Under MoCRA, the factory that makes a cosmetic registers with FDA and renews every 2 years, and the company named on the label (the responsible person) lists every product within 120 days of first sale and updates the listing every year. The responsible person also keeps proof that each product is safe, reports serious adverse events to FDA within 15 business days, keeps adverse event records for 6 years, and prints a US address, US phone number or website for adverse event reports on the label. FDA charges no fee, issues no certificate and approves nothing; small businesses under $1 million in average yearly US cosmetic sales skip registration and listing but keep every other duty.
What MoCRA is and what it covers
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed on December 29, 2022. It added a new chapter to the Federal Food, Drug, and Cosmetic Act (FD&C Act), now in 21 U.S.C. 364 to 364j. Before MoCRA, registering with FDA was voluntary. Now registration, listing, adverse event reporting, safety records and a label contact are legal duties, and FDA gained the power to order recalls and suspend a factory's registration.
Four terms decide everything that follows:
- Cosmetic. A product meant to cleanse, beautify, promote attractiveness or alter appearance. A serum, toner, cream or cleanser sold for how skin looks and feels is a cosmetic.
- Drug. A product meant to treat or prevent disease or affect the body's structure or function. Sunscreen, acne treatments and antidandruff shampoos are over-the-counter (OTC) drugs in the US. Products that are drugs follow FDA's drug rules, and the law exempts them from MoCRA's registration, listing, adverse event and safety substantiation sections (21 U.S.C. 364i). Our cosmetic vs drug guide shows where the line sits.
- Responsible person. The manufacturer, packer or distributor whose name appears on the label. If your brand name and company are on the box, that is you.
- Facility. The establishment that manufactures or processes the cosmetic, including filling and labeling. For skincare made in Korea, the Korean factory is the facility.
MoCRA is not an approval system. FDA does not review formulas before sale, and a registration or listing number does not mean FDA approved anything. FDA repeated this in a September 9, 2026 notice: it does not issue certificates, verification letters or other documents for registration or listing.
Who is legally responsible for what
MoCRA assigns each duty to a role, not to whoever pays. A brand in Texas selling a serum made in Korea typically splits the work like this:
| Duty | Who carries it | Deadline |
|---|---|---|
| Facility registration | Owner or operator of the factory (a brand may submit it on the factory's behalf) | Within 60 days of starting US production; renew every 2 years; changes within 60 days |
| US agent | Named by every foreign facility in its registration | At registration |
| Product listing | Responsible person | Within 120 days of first marketing; update every year |
| Safety substantiation records | Responsible person | Before sale, kept up to date |
| Serious adverse event reports | Responsible person | 15 business days after receiving the report |
| Adverse event records | Responsible person | Keep 6 years (3 for qualifying small businesses) |
| Label contact for adverse events | Responsible person | On every label since December 29, 2024 |
| Recall when FDA asks | Responsible person | Within the time FDA sets |
An importer that is not named on the label and does not manufacture or process the product has no registration or listing duty of its own under FDA's guidance. A retailer or Amazon seller reselling your product is also not the responsible person, unless its name goes on the label.
Facility registration in depth
Under 21 U.S.C. 364c(a), every facility that manufactures or processes cosmetics for distribution in the US registers with FDA. A facility that first starts US production after December 29, 2022 registers within 60 days of starting.
- What the registration contains. The facility's name, physical address, email and phone; for a foreign facility, the contact for its US agent; every brand name made there; and the product categories and responsible person for each product.
- US agent. FDA's guidance describes a US agent as a person or company with a place of business in the US who is physically present there. The agent helps FDA communicate with the foreign facility, answers questions about its products and helps schedule inspections. A Korean factory cannot register without one.
- FEI number. FDA uses the FDA Establishment Identifier (FEI) as the registration number. The factory must obtain an FEI before it registers.
- One registration for a contract manufacturer. A factory that makes products for many brands registers once, and any brand made there may submit that single registration for it.
- Renewal every 2 years. FDA counts the 2 years from the date of initial registration. Since February 11, 2026, Cosmetics Direct shows a registration status and renewal date and sends automated renewal reminders. A factory with no changes can file an abbreviated renewal.
- Changes. Changes to the registration information are reported within 60 days.
- Suspension. FDA can suspend a registration if a product made there has a reasonable probability of causing serious adverse health consequences or death and other products there may be affected. No cosmetic from a suspended facility may be introduced into US commerce.
