To sell a Korean centella (cica) facial serum in the United States, you and your Korean supplier must meet the rules in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): the Korean factory registers its facility with FDA and names a US agent, a US responsible person lists the product, and the label and safety records meet FDA requirements. The single point that confuses most buyers is that the US agent (required for the foreign facility's registration) and the US responsible person (named on the product label) are two different roles. This guide explains both roles, the registration path through Cosmetics Direct, the documents you need, and the deadlines.
US Agent vs. US Responsible Person: The Distinction That Trips Up Buyers
Before any paperwork, settle one question that derails more K-beauty import projects than any other: who is the US agent, and who is the responsible person? They sound similar, but they sit on opposite sides of the supply chain.
The US agent belongs to the facility. According to the U.S. Food and Drug Administration (FDA), a foreign facility must designate a United States agent for registration purposes. The US agent must reside in the US or keep a US place of business, must be physically present in the US, and may not be a mailbox, an answering machine, or an answering service. In short, the US agent is FDA's point of contact for your Korean factory.
The responsible person belongs to the product. Per the FDA, a responsible person is the manufacturer, packer, or distributor of a cosmetic whose name appears on the product label, in line with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The responsible person lists each marketed product with FDA, keeps safety records, and reports serious adverse events.
For a US retailer importing a Korean cica serum, this usually means your Korean OEM/ODM (the facility) needs a US agent, while you (the importer or distributor named on the label) act as the responsible person. One company can sometimes fill both roles, but the duties stay separate. Sort this out first, because the rest of the path depends on it.
US agent vs. US responsible person under MoCRA
| US agent (for the foreign facility) | Responsible person (for the product) | |
|---|---|---|
| What it is tied to | The Korean facility's FDA registration | The cosmetic product and its label |
| Who it usually is | A US-based contact named at registration | The manufacturer, packer, or distributor whose name is on the label |
| Where the name appears | In the facility registration record, not on the product | On the product label (per section 609(a) of the FD&C Act) |
| Core duty | Acts as FDA's point of contact for the foreign facility; must be physically present in the US and may not be a mailbox or answering service | Lists the product, keeps safety substantiation, and reports serious adverse events |
The MoCRA Compliance Path: Facility Registration and Product Listing
MoCRA is described by the FDA as the most significant expansion of FDA's authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act passed in 1938. Under it, manufacturers and processors must register their facilities and list their products. For an imported serum, that breaks into a clear order.
MoCRA facility registration and product listing path
- 1
Korean facility registers with FDA
The Korean OEM/ODM that manufactures or processes the serum registers its facility and names a US agent, because a US agent is required for a foreign facility.
- 2
Receive the facility registration number
Registration gives the facility a number that the product listing will reference, so the facility should register before the listing is completed.
- 3
Responsible person lists the product
The responsible person lists the marketed cosmetic with FDA, including its ingredients, using the facility registration number.
- 4
Submit through Cosmetics Direct
File using Cosmetics Direct (the FDA SPL authoring tool), the Electronic Submissions Gateway NextGen, or paper Forms 5066 (facility) and 5067 (listing).
- 5
Keep the records current
Update the facility registration within 60 days of a change, renew it every two years, and update the product listing annually.
First, the facility registers. Per the FDA, cosmetic product manufacturers and processors must register their facilities with FDA. Your Korean OEM/ODM that makes or processes the serum is the facility, and (from the section above) it must name a US agent to register.
Second, the product gets listed. The FDA says a responsible person must list each marketed cosmetic product with FDA, including its ingredients, and provide updates annually. A product listing must generally include the facility registration number of each facility where the product is made or processed. That order matters: register the facility first, because the listing references the facility's number.
You file through FDA's tools. Cosmetics Direct is the FDA-provided Structured Product Labeling (SPL) authoring tool for facility registration and product listing. Submissions can also go through the Electronic Submissions Gateway NextGen or other SPL software, and FDA Form 5066 (facility registration) and Form 5067 (product listing) are the paper options.
One expectation to reset for your team: this is not an approval program. The FDA states that facility registration and product listing is neither a cosmetic approval program nor a promotional tool, and that FDA does not issue "certificates" for cosmetic facility registrations or product listings. So you cannot market your serum as "FDA approved" or "FDA certified" — there is no such certificate to earn.
Required Documents and Data for MoCRA Compliance
MoCRA compliance is less about a single filing and more about a package of records and data points that line up. Use the list below to see what the facility supplies, what the responsible person owns, and what feeds the label.
MoCRA documentation and data the buyer assembles
- Facility registration recordFor the Korean OEM/ODM, with a named US agent who is physically present in the US.
- Facility registration numberGenerated at registration; the product listing must generally include it.
