MoCRA for K-Beauty Brands: What Selling in the US Means for You
If you plan to sell Korean-made skincare in the United States, you will run into the term MoCRA. It stands for the Modernization of Cosmetics Regulation Act of 2022, and it changed what brands and manufacturers have to do for cosmetics sold in the US. For a new brand, the main question is simple: which of these duties are mine, and which belong to the manufacturer?
This guide is a plain-language overview based on FDA's public information. It is meant to help you ask the right questions, not to tell you what to do.
What MoCRA is
MoCRA is a US law that added new requirements for cosmetic products and the companies behind them. FDA describes it as the most significant expansion of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938. It covers everyday products such as moisturizers, cleansers and other skincare.
This guide covers cosmetic products only. Other product categories follow different rules and are outside its scope.
Who is the Responsible Person?
Many of MoCRA's duties fall on the Responsible Person. FDA defines this as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label.
For a private label product, the name on the label is usually the brand. That means the brand named on the label is usually the Responsible Person under MoCRA, even though a Korean manufacturer makes the product. If a different company appears on the label, such as a distributor, that company may be the Responsible Person instead.
The main requirements at a glance
| Requirement | Who it applies to | In short |
|---|---|---|
| Facility registration | Owner or operator of the facility | Register, and renew every two years |
| Product listing | Responsible Person | List each marketed product with its ingredients, and update annually |
| Safety substantiation | Responsible Person | Keep records that support the safety of the product |
| Adverse event reporting | Responsible Person | Report serious events to FDA within 15 business days |
| Label contact information | Responsible Person | Show a US address, US phone number or electronic contact |
Facility registration
Manufacturers and processors must register their facilities with FDA and renew the registration every two years. This is the duty of the facility's owner or operator, and it applies to foreign facilities too. A foreign facility must name a US agent as part of registration.
Product listing
The Responsible Person must list each marketed cosmetic product with FDA, including its ingredients, and provide updates annually. Listing is separate from facility registration. A manufacturer's registered facility does not by itself list your products.
Safety substantiation
The Responsible Person must ensure and keep records that support adequate safety substantiation for each product. FDA notes that neither the law nor its regulations require specific tests for individual products or ingredients. Manufacturers can use relevant safety data that already exists, as long as it comes from scientifically robust methods.
Adverse event reporting
The Responsible Person must report serious adverse events to FDA within 15 business days, with a copy of the label. Serious adverse events are defined in the law and include outcomes such as hospitalization, significant disability and persistent or significant disfigurement. The Responsible Person must also keep adverse event records for 6 years, or 3 years for small businesses.
Label contact information
Your label must include a US address, US phone number or electronic contact, such as a website or email, so that adverse event reports can reach you.
Small business exemptions
MoCRA exempts certain small businesses from some requirements. A small business is generally one with average US cosmetic sales under about $1 million per year over the previous three years, adjusted for inflation. Such businesses are exempt from facility registration and product listing.
There are important limits. The exemption does not apply to those who make products that regularly contact the mucous membrane of the eye, are injected, are used internally, or are meant to alter appearance for more than 24 hours. And even small businesses still have adverse event reporting, safety substantiation and labeling duties. Check the current rules for your own situation.
What this means for a K-beauty brand
The brand named on the label is usually the Responsible Person under MoCRA. Our manufacturing partner maintains its own FDA facility registration, and we can provide manufacturer documents, such as the INCI list, test reports and stability data, to support your listing and safety substantiation.
It is also worth knowing that FDA is developing good manufacturing practice (GMP) requirements for cosmetic facilities. Check FDA's page for the current status.
A practical checklist for a brand preparing to sell in the US:
- Confirm who is on the label. That company is usually the Responsible Person.
- Plan your product listing. Collect the ingredient list and product details you will need.
- Set up safety records. Gather the documents that support the safety of each product.
- Prepare an adverse event process. Decide who receives reports and how you will submit them within 15 business days.
- Add contact details to the label. Use a US address, US phone number or electronic contact.
- Check whether the small business exemption applies. Do this before assuming you are exempt.
Selling beyond the US
If you plan to sell in more than one market, it helps to know that other regions have their own systems. This is a general overview, and the rules differ by product category and change over time.
- EU (CPNP). The European Union requires a Responsible Person based in the EU, a product information file that includes a safety assessment, and a notification through the Cosmetic Products Notification Portal (CPNP) before the product is placed on the market.
- China (NMPA). China's National Medical Products Administration (NMPA) oversees cosmetics. Imported products generally need to be filed or registered with the NMPA before import, depending on the category, and a China-based responsible party acts for the brand.
Our Korean manufacturing partner can support the documentation and requirements for MoCRA (US), CPNP (EU) and NMPA (China). The brand, or its responsible person or agent, remains the registrant where the law says so, and we cannot guarantee any registration or filing outcome.
Where to read more
The best place to start is FDA's own page on the law: FDA's MoCRA page. FDA also publishes guidance on registration and listing.
This guide is general information, not legal or regulatory advice. Requirements change; check current FDA guidance or consult a U.S. regulatory professional.
If you are planning a first product, our guide on how a unit price is built and our guide on how long production takes can help you plan the rest.
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