What Changed in US Cosmetics Regulation
For decades, cosmetics in the United States were one of the least-regulated consumer product categories. The 1938 Food, Drug, and Cosmetic Act gave the FDA limited authority over cosmetics — no pre-market approval, no facility registration, no mandatory adverse-event reporting. Brands could import a Korean OEM cosmetic with little more than compliant labeling.
That changed with the Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022 and phased in through 2023–2024. MoCRA is the most significant cosmetics regulatory change in 80 years, and it directly affects every brand importing Korean OEM products into the US market.
This guide explains what MoCRA actually requires, what your Korean OEM manufacturer can support, and what you (the brand of record) must handle yourself. It's written for buyers — not lawyers — and covers the practical decisions you face when sourcing Korean cosmetics for US distribution.
What MoCRA Requires (the Short Version)
If you sell cosmetics in the US, MoCRA imposes six core obligations:
- Facility registration — every facility manufacturing or processing cosmetics for the US market must register with the FDA, including foreign facilities like Korean OEM factories
- Product listing — every cosmetic product distributed in the US must be listed with the FDA
- Responsible Person designation — every product must have a designated US Responsible Person on the label
- Safety substantiation — brands must hold records demonstrating product safety
- Adverse event reporting — serious adverse events must be reported to the FDA within 15 days
- Good Manufacturing Practices (GMP) — formal GMP regulations for cosmetics (currently being finalized by the FDA)
We'll go through each in the context of Korean OEM sourcing.
Facility Registration: Your Korean OEM Handles This
Foreign cosmetic manufacturing facilities producing for the US market must register with the FDA. Each facility receives a FDA Establishment Registration Number which links to the products it produces.
For Korean OEM buyers, this is the manufacturer's responsibility, not yours. Established Korean OEM factories with US export experience completed FDA facility registration in 2023–2024 and renew biennially as required. When evaluating manufacturers, ask whether they are FDA-registered for cosmetic manufacturing — established factories will provide the registration number on request.
Smaller or domestic-focused Korean factories that haven't historically exported to the US may not be FDA-registered. If you're sourcing from a smaller specialist, confirm registration status before committing to production. Registration is straightforward but takes 4–8 weeks if the factory hasn't done it yet — which can delay your launch.
Product Listing: This Is Your Job
Each cosmetic product distributed in the US must be listed with the FDA, including:
- Product brand name
- Product category and subcategory
- Ingredient list
- Responsible Person information
- Manufacturing facility (the FDA registration number from your Korean OEM)
Product listing is the brand of record's responsibility, not the manufacturer's. Your Korean OEM provides the inputs (formulation, INCI list, facility registration number), but you submit the listing through the FDA Cosmetics Direct portal.
Most brands either handle this in-house (it's not difficult — the portal is free and the form is straightforward) or use a regulatory consultant for $200–$500 per product if they want hands-off support. Korean OEM factories generally don't handle US product listing on behalf of brands because the legal liability sits with the Responsible Person, not the manufacturer.
Responsible Person: The Most Common Confusion
Every cosmetic product sold in the US must have a designated Responsible Person whose name and US address appear on the label. The Responsible Person is the entity legally accountable for the product in the US — they handle adverse event reporting, recall coordination, and FDA inquiries.
This is often the source of the most confusion for international brands sourcing Korean OEM. Three common scenarios:
Scenario 1: You have a US business entity. Your US LLC or corporation is the Responsible Person. The label shows your US business name and address. This is the cleanest setup.
Scenario 2: You're an international brand without US presence. You can either (a) register a US business entity, (b) use a third-party Responsible Person service (typically $1,000–$3,000/year), or (c) sell through a US distributor who acts as the Responsible Person. Option (c) only works if the distributor agrees and is named on the label.
Scenario 3: Your Korean OEM is the Responsible Person. This is rare. Most Korean OEM factories will not act as Responsible Person for legal-liability reasons. Don't assume your manufacturer handles this — confirm in writing.
The Responsible Person designation appears on the product label as the manufacturer/distributor information. It's not optional, and FDA enforcement on labeling has historically been the most common source of import detention for cosmetics.
Safety Substantiation: What You Need on File
MoCRA requires brands to maintain records demonstrating that each product is safe under labeled and reasonably foreseeable use conditions. This doesn't require new safety testing — but it requires documentation.
