FDA refusal charge REFUSE EI: refused establishment inspection
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The REFUSE EI charge appeared in 55 FDA import refusals between 2020 and 2026 — 0.3% of the 19,123 refusals that identify a hazard. The origins cited most often are China, South Korea, India. The most-affected product category is Candy Without Chocolate, Candy Specialties, and Chewing Gum. Volume in 2025 was up 367% on 2024.
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What FDA's charge says
REFUSE EI is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
REFUSE EI refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 2 | — | |
| 2021 | 1 | -50.0% | |
| 2022 | 1 | +0.0% | |
| 2023 | 3 | +200.0% | |
| 2024 | 3 | +0.0% | |
| 2025 | 14 | +366.7% | |
| 2026 | 31 | — | YTD |
| Total | 55 |
Origins most often refused under REFUSE EI
| # | Origin country | Refusals |
|---|---|---|
| 1 | China | 16 |
| 2 | South Korea | 14 |
| 3 | India | 7 |
| 4 | Brazil | 6 |
| 5 | Taiwan | 4 |
| 6 | Mexico | 3 |
| 7 | Oman | 2 |
| 8 | Italy | 1 |
| 9 | Japan | 1 |
| 10 | Poland | 1 |
Product categories refused under REFUSE EI
| # | Product category | Refusals |
|---|---|---|
| 1 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 8 |
| 2 | Fruit and Fruit Products | 6 |
| 3 | Fishery/Seafood Products | 5 |
| 4 | Spices, Flavors, and Salts | 5 |
| 5 | Vegetables and Vegetable Products | 5 |
| 6 | Snack Food Items (Flour, Meal, or Vegetable Base) | 4 |
| 7 | Macaroni and Noodle Products | 3 |
| 8 | Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet) | 3 |
| 9 | Nuts and Edible Seeds | 3 |
| 10 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 3 |
| 11 | Baby (Infant and Junior) Food Products | 1 |
| 12 | Bakery Products, Doughs, Bakery Mixes, and Icings | 1 |
| 13 | Dietary Conventional Foods and Meal Replacements | 1 |
| 14 | Dressings and Condiments | 1 |
| 15 | Food Additives - for Human Use | 1 |
Latest refusals citing REFUSE EI
- 581-0316114-6 SESAME SEED (EDIBLE SEED)From India, Nuts and Edible Seeds. refused establishment inspection
- 9KJ-0011500-2 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. refused establishment inspection
- 1FX-3939997-7 TAPIOCA PUDDING (PIE FILLING) MIX (NOT CUSTARD)From Brazil, Gelatin, Rennet, Pudding Mixes, and Pie Fillings. refused establishment inspection
- U47-2608728-9 PEPPER, HOT, DRIED OR PASTEFrom South Korea, Vegetables and Vegetable Products. refused establishment inspection
- KM6-3678296-3 SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.From India, Snack Food Items (Flour, Meal, or Vegetable Base). refused establishment inspection
- AZ2-4055215-8 FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE)From China, Food Additives - for Human Use. insanitary plantrefused establishment inspectioninsanitary handling
- U47-2605126-9 PEPPER SAUCE (HOT, MILD, ETC.)From South Korea, Dressings and Condiments. refused establishment inspection
- U47-2602039-7 FISH, N.E.C.From South Korea, Fishery/Seafood Products. refused establishment inspectionlisting refusal
- KM6-3673483-2 TAMARIND, DRIED OR PASTEFrom India, Fruit and Fruit Products. refused establishment inspectionfilth
- E37-0255986-4 PEPPER, BLACK, GROUND, CRACKED (SPICE)From China, Spices, Flavors, and Salts. refused establishment inspection
- E37-0255948-4 PEPPER, BLACK, GROUND, CRACKED (SPICE)From China, Spices, Flavors, and Salts. refused establishment inspection
- F87-2501083-6 SAFFRON, WHOLE (SPICE)From Oman, Spices, Flavors, and Salts. refused establishment inspection
- 9NX-0007593-0 MIXED STARCH SNACKS, BAKEDFrom South Korea, Snack Food Items (Flour, Meal, or Vegetable Base). refused establishment inspection
- 1FX-1064742-7 BANANA SNACKS, FRUIT SNACK FOODS, BAKEDFrom Brazil, Snack Food Items (Flour, Meal, or Vegetable Base). refused establishment inspectionlisting refusal
- 9GH-0039455-9 ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.)From South Korea, Macaroni and Noodle Products. refused establishment inspection
- U47-2600249-4 RICE FLAKES/PAPERFrom South Korea, Macaroni and Noodle Products. refused establishment inspectionlisting refusal
- B7S-2512177-4 SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.From South Korea, Snack Food Items (Flour, Meal, or Vegetable Base). refused establishment inspection
- FY1-4085434-7 LYCHEE, LICHEE, LITCHI, LEECHEE (SUBTROPICAL AND TROPICAL FRUIT)From China, Fruit and Fruit Products. refused establishment inspectionlisting refusal
- U47-2600415-1 NOODLES AND NOODLE PRODUCTS, N.E.C.From South Korea, Macaroni and Noodle Products. refused establishment inspection
- BRI-0099131-5 CEREAL, N.E.C. (BABY)From South Korea, Baby (Infant and Junior) Food Products. refused establishment inspection
About REFUSE EI
What does the FDA import refusal charge REFUSE EI mean?
FDA uses REFUSE EI for: refused establishment inspection. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.”
Is REFUSE EI a food safety finding?
Yes. This site counts REFUSE EI as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.
What happens to a shipment refused under REFUSE EI?
Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.