“Our dumplings sell very well in Taiwan and we want to export them to the US.” This is the enquiry we receive most often — and the one where we most often have to say “wait a moment.” It is not that the dumplings are bad; it is that the filling contains pork. Frozen food containing meat is not regulated by FDA but by the USDA’s Food Safety and Inspection Service (FSIS), and Taiwan is not currently on the list of countries approved by FSIS to export pork to the US. So pork dumplings simply cannot get in at present, no matter how well the FDA registration is done. The first step in exporting frozen food to the US is not checking FDA — it is confirming which agency actually regulates your product.
Gate one: which agency regulates this frozen product
The US splits food between two agencies:
- FDA covers the vast majority of foods, including frozen vegetables, seafood, dough products and products with only a small amount of meat
- USDA FSIS covers meat, poultry and egg products, and the threshold is low: roughly more than 2% cooked meat or more than 3% raw meat puts a product under FSIS
FSIS-regulated products must be exported from an “approved establishment” in a country FSIS has recognized as equivalent. Taiwan currently has no equivalence recognition for pork or beef, so frozen foods containing pork or beef cannot be exported to the US at present; poultry and egg products each have their own lists, so check the latest version before shipping.
So scallion pancakes, turnip cake, vegetarian dumplings, frozen vegetables, frozen seafood and frozen fruit go through FDA; pork dumplings, beef noodle soup and meat zongzi go through FSIS — and that road is closed to Taiwanese plants for now.
Gate two: the FDA product code and Prior Notice must say “frozen”
The Prior Notice requires an FDA product code, and one digit of the code is the “process.” Frozen products must use a frozen process (for example frozen or IQF). File it as ambient or chilled, and when the port inspection does not match, the cargo is held.
Another classification issue that is often overlooked: low-acid canned foods (LACF) and acidified foods need a separate FCE / SID registration with FDA. Frozen products are normally outside this category (they are preserved by freezing, not by sterilization), but if your product is a retort pouch “sterilized and stored at room temperature,” it must go through FCE / SID and cannot be declared as frozen.
Gate three: Listeria in ready-to-eat frozen food
FDA has zero tolerance for Listeria monocytogenes in “ready-to-eat” (RTE) food: a positive result means non-compliance. Freezing does not kill Listeria; it only stops it growing. So the question is whether your product counts as ready-to-eat:
- Requires thorough cooking before eating (raw scallion pancakes, raw dumplings): the label must carry clear “cook before eating” instructions, and the product is not tested to the RTE standard
- Eaten after thawing (frozen cooked dishes, cold salads, frozen desserts): tested to the RTE standard, and the plant needs environmental monitoring and a Listeria control plan
GoodMall scallion pancakes belong to the first group; during label review we specifically added English cooking instructions precisely to avoid the product being sampled as ready-to-eat.
Gate four: where the cargo sits during inspection, and at what temperature
When FDA samples frozen products, the cargo must wait for the results in a frozen state, usually three to ten working days. There are three arrangements: the container stays on dock power, the goods go into the importer’s cold store, or into a third-party cold store. Who arranges it, who pays and who records the temperature must be settled before shipment.
SKYCARGO INC holds FDA and USDA agent status and can act as Importer of Record and consignee: during inspection the cargo goes into our cold store, the warehouse issues the temperature record, and sampling, holds and release are handled by the same team, with cold-chain delivery into the channel after release. This is exactly how GoodMall scallion pancakes went through — passed FDA inspection and went on shelf after the label was adjusted to the US format.
Four checks before you export
| Check | If it fails |
|---|---|
| Does the meat content exceed the FSIS threshold? | Products with pork or beef cannot enter the US at present — reformulate or switch products |
| Does the product code use a frozen process? | Mismatch at the port, cargo held |
| Is it ready-to-eat, and does the label carry cooking instructions? | Tested under the zero-tolerance Listeria standard |
| Cold store and temperature records on the US side during inspection? | Unclear liability for a broken chain, whole shipment may be re-exported |
With all four confirmed, exporting frozen food to the US becomes a matter of logistics and paperwork. Tell us the recipe, packaging and heating method and we will reply within one working day on whether it falls under FDA or FSIS and which documents you need.
This article summarizes FDA 21 CFR and USDA FSIS import rules for reference only. The FSIS list of recognized countries and establishments is updated continually — check the latest FSIS and FDA announcements before shipping.
