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MoCRA checklist: 8 compliance steps for importing cosmetics to the USA

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QUICK ANSWER A MoCRA checklist for importing cosmetics has eight steps. Confirm MoCRA covers your product and company, identify the responsible person and every facility, check the factory's FDA registration and FEI number, and list each product within 120 days of marketing. Then bring the label in line with US rules, keep safety substantiation records, report serious adverse events from product use in the US within 15 business days and prepare each shipment for FDA review at the border. Registrations renew every two years, and listings are updated every year. FDA issues no certificate for either, so the FEI number and your own records are your proof.

This MoCRA checklist is for brands and importers bringing cosmetics into the US. Platton is an import-focused US forwarder that ships cosmetics from Asia and Europe with reliable, on-time service. Our AI-driven platform tracks each shipment in real time, so you always know where your products are, and a quote for your next order comes back with live pricing. We handle the freight so you can focus on the eight steps below.

1. Confirm MoCRA covers your product and your company

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, became law on December 29, 2022 and amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). Two questions decide how much of MoCRA reaches you: is the product a cosmetic under US law, and does your company qualify as a small business? If this is your first import, our first-time importer guide covers the freight and customs basics that run alongside these MoCRA requirements.

TAKEAWAY Check the claims first: sunscreens are cosmetics in some countries and drugs in the US. A moisturizer or makeup product sold with a sun-protection claim is a cosmetic and a drug at once, and it must meet both sets of rules.

Cosmetic, drug or both: products that follow drug rules

FDA classifies a product by its intended use. It reads that use from the claims on the label, in advertising and online, from how consumers perceive the product and from ingredients with a known therapeutic use. Claims to restore hair growth or regenerate cells make a product a drug. So do claims about acne, dandruff, eczema or anti-aging effects on the structure or function of the skin. Antidandruff shampoo, fluoride toothpaste and antiperspirant deodorants are both cosmetics and drugs. A drug needs an approved new drug application or must conform to an OTC monograph.

A cosmetic that is also a drug and subject to the drug rules is exempt from MoCRA's sections on registration and listing, good manufacturing practice (GMP), adverse event reporting, safety substantiation, the label contact, records access and recalls. A factory that also makes cosmetics that are not drugs stays covered for those products.

The small business exemption: $1 million and four product types

A responsible person or facility owner or operator is exempt from registration and listing when its average gross annual US sales of cosmetic products over the previous three years were under $1,000,000, adjusted for inflation. FDA collects no proof of small business status and issues no exemption certificate, so keep your own sales calculation on file.

The exemption does not apply to a business that makes any of these four product types:

  • products that regularly touch the mucous membrane of the eye, such as eye shadow, eye makeup remover, liquid or mucosal eyeliner and false eyelash adhesive (facial cleansers, moisturizers and serums generally do not)
  • injected products
  • products for internal use
  • products meant to alter appearance for more than 24 hours where removal by the consumer is not part of customary use, such as certain nail polishes, some hair and eyebrow dyes, tattoo inks and certain leave-on skin preparations

What the small business exemption does and does not cover

MoCRA requirement For an exempt small business
Facility registration Not required
Product listing Not required
GMP rules, once issued Not required
Serious adverse event reporting Still required
Adverse event records Kept 3 years instead of 6
Safety substantiation Still required
Label contact and other labeling rules Still required

2. Identify the responsible person and every facility

MoCRA splits its duties between two roles. The responsible person, the company named on the label, carries the product duties: listing, the label contact, safety records and adverse event reports. A facility, any site that manufactures or processes the product for US distribution, registers with FDA. Any party in an import can hold either role or both, so the MoCRA requirements for importers depend on the role you actually hold. Map every party before the first shipment.

MoCRA roles in a cosmetics import

Party MoCRA role What the role requires
Brand named on the label, US or foreign Responsible person Product listing, label contact, safety substantiation records, serious adverse event reports
Factory or contract manufacturer Facility FDA registration, renewed every 2 years
Factory outside the US Facility FDA registration with a US agent physically present in the US
Importer named on the label, for example as distributor Responsible person The same duties as any responsible person
Importer whose warehouse fills containers with product Facility Registration of that warehouse
Importer that only stores, distributes, labels or repacks Neither, unless named on the label No registration and no listing

TAKEAWAY What FDA says about importers: an importer registers or lists only when it meets the definition of a facility or a responsible person and no exemption applies; otherwise it does neither (FDA registration and listing guidance, Question 10).

