New MoCRA Legislation: How It Impacts Your Exports

• Contents

The new MoCRA legislation (Modernization of Cosmetics Regulation Act of 2022) represents the most significant update to FDA (Food and Drug Administration) oversight of the cosmetics industry since 1938.

In practice, this act significantly expands the U.S. government's enforcement powers, requiring international manufacturers and exporters to comply with strict new rules regarding facility registration and product listing.

It also establishes rigorous standards for safety substantiation and adverse event reporting. For global companies exporting to the U.S., MoCRA transforms guidelines that were once voluntary into strict legal obligations.

Why do we still refer to MoCRA as "new" legislation?

Although the law was signed in late 2022, it is treated as "new" because its practical implementation and effective enforcement have reached full strength throughout 2024 and 2025.

The FDA established grace periods for companies to adapt. Many of the electronic registration requirements and new Good Manufacturing Practices (GMP) guidelines have only recently begun to be strictly enforced.

Therefore, the international market is still experiencing the real impact of this transition. The "adjustment" period is over, and inspection rigor has increased considerably.

Why MoCRA changes the game for exporters

If your company already operates in the North American market or plans to export cosmetics to the USA, you must understand that the landscape has shifted.

Until recently, cosmetic regulation on American soil was often perceived as more flexible compared to European standards or other strict international bodies. With MoCRA, the FDA now possesses far more robust tools to intervene in the market.

The core objective is transparency. Given the high daily usage of cosmetic products by consumers, the government decided to modernize the rules. Now, the responsibility for safety falls heavily on the designated "Responsible Person."

The fundamental pillars of the new MoCRA legislation

To ensure your company remains competitive and compliant, it is essential to master the four main requirements established by the new law:

1. Facility Registration and Product Listing

Unlike the previous model, which was voluntary, all facilities that manufacture or process cosmetics for distribution in the U.S. must now register with the FDA.

This registration must be renewed every two years. Additionally, the Responsible Person must list each marketed product, detailing its ingredients and composition.

2. Safety Substantiation

This is one of the most critical sections. Companies must maintain records that scientifically prove the product is safe for its intended use.

The FDA does not mandate a specific test, but it requires that you possess robust data substantiating safety. If you lack this documentation, the product can be deemed adulterated and banned from the market.

3. Serious Adverse Event Reporting

If a U.S. consumer experiences a serious reaction to your product, the company has a strict deadline of 15 business days to report the incident to the FDA.

Maintaining a cosmetovigilance system has become mandatory. This includes reporting everything from infections to significant hair loss or severe allergic reactions.

4. New Good Manufacturing Practices (GMP)

MoCRA authorizes the FDA to establish specific Good Manufacturing Practices regulations for cosmetics.

This means that hygiene and quality control standards at international factories will be audited against a much higher bar, aligning with global excellence standards.

Expert Tip: If you are still unsure about the role of the U.S. regulatory body, it is worth checking our detailed guide on what is the US FDA and how it acts to protect public health.

Recall Authority and Business Suspension Risks

One of the points that most concerns business owners is the Mandatory Recall Authority. Before MoCRA, the FDA generally requested that companies voluntarily withdraw dangerous products.

Now, if there is a risk of serious harm and the company refuses to act, the FDA can order an immediate recall.

Furthermore, the agency has the power to suspend a facility's registration. If registration is suspended, no product coming from that factory can enter or be sold in the United States.

This can paralyze your entire export operation, causing financial losses and immeasurable damage to your brand's reputation abroad.

Small Businesses and Exemption Rules

MoCRA provides exemptions for certain small businesses regarding GMPs and facility registrations, based on average sales volume over the last three years.

However, these exemptions DO NOT apply if you manufacture products that:

• Come into contact with the mucus membrane of the eye.
• Are injectable.
• Are intended for internal use.
• Alter appearance for more than 24 hours.

The vast majority of companies exporting dermocosmetics or high-end beauty products will need to fully comply with the law, regardless of their size.

How to adapt and ensure export success

The cosmetics market in the U.S. is one of the largest and most promising in the world, but international bureaucracy requires strategic partners and technical knowledge.

The first step toward compliance is understanding the technical process of how to register with the FDA correctly and efficiently.

Here are some practical steps your company should take today:

• Safety Audit: Verify if your safety dossiers are up to date and follow robust, internationally accepted methods.
• Labeling: MoCRA introduces new requirements for fragrance and allergen labeling. Be ready to adjust your packaging design.
• US Agent: Have clarity on who will be your U.S. Agent and the official point of contact with the FDA for reporting.
• Substances under Scrutiny: Stay alert to discussions regarding substances like Talc and PFAS, which are under constant scrutiny by the new law.

The future of the cosmetics trade under MoCRA

The new MoCRA legislation should not be viewed merely as a bureaucratic hurdle, but as an opportunity for professionalization.

Being FDA compliant elevates your company's status to a global level of trust. This facilitates entry not only into the U.S. but also into other rigorous markets that view FDA approval as a seal of quality.

International trade requires agility and technical expertise. With the rules fully in force, the time to act and review your processes is now.

Ensure your documentation is up to date to avoid customs blocks and strengthen your presence in the American market.

Do you need help adapting your company to the new MoCRA requirements or are you looking to expand your exports safely? Talk to the experts at B2B TradeCenter and simplify your entry into the USA!