Home > Cosmetic regulations > MoCRA FDA

MoCRA FDA

Q: What is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) is the first major update to FDA cosmetics regulation in 85 years. Above all, it focuses on product safety and manufacturing standards. Under MoCRA, non-US cosmetic facilities need a US Agent . For this reason, Cosmeservice offers US Agent services to ensure compliance and liaise with the FDA.

Q: How do I substantiate the safety of my products under MoCRA?

You need documented safety substantiation based on toxicological data, safety testing or a written assessment by a qualified expert. Moreover, you must keep this documentation available in case the FDA requests it.

Q: What are the new labeling requirements under MoCRA?

Since December 2024 , cosmetic labels must include: Direct contact information (address, phone, email or website) so consumers can report adverse events. Clear indication if the product is for professional use only (e.g. in salons or clinics). Of course, all existing FDA labeling rules still apply, including ingredient listing, net quantity, function and warnings.

We handle your MoCRA FDA compliance, from facility registration to product listing, so you can sell your cosmetics in the US

MoCRA FDA: Key Changes in US Cosmetic Regulations

The Modernization of Cosmetics Regulation Act (MoCRA) introduces new obligations for companies that sell cosmetic products in the US. These include facility registration, product listing, safety substantiation and adverse event reporting. For the first time, cosmetic manufacturers and distributors must meet compliance standards that the FDA enforces. Whether you already sell in the US or plan to expand, understanding MoCRA FDA is therefore essential. In this way, you can stay fully aligned with current US cosmetic regulations.

Check your MoCRA compliance

Who is affected by the MoCRA FDA Act?

The MoCRA Act mainly affects cosmetic manufacturers, importers, packers and distributors. Some small businesses are exempt from certain requirements, such as GMP and registration. Specifically, this applies to companies with US cosmetic sales under $1M over the past three years. However, most larger companies must fully comply with MoCRA’s provisions.

MoCRA defines cosmetic products as “formulations with a specific ingredient composition intended for finished product use.”

On the other hand, MoCRA doesn’t govern over-the-counter (OTC) products, such as sunscreens with cosmetic claims. Instead, these fall under OTC compliance, except for the new provisions on fragrance allergen disclosure and professional use labeling.

Are you interested in OTC? Click here and find out how to comply with the regulations.

MoCRA FDA compliance steps

Safety substantiation

Under MoCRA, the Responsible Person must keep records that prove product safety. These include tests, studies and other expert-approved evidence.

Cosmetic product listing

The Responsible Person must list each cosmetic product with the FDA and update the listing every year. In addition, MoCRA sets specific deadlines for both existing and new products.

Good Manufacturing Practices

MoCRA highlights the importance of Good Manufacturing Practices (GMP) for cosmetic safety. For this reason, the law required the FDA to propose GMP rules by December 29, 2024, in line with international standards like ISO 22716.

Labelling requirements

Section 609 of the FD&C Act, added by MoCRA, introduces new labeling requirements for cosmetics. For example, labels must include contact information for reporting adverse events. Moreover, they will need to identify fragrance allergens.

Facility registration

Under MoCRA and Section 607(a), cosmetic facilities must register on the FDA platform. The law sets deadlines for both existing and new facilities. Furthermore, companies must renew their registration every two years.

Adverse event reporting

Companies must keep adverse event records for six years, or three years for small businesses. In addition, for serious events, the Responsible Person must inform the FDA. They must also send any new medical information for one year after the initial report.

MoCRA FDA compliance deadlines

Facility Registration & Product Listing

To comply with MoCRA FDA, you need an FEI number, facility registration and product listing. First, we verify or obtain your FEI (FDA Establishment Identifier). Then, we handle facility registration and product listing on your behalf.

Safety Substantiation report

We make sure your cosmetic products comply with FDA standards and MoCRA Act requirements. To do so, we review formulas, labels and claim justifications.

