FDA Registration for Cosmetics | MoCRA Compliant Services

Navigate U.S. Cosmetic Compliance with Confidence

The United States remains the world's largest market for cosmetic products. With the introduction of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the U.S. Food and Drug Administration (FDA) has significantly strengthened cosmetic regulatory requirements. While traditional regulations did not require pre-market approval for most cosmetic products, MoCRA now grants the FDA greater authority to review products, oversee compliance, and mandate recalls when necessary.

At Freyr, we help cosmetic brands streamline FDA registration and compliance processes. Our regulatory experts support businesses in meeting MoCRA requirements, enabling a smooth and confident entry into the U.S. market.

Understanding the U.S. Cosmetic Regulatory Landscape

The regulatory framework for cosmetics in the United States has evolved considerably under MoCRA. Products such as antiperspirants, anti-dandruff treatments, acne products, and certain mouthwashes that make therapeutic claims may be classified as drugs rather than cosmetics. As a result, these products are subject to stricter regulatory requirements, including additional approvals and compliance obligations.

Products that fail to meet updated regulatory standards may be subject to FDA review, enforcement actions, or recalls. In addition, the FDA now places greater emphasis on post-market surveillance and adverse event reporting. Maintaining accurate product records, tracking safety information, and ensuring timely reporting can be complex and resource-intensive for manufacturers and brand owners.

Freyr provides end-to-end regulatory support to help organizations stay compliant, minimize risks, and efficiently manage evolving FDA cosmetic requirements.