Ensuring your cosmetic products meet FDA requirements demands expertise and precision. Sobel guides you through cosmetics compliance in the U.S. With our support, you streamline approval, without compromising compliance.
Seeking expert guidance to meet FDA cosmetics compliance requirements
Looking for regulatory support and U.S. representation
Needing FDA-compliant documentation and product registration
Requiring technical support for safety substantiation and FDA submissions
The FDA’s Modernization of Cosmetics Regulation Act (MoCRA) introduces new obligations for companies selling cosmetics in the U.S. — from formula compliance and safety substantiation to stricter FDA cosmetic labeling requirements.
For many businesses, adapting to MoCRA raises key questions:
Under MoCRA, companies must maintain safety substantiation for each cosmetic product, including toxicological risk assessments, ingredient information, manufacturing records, and labeling that complies with FDA requirements. Depending on the product, additional reports or facility registration may also apply.
Formula compliance requires a full review of ingredients against FDA restrictions, MoCRA updates, and international standards where relevant. This includes verifying concentrations, permitted uses, and possible allergens or restricted substances. Our consultants analyse formulations to identify risks before submission.
Labels must accurately reflect product identity, function, ingredients, warnings, and responsible person details. The FDA also requires the net quantity in U.S. customary units, the name and full address of the brand owner or importer, and contact information for reporting adverse events. Ingredient lists must appear under the heading “Ingredients:” in descending order of predominance, and labels must state if the product contains fragrances or flavors.
Specialized cosmetics compliance consultants, like Sobel, help brands interpret MoCRA obligations, prepare documentation, and act as U.S. agents when needed. With expert guidance, companies can manage compliance efficiently and reduce the risk of regulatory setbacks.
With Sobel’s cosmetics compliance consultants, you gain clarity and expert guidance. We help you prepare documentation to bring your products to the U.S. market with confidence.
That’s where Sobel comes in — making the process clearer and more efficient. Our consultants provide end-to-end support: reviewing ingredient safety, ensuring labeling accuracy, and preparing documentation for inspections, audits, and product lifecycle maintenance.
We also act as your U.S. agent for FDA cosmetics compliance, bridging the gap between your brand and FDA expectations.
With Sobel as your partner, you reduce compliance risks, speed up time-to-market, and strengthen trust with both consumers and authorities — while focusing on innovation and growth.
Explore our FDA cosmetics compliance services and how Sobel supports your brand:
Registration, label review, and safety substantiation for full regulatory compliance.
We help cosmetic manufacturers revise documentation for full compliance.
Compilation of safety data to support cosmetic product compliance with MoCRA requirements.
Get FDA- and GMP-ready SOPs for your cosmetics business.
Cosmetic Registration and Product Listing according to the FDA regulamentations.
Pre-registration review of cosmetic documents to identify gaps and guide compliance.
Registration of cosmetic companies with the FDA under the new regulations.
Representation of foreign cosmetic companies. Support and communication with the FDA.
Expert support for label verification, gap assessment, and revision under the MoCRA.
Before launching a cosmetic in the U.S. market, every formulation must comply with MoCRA.
Support with FDA cosmetic registration changes, from documentation review to submission.
Explore our FDA cosmetics compliance services and how Sobel supports your brand:
Sobel is your ally in navigating the U.S. cosmetics market. From ensuring formula and labeling compliance to preparing you for audits, we simplify complex FDA requirements and give you confidence at every stage.
Working together, you can expect:
Navigating FDA and MoCRA regulations doesn’t have to be overwhelming. Connect with our experts to learn how we guide your compliance process with confidence.
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