The responsible person is the company named on the label

If your brand is on the pack, you are the responsible person, even when a contract manufacturer makes the product. MoCRA gives the role to the manufacturer, packer or distributor whose name appears on the label, so the label settles the question. A label that reads "Distributed by" with your company's name gives you the role as the importer.

A foreign brand can be the responsible person too, when it is the manufacturer, packer or distributor named on the label. Its label still needs a domestic address, a domestic phone number or an electronic contact where adverse event reports can reach it. Whoever holds the role owns steps 4 to 7 below.

When an importer's warehouse counts as a facility

A warehouse that decants bulk lotion into bottles registers with FDA. MoCRA counts an importer's establishment as a facility only when it manufactures or processes cosmetics distributed in the US, and filling a container counts as processing. A site that only labels, relabels, packs, repacks, stores or distributes finished products is outside the definition.

3. Check the factory's FDA registration, FEI number and US agent

Unless an exemption applies, every factory that manufactures or processes your cosmetics for the US must be registered with FDA, wherever it is located. Confirm it before you order. Ask for the FEI number, the renewal date and, for a factory abroad, the name of its US agent.

FDA registration dates and figures

Date or figure What it means
December 29, 2023 Registration deadline for facilities operating on December 29, 2022
July 1, 2024 FDA starts enforcing registration and listing
60 days For a new facility to register after it first manufactures or processes, and for reporting any change
7 to 10 business days Typical FDA processing time for a cosmetic FEI request
1 to 3 weeks To set up an ESG NextGen account for electronic submissions
$0 FDA fee for registration or listing
2 years Renewal cycle, counted from the date of initial registration
February 11, 2026 Cosmetics Direct starts showing registration status and renewal date, with automated reminders
5 business days For the responsible person to give FDA a plan after notice of a possible suspension
16,398 Active facility registrations on June 30, 2026

TAKEAWAY ISO 22716 and registration: a contract manufacturer outside the US that makes products distributed in the US must register. FDA's guidance (Question 14) states that following ISO 22716 is not an exemption.

What registration requires and by when

A facility that starts later registers within 60 days of first manufacturing or processing. Changes also go to FDA within 60 days. A contract manufacturer files a single registration even when it makes products for several brands, and the factory or any of those brands can submit it.

The registration names every brand sold from the facility, its product categories and the responsible person for each product, so ask the factory to confirm your brand is on it. A facility can file in Cosmetics Direct, FDA's portal, or use Structured Product Labeling (SPL) software over an ESG NextGen account.

FDA can suspend a registration when a product from the facility has a reasonable probability of causing serious adverse health consequences or death and the failure is not isolated to one product. Once a registration is suspended, nobody may introduce cosmetics from that facility into US commerce. Failing to register is itself a prohibited act under section 301 of the FD&C Act.

The FEI number and the US agent for a foreign factory

The registration number is the factory's FDA Establishment Identifier, or FEI. The owner or operator requests it before registering. Ask for the number in writing with your other supplier documents, because each product listing in step 4 must give the registration number of every facility that makes the product.

A foreign factory registers with a US agent who lives in or keeps a place of business in the US and is physically present there. A mailbox or an answering service does not qualify. FDA's draft guidance describes the agent's role as helping FDA communicate with the factory, answering questions about its products imported or offered for import and helping schedule inspections.

2026 renewals, and why there is no FDA certificate

A registration renews every two years from the date of the first registration. Early renewal is allowed, and a facility with no changes can file the abbreviated renewal. A facility registered by the July 1, 2024 enforcement date had to renew two years after its own registration date, so by July 1, 2026 at the latest.

On September 9, 2026, FDA announced that it issues no certificate, verification letter or email confirming a cosmetic registration or listing, and no document confirming that a company does not need to register. A registration or listing number is not an FDA approval.

