With the beauty and personal care industry reaching new heights globally, the U.S. has stepped up its oversight of cosmetic products. The Modernization of Cosmetics Regulation Act (MoCRA) is the most comprehensive update to U.S. cosmetic laws in over 80 years, fundamentally changing how companies manage compliance. Central to this transformation are three key requirements: Cosmetic Facility Registration, FDA Cosmetic Registration and MoCRA Registration.
Consumer Safety Drives Legislative Reform
MoCRA prioritizes consumer safety by enforcing greater transparency, product traceability, and incident reporting. This new structure gives the FDA clear authority to oversee cosmetics in ways that align with international norms, protecting public health and elevating industry standards.
The Essentials of Cosmetic Facility Registration
Who Needs to Register?
Under MoCRA, all manufacturers, packagers, and processors of cosmetic products marketed in the United States must complete Cosmetic Facility Registration. This requirement applies to:
- Domestic and international facilities
- Contract manufacturers
- Third-party processors
- Private-label product handlers
Each facility must be registered biennially, and foreign facilities must designate a U.S. agent for correspondence and inspections.
What Information Must Be Submitted?
Registrants must provide:
- Facility name and physical address
- Contact person and responsible party
- Product types and categories produced
- Associated brand names
Failure to register may result in enforcement action, refusal of entry at U.S. ports, or product seizure.
Breaking Down FDA Cosmetic Registration
Product Listing and Transparency
Every product must be listed through FDA Cosmetic Registration. This registry helps the FDA monitor formulations and safety profiles. Required details include:
- Product name and function
- Ingredient list using INCI nomenclature
- Product labeling and usage instructions
- Responsible person (manufacturer or distributor)
Updates must be submitted annually or when any changes occur to the formulation, packaging, or marketing claims.
Enhancing Public Trust Through FDA Oversight
With FDA involvement more prominent under MoCRA, cosmetic companies must demonstrate that their products are not only attractive but safe. FDA Cosmetic Registration offers assurance that ingredients meet acceptable use standards and that labeling accurately represents product claims.
How MoCRA Registration Sets the Compliance Standard
The Backbone of U.S. Cosmetic Safety
MoCRA Registration includes several layers of accountability, such as:
- Adverse event reporting
- Labeling compliance
- GMP (Good Manufacturing Practice) adherence
- Responsible person identification
Companies must also maintain safety substantiation records for each product, documenting that it is safe under labeled conditions of use.
Preparing for Inspections and Recalls
MoCRA grants the FDA authority to issue product recalls and conduct inspections without prior notice. Facilities that are registered and compliant are less likely to face regulatory penalties. MoCRA Registration, helps companies stay audit-ready and agile in case of safety alerts.
Conclusion: A Safer, Smarter Future Through MoCRA Compliance
The new regulatory framework under MoCRA presents both a challenge and an opportunity. With thorough Cosmetic Facility Registration, complete FDA Cosmetic Registration, and consistent MoCRA Registration, companies not only fulfill legal requirements but also build safer, more reliable brands. Compliance is no longer just a formality—it’s a core element of competitive success in today’s beauty industry.