Facility Registration and Product Listing

FDA Facility Registration and Product Listing for Cosmetics

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced mandatory registration requirements for all facilities that manufacture or process cosmetic products for distribution in the United States.

This includes both U.S.-based and foreign cosmetic manufacturers, who must now register their facilities and list their products with the Food and Drug Administration (FDA).

We help cosmetic companies manage the FDA facility registration and product listing process with a focus on MoCRA compliance and risk reduction.

Whether you’re entering the U.S. market for the first time or updating your current records, we simplify the path to registration and protect your market access!

How we support your company with FDA Facility Registration and Product Listing

Registering a facility with the FDA is more than just submitting a form. Our end-to-end service covers the entire process, including:

Facility registration submission: We register your cosmetic manufacturing or processing facility with the FDA, providing all required MoCRA-compliant information;
Foreign facility support: For non-U.S. entities, we ensure accurate submission of location, contacts, and registration agent data;
FDA product listing: Cosmetic products manufactured at the registered facility are listed with the FDA, as required by MoCRA;
Documentation preparation: All necessary data is compiled, reviewed, and formatted to meet FDA electronic submission standards;

This process ensures your business is fully aligned with FDA MoCRA requirements, avoiding market disruptions and regulatory penalties.

Why do you need this service?

Facility registration and product listing are now mandatory under U.S. law.

Foreign companies face complex submission steps. Navigating the process without local expertise can lead to delays or rejections.

Proper registration demonstrates commitment to compliance.

Complying with FDA registration obligations is a legal requirement for all cosmetic facilities serving the U.S. market.

With Sobel’s support, your FDA registration process becomes accurate, efficient, and stress-free, keeping your operations compliant and your products on the market.

Need to Register Your Cosmetic Facility with the FDA?

We can help you meet every new requirement with confidence. From determining whether your change qualifies as an update to submitting the registration and fees correctly, our team makes sure your business stays compliant and ready for inspection.

Don’t wait for a warning letter — let us manage your cosmetic registration update today.