U.S. Cosmetics Import Requirements Under MoCRA — Registration, Listing, Labeling
MoCRA (2022) rewrote cosmetics regulation for the first time in 84 years — facility registration, product listing, adverse-event reporting, and safety substantiation are all brand-new obligations that didn't exist before. This category matters a lot given how much Korean cosmetics gets exported.
Requirements Specific to This Category
MoCRA — A Different Era Starting December 29, 2022
MoCRA (Modernization of Cosmetics Regulation Act of 2022, enacted 12/29/2022) is what FDA itself calls 'the largest expansion of FDA's cosmetics authority since the 1938 FD&C Act.' Before MoCRA, there was no facility registration, no ingredient notification, and no adverse-event reporting requirement, and FDA had no mandatory recall authority. New obligations MoCRA created: ① facility registration (existing facilities by 7/1/2024) ② product listing (existing products by 7/1/2024) ③ adverse-event reporting (effective 12/29/2023) ④ maintaining safety substantiation (effective 12/29/2023) ⑤ FDA mandatory-recall authority (effective 12/29/2023) ⑥ GMP regulations (final rule still in progress as of when this knowledge base was written — recheck the latest status at fda.gov/cosmetics). An importer who does more than pure distribution — repackaging, relabeling, etc. — can be considered a 'Facility' and become subject to registration.
Cosmetic vs. Drug — 'Changing Appearance' vs. 'Making a Treatment Claim'
The FD&C Act defines a cosmetic as a substance applied to cleanse, beautify, or alter the appearance of the body — the key word is 'appearance,' not affecting body structure or function. The moment wording like 'skin regeneration,' 'breaks down cellulite,' 'prevents hair loss,' or 'treats acne' appears on the label or in marketing, the product is reclassified as a drug and cannot be sold without prior FDA approval. Products that combine cosmetic and drug functions — sunscreen (SPF), anti-dandruff shampoo, antiperspirant — must satisfy both sets of rules simultaneously. FDA determines the category based on the 'intended use' conveyed by the label, advertising, and all marketing materials taken together.
Designating the Responsible Person — If Your Name Is on the Label, It's You
MoCRA's core obligations — product listing, adverse-event reporting, safety substantiation, and a U.S. contact on the label — all fall on the Responsible Person. That's whichever manufacturer, packer, or distributor is named on the cosmetic's label (FD&C Act §609(a), FPLA §4(a)). If you import and sell an OEM cosmetic under your own brand, you become the Responsible Person almost without exception; a pure logistics agent whose name doesn't appear on the label may not — confirm your own role first.
Facility Registration
Facilities (including foreign ones) that manufacture or process cosmetics must register with FDA. Steps: ① obtain an FEI (FDA Establishment Identifier) number ② register via the Cosmetics Direct electronic portal (direct.fda.gov) — paper Form FDA 5066 is also available ③ receive confirmation and a registration number ④ renew every 2 years ⑤ update facility information within 60 days of any change. Small-business exemption: businesses averaging under $1M in sales over the past 3 years may be exempt, but not if they make products that contact mucous membranes of the eye (e.g., mascara), injectable products, products taken internally, or products that alter appearance for more than 24 hours — those disqualify the exemption regardless of business size. Product listing requires this facility registration number, so registration has to be completed first.
Product Listing
The Responsible Person must list every cosmetic product sold in the U.S. with FDA. Required information: product name (including brand), facility registration number, an ingredient list using INCI names, product category, and Responsible Person information. Deadlines: products already on sale before 12/29/2022 had to be listed by 7/1/2024; products launched afterward must be listed within 120 days of going to market, then updated annually as information changes. Ingredients must use FDA-recognized INCI (International Nomenclature of Cosmetic Ingredients) names — a Korean ingredient name or a brand's own coined name (e.g., '병풀추출물') isn't acceptable; it must be the international standard name, such as 'Centella Asiatica Extract.'
Serious Adverse Event Reporting — 15 Business Days (Note: Different Clock Than Supplements)
A cosmetic serious adverse event (SAE) — death, life-threatening condition, hospitalization or a prolonged one, permanent disability, birth defect, serious infection, significant disfigurement, and similar — must be reported to FDA within 15 business days of receipt via MedWatch Form 3500A (attach product and label copies, send to CosmeticAERs@fda.hhs.gov). The dietary-supplement SAE deadline is 15 calendar days, but cosmetics run on business days — it's easy to mix these up. If new medical information comes in within a year of the initial report, you must file a follow-up report within another 15 business days. Don't delay reporting to conduct an internal investigation — reporting and investigating can proceed at the same time. The label must always carry a U.S. address or phone number for receiving SAE reports.
Safety Substantiation — Holding Your Own Evidence of Safety
FDA still doesn't pre-approve cosmetics post-MoCRA, but now the Responsible Person must independently hold and maintain 'adequate substantiation of safety' — evidence that the product is safe for consumers. Acceptable evidence includes raw-material safety data (toxicology studies), finished-product testing (e.g., skin irritation), published peer-reviewed literature, and ingredient suppliers' own safety data. MoCRA also gave FDA the authority to inspect these records at registered facilities — a product without this evidence on file can be deemed adulterated. Even a product that already cleared safety review in Korea needs a separate file of evidence built to meet U.S. FDA standards.