US Agent & Responsible Person Support

The US Responsible Person appears on the cosmetic label and holds legal responsibility for its safety, compliance and labeling. In addition, companies based outside the US must appoint a US Agent to communicate with the FDA.

Everything is ready!

At this point, your cosmetic products fully comply with MoCRA FDA standards. From then on, as your US representative, we monitor your products and keep you informed of regulatory updates.

December 29, 2022

Enactment of MoCRA

December 29, 2023

Safety substantiation, serious adverse event reporting, and professional use labeling requirements take effect

June 24, 2024

Proposition of a list of fragrance allergens

July 1, 2024

Mandatory registration of facilities and product listing via the Cosmetic Direct portal

December 29, 2024

New labeling rules take effect (e.g. responsible person contact)

February, 2025

Final approval of allergen labeling regulation

December 29, 2025

Final rule on Cosmetic GMP expected to take effect. FDA publishes PFAS report

US Agent & Responsible Person support for MoCRA FDA compliance

Under MoCRA, all non-US cosmetic manufacturers must appoint a US Agent to access the US market. This representative acts as the official point of contact with the FDA for regulatory communications.

At Cosmeservice, we act as your MoCRA US Agent. In this role, we support FDA compliance, manage product listings and assist with safety documentation and adverse event reports.

In addition, we provide complete Responsible Person Support for the United States. As a result, every product you place on the US market meets MoCRA requirements, with accurate information, compliant labeling and proper record keeping.

What our clients say about us

They are always available to clarify doubts and ensure everything runs seamlessly.

A good long relationship

Very polite and helpful in their service.

Long-term experience with a lot of learning and trust

It's a delight to work with Cosmeservice. There is always a response and willingness to help achieve the most professional result.

We appreciate their friendly attitude and quick response, and explains about regulation patiently when we make a inquiry.

We always have answers and high-quality studies.

Reliable service.

FAQS

What is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) is the first major update to FDA cosmetics regulation in 85 years. Above all, it focuses on product safety and manufacturing standards. Under MoCRA, non-US cosmetic facilities need a US Agent. For this reason, Cosmeservice offers US Agent services to ensure compliance and liaise with the FDA.

Should I wait for more information from the FDA before working on MoCRA compliance?

No, we recommend starting early. The FDA has already outlined many requirements. Therefore, if you start now, you stay ahead and avoid business disruptions due to non-compliance.

What is the deadline for registering products and facilities under MoCRA?

The original deadline was December 29, 2023. However, the FDA delayed enforcement until July 1, 2024. Since then, facility registration and product listing are mandatory. In addition, new facilities and products must register or list within the deadlines that MoCRA sets.

What if my contract manufacturer isn't aware of MoCRA?

Every company responsible for a cosmetic product sold in the US must comply with MoCRA. So, share your manufacturer’s contact details with experts like us. That way, we can make sure they understand the requirements and comply.

How do I substantiate the safety of my products under MoCRA?

You need documented safety substantiation based on toxicological data, safety testing or a written assessment by a qualified expert. Moreover, you must keep this documentation available in case the FDA requests it.

What are the new labeling requirements under MoCRA?

Since December 2024, cosmetic labels must include:

Direct contact information (address, phone, email or website) so consumers can report adverse events.
Clear indication if the product is for professional use only (e.g. in salons or clinics).

Of course, all existing FDA labeling rules still apply, including ingredient listing, net quantity, function and warnings.

How often do I need to renew my facility registration?

Under MoCRA, you must renew your facility registration every two years.

Who is exempt from MoCRA?

Small US businesses with cosmetic sales under $1M in the last three years are exempt from GMP, facility registration and product listing. However, these exemptions don’t apply to certain products. These include products that contact the eye, injectables, products for internal use and products that alter appearance for more than 24 hours.

MoCRA FDA

MoCRA FDA: Key Changes in US Cosmetic Regulations

Who is affected by the MoCRA FDA Act?