The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, marked the most significant expansion of FDA oversight in the history of the U.S. cosmetics industry. As of late 2023, many of MoCRA’s core provisions are now actively being enforced—including requirements for facility registration and product listing. And the regulatory landscape will continue to tighten, with even more standards, such as mandatory Good Manufacturing Practices (GMP), set to take effect by the end of 2025.
MoCRA extends the FDA’s authority over cosmetic and personal care products, including those imported into the U.S., and introduces a formal structure for product safety, manufacturing practices, and adverse event reporting.
Key requirements include:
- Facility Registration: Manufacturers and processors must register their facilities with the FDA and update any changes within 60 days. Registration must be renewed every two years.
- Product Listing: Each marketed cosmetic product must be listed with the FDA, including an ingredient list, and updated annually.
- Adverse Event Reporting: Manufacturers must report serious adverse events to the FDA within 15 business days and maintain records for six years (three years for small businesses).
- Good Manufacturing Practices (GMP): The FDA will establish mandatory GMP regulations for cosmetics by December 29, 2025 to ensure product safety.
Who Needs to Comply?
Responsible Parties:
✔ Manufacturers – Companies producing cosmetics for U.S. distribution.
✔ Packagers – Businesses responsible for packaging cosmetics, if also the manufacturer.
✔ Distributors – Firms marketing cosmetics under their own brand, even if another company manufactures the product.
✔ Contract Manufacturers – Third-party manufacturers producing private-label cosmetics must collaborate with brand owners for compliance.
How We Can Help
Navigating MoCRA’s complex requirements can be time-consuming. We simplify the process, saving you both time and money with:
✅ Individual Services – Tailored to your compliance needs.
✅ Customized Service Packages – Bundled services covering all MoCRA requirements.
✅ Comprehensive MoCRA Compliance Officer Service – Full-scale compliance management.
Pricing
| 1-5 Labels | $4,000 |
| 51-100 Labels | $7,500 |
| 101-500 Labels | $12,500 |
What We Need From You
Product Labels – Upload in PDF format.
Basic Information – Fill out this form with your legal name, address, phone number, and email.
Terms to Know
FDA (Food and Drug Administration) – The federal agency responsible for regulating food, drugs, and cosmetics in the U.S.
Responsible Person – The entity whose name appears on a cosmetic product label; this party is responsible for ensuring compliance with MoCRA regulations.
Good Manufacturing Practices (GMP) – FDA-enforced quality control standards to ensure the safety and consistency of cosmetic products.
Adverse Event Reporting – The process of reporting harmful reactions or safety concerns related to a cosmetic product to the FDA.
Serious Adverse Event (SAE) – A reaction to a cosmetic product that results in hospitalization, disfigurement, disability, or death, requiring FDA notification within 15 business days.
Facility Registration – Mandatory registration of all manufacturing facilities with the FDA, ensuring regulatory oversight. Product Listing – The FDA’s requirement that all marketed cosmetics be registered with an ingredient list and updated annually.
Get MoCRA Compliant Today
Compliance with MoCRA is mandatory for anyone in the U.S. cosmetics industry. Our team is here to help you every step of the way. Contact us today to get started.
