FDA Facility Registration and Product Listing

MoCRA has made FDA facility registration for cosmetics and product listing a legal obligation for all companies aiming to sell in the United States. With Sobel, this process becomes straightforward and reliable, giving you the confidence to focus on growing your brand.

For who?

With Sobel as your partner, FDA facility registration for cosmetics becomes a straightforward, stress-free process.

Why do you need this service?

FDA facility registration for cosmetics and product listing are now legal obligations. Non-compliance can lead to penalties or market restrictions.

Foreign companies face extra challenges. This is why handling documentation requires expertise to avoid costly errors.

Proper registration shows regulators and consumers that your company operates with transparency, reliability, and commitment to quality.

How to register your cosmetic facility

We simplify the registration process, aligning your facility and product data with MoCRA requirements and FDA submission standards.

Count on Sobel to be your partner in this regulatory journey.

Initial Assessment

We analyse your facility and product portfolio to determine registration needs.

Documentation Preparation

All required data is compiled, reviewed, and formatted according to FDA’s electronic system.

Facility Registration Submission

Your cosmetic manufacturing or processing facility is registered with the FDA.

Foreign Entity Support

For non-U.S. companies, we can also manage agent designation for correct submission.

Product Listing

Each cosmetic product manufactured at the facility is listed with the FDA.

Related
Services

To fully support your cosmetic compliance journey, we provide related services that go hand in hand with FDA facility registration and product listing.

US Agent Service

Representation of foreign cosmetic companies. Support and communication with the FDA.

Cosmetic Registration

Cosmetic Registration and Product Listing according to the FDA regulamentations.

Safety Substantiation

Compilation of safety data to support cosmetic product compliance with MoCRA requirements.

Secure your FDA compliance today

FDA facility registration for cosmetics is not optional — it is a legal requirement under MoCRA.

With Sobel as your partner, you eliminate risks of delay, rejection, or penalty while your products remain available in the U.S. market.

Still have questions? Checkout our FAQ

1. Who needs to register their facility with the FDA?

Any person who owns or operates a facility that manufactures or processes cosmetics for distribution in the U.S. must register the facility with the FDA and list their products.

2. Do facilities that only handle ingredients need to register?

No. Only facilities engaged in the manufacturing or processing of final cosmetic products must register. Facilities that merely handle or supply ingredients (that are not the final formulation) are not required to register or list under MoCRA.

3. Do samples or giveaways need to be listed?

Yes — free samples and promotional products intended for consumer use must also be listed, except in cases of research and development not intended for final market use.

4. Is there a tool to check if I need to register?

Navigating the requirements and ensuring full compliance often goes beyond what the tool can cover. That’s why working with an experienced consultancy like Sobel ensures accuracy, efficiency, and peace of mind throughout the FDA facility registration process.

5. How often must cosmetic registration FDA records be updated?

Both facility registration and product listing must be updated annually. Updates are also required if products are discontinued or significant changes are made.