Mandatory Cosmetic Label Elements — Six Items
Required disclosures: ① an identity statement making clear what the product is ② net quantity (both U.S. and metric units) ③ the manufacturer/packer/distributor's name and U.S. address ④ an ingredient list (INCI names, descending order by weight — ingredients under 1% may be listed in any order, colorants may be listed separately, and fragrance/perfume may be listed simply as 'fragrance' or 'perfume') ⑤ any necessary usage warnings ⑥ a U.S. contact for SAE reporting. Foreign-made products must also carry country-of-origin marking (19 U.S.C. §1304). Missing even one of these results in a misbranding finding.
Prohibited Label Claims — No Drug Claims, Period
Claims of diagnosing, treating, or preventing disease cannot appear on a cosmetic label: 'skin regeneration,' 'treats acne,' 'prevents hair loss,' 'breaks down cellulite,' and 'clinically tested' (when used without evidence) are all prohibited. 'Repairs damaged skin,' 'regenerates skin cells,' and 'treats eczema' are equally classified as drug claims. It's just as much of a problem if these words (regeneration, repair, treatment) appear in the product name itself — review the product name, not just the body copy. By contrast, 'moisturizes skin,' 'reduces the appearance of wrinkles,' and 'supports the skin barrier' describe changes in appearance and stay within cosmetic territory.
Color Additive Preapproval
Colorants used in cosmetics must appear on FDA's approved list, and some require batch certification. An unapproved colorant is immediate grounds for detention, and products used around the eyes face stricter rules. Note, though, that an approved colorant doesn't mean the raw material itself is free of heavy-metal impurities (such as lead) — lip products in particular should undergo separate heavy-metal testing at the raw-material stage, and that test result should be part of your safety substantiation file.
SPF Products — Dual Regulation as Drug and Cosmetic
Products claiming sun protection (SPF) are regulated as both a cosmetic and an OTC drug. Under FDA's OTC Monograph (21 CFR Part 352), you need — on top of standard cosmetic labeling — ① a separate Active Ingredient listing (e.g., Zinc Oxide, Titanium Dioxide) ② a Drug Facts box ③ compliance with SPF-value labeling rules. This applies just as much to combination products like 'sunscreen + moisturizer' if they carry an SPF claim — following only cosmetic labeling rules and skipping the Drug Facts box results in misbranding.
Requirements Common to All FDA-Regulated Goods
Entry Filing (via CBP/ACE)
Every import shipment is filed with U.S. Customs and Border Protection (CBP) through the ACE/ABI system. FDA-regulated goods are electronically filed with FDA at the same time, and the PREDICT risk-screening system reviews them automatically. This is typically handled by a customs broker.
Confirm the FDA Product Code
FDA assigns every regulated item a unique product code (industry–class–subclass–PIC). An accurate code is required at entry filing; an incorrect one causes review delays and misclassification. Look up or build the code with the FDA Product Code Builder.
Check Import Alerts in Advance — DWPE Risk
Specific countries, manufacturers, or products can appear on an Import Alert and become subject to Detention Without Physical Examination (DWPE) — an automatic hold with no inspection. Alerts come in three tiers: Red List (automatic detention), Yellow List (conditional detention), and Green List (exempted). A single violation can trigger listing, and suppliers rarely disclose it proactively. Search by company name + address + country + product every time before shipping. Once listed, how you respond in the first 24 hours determines whether recovery takes 6 months or several years — waiting it out or sending only export-country paperwork does not work; you need to engage FDA's compliance staff directly through the formal process. Searchable in this tool's 'Live Lookup' tab.
💡 Practical Tips
- Watch the line between 'cosmetic' and 'OTC drug' — sunscreen (SPF), skin-whitening, and acne-treatment claims are treated as drugs in the U.S., which completely changes the registration and regulatory path.
- Cosmetics aren't food, so Prior Notice does not apply to them.
- No matter how good the label is, customs clearance itself is blocked without facility registration and product listing — check MoCRA registration steps before you polish the label.
- Cosmetic SAE reporting runs on 15 business days; dietary supplement SAE reporting runs on 15 calendar days — don't confuse the two.
- The final GMP regulation hasn't been finalized yet (as of when this knowledge base was compiled) — recheck the latest status at fda.gov/cosmetics.
📋 Quick Reference Table
| Requirement | Description | Applies To | Notes |
|---|---|---|---|
| Facility registration | FDA registration for manufacturing/processing facilities; renew every 2 years, update within 60 days of changes | Facility owner/operator | Small businesses (under $1M) may be exempt |
| Product listing | FDA listing of each product sold, including ingredients; update annually | Responsible Person | Requires the facility registration number first |
| SAE reporting | Reporting serious adverse events to FDA | Responsible Person | 15 business days |
| Safety Substantiation | Holding and maintaining evidence of product safety | Responsible Person | Submit upon FDA's request to inspect |
| Mandatory recall | FDA's authority to order a mandatory recall | FDA authority | Applies when a voluntary recall is refused |
| GMP | Manufacturing standard regulation still being finalized | Manufacturing facility | Final rule not yet settled (as of this writing) — recheck fda.gov/cosmetics |
🗣️ Allowed / Prohibited Claim Glossary
⚡ Related Real-World Cases
- BB Cream — Classified as a Drug — One 'Skin Regeneration' Claim Was the Problem
- SPF 50 Sunscreen — Failed the Drug/Cosmetic Dual Regulation — No Drug Facts Box
- Hair Treatment — No Facility Registration — Exported Without Knowing the MoCRA Obligation
- Skincare Set — Delayed SAE Reporting — Missed the 15-Business-Day Window
- Lipstick — a Prohibited Ingredient — Lead Content Over the Limit