Safety Substantiation for Cosmetics

FDA-Compliant Safety Documentation for Cosmetic Products

MoCRA introduced a clear expectation for all cosmetic companies: be able to prove your products are safe. To meet FDA requirements, manufacturers must maintain well-documented safety evidence — ready for review in the event of an inspection or inquiry.

Our safety substantiation service for cosmetics helps your company compile a complete, scientifically sound dossier that demonstrates your product is safe for use under labeled conditions.

We gather and organize tests, studies, expert analyses, and published articles to create clear, credible documentation — aligned with MoCRA and FDA safety compliance requirements.

How we support your Cosmetic Safety Substantiation Process

Creating a strong safety file requires more than collecting test results — it demands regulatory understanding, scientific judgment, and structured presentation. Our service includes:

Data sourcing and review: We identify and assess all available safety data related to your product’s ingredients and final formulation;
Scientific literature and study integration: Relevant toxicological studies, clinical data, and expert reports are selected to support your safety claims;
Dossier assembly: All safety documentation is compiled into a structured file that meets FDA inspection standards and MoCRA expectations;
Gap analysis: We identify missing or weak areas in your current safety documentation and suggest steps to address them;
Audit readiness: The final report is formatted and stored to be ready for review during an FDA inspection or market inquiry.

This ensures your product has robust, well-organized safety evidence, reducing risk and improving market readiness.

Why do you need this service?

MoCRA requires documented safety proof. Every cosmetic must have accessible evidence demonstrating safety under intended use.

Missing or disorganized safety data can lead to delays, detentions, or product recalls. Incomplete files increase risk of enforcement.

Comprehensive documentation reassures regulators and builds trust with partners and consumers.

Meeting FDA safety substantiation standards is a core requirement under MoCRA for all cosmetic products sold in the U.S.

With Sobel’s support, creating your cosmetic safety documentation for FDA becomes a guided, structured process — so your team can stay focused on innovation, not regulation.

Need Help with FDA Safety Substantiation for Cosmetics?

We help you compile all the safety data required under MoCRA to support your cosmetic products. From test results to literature reviews, we organize your compliance dossier, so you’re always inspection-ready.

Let Sobel build your FDA-compliant safety file and give your product the confidence it needs to thrive in the U.S. market.