Cosmetics

MoCRA AND FDA COSMETIC COMPLIANCE SUPPORT FOR MANUFACTURERS, PACKAGERS, AND BRAND OWNERS

Ensuring Safety, Quality, and Compliance

cGMP Consulting provides cosmetic compliance consulting that helps manufacturers, packagers, and brand owners meet the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and existing FDA cosmetic regulations. MoCRA introduced facility registration, product listing, safety substantiation, adverse event reporting and future GMP obligations. We help you customize your procedures to meet these requirements and bring safe, high-quality products to market.

Elevate Your Brand

Why Compliance Matters

We help you address all aspects of MoCRA and enhance your operational efficiency and brand integrity through:

  • Safety: Protects consumers from unsafe, contaminated, or mislabeled products.
  • Quality: Ensures consistency across every batch and formulation.
  • Market Access: Retailers and e-commerce platforms increasingly require documented compliance before listing products.
  • Compliance: Reduces the risk of recalls, penalties, and other FDA action.

Our Cosmetic Compliance Services

Each MoCRA service is designed with your success in mind

Facility Registration

Facility Registration

Understand the FDA registration requirements for your facility. Our team of experts will guide you through each step to ensure a seamless and successful registration.

Product Listing

Product Listing

We can consult and also manage the process of listing your cosmetic products with the FDA under MoCRA. Our expert guidance will help you avoid common pitfalls and ensure a seamless registration.

Safety Substantiation

Safety Substantiation

Our experts will work with you to understand and implement the safety standards and approved testing methods mandated by MoCRA to ensure your products are safe for consumers.

Product Labeling Support

Labeling Support

Our team will guide you through MoCRA’s labeling requirements, including fragrance allergens and professional use instructions, ensuring your products meet regulatory standards.

Adverse Events Reporting

Adverse Events Reporting

Implement the requirements for adverse event classification and FDA reporting. Learn best practices for managing mandatory recalls and maintaining compliance.

Customized GMP System

Customized GMP

Understand the GMP requirements under MoCRA. Our team will guide you in implementing and maintaining these customized GMP procedures to ensure product quality and safety.

Tailored GMP Plans for MoCRA Compliance

Discover our customized GMP plan, designed to meet MoCRA’s strict requirements and your unique operational needs.

Implementing a new system or updating an established GMP system can be time and resource intensive. Let us put our expertise to work to take this burden off your organization.

Here’s our approach:

1

GMP Gap Assessment

We conduct a comprehensive gap assessment of your current processes and procedures. This expert analysis forms the foundation for leading your organization toward full compliance.

2

Standard Operating Procedures (SOPs)

We develop customized SOPs that meet all aspects of MoCRA’s new requirements while aligning with your existing internal systems. We work closely with you to preserve the integrity and unique aspects of your procedures while ensuring regulatory compliance.

3

Documentation & Record-Keeping

We ensure that all manufacturing and testing processes are thoroughly documented to prevent regulatory issues. Whether your records are paper-based or electronic, we assist in capturing and maintaining your essential reports.

4

Employee Training & Education

We empower your team with the knowledge to implement and sustain compliance. Introducing new systems can be challenging, but we provide the necessary training to help your staff embrace and maintain a robust quality system.

FREQUENTLY ASKED QUESTIONS

What is MoCRA, and who must comply?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the federal law that expanded FDA oversight of cosmetics. It applies to manufacturers, packagers, and distributors of cosmetic products marketed in the United States, with limited exemptions for certain small businesses.

Yes. Under MoCRA, cosmetic manufacturing and processing facilities must register with the FDA and renew registration on the required cycle. Each marketed product and its ingredients must also be listed with the FDA.

MoCRA directs the FDA to establish cosmetic Good Manufacturing Practice (GMP) regulations. Manufacturers should build GMP-aligned quality systems now so they are prepared when those requirements take effect. Refer to ISO 22716 and the FDA draft guidance.

The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. This party is accountable for safety substantiation, labeling, and adverse event reporting.

We provide MoCRA readiness assessments, facility registration and product listing support, ingredient and label review, GMP system development and more. Contact us to discuss your program.

lab working packaging lotion bottles

Blogs

FDA Critical Deadlines

Stay ahead of MoCRA’s critical deadlines with cGMP Consulting
Timeline

July 1, 2024

• Facility Registration & Product Listing
• Adverse Event Reporting
• Safety Substantiation & Recall Authority

December 29, 2024

• Disclose Fragrance Allergens
• Provide Label Contact Information

November 2027

• GMP Notice of Proposed Rulemaking

TBD

• GMP Final Rule

Resources

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

MoCRA BILL

Registration & Listing of Cosmetic Product Facilities and Products

Product Testing of Cosmetics

Good Manufacturing Practices for Cosmetic Products

Draft Guidance for Industry: Cosmetic Good Manufacturing Practices

Public Meeting: Good Manufacturing Practices for Cosmetic Products

Summary of Cosmetics Labeling Requirements

Compliance with cGMP Consulting

Partner with cGMP Consulting to ensure you meet these new requirements efficiently. We tailor our solutions to meet your specific needs, enabling you to focus on your strengths.

Contact us today to discover how cGMP Consulting can assist your cosmetic business with MoCRA compliance and enhance your business’s success.