FDA Import Refusals Logged by DSEI
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The DSEI import division logged 6,730 FDA refusals between 2020 and 2026, 25.4% of all US import refusals in the dataset. The origins it rejects most often are India, Mexico, Indonesia. Its most-rejected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 67% on 2024.
What these division codes mean
- DNEI
- Division of Northeast Imports.
- DSEI
- Division of Southeast Imports.
- DWCI
- Division of West Coast Imports.
- DSWI
- Division of Southwest Imports — the Mexican land border.
- DNBI
- Division of North Border Imports — the Canadian land border.
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FDA refusals logged by DSEI, by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 639 | — | |
| 2021 | 812 | +27.1% | |
| 2022 | 974 | +20.0% | |
| 2023 | 823 | -15.5% | |
| 2024 | 827 | +0.5% | |
| 2025 | 1,385 | +67.5% | |
| 2026 | 1,270 | — | YTD |
| Total | 6,730 |
Origins most often refused by DSEI
| # | Origin country | Refusals |
|---|---|---|
| 1 | India | 1,194 |
| 2 | Mexico | 624 |
| 3 | Indonesia | 465 |
| 4 | Guatemala | 317 |
| 5 | United Kingdom | 285 |
| 6 | Australia | 251 |
| 7 | China | 223 |
| 8 | Malaysia | 209 |
| 9 | Colombia | 181 |
| 10 | Vietnam | 176 |
| 11 | Brazil | 168 |
| 12 | Thailand | 164 |
| 13 | Turkey | 161 |
| 14 | Germany | 115 |
| 15 | Dominican Republic | 110 |
| 16 | Portugal | 109 |
| 17 | Spain | 108 |
| 18 | Switzerland | 97 |
| 19 | Honduras | 94 |
| 20 | Ecuador | 83 |
| 21 | Costa Rica | 80 |
| 22 | Italy | 78 |
| 23 | United States | 72 |
| 24 | Canada | 69 |
| 25 | Japan | 67 |
| 26 | South Korea | 66 |
| 27 | Nicaragua | 62 |
| 28 | Peru | 55 |
| 29 | Jamaica | 52 |
| 30 | Nigeria | 49 |
Product categories most often refused by DSEI
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 2,840 |
| 2 | Fishery/Seafood Products | 685 |
| 3 | Fruit and Fruit Products | 532 |
| 4 | Vegetables and Vegetable Products | 438 |
| 5 | Dietary Conventional Foods and Meal Replacements | 266 |
| 6 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 238 |
| 7 | Color Additives for Foods, Drugs, and Cosmetics | 221 |
| 8 | Baby (Infant and Junior) Food Products | 215 |
| 9 | Bakery Products, Doughs, Bakery Mixes, and Icings | 196 |
| 10 | Spices, Flavors, and Salts | 178 |
| 11 | Nuts and Edible Seeds | 127 |
| 12 | Snack Food Items (Flour, Meal, or Vegetable Base) | 119 |
| 13 | Chocolate and Cocoa Products | 105 |
| 14 | Soft Drinks and Waters | 98 |
| 15 | Whole Grains, Milled Grain Products, and Starch | 92 |
Recent refusals logged by DSEI
- 1FX-5769925-9 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Saint Lucia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. plant part not declaredunapproved new drug
- 1FX-6375016-1 VITAMIN E (TOCOPHEROL)From Guatemala, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. labelingunauthorized health claim
- AEK-2341507-7 FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERSFrom Vietnam, Dietary Conventional Foods and Meal Replacements. not in English
- 1FX-3654157-2 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Japan, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. supplement labelingnot in Englishnutrition labeling
- 1FX-5630652-6 TODDLER MILK BASED FORMULA/DRINK PRODUCT (12-36 MONTHS), POWDER FORMULAFrom Switzerland, Baby (Infant and Junior) Food Products. no premarket notificationlabel not conspicuousnot in Englishnutrition units incorrect
- AEK-2234055-7 GINSENG (HERBAL & BOTANICALS, NOT TEAS)From Colombia, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unapproved new drug
- AEK-2187557-9 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Sri Lanka, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unapproved new drug
- AEK-2265463-5 TAMARIND, DRIED OR PASTEFrom Thailand, Fruit and Fruit Products. filth
- GLD-0223712-5 INFANT FORMULA RAW MATERIAL COMPONENT, N.E.C.,From Canada, Baby (Infant and Junior) Food Products. false or misleading label
- GLD-0328419-1 MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULAFrom United Kingdom, Baby (Infant and Junior) Food Products. false or misleading label
- 1FX-5649391-0 ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unapproved new drug
- GLD-0003307-0 OTHER FORMULA PRODUCTS, N.E.C., READY TO FEEDFrom United Kingdom, Baby (Infant and Junior) Food Products. false or misleading label
- AEK-2058257-2 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unapproved new drug
- AEK-2027330-5 VITAMIN, N.E.C.From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unapproved new drug
- 1FX-8631279-1 CALCIUM (MINERAL)From India, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. establishment not listedunapproved new drug
- 1FX-2061917-8 FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERSFrom Kenya, Dietary Conventional Foods and Meal Replacements. unapproved new drug
- SCS-8405454-1 MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULAFrom United Kingdom, Baby (Infant and Junior) Food Products. false or misleading label
- 900-0220797-6 TOMATOES (FRUIT USED AS VEGETABLE)From Dominican Republic, Vegetables and Vegetable Products. pesticide residueno manufacturer name
- AEK-2044247-0 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From Sri Lanka, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. unapproved new drug
- GLD-0349392-5 GOAT MILK INFANT BASED FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULAFrom United Kingdom, Baby (Infant and Junior) Food Products. false or misleading label
About FDA import refusals
What is an FDA import refusal?
An FDA import refusal is an entry that FDA examined, or sampled, and refused admission into US commerce — most often because it appeared adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act. It is an entry-level administrative action, not a finding of guilt and not an adjudication; the importer may recondition, re-export or destroy the goods.
What is the difference between the import division and the country of origin?
The import division is one of FDA's own operating divisions that processed the entry and issued the refusal. The country of origin is where the refused product was produced or shipped from. These pages rank import divisions by the number of refusals they issued, separately from the origin-country breakdown.
Do import refusals keep unsafe food out of the United States?
Yes, that is their purpose: refusing an entry at the border stops a non-compliant consignment from reaching US commerce. Not every refusal is a safety finding, though — more than a quarter are labelling or registration failures rather than a hazard in the product itself, which is why this site counts hazard and paperwork refusals separately.