TAKEAWAY About "FDA registration certificates": a certificate sold by a third party is not an FDA document, because FDA issues none for cosmetics. What counts is the FEI number and the status shown in Cosmetics Direct.

4. List every product with FDA within 120 days

The responsible person submits a listing for each cosmetic product, or makes sure it is submitted. Products on the market when MoCRA passed were due by December 29, 2023. A new product is listed within 120 days of first marketing in interstate commerce. Listings are updated every year, including when a product is discontinued, and an abbreviated renewal covers listings with no changes.

Each listing carries:

  • the registration number of every facility where the product is made or processed
  • the responsible person's name and contact number
  • the product name as it appears on the label, which FDA treats as separate from the brand name
  • the product category
  • the ingredient list, fragrances, flavors and colors included, under 21 CFR 701.3 or common names
  • any prior listing number

Listings also go in through Cosmetics Direct. FDA does not publish listing numbers, so keep your own record of each one.

TAKEAWAY One listing per formula: products with identical formulas, or formulas that differ only in color, fragrance, flavor or quantity of contents, can share one listing. A lipstick sold in many shades of one base formula can go in a single listing.

5. Make every label meet US rules

A packaged cosmetic is misbranded when its label lacks the name and place of business of the manufacturer, packer or distributor, an accurate net quantity or the information MoCRA added. These FDA requirements for cosmetics apply to imports and US-made products alike. Check the artwork against this table before the supplier prints.

Label checks for imported cosmetics

Element Rule Source
Language All required information in English; if the label also uses another language, all required information appears in that language too 21 CFR 701.2(b)
Statement of identity On the principal display panel 21 CFR 701.11
Name and place of business Manufacturer, packer or distributor with street address, city, state and ZIP code; "Manufactured for" or "Distributed by" when that firm did not make the product 21 CFR 701.12
Net quantity Weight, measure or count: fluid measure for liquids, weight for solids 21 CFR 701.13
Ingredient order Descending order of predominance; alternatively, ingredients above 1 percent first in descending order, then those at 1 percent or less in any order, then color additives in any order (21 CFR 701.3(f)); letters at least 1/16 inch high 21 CFR 701.3
Ingredient names US common or usual names; "fragrance" and "flavor" may be declared as such; "aqua", "mel" and "parfum" only in parentheses; Latin INCI botanical names only in parentheses after the common name; C.I. numbers only after the US color additive name FDA cosmetics importers page
Color additives Approved for the intended use; some must come from batches certified by FDA FDA cosmetics importers page
Adverse event contact Domestic address, domestic phone number or electronic contact such as a website 21 U.S.C. 364e
Professional-use products Clear, prominent statement that only professionals authorized by a state to practice may use the product 21 U.S.C. 364e
Aerosols The warning in 21 CFR 740.11(a)(1), including "Do not store at temperature above 120 °F" 21 CFR 740.11

What MoCRA added to the label

Since December 29, 2024, every cosmetic label must carry a domestic address, a domestic phone number or an electronic contact (a website counts) where the responsible person receives adverse event reports. FDA advises that a fax number or a QR code is unlikely to work for this. Once FDA lists fragrance allergens by regulation, the label will have to name each one in the product; step 6 shows where that rule stands.

Where foreign-made labels fail FDA rules

FDA names faulty ingredient declarations and missing English among the labeling violations behind its refusals of imported cosmetics, so check those rows of the table first. For articles distributed solely in Puerto Rico or a US territory where the predominant language is not English, that language may take the place of English. Country of origin marking is a separate requirement of US Customs and Border Protection (CBP) for most imported goods, set out in our guide to country of origin marking.

Bulk product labeled after import

Bulk cosmetics shipped to another establishment to be processed, labeled or repacked are exempt from labeling in transit and while held there. The shipper must operate that establishment or hold a written agreement signed by its operator. FDA says the agreement must be available to customs officials when the shipment is offered for import. The exemption is void if the product leaves that establishment unlabeled.

6. Keep safety substantiation records for every product

A cosmetic without adequate safety substantiation is adulterated under the FD&C Act. The responsible person must make sure the safety of each product is adequately substantiated and keep the records that support it.

