US Market

US FDA Cosmetic compliance

Regulatory Compliance Solutions for the U.S. Cosmetic Industry

Discover the evolving landscape of the U.S. cosmetic market under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a pivotal shift in FDA’s oversight since 1938. MoCRA represents a significant advancement in ensuring the safety of the daily-used cosmetic products, such as makeup, moisturizers, and haircare items. On average, American consumers utilize between 6 to 12 cosmetic products daily, highlighting the need for stringent regulatory measures 1.

MoCRA introduces comprehensive regulations, including mandatory facility registration, product listing, and adverse event reporting, to enhance product safety. Additionally, it sets forth Good Manufacturing Practices (GMP) for cosmetic facilities and standardized testing methods for specific ingredients, ensuring a higher safety standard for consumers 12.

Moreover, with MoCRA, the FDA gains new powers, like accessing safety records and enforcing mandatory recalls if a product poses serious health risks, thereby reinforcing consumer protection 12. This act also clarifies responsibilities, defining a “responsible person” as the entity whose name appears on the product label, further ensuring accountability in the cosmetic industry 2.

For companies, navigating this regulatory landscape becomes crucial for market access and consumer trust. MoCRA not only ensures products’ safety and compliance but also guides manufacturers through the intricacies of legal requirements.

In essence, MoCRA marks a new era for the U.S. cosmetic market, fostering a safer, more regulated environment for both consumers and companies, and the FDA plays a central role in this transformation, safeguarding public health while supporting industry innovation.

Our Services


Facility Registration

Ensure MoCRA compliance with our FDA facility registration service. We handle mandatory registration for cosmetic manufacturers, ensuring your facility meets all registration requirements.

Quality Management

Product Listing

Ensure your cosmetic products comply with MoCRA by utilizing our FDA product listing service. Our team expertly navigates the FDA’s Cosmetics Direct portal for efficient product listing, including ingredient documentation and annual updates.

Label & Ingredient Review

Our Label & Ingredient Review service meticulously evaluates your cosmetic products against MoCRA’s newly established requirements, fragrance allergen labeling, and standardized asbestos testing in talc-containing products. We ensure your labels and ingredients meet all FDA standards.

Safety Substanciation

Achieve MoCRA compliance effortlessly with our in-house FDA Safety Substantiation service for cosmetics. Expertly conducting safety assessments, including toxicological profiles and risk analysis, we ensure your products meet all new requirements. Navigate regulatory landscapes confidently, safeguarding consumer safety and securing market entry.

Biological Evaluation

Toxicological Risk Assessment

Safeguard your cosmetics with our in-house Toxicological Risk Assessment, tailored to MoCRA and FDA standards. We meticulously evaluate ingredient safety, ensuring compliance and consumer protection. Trust us to navigate complex regulations, providing peace of mind and a clear path to market.

Adverse Event Reporting

Streamline your response to cosmetic incidents with our FDA Adverse Event Reporting service, aligned with MoCRA regulations. We expertly manage reports, ensuring compliance and consumer safety. Trust us to navigate this critical aspect, providing assurance and maintaining your brand’s integrity in the market.

US Agent service

Ensure MoCRA compliance with our US Agent Service for foreign cosmetic manufacturers. We facilitate smooth communication with the FDA, manage regulatory submissions, and ensure timely responses. Trust us to navigate complex regulations, ensuring market access and maintaining your brand’s compliance.

Select Your language