Formula Review for Cosmetic Registration

Before launching a cosmetic in the U.S. market, every formulation must comply with MoCRA. Sobel’s cosmetic ingredient review service analyses your product’s composition, verifying that ingredients are permitted, within legal limits, and free from regulatory risks.

For who?

With Sobel, you gain confidence that your formulas meet FDA standards before registration or commercialization.

Why do you need this service?

Ingredient restrictions under MoCRA are stricter, and non-compliant formulas may be blocked from the market.

Hidden risks in formulations can lead to safety concerns, allergen disclosure issues, or FDA inspection setbacks.

A professional cosmetic ingredient review saves time and prevents costly reformulations late in the process.

How Sobel supports your formula review process

Our experts conduct a thorough analysis of each formulation, checking ingredient compliance with FDA rules while also identifying potential risks related to restrictions, allergen disclosures, or safety concerns under MoCRA.

Count on Sobel as your partner to secure ingredient compliance!

Formula submission

You provide the complete list of ingredients and concentrations.

Regulatory screening

Each ingredient is checked against FDA and MoCRA requirements, including bans, limits, and disclosure rules.

Risk identification

Ingredients flagged as restricted or high-risk are highlighted with recommendations for alternatives.

Technical report

You receive a detailed review confirming compliance or identifying corrective actions needed.

Related
Services

We provide a detailed assessment that goes beyond a simple compliance check, giving you clarity on ingredient safety, regulatory restrictions, and documentation needs, so your formula is prepared to meet both FDA expectations and market demands.

But you can also count on our guidance to:

Product Labeling (Review)

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

Internal Audit

Prepare for FDA, GMP, or certification audits with expert support.

Cosmetic Registration

Cosmetic Registration and Product Listing according to the FDA regulamentations.

FDA compliance with Sobel’s cosmetic ingredient review

Launching a cosmetic in the U.S. without confirming ingredient compliance can put your business at risk.

Sobel’s experts provide a clear, structured cosmetic ingredient review, giving you the confidence to move forward with FDA registration and commercialization.

Talk to our team today and secure FDA approval for your cosmetic formulas.

Still have questions? Checkout our FAQ

1. Why is a cosmetic ingredient review necessary under MoCRA?

MoCRA requires that all cosmetic products marketed in the U.S. use only permitted ingredients, within safe concentration limits. A professional review ensures compliance, reducing risks of rejection or enforcement by the FDA.

2. What does the technical review report include?

The report prepared by Sobel verifies whether all ingredients in your formula are permitted in the U.S., highlights any restrictions or bans, and points out areas that may require adjustment before FDA registration.

3. Does Sobel also handle product listing with the FDA?

No. Formula review is a separate service. However, Sobel also offers Cosmetic Product Listing and Facility Registration support under MoCRA through complementary services.

4. Can Sobel suggest alternatives for restricted ingredients?

Yes. If an ingredient is restricted or banned, our team provides regulatory guidance and practical recommendations to adjust your formula while maintaining compliance.

5. Does this service include safety substantiation or toxicological testing?

No. Sobel does not conduct lab tests or create toxicological reports. We focus on reviewing your formulation for compliance with FDA and MoCRA requirements, while safety substantiation is offered as a separate service.