MoCRA: What Do Foreign Cosmetic Brands Need to Prepare?

Facility registration, product listing and adverse events: who does what, and by when?

Cosmetic brands from Korea and across Asia ask us the same questions before a US launch:

"Where do we get MoCRA certification, and what does it cost?"

"TikTok Shop wants proof of FDA registration. Where do we get the certificate?"

"A contract manufacturer makes our products. Who registers with FDA, us or the factory?"

The short answer: MoCRA is not a certificate you get once. It is a set of duties that the factory and the brand each carry for as long as the product is sold in the US. Below, we go through who does what, and by when.

What is MoCRA?

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, is the US cosmetics law signed on December 29, 2022 (FDA guidance). FDA held off enforcing facility registration and product listing until July 1, 2024. That grace period is over.

Two terms make the rest easy (FDA MoCRA page):

• Facility: any site that manufactures or processes cosmetics sold in the US. An importer's site counts if it manufactures or processes product.
• Responsible person: the manufacturer, packer or distributor whose name appears on the product label.

As of June 30, 2026, FDA counted 16,398 active facility registrations and 1,298,361 active product listings (FDA registration and listing page).

MoCRA requirements at a glance: who does what, and when

The duties split between the facility and the responsible person.

Duty	Who	Deadline / timing
Facility registration	Facilities that make cosmetics for US sale, including in Korea	New facilities within 60 days of starting; renew every 2 years; report changes within 60 days (21 U.S.C. 364c)
US agent	Foreign facilities	At registration (FDA guidance)
Product listing	Responsible person	New products within 120 days of US marketing; update every year (21 U.S.C. 364c)
Serious adverse event report	Responsible person	Within 15 business days of receiving the report (21 U.S.C. 364a)
Adverse event records	Responsible person	Keep 6 years, or 3 years for small businesses (21 U.S.C. 364a)
Safety substantiation records	Responsible person	No set deadline; keep the evidence on file (FDA)
Adverse event contact on the label	Responsible person	Required since December 29, 2024 (21 U.S.C. 364e)
GMP	Facility	Rule not final as of October 2026 (Unified Agenda)

1. There is no MoCRA certification

FDA has stated that it issues no certificates or other documents to verify facility registration or product listing. It also said registration and listing are neither an approval program nor a promotional tool.

So a "certificate" from any vendor is not an FDA document. What you need is not a certificate but registration and listing data that you keep current.

The same notice says platforms such as TikTok Shop may ask sellers for proof of FDA registration. Follow the platform's instructions, knowing that no FDA certificate exists.

2. MoCRA registration: foreign factories register too

Every facility that manufactures or processes cosmetics for the US must register with FDA, wherever it is. FDA's guidance (Q14) says a contract manufacturer outside the US must register if its products are sold in the US, and that following ISO 22716 is no exemption (FDA guidance).

• One factory registers once, even if it makes products for several brands. The factory can file, or a responsible person whose products it makes can file for it (21 U.S.C. 364c).
• A new facility registers within 60 days of starting production and renews every 2 years from the first registration date. Changes go to FDA within 60 days.
• The registration number is the FDA Establishment Identifier (FEI). An FEI request typically takes 7 to 10 business days, and a free account on FDA's ESG NextGen submission system takes 1 to 3 weeks (FDA registration and listing page).

Sites that only label, package, hold or distribute do not register. A US 3PL that only stores and ships your product is not a facility under this rule. An importer has duties only if it manufactures, processes or is the responsible person (guidance Q10). Its customs role is covered in our importer of record post.

Registration follows the factory that makes the product, not the brand.

3. Foreign facilities need a US agent

A facility outside the US must name a US agent when it registers (FDA guidance). The US agent is a person or company physically present in the US. A mailbox, an answering service or an unstaffed address does not qualify.

Under FDA's draft Q&A (Q20), the agent's role is limited: helping FDA reach the facility, scheduling inspections and receiving documents. FDA does not endorse any agent.

A US agent is FDA's contact point. Product listing and adverse event reporting stay with the responsible person.

4. The responsible person lists each product

FDA's guidance (Q3) says a company outside the US can be the responsible person if its name is on the label as manufacturer, packer or distributor. If your Korean head office is on the label, it is the responsible person. If a US distributor is named instead, that distributor can be.

A consultant can be the responsible person only if it meets the same definition (guidance Q2). So the label, not a service contract, decides who the responsible person is.

Each product listing includes (21 U.S.C. 364c):

• the registration number of each facility that makes it
• the responsible person's name and contact number, and the product name as shown on the label
• the product category
• the full ingredient list, including fragrances, flavors and colors

List a new product within 120 days of US marketing and update it every year. You need the factory's registration number to file, so get it first.

5. Serious adverse events: report within 15 business days

The responsible person must send FDA each serious adverse event report within 15 business days of receiving it, with a copy of the label (21 U.S.C. 364a). FDA has enforced this since December 29, 2023 (FDA notice).

• A serious adverse event is one that leads to death, a life-threatening event, hospitalization, lasting disability, a birth defect, an infection or significant disfigurement, or that needs medical care to prevent one of these.
• New medical information received within 1 year also goes to FDA within 15 business days.
• You can report by electronic submission through ESG, through the Safety Reporting Portal, or by emailing Form FDA 3500A (FDA reporting page).
• Keep adverse event records for 6 years, or 3 years for small businesses.

Some guides say "15 days". The law says 15 business days. Small businesses are not exempt from adverse event reporting.

