Exporting Cosmetics to the US: No MoCRA, No Sale. FDA Facility Registration, Responsible Person, Product Listing

The US is the world's largest cosmetics market and a core export destination for K-beauty. But if you take "the US does not pre-approve cosmetics" at face value and ship without preparing, you will hit a wall. There is indeed no approval step, yet under MoCRA, enacted in 2022, distribution itself is unlawful unless you register the manufacturing facility with the FDA and list your products. This guide breaks down, document by document, the MoCRA requirements a K-beauty brand must clear to export to the US. To see where the US sits among destination markets first, start with the cosmetics export overview.

What MoCRA is

MoCRA (the Modernization of Cosmetics Regulation Act of 2022) is the US law that overhauled cosmetics regulation for the first time in about 80 years. Signed in December 2022, it greatly expanded the FDA's authority over cosmetics. The key point is that while the US still does not approve individual products before sale, it places registration, listing, and safety accountability on whoever puts the product on the market.

This is where Korean brands often get it wrong. There is no "FDA approval" stamp, but a product that is not registered and listed cannot be sold in the US. No pre-approval is not the same as no regulation.

The Responsible Person: the party behind every obligation

Every MoCRA obligation falls on the Responsible Person. The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. Facility registration, product listing, safety substantiation, adverse event reporting, and the label requirements are all this person's responsibility.

The first question to settle in a K-beauty export is "who is the responsible person." If a Korean brand sells through a US distributor and that distributor's name goes on the label, the distributor can be the responsible person, while if the brand puts its own name on the label, the brand is. Because registration and reporting duties, and control, shift with who the responsible person is, settle it before signing a distribution contract.

Facility registration

Every facility that manufactures or processes cosmetics for US distribution must register with the FDA. A factory located in Korea is no exception. A foreign facility must designate a US Agent when registering.

The timing and renewal basis are as follows.

Registration covers the facility owner, address and contact, the FDA Establishment Identifier (FEI), and the product categories handled. It is not one and done: because it renews every two years, managing the renewal deadline is the practical crux.

Product listing

Separate from facility registration, the responsible person must list each product individually. A product listing includes the product category, responsible person details, the manufacturing facility, and an ingredient list including fragrances and colors. The product listing is updated once a year. Do not confuse this with the two-year facility cycle: the renewal cadences differ.

Safety substantiation and adverse event reporting: regardless of size

Two MoCRA obligations apply to every responsible person regardless of size.

Safety substantiation: the responsible person must hold the tests, studies, and analyses that support the product's safety. Listing the ingredients is not enough; you must secure your own basis that the product is safe under normal use.

Adverse event reporting: if a serious adverse event related to product use occurs in the US, the responsible person must report it to the FDA within 15 business days of learning of it. Related records are kept for six years (three years for small businesses).

Neither of these is covered by the small-business exemption discussed below. Even a small operation must meet them.

Label requirements

MoCRA also added label requirements. A cosmetic label must show a US contact for receiving adverse event reports (a domestic address, phone number, or electronic means), a requirement that took effect on December 29, 2024. Items such as fragrance allergen labeling are set to be defined by separate FDA rules, so it is best to design the label to the destination's standard from the start to avoid rework.

The small-business exemption: what counts and what does not

MoCRA provides a partial exemption for small operators. A business with average US cosmetic sales under 1 million dollars over the prior three years is exempt from facility registration, product listing, and GMP.

Two things must be clear. First, the safety substantiation and adverse event reporting seen above are not exempt. Even with small sales, both must be met. Second, higher-risk types, such as products that contact the mucous membrane of the eye or are intended to be injected or used internally, are excluded from the exemption even for a small business. Before assuming "we are small, so this does not apply," check the product type and each obligation one by one.

Still awaiting effect

MoCRA left several items for the FDA to flesh out in follow-on rules. Good manufacturing practice (GMP) regulations, asbestos testing for talc-containing products, PFAS use reporting, and the FDA's mandatory recall authority are among them. Some are still at the rulemaking stage, so if you are preparing to export to the US, keep watching their effective dates.

A K-beauty US export checklist

• Decide the responsible person first: whose name goes on the label, and whether the distributor or the brand is the responsible person, settled before the contract.
• Register the manufacturing facility: including the Korean factory, register with the FDA and designate a US Agent. Renew every two years.
• File the product listing: a per-product listing including ingredients, updated annually.
• Hold safety data: regardless of size, secure the test and study basis.
• Build an adverse event process: a 15-business-day reporting workflow and record keeping.
• Align the label: show a US contact for adverse event reports.

For a US export, customs and shipping only matter once the regulation is cleared. Prepare the HS code classification and export customs procedure, and if you want to lower US duty through the Korea-US FTA, a certificate of origin as well. Other markets, China NMPA and EU CPNP, are covered in the articles that follow.

This guide is general information as of July 2026. MoCRA requirements and dates keep changing as the FDA issues follow-on rules, so verify with FDA notices and a specialist before you export.