FDA and MoCRA compliance for cosmetics: export and import to the U.S. safely

Expert services to ensure the legality, safety, and success of your cosmetic products in the U.S. market. Schedule your consultation today.

What Is MoCRA and why is it important for your cosmetics business?

The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant reform in decades within the U.S. cosmetics industry. It establishes new registration, listing, and safety control obligations designed to strengthen consumer confidence and ensure that every product is safe before reaching the market.

Complying with MoCRA is not only a legal requirement—it is the key to positioning your brand as responsible and trustworthy,with full access to the U.S. market. That is why MoCRA compliance for cosmetics is considered the minimum standard to compete in an increasingly regulated environment.

Benefits of MoCRA compliance:

Legal protection

Avoid penalties, customs rejections, and distribution delays.

Consumer trust

Your customers know your products meet high standards of safety and transparency.

Secure market access

FDA and MoCRA compliance opens the door to selling in the United States without risk.

Complying with MoCRA is more than an obligation—it is your passport to success in the U.S. market.

First Steps to Enter the U.S. Market

General FDA Compliance Services for Cosmetics

To commercialize cosmetics in the United States, you must comply with general requirements that form the foundation of the entire regulatory process. Key elements include the DUNS number for cosmetic companies, the FDA Agent for cosmetics, and FDA-compliant cosmetic labeling—three essential pillars to avoid delays and ensure your brand meets regulatory requirements from the outset.

Start your FDA compliance process with the general services that will help your brand grow in the U.S.

The DUNS number is a unique identifier for your company and is required for various commercial and customs procedures. Without it, your brand cannot complete essential filings with the FDA.

Every foreign manufacturer must appoint an FDA Agent in the United States, who serves as the official liaison with the regulatory authority. This representative ensures timely and effective communication with the FDA.

Labels That Inform, Protect, and Sell

MoCRA-compliant labeling: clarity and compliance for your cosmetics

FDA cosmetic labeling is one of the most critical requirements under the MoCRA cosmetics compliance framework. TEvery label must meet specific guidelines to ensure consumer transparency and safety.

MoCRA-compliant labeling not only prevents penalties or customs rejections; it also builds consumer trust, reinforces brand transparency, and positions your company as a reliable player in the U.S. market.

Full ingredient list in descending order of concentration
Clear and verifiable product claims
Allergen warnings to protect sensitive consumers

MoCRA-compliant labeling not only prevents penalties and customs rejections—it also builds customer confidence and strengthens your brand reputation in the U.S. market.

Proper labeling is your brand’s first impression: comply with MoCRA and earn the trust of the U.S. market. Let’s get started with the creation or review of your labels.

Procedure and Key Requirements

FDA Cosmetic Product Listing

FDA cosmetic product listing is a mandatory step under the Modernization of Cosmetics Regulation Act (MoCRA). This process ensures your products comply with safety and disclosure regulations, increasing consumer confidence and facilitating access to the U.S. market.

To complete the process, detailed information must be submitted, including:

Product name
Primary cosmetic function
Full ingredient list

Meeting these requirements ensures your brand aligns with FDA standards and avoids penalties that could impact your business.

At CORE, we help you complete product listing efficiently, securely, and without complications. Contact us for specialized guidance.

Essential Requirement Under MoCRA

Cosmetic facility registration with the U.S. FDA (FEI): what it is and why you need it

The FEI (Facility Establishment Identifier) is the unique number assigned by the U.S. FDA (Food and Drug Administration) to each facility that manufactures, processes, packages, or distributes cosmetic products in the United States. This registration is an essential MoCRA requirement and represents a mark of transparency and regulatory compliance.

Having an active FEI not only ensures FDA compliance, but also:

Facilitates access to the U.S. market
Demonstrates your brand’s commitment to compliance
Prevents penalties or regulatory restrictions
Shows regulatory accountability

Do you need to obtain your FEI number and comply with FDA requirements? Our team will guide you step by step through the cosmetic facility registration process with the U.S. FDA. Let’s talk about your project.

What You Need to Know to Comply Without Complications

MoCRA exemptions for small businesses

If your company has limited annual sales or produces cosmetics for personal use or specific purposes, you may be exempt from certain MoCRA requirements. Possible exemptions include:

Annual cosmetic product sales below USD 1 million
Cosmetics manufactured exclusively for personal use
Products developed for research or internal testing

Contact us to find out whether your small business qualifies for MoCRA exemptions and optimize your compliance strategy.

Understanding the FDA Distinction

When does a cosmetic become a drug?

The FDA distinguishes between cosmetics and drugs based on their intended use and effects on the human body.

Cosmetic

Products intended solely to cleanse, beautify, or perfume, such as lipsticks, moisturizers, or nail polish.

Drug

Products intended to prevent, treat, or cure disease, or that affect the structure or function of the body, such as certain sunscreens with therapeutic SPF claims or topical treatments with medical effects.

Understanding this distinction is essential to comply with the correct regulations and avoid penalties or customs rejections.

Make sure your products are properly classified and comply with FDA requirements without legal risk.

Key Advantages for Your Cosmetics Business

Benefits of our FDA and MoCRA compliance services

By relying on our specialized FDA and MoCRA cosmetics compliance services, your company gains clear, measurable advantages that make a real difference:

Safe and efficient compliance

We ensure all your cosmetic products meet FDA and MoCRA regulatory requirements smoothly and without disruptions.

Reduced legal and customs risks

Minimize the risk of penalties, customs rejections, or delays in commercialization within the U.S. market.

Stronger brand reputation

A compliant, transparent brand builds trust with distributors and consumers, increasing your competitiveness in the United States.

Our regulatory experts support you at every stage, ensuring your business meets MoCRA cosmetics compliance and FDA requirements effectively.

Take your business to the
next level

We have the solution

Explore all our MoCRA and FDA services—registration, labeling, product listing, and more. Optimize your cosmetic compliance and secure success in the U.S. market.

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