What this means for you: before you set a launch date, ask your manufacturer for its FEI registration number and confirm it is current. You cannot complete a product listing without it.
Product listing in depth
Under 21 U.S.C. 364c(c), the responsible person lists each cosmetic product, or makes sure the listing is filed. A product first marketed after December 29, 2022 is listed within 120 days of marketing it in interstate commerce. Updates are filed every year.
A listing contains:
- the registration number of every facility where the product is made or processed;
- the responsible person's name and contact number, and the product name exactly as it appears on the label;
- the product category, chosen from FDA's list of cosmetic category codes;
- the full ingredient list, including fragrances, flavors and colors, using the names required for US ingredient labels (21 CFR 701.3) or the common name;
- the product listing number, once FDA has assigned one.
Flexible listings. One listing can cover products with identical formulas, or formulas that differ only in color, fragrance, flavor or pack size. A 30 mL and a 50 mL bottle of the same serum can share a listing; a serum with 5% niacinamide and one with 10% cannot.
Formula changes. The law requires updates once a year, with an abbreviated renewal when nothing changed. If you change an ingredient, record it and include it in the next update at the latest. Many brands update at the time of the change so the FDA record matches what is on shelves.
How to file. Through Cosmetics Direct, FDA's free online portal, which builds a Structured Product Labeling (SPL) file and submits it; or with your own SPL software through FDA's electronic gateway (ESG NextGen), where an account can take 1 to 3 weeks to set up; or on paper with Form FDA 5066 (registration) and 5067 (listing). FDA strongly encourages electronic filing.
Step by step: from formula to legal US sale
The steps below follow a 30 mL vitamin C serum made in Korea and sold on a brand's own website and Amazon US.
- Confirm the product is a cosmetic
Read every planned claim on the label, website and Amazon listing. "Brightens dull skin" is a cosmetic claim; "treats acne" or "SPF 30" makes it a drug, which needs OTC monograph compliance and drug registration instead. Decide this before the formula is final.
- Check every ingredient against US rules
Confirm that no ingredient is prohibited or restricted under 21 CFR 700, that every color additive is approved for the intended use under 21 CFR 73, 74 and 82, and that the formula meets the state laws where you sell (see the state ingredient bans guide).
- Get the facility details from your manufacturer
Ask for the factory's FEI registration number and the name of its US agent. At KoreanOEM the production facility is FDA registered, and our team uses its registration number when we file your listing.
- Decide who the responsible person is
Usually your company. Its name goes on the label with "Distributed by" or "Manufactured for". A company outside the US can be the responsible person, but the label still needs a US address, US phone number or electronic contact for adverse event reports.
- Build the safety file
Collect the formula and INCI list, ingredient safety data, stability results, preservative efficacy (challenge) test, any skin tests and the batch certificates of analysis (COA). Expect 2 to 8 weeks if new tests are needed. Details are in the next section.
- Approve a compliant label
Identity, net contents in US units, ingredients in the US format, the responsible person's name and address, "Made in Korea", warnings and the adverse event contact. See the label requirements by country for the full US list.
- Produce and import
The goods enter through US Customs and Border Protection, and FDA reviews cosmetic entries. FDA can detain products that appear adulterated or misbranded, for example with no English ingredient list. The import papers are covered in our guide to importing skincare from Korea.
- List the product within 120 days of first sale
File in Cosmetics Direct with the facility registration number, the category code and the full ingredient list. Save the confirmation; FDA assigns a listing number but does not publish it.
- Set up adverse event handling
One inbox and phone line that match the label, a log, and a person who decides within days whether a report is serious. Then put the yearly listing update and the factory's 2-year renewal in a calendar.
Safety substantiation and records
Under 21 U.S.C. 364d, the responsible person must ensure, and keep records showing, that there is adequate substantiation of safety for each product. The law defines this as tests, studies, research, analyses or other evidence that qualified experts consider enough to support a reasonable certainty that the product is safe as used. "Safe" means not injurious to users under the labeled or customary conditions of use; minor, passing irritation in some users does not by itself make a product unsafe.
Neither the law nor FDA prescribes specific tests, and animal testing is not required. A practical file for a Korean-made skincare product holds:
- the quantitative formula and the INCI list, with the function of each ingredient;
- safety data for each ingredient (supplier safety data, published reviews such as Cosmetic Ingredient Review conclusions, use levels);
- stability and packaging compatibility data that support the shelf life;
- a challenge test showing the preservative works, and microbiology results per batch;
- skin tests where claims or risk call for them (patch test or HRIPT);
- a signed review by a qualified person tying the evidence to the product's intended use.
