MOCRA FDA

MOCRA: What Cosmetic Brands Need to Know About the New US Regulations

The Modernization of Cosmetics Regulation Act (MOCRA), signed into law in December 2022, represents the most significant change to US cosmetic regulations in over 80 years. It brings the cosmetic industry under FDA oversight similar to that seen with dietary supplements and OTC drugs, increasing safety and transparency expectations for all brands.

If you’re marketing cosmetics in the US—or planning to—this article is essential reading. At AF Pharma, we’re here to ensure that your brand is fully MOCRA-compliant with minimal disruption and maximum efficiency.

What Is MOCRA?

MOCRA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish a comprehensive, national framework for cosmetic regulation. It applies to all cosmetic products marketed in the United States, both domestic and imported.

Key areas now regulated include:

• Facility Registration

• Product Listing

• Responsible Person designation

• Safety Substantiation

• Adverse Event Reporting

• Labeling Requirements

• Recordkeeping and GMPs

Who Is the Responsible Person (RP) Under MOCRA?

MOCRA introduces the concept of a “Responsible Person” (RP)—similar to the EU and UK framework. This is the manufacturer, packer, or distributor whose name appears on the label of a cosmetic product marketed in the US.

The RP must:

• Submit facility registrations and product listings to the FDA.

• Ensure substantiated safety of each product.

• Maintain a system for adverse event reporting.

• Update records and listings annually or within 60 days of any changes.

What Are the New Requirements?

1. Facility Registration; Cosmetic facilities (domestic and foreign) must register with the FDA and renew every two years.

2. Product Listing: Each marketed cosmetic must be listed with the FDA, including ingredient details, intended use, and a product image or label.

3. Safety Substantiation: Manufacturers must ensure and document that their products are safe under labeled or customary conditions of use.

4. Labeling: New labeling must include the RP’s contact details, and declarations of allergens will soon become mandatory.

5. Adverse Event Reporting: Serious adverse events must be reported to the FDA within 15 business days of learning about them.

6. Recordkeeping and GMPs: Manufacturers must retain records for 6 years, and compliance with Good Manufacturing Practices (GMP) will be mandatory.

Deadlines You Can’t Miss

• July 1, 2024: Product listing and facility registration deadline (extended from December 2023).

• Mid-2025: GMP regulations expected to be finalized and enforced.

AF Pharma: Your US Agent

AF Pharma offers comprehensive support for MOCRA compliance:

✅ We act as your US Responsible Person (RP) - US Agent

✅ We handle FDA facility registration and product listings

✅ We help compile safety substantiation dossiers

✅ We support you in meeting adverse event and GMP obligations

With experience across the US, UK, EU, and Australia, our team ensures your cosmetic products stay compliant, competitive, and confidently marketable.

Whether you're launching a new brand or scaling globally, AF Pharma is your trusted regulatory partner.

Get MOCRA-Ready with AF Pharma

Let us simplify your transition to MOCRA. Our services are tailored for startups, SMEs, and international brands seeking affordable, efficient US market access.

📧 Contact us at info@afpharmaservice.com

🌐 Visit www.afpharmaservice.com

💼 Regulatory support across the US, UK, EU, and Australia