Short answer: Going by FDA's own data, medical devices, tobacco and vape products, foods, drugs and cosmetics carry the most FDA refusals for China-made goods since 2024. If you import in these categories, the factory's FDA record matters as much as its price.
Most China shipments clear. Most suppliers are good. But FDA keeps records on factories, and some categories show up far more than others. Here is what the public data says. We pulled it on Oct 30, 2026.
Refusals since 2024, by product area
FDA publishes every refusal in its Import Refusal Report. We counted refusal lines (one entry can have several lines) where the listed manufacturer is in China, from January 2024 to September 24, 2026, the latest date in the files. The grouping by FDA industry code is ours. (FDA Import Refusal Report)
| Product area | China refusal lines, Jan 2024 to Sept 24, 2026 |
|---|---|
| Medical devices | 3,419 |
| Foods | 2,993 |
| Tobacco and vapes | 2,549 |
| Drugs | 613 |
| Cosmetics | 287 |
| Radiation-emitting products | 197 |
| Dietary supplements | 136 |
The single products with the most China lines in that period: piston syringes (1,424), vape product codes (about 1,990 combined), vinyl and poly exam gloves (429), fruit ices on a stick (191), sunglasses (148) and eye shadow (107).
The most common reasons, in plain terms: tobacco products without FDA authorization, devices not listed with FDA (1,428), device manufacturing practice problems (1,391), foreign manufacturer not registered (1,138), melamine (1,026, mostly baked goods and fruit ices) and devices without 510(k) clearance (782).
One caution. Total refusals have risen since 2024, but much of that rise is tobacco and vapes. China's share of all refusal lines was 18.5% in 2024, 10.6% in 2025 and 5.5% in 2026 to Sept 24.
Chinese factories on import alerts
An import alert lets FDA hold a factory's goods without even looking at them. FDA's China page lists 85 import alerts that name China firms or products. (FDA import alerts, China) A few of the biggest, counting firms with a China address (our script count, so close rather than exact):
| Import alert | What it covers | China firms listed |
|---|---|---|
| 89-08 | Devices without 510(k) or PMA | 409 |
| 66-41 | Unapproved new drugs | 232 |
| 66-79 | Drug firms that refused FDA inspection | 169 |
| 66-40 | Drug manufacturing practices not met | 159 |
| 53-06 | Cosmetics, color additives | 149 |
| 99-45 | Unsafe food additive, including ceramicware | 102 |
| 99-42 | Heavy metals in foods | 43 |
| 89-04 | Device quality system not met | 38 |
| 53-17 | Cosmetics, microbial contamination | 29 |
| 54-16 | Foods or supplements that appear to be drugs | 28 |
On ceramic plates, cups and mugs: the old ceramicware alert (52-08) is deactivated, and its firms now sit on 99-45. Of the 296 foodware, cookware or tableware entries there, 67 have a China address. These pages show only today's list, so they can't show a trend over time.
What this means for you
If your product is a device, a vape, a food, a drug, a supplement or a cosmetic, check who really makes it and whether that factory already has an FDA record, before you pay the deposit. Then get the right papers before you ship: here is our document checklist.
If a shipment is already held, read what to do when FDA and CBP hold the same shipment, or book a free 30-minute call.
Data pulled Oct 30, 2026 from FDA's Import Refusal Report downloads and import alert pages. Counts are ours and may differ slightly from FDA's. China Agent is not a law firm; legal questions go to counsel or a trade lawyer.
