

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