- Product listing with full ingredient listFiled by the responsible person via Cosmetics Direct, ESG NextGen, or Forms 5066/5067.
- Safety substantiation recordsAdequate substantiation of safety; specific or animal tests are not required by law or FDA regulation.
- Compliant US label dataINCI ingredient declaration, English-language statements, net quantity, and country of origin.
- Responsible person's US name and addressThe marketing firm's name and place of business for the information panel.
| Item | What it covers | Who handles it |
|---|---|---|
| Facility registration | The Korean OEM/ODM registered with FDA, with a US agent | Korean facility + US agent |
| Facility registration number | The number the product listing must reference | Generated at registration |
| Product listing | The marketed serum and its full ingredient list, updated annually | Responsible person |
| Filing route | Cosmetics Direct, ESG NextGen, or Forms 5066/5067 | Responsible person |
| Safety substantiation records | Records supporting adequate safety substantiation | Responsible person |
| Compliant US label | INCI ingredients, English text, net quantity, country of origin | Responsible person / importer |
On the safety records, the FDA is specific: MoCRA requires a responsible person to ensure, and keep records supporting, that there is adequate substantiation of safety for the product. Neither the law nor FDA regulations require specific tests, animal testing is not required, and existing relevant safety data may be used if it comes from scientifically robust methods. For a fragrance-free cica serum built on known ingredients, that means assembling solid existing safety data rather than commissioning a fixed test list.
Deadlines, Renewals, and Reporting Cadence
Timing is where compliant suppliers separate themselves from risky ones. There are three clocks to watch.
The enforcement clock is already running
Facility registration and product listing have been enforced since July 1, 2024
FDA delayed enforcement of the facility registration and product listing requirements by six months, to July 1, 2024, to give industry time to submit. That date has passed, so treat registration and listing as current obligations, not future ones. Serious adverse event reporting became enforceable earlier, on December 29, 2023.
The first is the enforcement deadline. Per the FDA, the agency delayed enforcement of the facility registration and product listing requirements by six months, until July 1, 2024, to give industry time to submit. That deadline has passed, so registration and listing are live obligations now.
The second is the renewal and update cadence. The FDA requires facilities to update their registration within 60 days of any change and to renew it every two years (biennially). An abbreviated renewal option is available when there have been no updates since the most recent submission. Product listings, separately, must be updated annually.
The third is adverse event reporting. The FDA says a responsible person must report serious adverse events tied to a cosmetic used in the US within 15 business days, and must include a copy of the label on or within the retail packaging. If new medical or other information about the event arrives within one year of the first report, it must be sent to FDA within 15 business days as well. These requirements became enforceable on December 29, 2023, and the FDA recommends using MedWatch Form 3500A, emailed to [email protected].
There is real weight behind these dates. The FDA may suspend a facility's registration if a product made there has a reasonable probability of causing serious adverse health consequences or death, and once suspended, distributing or selling that facility's products in US interstate commerce becomes a prohibited act. MoCRA also gives FDA mandatory recall authority and access to certain safety records. Missing a deadline is not a paperwork slip — it can stop your goods.
Labeling Your Cica Serum for the US Market
A US label is its own compliance task, governed by the FD&C Act and the Fair Packaging and Labeling Act, codified at 21 CFR 701 and 740. The FDA notes that a cosmetic that is false or misleading, or not labeled to these requirements, may be considered misbranded and subject to action.
Start with the ingredient declaration. Per the FDA, cosmetics sold at retail must bear an ingredient declaration under 21 CFR 701.3, listing ingredients in descending order of predominance. Ingredients at one percent or less, and color additives, may be listed without regard to order, and ingredients must use the names set by regulation (INCI names). For your serum, that means centella asiatica extract, niacinamide, hyaluronic acid, and the rest declared correctly.
Next, the format rules. The FDA states that required label statements must be in English and conspicuous (21 CFR 701.2). The principal display panel must show the product name, identify what the product is, and carry an accurate net quantity of contents (21 CFR 701.10) — for example, the 30 ml fill on an airless pump bottle.
Then, the firm and origin. The FDA requires the name and place of business of the marketing firm on an information panel (21 CFR 701.12); if the distributor is not the manufacturer or packer, the label must say "Manufactured for ..." or "Distributed by ..." or similar. This is where your US responsible person's name and US address appear. The Tariff Act of 1930 also requires imported articles to state the English name of the country of origin — so "Made in Korea" (or equivalent) belongs on the label.
Two more points round this out. The FDA does not pre-approve cosmetics or ingredients, with the notable exception of certain color additives, which must be approved for their intended use and, in many cases, certified for purity in FDA labs — relevant if a tinted variant is ever added. And if safety is not adequately substantiated, the product may be misbranded unless the label bears the warning "Warning--The safety of this product has not been determined" (21 CFR 740.10). Solid safety records keep that warning off your box.