For Korean OEM products, safety substantiation usually includes:
- Stability testing data (3-month minimum, conducted by the OEM)
- Microbial testing data (challenge testing, conducted by the OEM)
- Patch testing (RIPT testing — required for sensitive claims like "hypoallergenic")
- Ingredient safety data for any unusual or high-concentration actives
- Compatible packaging testing (some actives degrade in certain packaging)
Korean OEM manufacturers with US export experience routinely provide a Cosmetic Product Safety Report (CPSR) or equivalent documentation package. Smaller factories may provide individual test reports rather than a packaged dossier. Either is acceptable for MoCRA — what matters is that you can produce the records on FDA inquiry.
Keep the documentation for at least 6 years after the last sale of the product.
Adverse Event Reporting
Serious adverse events (events involving hospitalization, persistent disability, life-threatening injury, or death) must be reported to the FDA within 15 business days. The Responsible Person handles reporting, not the manufacturer.
For a typical cosmetic product, serious adverse events are rare. Most brands never file an adverse event report. But you must have a system in place — typically a customer service inbox monitored for safety complaints, with escalation procedures if a serious event is reported.
This is process, not paperwork. You don't pre-register an AE system with the FDA — you just need to be able to demonstrate one exists if asked.
GMP Regulations: Coming, Not Yet Final
MoCRA directs the FDA to issue formal Good Manufacturing Practice (GMP) regulations for cosmetics. As of mid-2026, the regulations are still being finalized, with a likely effective date in 2027–2028.
For Korean OEM sourcing, this is largely a non-issue. Established Korean cosmetic manufacturers operate under ISO 22716 (the international cosmetic GMP standard) and Korea's own CGMP framework. Both meet or exceed what the FDA's MoCRA GMP regulations are expected to require. Confirm your OEM is ISO 22716-certified — this is standard at any export-ready Korean cosmetic factory.
Sunscreen Is Different (and Stricter)
A critical exception: sunscreens are regulated as OTC drugs in the US, not cosmetics. MoCRA does not apply. Instead, sunscreens fall under the FDA's OTC drug monograph system, which has stricter requirements:
- Only FDA-approved UV filters (avobenzone, homosalate, octisalate, octinoxate, etc.) — Korean and EU filters like bemotrizinol are not currently approved
- Drug Facts label panel
- NDC (National Drug Code) registration
- More stringent manufacturing requirements
If you're sourcing Korean sunscreen for the US market, see our dedicated Korean Sunscreen OEM Guide for the full regulatory breakdown.
Common Mistakes to Avoid
A few patterns that get brands into trouble:
Assuming your Korean OEM handles US compliance. They handle facility registration and provide safety documentation, but product listing, Responsible Person designation, and adverse event reporting are your responsibility.
Using non-FDA-approved UV filters in sunscreen. A Korean sunscreen using only EU-approved filters cannot legally be sold as a sunscreen in the US, regardless of MoCRA compliance.
Mismatched ingredient lists. Your product listing INCI must exactly match the label INCI. Discrepancies trigger FDA inquiries.
Missing Responsible Person info on labels. This is the single most common cause of import detention. The Responsible Person's US address must appear on the label.
Ignoring color additive restrictions. Some colorants used in Korean cosmetics are not FDA-approved for cosmetic use in the US. Korean OEMs familiar with US export will flag this; smaller factories may not.
What to Ask Your Korean OEM
When briefing a Korean manufacturer for US-market production, ask explicitly:
- Are you FDA-registered for cosmetic manufacturing? What's your establishment registration number?
- Do you provide a Cosmetic Product Safety Report or equivalent documentation package?
- Have you previously exported this product category to the US? What documentation did you provide?
- Does the formula use any colorants restricted in the US?
- Is the labeling compliant with FDA cosmetic labeling rules (INCI in descending order, net weight, drug facts panel for OTC products)?
Established Korean OEMs with US export experience answer all five clearly and provide written documentation. If a manufacturer hesitates on any of these, treat it as a signal to look elsewhere.
Getting Started
MoCRA looks intimidating from a distance but breaks down into clear, manageable obligations once you know what's yours and what's your manufacturer's. The work is roughly 70% Korean OEM-handled (facility registration, GMP, safety testing) and 30% brand-of-record-handled (product listing, Responsible Person, adverse event system, label compliance).
Start by confirming your Korean OEM is FDA-registered, choosing your Responsible Person setup, and budgeting for product listing (free if self-filed, $200–$500 per product through a consultant).
Submit your RFQ here and we'll match you with FDA-registered Korean OEM manufacturers experienced in MoCRA-compliant US export. Free for buyers.
Related Reading
- Korean Sunscreen OEM Guide — sunscreen regulatory rules differ from cosmetics
- How to Find Korean Cosmetics Manufacturers
- Skincare Private Label category — full-line sourcing for US-market launches