How to Import Korean Cosmetics to the USA: FDA & MoCRA Compliance 2026

How to Import Korean Cosmetics to the USA: FDA & MoCRA Compliance 2026

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, represents the most significant update to US cosmetics regulation in over 80 years. For Korean beauty importers, understanding these requirements is now essential for legal market entry. This guide covers everything you need for compliant importation in 2026.

MoCRA Overview: What Changed

MoCRA amended the Federal Food, Drug, and Cosmetic Act to give the FDA new authority over cosmetics, including:

• Facility registration for manufacturers, processors, and packers
• Product listing for all cosmetics marketed in the US
• Safety substantiation documentation requirements
• Adverse event reporting within 15 business days
• Mandatory recall authority for the FDA
• Good Manufacturing Practice (GMP) rulemaking
• Ingredient review and restriction powers

What Applies Now and What Is Still Pending

Checked November 2026. FDA rules can change, so confirm each point on FDA's website or with a US regulatory adviser. This guide is general information, not legal advice.

• Facility registration and product listing: FDA began enforcing these in July 2024
• Serious adverse event reporting: In effect
• GMP rule: Required by MoCRA, but reported as not yet finalized by FDA
• Fragrance allergen labeling rule: Required by MoCRA, but reported as not yet issued by FDA
• Small business exemptions: Available to some companies with under about USD 1 million in average annual cosmetics sales, with exceptions for certain product types

Step-by-Step Import Process

Step 1: Establish a US Responsible Person

Every cosmetic product sold in the US must have a "responsible person" — the manufacturer, packer, or distributor whose name appears on the product label. As an importer, you typically serve this role.

What the responsible person must handle:

• Must maintain adverse event records
• Must submit serious adverse event reports to FDA
• Must ensure products comply with all FDA regulations

Step 2: FDA Facility Registration

Facilities that manufacture or process cosmetics for the US market must register with the FDA. That usually includes the Korean factory.

Korean facility registration:

• Done through the FDA's Cosmetics Direct portal
• Must be renewed every two years, and changes must be updated within 60 days
• A foreign facility must name a US agent who is physically present in the US

US warehouses and distributors:

• FDA's guidance excludes establishments that only label, relabel, package, repackage, hold or distribute cosmetics
• If your US site does anything more, check whether it must register

Step 3: Product Listing

Every product you import must be listed with the FDA.

Product listing includes:

• Product name and category
• Complete ingredient list (INCI format)
• Responsible person information
• Listing must be submitted within 120 days of marketing the product
• Listings must be updated every year

Step 4: Labeling Compliance

Korean cosmetics labels must meet FDA requirements before they can be sold in the US.

Required label elements:

• Product identity/name
• Net quantity of contents
• Name and place of business of the responsible person
• US contact details for receiving adverse event reports
• Ingredient declaration in descending order of predominance
• Any required warnings (sunscreen, color additives, etc.)

Common labeling issues with Korean products:

• Korean-only labels without English translation
• Metric-only measurements (must include US customary units)
• Missing US contact details for adverse event reports
• Ingredient names not in standard INCI format
• Health claims that would classify the product as a drug

Step 5: Safety Substantiation

Under MoCRA, responsible persons must have adequate evidence that their products are safe. This does not require pre-market approval, but documentation must exist.

Acceptable safety evidence:

• Toxicological assessments of individual ingredients
• Clinical studies or consumer use tests
• Published scientific literature
• Existing safety assessments from other markets (EU CPSR can serve as a foundation)

Step 6: GMP Readiness

MoCRA tells FDA to set GMP rules for cosmetics, but the final rule has been reported as still pending. ISO 22716 is a sensible standard to ask about in the meantime.

Key GMP elements to ask about:

• Personnel training and hygiene
• Building and facility cleanliness
• Equipment maintenance and calibration
• Raw material and packaging controls
• Production and process controls
• Quality control and testing
• Documentation and record keeping

Request GMP certifications from Korean manufacturers. Ask to see the certificate rather than assuming a factory holds one.

Choosing products to import? Build a free sample box and test them before you start compliance work (approved buyers' first box ships free). Build my Naru Box →

Customs and Import Procedures

Customs Entry

Work with a licensed customs broker. The broker files the entry, and FDA can review imported cosmetics at the border. Ask your broker which FDA information it needs from you before the goods ship.

HS Codes for Korean Cosmetics

Common Harmonized System codes:

• 3304.99.50 - Beauty or make-up preparations
• 3304.10.00 - Lip make-up preparations
• 3304.20.00 - Eye make-up preparations
• 3304.30.00 - Manicure or pedicure preparations
• 3304.91.00 - Powders
• 3305.10.00 - Shampoos
• 3305.90.00 - Other hair preparations

Sunscreens are regulated as drugs in the US, so don't treat them as ordinary cosmetics. Confirm the classification of each product with your broker.

Duties: US tariffs on Korean goods have changed several times since 2025, so don't assume that Korean cosmetics enter duty-free under the KORUS FTA. Ask your broker for the current rate before you set your prices, and keep a valid Certificate of Origin.

FDA Detention and Refusal

Your shipment may be detained if:

• Facility is not registered
• Products are not listed
• Labels do not comply
• Products contain prohibited ingredients

If detained, you typically have a limited window to bring products into compliance or re-export them.

Prohibited and Restricted Ingredients

The FDA maintains a list of prohibited and restricted cosmetic ingredients. Common ingredients in Korean products that require attention:

• Mercury compounds - Prohibited (check skin-lightening products)
• Chloroform - Prohibited as an ingredient
• Methylene chloride - Prohibited
• Hydroquinone - Removed from the US over-the-counter drug market in 2020, so check any lightening product closely
• Lead acetate - FDA has ended its listing as a hair dye color additive
• Talc - Subject to increased scrutiny (asbestos-free testing recommended)
• PFAS - Several states have enacted bans; federal regulation is expanding

Looking for Korean brands to import? Browse verified Korean beauty brands and ask each one about its US documents. Browse wholesale brands →

Working with Korean Suppliers for US Compliance

When sourcing through platforms like Hannaru, discuss these compliance topics with brand owners before ordering:

1. FDA facility registration status of the manufacturing facility
2. GMP certification (ISO 22716 or equivalent)
3. Safety substantiation documentation available for each product
4. English-language labels or willingness to create compliant labels
5. INCI ingredient lists in FDA-compliant format
6. Product stability and safety testing data
7. Certificate of Free Sale from Korean MFDS (useful for customs)

Many Korean brands exporting to the US already have systems in place for FDA compliance. Brands on hannaru.com with US export experience can share their compliance documentation and help streamline your import process.

Estimated Compliance Costs

Item	Estimated Cost	Frequency
FDA facility registration	Free	Every 2 years
Product listing	Free	Per product, update as needed
Safety assessment per product	USD 1,000-5,000	Per product
Label design and compliance review	USD 500-2,000	Per SKU
GMP audit of Korean facility	USD 3,000-8,000	Annual
Customs broker fees	USD 150-400	Per shipment
Regulatory consultant	USD 150-300/hour	As needed

These figures are rough estimates, not quotes. Costs vary widely, so get quotes from your own providers and build them into your pricing.