What the data shows
The FDA refused entry to 73 shipments of South Korean cosmetics (FDA product code 53) in July and August 2026: 44 in July and 29 in August. The refusals involved 27 Korean manufacturers named in the records.
More than half of the refusals, 39 of 73, cited at least one drug-related reason, compared with 25 that cited labelling. In 18 refusals the FDA said the products did not appear to meet drug manufacturing standards (current good manufacturing practice), and in 17 it said the product appeared to be an unapproved new drug.
Thirteen refusals said products appeared to have been made, processed or packed under insanitary conditions, and five shipments were refused as medical devices without the required FDA clearance or approval.
Why cosmetics end up treated as drugs
In the United States, a product that claims to prevent sunburn, treat dandruff, lighten skin or reduce wrinkles can be regulated as an over-the-counter drug rather than a cosmetic. That brings drug manufacturing standards, registration of the manufacturing facility and listing of the product with the FDA. Claims that are routine for Korean skin care can therefore turn a cosmetic into a drug at the US border.
An FDA import refusal means a shipment appears to violate US law. It is not a final legal finding against the company.
Reasons cited
Number of refusals citing each reason. A single refusal can cite several reasons.
| Drug manufacturing standards (cGMP) not met | 18 |
| Appears to be an unapproved new drug | 17 |
| Cosmetic labelling requirements | 14 |
| Made or packed under insanitary conditions | 13 |
| Ingredient list does not name each ingredient | 12 |
| Drug not listed with the FDA | 8 |
| Drug facility not registered | 8 |
| Facility delayed, denied or limited inspection | 6 |
| Package and net-contents labelling (FPLA) | 5 |
| False or misleading labelling | 5 |
| Medical device: no 510(k) clearance | 3 |
| Drug: adequate directions for use missing | 3 |
| Medical device: no premarket approval | 2 |
Refused shipments by product type
| Skin-care products (incl. moisturisers, toners, face and body products) | 47 |
| Hair products | 15 |
| Other cosmetics and personal-care products | 11 |
Methodology
We counted refusals recorded in the FDA Import Refusal Report for July and August 2026 where the country of origin was the Republic of Korea and the FDA product code was 53 (cosmetics). The FDA publishes the report monthly; the August data were available in late September 2026. Company names are in the FDA's public records; we do not list them here.
Source: FDA Import Refusal Report