FDA Cosmetic Registration Support

Get support throughout your entire journey of cosmetic registration with the FDA. From confirming product eligibility to final submissions, Sobel provides the guidance and expertise you need to comply with MoCRA requirements and secure access to the U.S. market.

For who?

Your compliance journey starts with Sobel! FDA cosmetic registration doesn’t have to be complex—our experts make the process clear and manageable.

Why do you need this service?

MoCRA requires cosmetic products and facilities to be registered. Missing deadlines can result in penalties or market holds.

Incorrect or incomplete submissions may lead to rejections, inspections, or restricted market access.

Expert support saves time and costs. Working with a consultancy frees your team to focus on product innovation and growth.

FDA cosmetic registration requirements under MoCRA

Cosmetic registration support with the FDA requires compliance with the Modernization of Cosmetics Regulation Act (MoCRA), including facility registration, product listing, safety substantiation, and U.S. Agent designation when applicable.

With Sobel, you have experts by your side to navigate the entire process.

We outline each step clearly, so your brand can stay compliant without unnecessary complications.

Regulatory Framework Verification

We confirm whether your product qualifies as a cosmetic under U.S. law.

Product Assessment

We review formulation, intended use, claims, and product category to ensure eligibility for FDA registration.

Product Registration and Listing

We submit all required data to the FDA system, including brand and product details.

Facility Registration Support

We assist with facility registration for both U.S. and foreign manufacturers.

MoCRA Compliance Guidance

Our team advises on additional MoCRA obligations to prepare your company for inspections and documentation requirements.

Related
Services

We guide your company through the FDA registration process, helping you meet MoCRA obligations with confidence.

Beyond FDA cosmetic registration, Sobel offers complementary services to strengthen compliance and support your long-term success:

US Agent Service

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

Change in Cosmetic Registration

Support with FDA cosmetic registration changes, from documentation review to submission.

Safety Substantiation

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

Get expert support for FDA cosmetic registration

FDA cosmetic registration and product listing are legal requirements under MoCRA, but it doesn’t need to be overwhelming.

With Sobel as your partner, you gain accuracy, confidence, and peace of mind while ensuring your products remain available in the U.S. market.

Let Sobel guide your FDA cosmetic registration process from start to finish.

Still have questions? Checkout our FAQ

1. Is cosmetic registration with the FDA mandatory?

Yes. Under MoCRA, both cosmetic products and manufacturing facilities must be registered with the FDA. Failure to comply can result in penalties, product holds, or loss of market access.

2. What information is required for cosmetic registration FDA submissions?

The FDA typically requires product and facility details, along with information that demonstrates compliance with U.S. cosmetic regulations. The exact documents depend on the type of product and company structure. To make this process easier, Sobel identifies and organizes all the documentation you need for a complete and compliant submission.

3. Do foreign cosmetic companies also need FDA registration?

Yes. Foreign facilities must complete cosmetic registration with the FDA and designate a U.S. Agent to communicate with the agency and assist with inspections.

4. How long does the cosmetic registration FDA process take?

Timelines vary depending on documentation readiness. With complete data, the process can be completed in a matter of weeks. Working with consultants like Sobel helps avoid delays.

5. What are the consequences of not complying with cosmetic registration FDA requirements?

Non-compliance may result in warning letters, product seizures, import holds, or reputational damage. Proper registration is essential for uninterrupted U.S. market access.

6. What are the main MoCRA requirements for FDA cosmetic registration?

MoCRA requires cosmetic companies to complete facility registration, product listing, safety substantiation, and adverse event reporting procedures. Foreign manufacturers must also designate a U.S. Agent. Proper preparation of these elements ensures smoother FDA cosmetic registration and reduces compliance risks.

7. Is FDA cosmetic facility registration required for MoCRA compliance?Yes. Under MoCRA, cosmetic manufacturers must complete FDA cosmetic facility registration to legally market their products in the United States. Facilities that fail to register may face compliance risks, including market access restrictions. Companies that need support with this process can rely on specialized FDA Cosmetic Facility Registration services to ensure accurate and timely submissions.

8. Do cosmetic labels need to comply with MoCRA requirements?

Yes. Cosmetic products marketed in the United States must follow specific labeling requirements defined under MoCRA, including ingredient declaration, responsible person information, and safety-related statements when applicable. Businesses that need assistance reviewing their labeling can benefit from MoCRA Label Compliance services to ensure labels meet current FDA expectations before commercialization.