Change in Cosmetic Registration FDA

Has your cosmetic changed? Even small adjustments in formulation, labelling, or packaging may require an update or a new registration with the FDA. With Sobel’s support, your change in cosmetic registration process becomes fast, secure, and fully compliant with MoCRA.

For who?

Failing to update cosmetic registrations in line with MoCRA can result in non-compliance, delays, or even penalties. With Sobel, you gain expert guidance, efficiency, and accuracy.

Why do you need this service?

FDA requirements have changed with MoCRA, and keeping outdated registrations may expose your company to compliance risks and regulatory penalties.

Uncertainty about whether to update or re-register can slow decision-making, delaying product launches and market entry.

Manual submissions without expert guidance increase the chance of errors, missed steps, and rejections by the FDA.

Your pathway to FDA compliance

From documentation review to FDA filing, we manage the entire change in cosmetic registration process on your behalf.

Helping you navigate every change in cosmetic registration with the FDA.

Documentation guidance

Clear instructions on the FDA-required documents.

Change analysis

Assessment of whether the modification is an update or a new registration.

Document compilation

Organization of all necessary paperwork for submission.

FDA submission

Filing through FDA Direct Cosmetics (with your account or ours).

Related
Services

Our specialists assist in the process of changing cosmetic product registrations with the FDA, guiding you through each requirement with clarity and precision.

But are you looking for end-to-end MoCRA support? These services often pair with cosmetic registration changes:

Product Labeling (Review)

Expert support for label verification, gap assessment, and revision under the MoCRA.

Safety Substantiation

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

Cosmetic Registration

Cosmetic Registration and Product Listing according to the FDA regulamentations.

Your cosmetics, FDA-compliant

Don’t risk non-compliance with FDA requirements. Sobel’s specialists handle every detail of your change in cosmetic registration, ensuring your product remains market-ready and compliant with MoCRA.

Talk to our team today and keep your cosmetic business FDA-compliant.

Still have questions? Checkout our FAQ

1. When do I need to update my cosmetic registration with the FDA?

Any modification in formulation, packaging, labelling, or product details may require an update. Sobel helps determine if the change qualifies as an update or if a new registration is needed.

2. How long does the FDA take to analyse a registration change?

The FDA typically reviews documentation within 30 to 90 days. However, once the protocol is issued, your product can already be marketed during this period.

3. Is updating a cosmetic registration mandatory under MoCRA?

Yes. Keeping outdated registrations may result in non-compliance, which could lead to regulatory issues or penalties.

4. Do I need a new registration if only the product name changes?

Not always. Some updates, such as product name or packaging adjustments, may be processed as an update. Sobel analyses each case to confirm the correct path.

5. Can international companies use this service?

Yes. We support both U.S. and non-U.S. companies exporting cosmetics to the American market, guiding them through the FDA Direct Cosmetics system.