Cosmetics Regulatory Services in the United States of America (USA)

Yes. Under the Modernization of Cosmetics Regulation Act (MoCRA), FDA Registration for Cosmetics is now mandatory. Manufacturers must submit FDA Cosmetic product listing and FDA Cosmetic facility registration to legally market products in the U.S.

MoCRA compliance refers to adhering to the updated US FDA Cosmetics Regulations under the Modernization of Cosmetics Regulation Act of 2022. It introduces mandatory product and facility registration, stricter safety substantiation, improved post-market reporting, and the FDA’s authority to enforce recalls.

Freyr offers end-to-end US Cosmetic Regulatory services, including FDA Cosmetic labeling requirements checks, FDA Cosmetic claims review, Cosmetic adverse event reporting and guidance on correct Cosmetic product categories for classification and compliance.

Not all. Products like antiperspirants, anti-dandruff shampoos, acne treatments, and mouthwashes with therapeutic claims are classified as drugs, not Cosmetics, and require different approvals. Freyr helps identify the correct Cosmetic product categories FDA and guides you through proper compliance.

For FDA Cosmetic product listing, you need details like product name, intended use, ingredient list (Cosmetic ingredient labeling FDA), manufacturer information, and facility details. Freyr ensures your submission meets FDA labeling requirements for Cosmetics and other MoCRA mandates.

The FDA Cosmetic labeling requirements cover proper product identity, net contents, ingredient list with correct nomenclature, manufacturer/importer details, warnings, and truthful claims. Freyr provides full Cosmetic label review to ensure labels comply with U.S. law.

Freyr supports ongoing Cosmetic adverse event reporting by helping brands track, document, and report post-market adverse events in line with MoCRA and FD&C Act requirements, reducing risk and ensuring Regulatory adherence.