💄

MoCRA

FDA Cosmetics Registration

FDA Cosmetics Registration Services

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) grants the US FDA increased authority and oversight over the cosmetics industry. Its core requirements went into effect December 29, 2023.

Get Started Today

For OEM Factories

Help Your Brand Customers Launch in the US, Starting at R&D

We partner with OEM factories to offer FDA compliance as part of what you bring to your brand customers, not a service they have to source separately. The earlier we’re involved, the more we can save them.

The core value: we recommend factories and brands engage us right at the R&D phase, before formulation is finalized, to determine whether a product is worth pursuing for the US market. Depending on ingredients and claims, a product can end up classified as a Cosmetic or as an OTC Drug under FDA rules, and that classification changes the entire compliance path, cost, and timeline. Catching this early avoids brands investing in a formulation that turns out to be far more expensive or slow to bring to market than expected.

Step 1

R&D-Stage Classification

Before formulation is finalized, we assess whether the product is likely to be classified as a Cosmetic or an OTC Drug in the US, and what that means for feasibility.

Step 2

Label Review

As production moves forward, we review packaging and labeling for US compliance early, avoiding costly redesigns after manufacturing.

Step 3

Product Registration

Once the brand is ready to launch, we handle FDA facility and product registration end-to-end.

Give your brand customers a real competitive edge: FDA-compliance-ready manufacturing from day one.

Talk to Us About Factory Partnership →

The Basics

What Is the FDA Cosmetic Law (MoCRA)?

MoCRA (Modernization of Cosmetics Regulation Act) is the legal framework the US FDA uses to regulate the manufacturing, labeling, and promotion of cosmetics in the United States. It provides a standardized guide for the cosmetic manufacturing process, protecting consumers from potential health risks while supporting innovation in the industry. MoCRA became effective for the US cosmetics market in December 2023.

Who Must Register

Businesses that manufacture, package, or distribute cosmetic products in the US are obligated to register under MoCRA.

Small Business Exemption

Businesses with three consecutive years of revenue below USD 1 million are exempt from registering manufacturing facilities and cosmetics, with exceptions below.

Exceptions

Products Not Exempt, Even for Small Businesses

Certain product categories must register regardless of business size.

•

Cosmetics regularly in contact with the mucous membranes of the eyes

•

Cosmetics injected into the body

•

Cosmetics for internal use

•

Cosmetics designed to alter appearance for over 24 hours without user removal

Compliance Duties

FDA Obligations for Cosmetic Businesses Exporting to the US

Meeting these requirements keeps your products moving through customs without delay.

Registering business facilities

Designating a US representative office (US Agent)

Registering products

Adjusting cosmetic packaging labels to US standards

Reporting incidents to the FDA

Adhering to Good Manufacturing Practices (GMP) for manufacturing facilities

Conducting safety testing for cosmetics

Our Services

US FDA Cosmetic Compliance Services

GOL helps clients worldwide navigate FDA compliance and fulfill MoCRA requirements.

Facility Registration

We help you achieve MoCRA compliance by registering your cosmetic facilities with the FDA, and can act as your US Agent if your facilities are located outside the USA.

Product Listings

FDA cosmetic listings can be complicated to file. We save you time and money by making product listings quick and easy.

Adverse Event Reporting

Complete your Adverse Event Report within 15 days of receiving a complaint from a consumer. We help you stay on top of initial reports and FDA follow-ups.

Label & Ingredient Review

MoCRA introduced new changes to how cosmetic product labels are handled. Our labeling specialists keep you compliant with all requirements.

Why Choose GOL

Why Brands Choose GOL for FDA Cosmetics Compliance

Specialized MoCRA expertise

We focus specifically on MoCRA compliance for cosmetics, from facility registration through adverse event reporting, not general import logistics.

End-to-end solution

From product listings to label review to ongoing adverse event support, one team handles your entire cosmetics compliance program.

23+ years of experience

We've helped businesses worldwide navigate FDA cosmetics regulations, including the transition to MoCRA.

Ready to Achieve MoCRA Compliance?

Talk to our team about facility registration, product listings, or label review for your cosmetics.

FDA Cosmetics Registration Service - GOL Solution