February 7, 2025
Understanding MoCRA: The Modernization of Cosmetics Regulation Act
The cosmetics industry in the United States has entered a new era of regulatory oversight with the passage of the Modernization of Cosmetics Regulation Act (MoCRA). This landmark legislation, enacted in December 2022, represents the most significant update to U.S. cosmetics regulations in over 80 years. Designed to enhance consumer safety, MoCRA imposes stricter compliance requirements on cosmetics manufacturers, importers, and distributors.
What is MoCRA?
MoCRA is a federal law that expands the FDA’s authority over cosmetic products sold in the United States. It introduces new compliance obligations, including mandatory product listing, adverse event reporting, safety substantiation, and facility registration.
Prior to MoCRA, cosmetics regulations under the Federal Food, Drug, and Cosmetic Act (FDCA) were relatively lenient compared to those for drugs and medical devices. With MoCRA, the FDA now has broader enforcement powers to ensure the safety and transparency of cosmetic products.
Key Provisions of MoCRA
MoCRA establishes several new requirements for cosmetic businesses, including:
Mandatory Facility Registration
🏭 Who Must Register? All U.S. and foreign facilities that manufacture or process cosmetics must register with the FDA.
📆 Renewal Period: Registrations must be renewed every two years.
Product Listing Requirements
📋 Every cosmetic product marketed in the U.S. must be listed with the FDA, including details such as ingredients and brand name.
⏳ Annual Renewal: Companies must update their product listings each year.
Safety Substantiation
🔬 Manufacturers must maintain records proving their products are safe and ensure they do not contain harmful ingredients.
Adverse Event Reporting
⚠️ Serious adverse events (e.g., hospitalizations, infections, or allergic reactions) must be reported to the FDA within 15 business days.
📂 Record-Keeping: Companies must maintain adverse event reports for six years.
Good Manufacturing Practices (GMPs)
🏭 The FDA will establish mandatory Good Manufacturing Practices (GMPs) for cosmetics to ensure product quality and safety.
How MoCRA Impacts the Cosmetics Industry
🔎 Greater FDA Oversight: Increased inspections and enforcement actions.
📜 Higher Compliance Costs: Businesses must invest in testing, documentation, and reporting.
🔄 Changes in Labeling: New requirements may include additional disclosures for allergens and warnings.
For companies selling cosmetics in the U.S., MoCRA compliance is no longer optional—it’s a legal requirement. Failing to adhere to these regulations could result in product recalls, fines, or restricted market access.
Stay MoCRA-Compliant with Provision Consulting Group
Navigating new regulations can be overwhelming, but Provision Consulting Group is here to help. Our team of regulatory experts specializes in MoCRA compliance, offering:
✅ Facility Registration & Product Listing Assistance
✅ Labeling & Safety Documentation Reviews
✅ Adverse Event Reporting Guidance
📩 Contact Us Today to ensure your cosmetics business remains compliant under MoCRA!
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We will streamline the regulatory processes so that our clients can utilize their time
and money most efficiently.
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