FDA Import Refusals of Korean Cosmetics: 2019–2026
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Bottom line: FDA import refusals of Korean cosmetics rose from 93 refused lines in 2024 to 178 in 2025 and 210 in just January–September 2026, and in 2021–2025 the most common charge, on 45.7% of refused lines, was “unapproved new drug”: products FDA treated as drugs without an approved application.
The figures come from the FDA’s own import refusal data files, filtered to Korea (country code KR) and to product codes in FDA industry code 53 (cosmetics). They count refusals; they say nothing about how many Korean cosmetics entered the US without problems.
FDA import refusals of Korean cosmetics by year
Swipe sideways to see the whole table.
| Year | Refused lines, Korea, industry 53 | Distinct entries | Refused lines, all countries, industry 53 | Korea’s share |
|---|---|---|---|---|
| 2019 | 92 | 30 | 632 | 14.6% |
| 2020 | 87 | 35 | 584 | 14.9% |
| 2021 | 84 | 37 | 527 | 15.9% |
| 2022 | 105 | 48 | 1,083 | 9.7% |
| 2023 | 81 | 42 | 1,092 | 7.4% |
| 2024 | 93 | 56 | 1,282 | 7.3% |
| 2025 | 178 | 98 | 1,000 | 17.8% |
| 2026 (Jan–Sep) | 210 | 148 | 854 | 24.6% |
Swipe sideways to see the whole table.
| Refusal charge (FDA code), Korea, industry 53, 2021–2025 | Refused lines | Share of 541 lines |
|---|---|---|
| UNAPPROVED-75: appears to be a new drug without an approved NDA | 247 | 45.7% |
| CSTIC LBLG-471: fails cosmetic labelling requirements (21 CFR Part 701)1 | 105 | 19.4% |
| NOT LISTED-118: drug or device not listed as required by section 510(j) | 67 | 12.4% |
| FRNMFGREG-3280: made in an establishment not registered under section 510 | 57 | 10.5% |
| COSM COLOR-197: contains an unsafe colour additive | 55 | 10.2% |
| DRUG GMPS-27: manufacturing controls do not appear to meet drug CGMP | 37 | 6.8% |
| COSMETLBLG-475: ingredient names not listed on the label | 29 | 5.4% |
Refused entry lines (FDA import refusal data)
Refused entry lines · Korean cosmetics (industry code 53), per year · Source: FDA Import Refusal Report · ACCESSED 2026-10-16 · lines
Definitions, sources and access date
- Scope: FDA Import Refusal Report data files “Import_Refusal_2019-2023” and “Import_Refusal_2024-present” (refusal dates 2 January 2019 to 24 September 2026). We kept rows where the manufacturer’s country code (ISO_CNTRY_CODE) is KR and the product code starts with 53, FDA’s cosmetics industry code, and counted rows (refused entry lines) by refusal year. “Distinct entries” counts unique entry numbers.
- Charges: each line can carry several charge codes. Codes are matched to the charge statements in the ACT_SECTION_CHARGES file shipped with the data. Shares divide the lines carrying a charge by the 541 Korean industry-53 lines refused in 2021–2025, so they add up to more than 100%.
- Korea’s share divides Korean lines by all-country industry-53 lines in the same year. All counts and shares are our calculations from the files.
- 2026 covers January to 24 September only and is not comparable with full years.
- Source: FDA Import Refusal Report: https://www.accessdata.fda.gov/scripts/importrefusals/ (data files: https://www.accessdata.fda.gov/scripts/importrefusals/downloads/Import_Refusal_2019-2023.zip and https://www.accessdata.fda.gov/scripts/importrefusals/downloads/Import_Refusal_2024-present.zip )
- FDA guidance cited: “Is It a Cosmetic, a Drug, or Both?” https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap · “Color Additives and Cosmetics: Fact Sheet” https://www.fda.gov/industry/color-additives/color-additives-and-cosmetics-fact-sheet
- Data accessed: 16 October 2026
What the charges tell exporters and buyers
Drug status is the biggest problem. Almost half of the refused Korean cosmetic lines were held as unapproved new drugs.
FDA explains that some products are both cosmetics and drugs and must meet both sets of requirements; moisturisers and make-up marketed with sun-protection claims are such cosmetic/drug products, and drugs generally need either an approved New Drug Application or conformity with an OTC monograph.
The related charges for drug listing (NOT LISTED-118), unregistered establishments (FRNMFGREG-3280) and drug manufacturing practices (DRUG GMPS-27) point the same way.
Labels come second. Cosmetic labelling failures (471), missing ingredient names (475) and labels not in English (NO ENGLISH-3260, 21 lines in 2021–2025) account for a large part of the rest. These are fixable before shipment.
Colour additives are a specific risk. One in ten refused lines carried an unsafe colour additive charge (197). FDA states that all colour additives used in cosmetics must be approved by FDA under a regulation that covers that use, and some must also be batch certified, so make-up formulated for other markets needs checking.
Refusals are rising. Korean lines nearly doubled from 2024 to 2025, and January–September 2026 already exceeds all of 2025. Korea’s share of all cosmetics refusals went from 7.3% in 2024 to 24.6% in 2026 so far. Part of this may simply reflect higher shipment volumes, since exports to the US have also grown, but the data cannot separate the two.
For anyone shipping Korean products to the US, the practical checks are: whether any product (especially sunscreen or products with treatment claims) is a drug in US terms, whether the label meets US cosmetic labelling rules in English, and whether colour additives are permitted in the US.
Related reading: Korean cosmetics exports by country · EU Safety Gate alerts on Korean cosmetics · Korean cosmetics recalls
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Notes
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Office of the Federal Register (US), 21 CFR Part 701 — Cosmetic Labeling, verified 2026-10-25. ↩