FDA refusal charge NEEDS FCE: no food-canning registration
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The NEEDS FCE charge appeared in 505 FDA import refusals between 2020 and 2026 — 1.9% of all 26,358 US import refusals. The charge is a process, registration or approval failure, not a contaminant or pathogen found in the product. The origins cited most often are China, Mexico, India. The most-affected product category is Vegetables and Vegetable Products. Volume in 2025 was up 70% on 2024.
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What FDA's charge says
NEEDS FCE 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.
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NEEDS FCE refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 69 | — | |
| 2021 | 75 | +8.7% | |
| 2022 | 69 | -8.0% | |
| 2023 | 67 | -2.9% | |
| 2024 | 60 | -10.4% | |
| 2025 | 102 | +70.0% | |
| 2026 | 63 | — | YTD |
| Total | 505 |
Origins most often refused under NEEDS FCE
| # | Origin country | Refusals |
|---|---|---|
| 1 | China | 75 |
| 2 | Mexico | 48 |
| 3 | India | 41 |
| 4 | Vietnam | 24 |
| 5 | Guatemala | 18 |
| 6 | Japan | 17 |
| 7 | South Korea | 17 |
| 8 | Brazil | 13 |
| 9 | Honduras | 13 |
| 10 | Thailand | 13 |
| 11 | Italy | 12 |
| 12 | Spain | 12 |
| 13 | Jordan | 10 |
| 14 | Taiwan | 10 |
| 15 | Turkey | 9 |
| 16 | Canada | 8 |
| 17 | Egypt | 8 |
| 18 | Jamaica | 8 |
| 19 | Colombia | 7 |
| 20 | Myanmar | 7 |
| 21 | Philippines | 7 |
| 22 | United Kingdom | 7 |
| 23 | France | 6 |
| 24 | Nigeria | 6 |
| 25 | Syria | 5 |
| 26 | United States | 5 |
| 27 | Bangladesh | 4 |
| 28 | Chile | 4 |
| 29 | Ecuador | 4 |
| 30 | El Salvador | 4 |
Product categories refused under NEEDS FCE
| # | Product category | Refusals |
|---|---|---|
| 1 | Vegetables and Vegetable Products | 105 |
| 2 | Fruit and Fruit Products | 78 |
| 3 | Milk, Butter, and Dried Milk Products | 52 |
| 4 | Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet) | 46 |
| 5 | Fishery/Seafood Products | 42 |
| 6 | Dressings and Condiments | 33 |
| 7 | Soft Drinks and Waters | 22 |
| 8 | Coffee and Tea | 21 |
| 9 | Bakery Products, Doughs, Bakery Mixes, and Icings | 11 |
| 10 | Snack Food Items (Flour, Meal, or Vegetable Base) | 9 |
| 11 | Spices, Flavors, and Salts | 9 |
| 12 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 9 |
| 13 | Whole Grains, Milled Grain Products, and Starch | 9 |
| 14 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 7 |
| 15 | Filled Milk and Imitation Milk Products | 7 |
Latest refusals citing NEEDS FCE
- KM6-3686478-7 SAUCES, N.E.C.From India, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). filthno food-canning registrationno process filing
- B4S-1015932-3 RELISH, FRUIT BASED RELISHFrom India, Dressings and Condiments. no food-canning registrationno process filing
- 918-5456115-5 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Mexico, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no food-canning registrationno process filing
- 9DH-0080372-1 NONCARBONATED SOFT DRINK, N.E.C.From Indonesia, Soft Drinks and Waters. no net quantityno food-canning registrationno process filing
- 9AR-0447184-3 STRAWBERRY JUICE, BERRY JUICE OR CONCENTRATESFrom Thailand, Fruit and Fruit Products. unsafe color additiveingredients not listedno net quantitynot in English+4 more
- 9LB-0006896-8 TZAHP CHOY (CHINESE CANNED SWEET PICKLES MADE FROM MIXED VEGETABLES) (MIXED VEGETABLES)From Jordan, Vegetables and Vegetable Products. no food-canning registrationno process filingunsafe color additive
- KM6-3681261-2 MIXED VEGETABLES, N.E.C.From India, Vegetables and Vegetable Products. poisonous or deleterious substanceno food-canning registrationno process filing
- AEK-9744514-0 TZAHP CHOY (CHINESE CANNED SWEET PICKLES MADE FROM MIXED VEGETABLES), WITH SAUCEFrom India, Vegetables and Vegetable Products. no food-canning registrationno process filing
- DP4-1069528-3 CHILI SAUCEFrom India, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). ingredients not listedlabelingno food-canning registrationno process filing+4 more
- FY4-0125551-5 RELISH, FRUIT BASED RELISHFrom United Kingdom, Dressings and Condiments. no net quantitynutrition labelingno food-canning registrationno process filing
- KM6-3681180-4 SAUCES, N.E.C.From India, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). filthno food-canning registrationno process filing
- BJG-0219758-9 SAUCES, N.E.C.From Mexico, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). unsafe food additiveno food-canning registrationno process filing
- 084-1806025-0 ONION BULB (YELLOW, WHITE, RED, ETC.) (ROOT & TUBER VEGETABLE)From United Kingdom, Vegetables and Vegetable Products. inadequate process controlno acidified-food filingno food-canning registration
- BQL-0113376-6 BABY AND JUNIOR FOOD N.E.C.From Croatia, Baby (Infant and Junior) Food Products. no food-canning registrationno process filing
- KM6-3678229-4 MANGO (SUBTROPICAL AND TROPICAL FRUIT)From India, Fruit and Fruit Products. no food-canning registrationno process filingfilthinsanitary conditions
- BJG-0217362-2 CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. label not conspicuousfalse or misleading labelnutrition labelingno food-canning registration+1 more
- AD1-0941842-7 BEAN CURD, FRESH - SOFT OR HARD (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS)From China, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). no net quantityno food-canning registrationno process filing
- 8MN-0018195-7 PAPAYA (PAPAW), JAM, JELLY, PRESERVES, MARMALADE,BUTTER OR CANDIEDFrom Philippines, Fruit and Fruit Products. no food-canning registrationno process filing
- DP4-1052020-0 ARTICHOKE (LEAF & STEM VEGETABLE)From Spain, Vegetables and Vegetable Products. no food-canning registrationno process filing
- DZ1-5232468-4 TEA, SPICEFrom Myanmar, Coffee and Tea. no food-canning registration
About NEEDS FCE
What does the FDA import refusal charge NEEDS FCE mean?
FDA uses NEEDS FCE for: no food-canning registration. Its published charge language reads: “It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).”
Is NEEDS FCE a food safety finding?
No. NEEDS FCE is a process, registration or approval failure: the charge records a missing filing, registration, approval or process control, not a contaminant or pathogen found in the product. This site counts a refusal citing it alone with paperwork. It can still mean the product cannot lawfully be sold in the US.
What happens to a shipment refused under NEEDS FCE?
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.