The responsible person must also keep evidence that each product is safe. FDA requires no specific test and no animal testing (FDA).

6. Labels need an adverse event contact since December 29, 2024

Since December 29, 2024, every cosmetic label must show a US address, a US phone number, or electronic contact information such as a website, where the responsible person can receive adverse event reports (21 U.S.C. 364e). Per FDA's guidance (Q3), an email or website can be foreign or domestic, but a fax number or QR code is unlikely to work.

A package that shows only a Korean phone number does not meet this rule.

• Products for use only by licensed professionals must say so on the label.
• The fragrance allergen labeling rule is not final as of October 2026 (see section 8).

The rest of the US label rules are in our post on FDA labeling requirements.

7. The small business exemption is narrow

A business with average annual US cosmetics sales under about $1 million (adjusted for inflation) over the last 3 years is exempt only from GMP, facility registration and product listing (21 U.S.C. 364h). The law says "$1,000,000, adjusted for inflation", and FDA recommends the GDP price deflator for the adjustment. Near the line, do the math yourself.

• Still required: serious adverse event reports, the label contact and safety records (adverse event records for 3 years)
• No exemption at any sales level for products that touch the eye's mucous membrane, are injected, are for internal use, or change appearance for more than 24 hours
• FDA issues no small business exemption certificate (guidance Q9)

The small business exemption covers GMP, registration and listing only.

8. Rules that are not final yet (October 2026)

As of October 2026, the GMP, talc testing and fragrance allergen labeling rules are all not final.

• GMP: the legal deadline to propose the rule (December 29, 2024) has passed. The federal Unified Agenda lists it under Long-Term Actions.
• Talc testing: the proposed rule of December 27, 2024 was withdrawn on November 28, 2025.
• Fragrance allergen labeling: the legal deadline to propose the rule (June 29, 2024) has passed (Unified Agenda). Trade publication HBW Insight reported that FDA would also miss its May 2026 target.

If a guide gives you a GMP deadline, check whether a final rule exists. Agenda dates are only targets.

9. Sunscreens and acne treatments are OTC drugs

In the US, sunscreen is regulated as a drug (FDA: Cosmetics & U.S. Law). Moisturizers and makeup that claim sun protection are both cosmetics and drugs, and products that claim to treat acne follow the OTC drug rules (FDA: Is It a Cosmetic, a Drug, or Both?).

• A product that is both a cosmetic and a drug is not listed as a cosmetic. It goes in the drug listing, marked as both (FDA guidance).
• A foreign drug maker must register, list its drugs, name one US agent and follow CGMP (FDA: Importing OTC drugs).

A sunscreen sold as a cosmetic at home is a drug in the US.

Five things to check before you sell in the US

1. Do you have your factory's FDA registration number (FEI)?

2. Whose name goes on the label as the responsible person?

3. Does the label show a US address, a US phone number or a website for adverse event reports?

4. Who reports a serious adverse event within 15 business days, and how?

5. Is any product, such as a sunscreen or an acne treatment, a drug in the US?

Wrap-up

The factory registers and renews. The responsible person lists products, reports adverse events, keeps safety records and puts a contact on the label. For GMP and fragrance allergens, track the status of the rule, not a date.

LinkONE runs receiving, storage and fulfillment for cosmetic brands at its 3PL in Fullerton, California, and checks customs and FDA preparation together with the brands it works with.

In the end, preparing for MoCRA is not about getting a certificate. It is about setting up the company on your label to carry the duties.

Frequently Asked Questions

What does MoCRA mean?

MoCRA is the Modernization of Cosmetics Regulation Act of 2022, the US cosmetics law signed on December 29, 2022 (FDA MoCRA page). Under it, facilities that make cosmetics for the US register with FDA. The responsible person named on the label lists each product, reports serious adverse events and keeps safety records.

Is there a MoCRA certification?

No. There is no MoCRA certification, and FDA does not issue certificates or other documents for facility registration or product listing (FDA notice). FDA also says registration is not an approval. A "MoCRA certificate" from a vendor is not an FDA document.

What are the requirements for MoCRA registration?

Every facility that makes or processes cosmetics for the US, including one abroad, must register with FDA, renew every 2 years and report changes within 60 days (21 U.S.C. 364c). A foreign facility must also name a US agent who is physically in the US (FDA guidance). Separately, the responsible person lists each product within 120 days of US marketing.

Who is exempt from MoCRA?

Only small businesses are exempt, and only from GMP, facility registration and product listing: those with average annual US cosmetics sales under about $1 million (adjusted for inflation) over the last 3 years (21 U.S.C. 364h). They still report serious adverse events, put a contact on the label and keep safety records. Products that touch the eye's mucous membrane, are injected, are for internal use or change appearance for more than 24 hours get no exemption.

How fast must you report an adverse event under MoCRA?

The responsible person must report a serious adverse event to FDA within 15 business days of receiving it, with a copy of the label (21 U.S.C. 364a). Records are kept for 6 years, or 3 years for small businesses. Small businesses are not exempt from this duty.

Sources

• FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• FDA: Registration & Listing of Cosmetic Product Facilities and Products
• FDA: Guidance for Industry, Registration and Listing of Cosmetic Product Facilities and Products (December 2024)
• FDA: FDA Clarifies It Does Not Provide Certificates or Other Documents to Verify Compliance

Fees and rules in this post are as of October 2026.

-LinkONE-