TAKEAWAY GMP status: FDA has published no proposed GMP rule, so no MoCRA GMP requirement binds cosmetic factories today. Under the FD&C Act, an ingredient that makes a product harmful under labeled or customary use is illegal with or without a specific rule. FDA also bans or restricts named ingredients such as bithionol, chloroform, hexachlorophene and mercury compounds.

What counts as adequate substantiation

The standard is a reasonable certainty that the product is safe, backed by tests, studies, research, analyses or other evidence that qualified experts consider sufficient. No law or FDA rule prescribes specific tests, and existing safety data can be used. Animal testing is not required. Minor and transient reactions in some users do not make a product unsafe.

FDA can reach these records. When it reasonably believes a product is likely adulterated and presents a threat of serious adverse health consequences or death, the responsible person and the facility must let FDA access and copy the related records.

When FDA finds a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious adverse health consequences or death, it first offers a voluntary recall. If the company refuses, FDA can order distribution to stop and amend the order into a recall.

MoCRA rules still pending in 2026

MoCRA rules and reports: status on October 8, 2026

Rule or report Status on October 8, 2026
Good manufacturing practice (GMP) MoCRA required a proposed rule by December 29, 2024 and a final rule by December 29, 2025. No proposed rule is in the Federal Register; FDA's MoCRA page links only a listening session and the draft guidance "Cosmetic Good Manufacturing Practices".
Fragrance allergens on the label MoCRA set June 29, 2024 for the proposed rule and 180 days after comments close for the final rule. Nothing has been published; the 2026 Unified Agenda lists the proposed rule (RIN 0910-AI90) for November 2026.
Asbestos testing methods for talc products Proposed rule published December 27, 2024 and withdrawn November 28, 2025.
PFAS in cosmetic products FDA published its "Report on the Use of PFAS in Cosmetic Products and Associated Risks" on December 29, 2025.
Formaldehyde in heated hair smoothing and straightening products (FD&C Act, outside MoCRA) A proposed ban on formaldehyde and formaldehyde-releasing chemicals is on the 2026 Unified Agenda for November 2026 (RIN 0910-AI83).

Until FDA lists fragrance allergens by regulation, 21 CFR 701.3 still lets a label declare fragrance as "fragrance". If a label change is coming anyway, check the status of the November 2026 proposal before you finalize the artwork. MoCRA also leaves states free to ban or limit ingredients and to keep the ingredient reporting rules they had before MoCRA.

7. Report serious adverse events within 15 business days

The clock starts on the day the responsible person receives a report of a serious adverse event associated with use of one of its products in the US. Within 15 business days, it must report the event to FDA with a copy of the retail label. Reports come in through the contact printed on the label (step 5).

An adverse event is serious when it results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability, a congenital anomaly, an infection or significant disfigurement. Disfigurement includes serious and persistent rashes, second- or third-degree burns, significant hair loss and persistent changes in appearance. An event that needs medical or surgical intervention to prevent one of these outcomes counts too.

TAKEAWAY The deadlines in this step:

  • 15 business days from receipt to report a serious adverse event, with the retail label attached
  • 15 business days for new and material medical information received within a year of the first report
  • 30 days to answer a written FDA request for the fragrance or flavor ingredients suspected in a serious event
  • 6 years to keep adverse event records, or 3 years for a small business that makes none of the four excluded product types

8. Prepare each shipment for FDA review at the border

FDA works with CBP, and imported cosmetics can be examined when they are offered for entry. FDA inspects or samples only part of the shipments and uses import alerts to target trends, so a product that has never been detained can still be detained. Cosmetics that appear adulterated or misbranded may be refused, and FDA publishes its refusals every month. The common reasons FDA lists are unsafe ingredients or contaminants, color additive violations, prohibited or restricted ingredients, microbial contamination, labeling violations and claims that make the product a drug. Since MoCRA, FDA can also refuse admission when it has credible evidence that the responsible person has not complied with the serious adverse event rules or has not allowed access to the adverse event records.

TAKEAWAY Prior notice: FDA prior notice applies to imported food, and cosmetics fall outside it. A cosmetics entry carries the FDA data below instead. For products that do need prior notice, see our guide to importing food.