FDA can inspect these records. Under 21 U.S.C. 364f, when FDA reasonably believes a product is likely adulterated in a way that threatens serious harm, it can access and copy related records, but not recipes or formulas, financial, pricing or personnel data. Our product testing guide explains each test and what it shows.
Serious adverse event reports
A serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, a birth defect, an infection, or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or a persistent or significant change in appearance not intended by the product), or that needs medical or surgical intervention to prevent one of those outcomes (21 U.S.C. 364).
- Receive and log every report
Record the date, the customer's contact, the product and batch, what happened and any medical details. Log non-serious complaints too: you must keep records of all adverse event reports you receive.
- Decide if it is serious
Use the legal definition above, not your own judgment of whether the product caused it. If in doubt, ask a medical professional or regulatory adviser the same day.
- Report serious events within 15 business days
Send the report to FDA with a copy of the product label, electronically or on MedWatch Form 3500A.
- Send follow-up information
New and material medical information received within 1 year of the first report goes to FDA within 15 business days of receipt.
- Keep the records
6 years for all adverse event records; 3 years for a qualifying small business that does not make the higher-risk products listed in the small business section.
The full incident and recall process, with log templates, is in our recalls and adverse events guide.
The label under MoCRA
MoCRA added two label duties to the existing FDA cosmetic labeling rules (21 CFR 701 and 740) and the Fair Packaging and Labeling Act:
- Adverse event contact (since December 29, 2024). Every label shows a domestic address, a domestic phone number or electronic contact information, which may be a website, where the responsible person receives adverse event reports (21 U.S.C. 364e(a)).
- Professional use only. A product meant only for licensed professionals (cosmetology, nail care, barbering or esthetics) must say clearly and prominently that it is to be used only by licensed professionals.
- Fragrance allergens (not yet in force). Allergens in fragrance will have to be named on the label once FDA defines them by regulation. See the pending rules section.
You do not print the FDA listing number or the factory's registration number on the label. The full US label, including net contents in US units and the ingredient order, is in our label requirements guide, and the INCI and claims guide covers ingredient names. Before printing, our label proof check compares your artwork against the US rules.
The small business exemption
Under 21 U.S.C. 364h, a responsible person or facility owner whose average gross annual US sales of cosmetics over the previous 3 years are less than $1,000,000, adjusted for inflation, counts as a small business. Check FDA's pages for the current adjusted figure before you rely on it.
| Duty | Small business | Everyone else |
|---|---|---|
| Facility registration | Exempt | Required |
| Product listing | Exempt | Required |
| Future GMP rule | Exempt | Will apply |
| Serious adverse event reports | Required | Required |
| Adverse event records | 3 years | 6 years |
| Safety substantiation | Required | Required |
| Label contact and professional use labeling | Required | Required |
| Mandatory recall | Applies | Applies |
The exemption never applies to a company that makes or processes products that regularly touch the mucous membrane of the eye, products that are injected, products for internal use, or products meant to change appearance for more than 24 hours where removal by the user is not part of normal use. Face serums, toners, creams and cleansers are usually not in these groups; eye makeup removers and some eye-area products can be.
The test is applied to each company separately. Your brand may be exempt while your Korean factory still must register, because its sales across all its brands count. FDA does not issue exemption letters, so keep your sales records as proof. Many small brands list anyway, because Amazon, TikTok Shop and retailers ask for listing details (see selling on Amazon and TikTok Shop).
Ingredient rules and claims
MoCRA did not create an ingredient list of its own. The US rules are still:
- Prohibited and restricted ingredients in 21 CFR 700, among them mercury compounds (with narrow eye-area exceptions), chloroform, methylene chloride, vinyl chloride, zirconium in aerosols, bithionol, halogenated salicylanilides, chlorofluorocarbon propellants and prohibited cattle materials; hexachlorophene is limited separately under 21 CFR 250.250.
- Color additives must be approved for the intended use and, for many, batch certified by FDA (21 CFR 73, 74 and 82). A colorant allowed in Korea or the EU may not be allowed around the eyes in the US.
- Adulteration and misbranding: a cosmetic must not contain a substance that makes it injurious under normal use, must be made in sanitary conditions, and its labeling must not be false or misleading.
- State laws move faster than FDA: California, Washington, Maine and other states ban specific ingredients such as intentionally added PFAS, formaldehyde releasers or certain phthalates in cosmetics, with dates that differ by state. See the Prop 65 and state bans guide.
