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) regulations
• Ingredient review and restriction powers

Key Compliance Deadlines (Already in Effect)

• Facility registration and product listing: Required since July 2024
• Adverse event reporting: Required since December 2023
• GMP compliance: Required since December 2025
• Fragrance allergen labeling: Required since mid-2025
• Small business exemptions: Limited to companies with under USD 1 million in annual cosmetics sales

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.

Requirements for the responsible person:

• US-based business entity
• 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

Both the Korean manufacturing facility and your US distribution facility must be registered with the FDA.

Korean facility registration:

• Done through the FDA's Cosmetics Direct portal
• Requires DUNS number for the facility
• Must be renewed every two years
• Korean manufacturers can register directly or authorize a US agent

US facility registration:

• Your warehouse or distribution center must also register
• If you use a third-party logistics provider, verify their registration status

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
• Updates required within 60 days of any changes

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 address of the responsible person (US entity)
• Ingredient declaration in descending order of predominance
• Any required warnings (sunscreen, color additives, etc.)
• Fragrance allergen disclosure (new under MoCRA)

Common labeling issues with Korean products:

• Korean-only labels without English translation
• Metric-only measurements (must include US customary units)
• Missing US responsible person information
• 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 Compliance

As of December 2025, all cosmetics facilities must follow FDA GMP requirements harmonized with ISO 22716.

Key GMP elements:

• 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. Many Korean facilities already comply with ISO 22716, which aligns closely with FDA's requirements.

Customs and Import Procedures

Prior Notice

Cosmetics shipments must have prior notice filed with the FDA before arrival. Your customs broker typically handles this through the FDA's Prior Notice System Interface (PNSI).

HS Codes for Korean Cosmetics

Common Harmonized System codes:

• 3304.99.50 - Beauty or make-up preparations, including sunscreen (duty rate: 0-4.9%)
• 3304.10.00 - Lip make-up preparations (duty rate: 0%)
• 3304.20.00 - Eye make-up preparations (duty rate: 0%)
• 3304.30.00 - Manicure or pedicure preparations (duty rate: 0%)
• 3304.91.00 - Powders (duty rate: 0%)
• 3305.10.00 - Shampoos (duty rate: 0-4.9%)
• 3305.90.00 - Other hair preparations (duty rate: 0-4.9%)

Note: The US-Korea Free Trade Agreement (KORUS FTA) provides duty-free treatment for most Korean cosmetics. Ensure your products have 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
• Prior notice was not filed

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 - Restricted (only in OTC drug products at 2%)
• Lead acetate - Under review
• Talc - Subject to increased scrutiny (asbestos-free testing recommended)
• PFAS - Several states have enacted bans; federal regulation is expanding

Working with Korean Suppliers for US Compliance

When sourcing through platforms like knok, 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 knokglobal.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 costs should be factored into your pricing strategy. For most importers, compliance adds USD 1-3 per unit to the landed cost, depending on order volume and product complexity.