The FDA data on a cosmetics entry

FDA's sheet "Information for Successfully Filing Entries of Cosmetics" lists what a cosmetics entry line needs. Each line carries the government agency program code COS, an FDA product code under industry code 50 or 53, a product description with the common or market name, and the quantity and units. It also names four parties with their addresses: the manufacturer, the shipper, the FDA importer (the importer of record) and the deliver-to party (the consignee). FEI and DUNS numbers are optional but encouraged. FDA asks importers to share the sheet with whoever files their entries.

FDA has not changed its import message set to collect MoCRA registration or listing information. Its page for importers says a registration number is not required to import cosmetics. The FDA lines ride on the CBP entry described in our guide to the customs entry process.

Cosmetics classify in chapter 33 of the Harmonized Tariff Schedule (HTS). Heading 3303 covers perfumes and toilet waters, and 3304 covers beauty, make-up and skin care preparations, sunscreen and manicure preparations included. Hair preparations go under 3305. Heading 3307 takes shaving preparations, deodorants, bath preparations, depilatories and other toilet preparations. An FDA flag on the HTS line tells the filer whether to send FDA data, and a cosmetic is under FDA rules with or without a flag. Our guide to HTS classification shows how to find and verify the code.

Import alerts 53-06, 53-17 and 53-21

An import alert lets FDA detain a product's shipments without physical examination (DWPE). Three DWPE alerts in FDA's 53 (cosmetics) series were active on October 8, 2026.

Cosmetics import alerts on October 8, 2026

Import alert What it covers Last published
53-06 Color additive violations July 31, 2026
53-17 Microbiological contamination September 30, 2026
53-21 Adulterated cosmetic products and ingredients beyond microbes and colors, such as heavy metals found by sampling or insanitary conditions found on inspection September 28, 2026

Alert 53-21 also covers mercury skin-whitening creams. Releasing a shipment under it takes evidence such as analytical results. FDA allows mercury compounds only in eye-area products, at up to 65 ppm, and in other products only as traces under 1 ppm.

Detention, refusal and the 90-day export window

A detained cosmetic must be shown to comply or brought into compliance, or it is refused. While it is detained, FDA can authorize relabeling or other corrective action. Once it is refused, the goods are destroyed unless they are exported within 90 days of the refusal notice, or within extra time CBP allows. Storage, cartage and labor for refused goods are charged to the owner or consignee. For the CBP side of a held container, see our guide to customs holds and exams.

The 8 steps in one table: owner, deadline, proof to keep

Use this MoCRA compliance checklist as the one-page version of the steps above.

MoCRA checklist for a cosmetics import

Step Owner Deadline or figure Proof to keep
1. Confirm MoCRA covers the product and company Responsible person Before the first order; exemption under $1 million average annual US sales over 3 years Review of label and online claims; the sales calculation behind any exemption
2. Identify the responsible person and facilities Brand, factory and importer Before the first shipment The label naming the responsible person; a list of every facility and its role
3. Check the factory's registration Factory owner or operator; for a contract manufacturer, the factory or any brand it makes for New facility within 60 days; changes within 60 days; renewal every 2 years FEI number, registration status and renewal date, US agent's name
4. List every product Responsible person Within 120 days of marketing; update every year Listing numbers and the date of each annual update
5. Check every label Responsible person Before printing; adverse event contact required since December 29, 2024 Final label artwork with ingredient names checked
6. Keep safety substantiation Responsible person For every product on the market Tests, studies, analyses and expert assessments for each product
7. Report serious adverse events Responsible person 15 business days; records kept 6 years, or 3 for small businesses Reports filed, retail label copies, adverse event records
8. Prepare the entry Importer of record and its entry filer At entry; 90 days to export after a refusal FDA entry data, FEI on the entry where available, analytical results for goods under an import alert

How Platton helps with cosmetics freight

As a forwarder specialized in imports into the US, we move your cosmetics at competitive rates negotiated with the major carriers, with quotes, bookings, documents and tracking on one platform.