Claims decide the category. Words like "treats", "heals", "prevents acne", "repairs the skin barrier" in a medical sense, "SPF" or "stimulates collagen production" can turn a cosmetic into a drug in FDA's eyes. Our claims guide and the sunscreen regulation guide cover this in depth.
Recalls and FDA enforcement powers
Most cosmetic recalls are voluntary: the company finds a problem, such as microbial contamination, and removes the product, often working with FDA. MoCRA added a mandatory recall power (21 U.S.C. 364g):
- FDA finds a reasonable probability of serious harm
The cosmetic is likely adulterated or misbranded, and use or exposure will cause serious adverse health consequences or death.
- FDA first offers a voluntary recall
The responsible person can cease distribution and recall on its own, within the time and manner FDA sets.
- If the company does not act, FDA orders it
FDA can order the company to stop distribution immediately, offers an informal hearing within 10 days, and can then amend the order to require a recall, including notice to the people affected.
FDA can also suspend a facility's registration, refuse imports, issue warning letters, and seek seizure or injunction through the courts. A clear batch number on every unit and a list of where each batch went make any recall smaller and faster.
Rules still pending: GMP, allergens, talc, PFAS
MoCRA ordered FDA to write several rules. As of October 2026, here is where each one stands:
| Rule | What MoCRA required | Status as of October 2026 |
|---|---|---|
| Cosmetic GMP (21 U.S.C. 364b) | Proposed rule by December 29, 2024, final rule by December 29, 2025, consistent where practicable with national and international standards | No proposed rule published. FDA's 2013 draft GMP guidance is still the document on record, and trade press reports the rule is not on FDA's July 2026 regulatory agenda. ISO 22716 is the international cosmetic GMP standard. |
| Fragrance allergen labeling (21 U.S.C. 364e(b)) | Proposed rule within 18 months (by June 29, 2024), final rule 180 days after comments close; FDA must consider EU rules | Not published. Trade press reports FDA's 2026 Unified Agenda (released July 3, 2026) targets a proposed rule, "Disclosure of Fragrance Allergens in Cosmetic Labeling", for November 2026. No labeling duty applies until a final rule sets the list and a date. |
| Asbestos testing for talc products | Proposed rule within 1 year, final rule 180 days after comments | Proposed December 2024, withdrawn November 2025. No new proposal as of October 2026. |
| PFAS report | Report on PFAS use and risks in cosmetics by December 29, 2025 | Published December 29, 2025. FDA found too little data to assess the safety of most PFAS it reviewed. There is no federal PFAS ban for cosmetics; several states have their own. |
| Formaldehyde in hair smoothing products (not a MoCRA mandate) | None | Trade press reports a proposed ban listed for November 2026 on the same agenda. It concerns hair products, not skincare. |
If you also sell in the EU, your labels already name the EU fragrance allergens, which is the list FDA must consider. Formulating with fragrance-free or low-allergen options avoids a relabel later; see our fragrance-free formulating guide.
Key dates
| Date | What happened |
|---|---|
| December 29, 2022 | MoCRA signed into law |
| December 29, 2023 | Legal deadline to register existing facilities and list existing products; adverse event reporting in force |
| July 1, 2024 | FDA begins enforcing registration and listing |
| December 29, 2024 | Adverse event contact and professional use statements required on labels |
| November 2025 | Talc asbestos testing proposal withdrawn |
| December 29, 2025 | FDA publishes its PFAS report |
| February 11, 2026 | Cosmetics Direct adds renewal dates and automated reminders for the first 2-year renewals |
| September 9, 2026 | FDA clarifies it issues no certificates for registration or listing |
| November 2026 (target) | Fragrance allergen proposed rule, per the Unified Agenda as reported |
What the importer does and what we provide
The US company that imports and is named on the label carries the MoCRA duties of the responsible person. Here is how the work divides when KoreanOEM makes the product:
| Task | Your company (responsible person) | KoreanOEM |
|---|---|---|
| Facility registration | Nothing to file | The production facility is FDA registered (MoCRA facility registration) |
| Product listing | Approve the details; remains your legal duty | Our team files the listing for USD 150 per SKU |
| Safety file | Own it, keep it, update it | Full INCI list after the NDA, COA and microbiology per batch, MSDS, specification, stability data for library formulas; challenge test from USD 1,000 per formula; patch test from USD 1,000; HRIPT from USD 3,000 |
| Label | Approve the final text; your designer supplies artwork | Dieline, print specs and a label proof check against US rules |
| Adverse events and recalls | Receive, assess and report; run any recall | Batch records and production data to support your investigation |
| Customs entry | Your customs broker files the entry | Commercial invoice, packing list, Certificate of Origin for the KORUS rate |
- Paying for an "FDA registration certificate". FDA issues none, and a paid certificate is not an FDA document.