GMP and ISO 22716: What FDA Expects Now
Buyers often ask whether their Korean factory's ISO 22716 (Cosmetics GMP) certificate satisfies FDA. The honest answer in 2026 is "it helps, and the rule is still forming."
Cosmetic GMP is still at the draft-guidance stage
MoCRA requires FDA to set GMP rules, but the GMP guidance is still in draft
MoCRA directs FDA to establish Good Manufacturing Practice regulations for cosmetic facilities, and FDA has published Draft Guidance for Industry on cosmetic GMP. Because it is draft guidance, confirm the current status before you rely on it. An ISO 22716-certified Korean factory is a strong starting point for aligning with these expectations.
Per the FDA, MoCRA requires the agency to establish regulations for Good Manufacturing Practices for cosmetic facilities, along with rules for fragrance allergen labeling and for standardized asbestos testing in talc-containing products. To support that, the FDA has published Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.
The key word is draft. The GMP framework is not yet a final binding rule, so you should confirm its current status rather than assume it is mandatory today. That said, a Korean factory already certified to ISO 22716 — the international cosmetics GMP standard — is well positioned to align with FDA's expectations as they firm up. It is a foundation, not a finish line.
How Brightwave Global Fits In
Most of this guide is about rules that apply to any Korean skincare exporter. Where a supplier makes a difference is in being export-ready: a facility that can register cleanly, documentation that lines up with the product listing, and a label that already reflects US rules.
Brightwave Global's Korean centella (cica) facial serum is produced by an ISO 22716 (Cosmetics GMP) certified OEM/ODM, in a 30 ml fragrance-free, water-based formulation built on centella asiatica extract, niacinamide, and hyaluronic acid. That certified base, plus a clean ingredient and specification record, gives your responsible person and US agent the documentation they need to register the facility, complete the Cosmetics Direct listing, and build a compliant US label with fewer surprises.
Last updated: 2026-06. This guide is for general information only. US cosmetic rules change and can depend on your specific product and shipment. Confirm current MoCRA, FDA registration, labeling, and GMP requirements with the FDA and a qualified regulatory professional before you import or sell.
Frequently Asked Questions
- Who is the "responsible person" for my imported Korean cica serum — me or the Korean factory?
- Usually you, the importer or distributor whose name appears on the US label. Per the FDA, the responsible person is the manufacturer, packer, or distributor of a cosmetic whose name is on the product label under section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The Korean factory is the registered facility, and it needs a US agent for registration — a separate role from the responsible person, although one company can sometimes fill both.
- Does my Korean OEM's facility need to be registered with FDA, and does it need a US agent?
- Yes to both. The FDA requires cosmetic manufacturers and processors to register their facilities, and for a foreign facility a US agent is required for registration. That US agent must reside or keep a place of business in the US, be physically present in the US, and may not be a mailbox, answering machine, or answering service. The facility should register before the product listing, because the listing must generally include the facility's registration number.
- How do I actually file the facility registration and product listing?
- Through FDA's tools. Cosmetics Direct is the FDA-provided SPL authoring tool for facility registration and product listing; you can also submit through the Electronic Submissions Gateway NextGen or other SPL software, or use paper Form 5066 (facility registration) and Form 5067 (product listing). Remember this is not an approval program — the FDA does not issue certificates for facility registrations or product listings.
- Is my supplier's ISO 22716 certificate enough to meet FDA's GMP expectations?
- It is a strong starting point, but the FDA rule is still forming. MoCRA requires FDA to establish GMP regulations for cosmetic facilities, and FDA has published Draft Guidance for Industry on cosmetic GMP — but it remains draft guidance, so confirm the current status before relying on it. An ISO 22716-certified Korean factory is well positioned to align with FDA's expectations as the rule is finalized.
- What are my obligations if a US customer reports a serious adverse reaction?
- You report it to FDA. Per the FDA, a responsible person must report serious adverse events tied to a cosmetic used in the US within 15 business days and include a copy of the label on or within the retail packaging; new information received within one year must also be submitted within 15 business days. These requirements became enforceable on December 29, 2023, and FDA recommends MedWatch Form 3500A, emailed to [email protected]. You must also keep records supporting adequate substantiation of the product's safety.
This information is provided for reference. Always confirm current MoCRA, FDA registration, labeling, and GMP requirements with the FDA and qualified regulatory experts before you import or sell.
References
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- FDA — Registration and Listing of Cosmetic Product Facilities and Products
- FDA — Registration and Listing Deadline (What It Means)
- FDA — Serious Adverse Event Reporting for Cosmetic Products
- FDA — Summary of Cosmetics Labeling Requirements
- FDA — Draft Guidance for Industry: Cosmetic Good Manufacturing Practices