Cosmetics orders by sea or air from Asia and Europe

Your cosmetics go by ocean freight, or by air freight when stock has to arrive fast. Shipping from China to the USA runs from Shanghai, Ningbo, Shenzhen, Qingdao and Xiamen. Shipping from India to the USA leaves from Nhava Sheva and Mundra, and shipping from Europe to the USA from Rotterdam, Antwerp, Hamburg, Felixstowe and Le Havre. We book weekly sailings from Asia and Europe with Maersk, MSC, CMA CGM, Evergreen and Hapag-Lloyd. Your beauty stock sails on the vessel you planned for, with space confirmed even in peak season. Flag aerosols when you request a quote, because they travel as dangerous goods under UN1950, in Divisions 2.1 and 2.2. The full service is on our beauty and cosmetics logistics page.

Several suppliers consolidated into one shipment

Buying from several factories? With buyers consolidation, we pick up each supplier's cartons at origin and ship them together. Smaller loads go as LCL shipping, and a full container takes over once the volume is there. You manage one booking and one arrival instead of one per supplier.

Supplier documents collected and checked before booking

A missing FEI number or label file is easier to fix while the goods are still at the factory. Our supplier document validation service collects each supplier's documents and checks that every set is complete before the cargo books, so gaps like these show up early. The documents sit on the same platform as your quotes and bookings, and automated documentation keeps each shipment file current.

Live tracking until beauty stock reaches your warehouse or Amazon

Cargo tracking on our AI-driven platform shows every container in real time, and proactive updates tell you when a sailing or an arrival time changes. After customs release, drayage takes the container from the port to your warehouse, with coverage at 42 US ports and rail ramps. For Amazon sellers, Amazon FBA prep handles FNSKU labels and poly bagging to Amazon's carton and pallet rules, and Amazon FBA shipping delivers the stock to fulfillment centers.

Ready to ship your next cosmetics order? Get a quote for ocean or air freight from China, India or Europe, with live pricing and rates locked at booking.

Common Questions About MoCRA for Importers

Does a cosmetics importer have to register with FDA under MoCRA?

Only when its own site manufactures or processes cosmetics, and filling containers counts as processing. A warehouse that only stores, distributes, labels or repacks finished goods does not register. An importer named on the label is the responsible person and lists the products, even with no facility to register.

Can a foreign brand be the responsible person under MoCRA?

Yes. A company outside the US is the responsible person when it is the manufacturer, packer or distributor named on the label. The label must still carry a domestic address, a domestic phone number or an electronic contact for adverse event reports.

Does FDA issue a MoCRA registration certificate for cosmetics?

No. FDA confirmed on September 9, 2026 that it issues no certificate, verification letter or email confirming a cosmetic facility registration or product listing. Keep the facility's FEI number together with the registration status and renewal date shown in Cosmetics Direct.

How often do MoCRA registrations and product listings need updating?

Every two years for a facility registration and every year for a product listing. The two-year cycle runs from the date of first registration, and changes are reported within 60 days.

Do cosmetics need FDA approval before they are imported?

No, apart from color additives. Cosmetic products and their ingredients need no FDA premarket approval, but color additives must be approved for their intended use, and some must come from FDA-certified batches. The products must still be safe and properly labeled under the same rules as US-made cosmetics. A product that is also a drug needs an approved new drug application or must conform to an OTC monograph.

Which small businesses are exempt from MoCRA registration and listing?

A responsible person or facility owner or operator qualifies when its average gross annual US sales of cosmetic products over the previous three years were under $1 million, adjusted for inflation. A business that makes eye-area products touching the mucous membrane, injected products, products for internal use or products that alter appearance for more than 24 hours cannot use the exemption. It reaches only registration and listing and the future GMP rules.

Are MoCRA GMP rules in force for cosmetic factories yet?

No. MoCRA set December 29, 2024 for a proposed GMP rule and December 29, 2025 for a final one. As of October 8, 2026, no proposed rule had been published in the Federal Register. The FD&C Act's adulteration rules still apply.

What happens if FDA refuses a cosmetics shipment at the port?

A refused shipment is destroyed unless it is exported within 90 days of the refusal notice, or within extra time CBP allows. FDA can authorize relabeling or other action to fix the problem only earlier, while the shipment is detained.

Written by

Max Kershnitskii

Operations Manager at Platton

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