- Launching before you have the factory's FEI registration number, then missing the 120-day listing deadline.
- Assuming the small business exemption covers adverse event reporting, safety records or the label contact. It does not.
- Printing a Korean or foreign phone number as the only contact. The label needs a US address, US phone number or electronic contact such as a website.
- Adding an SPF, acne or "heals" claim to a cosmetic. The product becomes an OTC drug with different rules.
- Changing the formula or adding a shade and forgetting the yearly listing update.
- Keeping only serious adverse event records. You must keep records of every adverse event report you receive.
- Treating MoCRA as the only US law: state ingredient bans and Prop 65 warnings still apply.
- Every claim reviewed: the product is a cosmetic, not a drug.
- Ingredients checked against 21 CFR 700, approved color additives and the state laws where you sell.
- Factory FEI registration number and US agent name received from the manufacturer.
- Your company confirmed as the responsible person, with its name and address on the label.
- US address, US phone number or website for adverse event reports printed on every label.
- Safety file complete: formula, INCI, ingredient data, stability, challenge test, batch COAs, signed review.
- Label proof checked: identity, net contents, ingredients, "Made in Korea", warnings.
- Product listing filed within 120 days of first sale, confirmation saved.
- Adverse event inbox, log and a named decision maker in place.
- Calendar set: yearly listing update and the factory's 2-year renewal.
- Sales records kept if you rely on the small business exemption.
- Watch list: FDA fragrance allergen and GMP rules, and your states' ingredient laws.
How KoreanOEM helps
We are a Korean skincare OEM and private label manufacturer: we develop your formula and produce it in Korea, at an ISO 22716 (cosmetics GMP) facility that is FDA registered under MoCRA. For a US launch we cover the manufacturer's side of MoCRA and file the part you are allowed to hand off.
- MoCRA product listing filed by our team, USD 150 per SKU.
- The documents for your safety file: full INCI list after the NDA, COA and microbiology for every batch, MSDS, specification and stability data for library formulas.
- Optional tests: challenge test (ISO 11930) from USD 1,000 per formula, patch test from USD 1,000, HRIPT from USD 3,000 (50 people) or USD 5,500 (100 people).
- A label proof check against US rules before printing, and a Certificate of Origin for KORUS duty rates.
- Cosmetic claims kept cosmetic at the brief stage. US sunscreen is an OTC drug, quoted case by case.
All fees are on our fees page, and the US market overview is on skincare manufacturing for the US.
Frequently asked questions
Is MoCRA registration the same as FDA approval?
Does a Korean factory need a US agent for MoCRA?
Who lists the product: the brand or the manufacturer?
How often do I update a MoCRA product listing?
Am I exempt from MoCRA as a small brand?
What counts as a serious adverse event for a skincare product?
Do I have to list fragrance allergens on US labels now?
Does MoCRA apply to sunscreen?
What does MoCRA compliance cost?
Sources
- FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA), status page
- FDA: Registration and Listing of Cosmetic Product Facilities and Products (renewal, FEI, Cosmetics Direct, 2026 updates)
- FDA: Guidance for Industry, Registration and Listing of Cosmetic Product Facilities and Products (December 2024)
- FDA: FDA clarifies it does not provide certificates for cosmetic registration (September 2026)
- US Code (Cornell LII): 21 U.S.C. 364 definitions, 364a adverse events, 364b GMP, 364c registration and listing, 364d safety substantiation, 364e labeling, 364f records, 364g mandatory recall, 364h small businesses, 364i drug exemption
- FDA: Small Businesses and Homemade Cosmetics, Fact Sheet
- FDA: How to report a cosmetic product related complaint
- FDA: Cosmetics Labeling Guide and eCFR: 21 CFR Part 700 (prohibited and restricted ingredients)
- Federal Register: withdrawal of the proposed talc asbestos testing rule (November 2025)
- ChemLinked: FDA targets November 2026 for fragrance allergen and formaldehyde proposals (2026 Unified Agenda)
- Farella Braun + Martel: FDA finds insufficient data to determine safety of most PFAS in cosmetics (summary of the December 2025 report)
Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.