SupplierRadar
Sign inStart free

FDA import refusals

FDA import refusals from Japan

Food, dietary supplements and animal food · October 2016 to October 15, 2026 · how the data is collected

FDA refused 1,266 shipment lines from Japan between October 2016 and October 2026, including 61 in 2026 through October 15, 2026; the most common charges were NO ENGLISH, UNSAFE COL and NUTRIT LBL, and the most refused category was candy and chewing gum.

Data from FDA public records, last checked .

1,266
refused shipment lines since October 2016
61
refused so far in 2026
1,333
Japan firms with an FDA record
260
firms on an active import alert

Refusals from Japan by year

Shipment lines FDA refused each year. The table has the same numbers as the chart.
Bar chart: refusal lines by 2016 to 2026. The same numbers are in the table.01002003002016 (from October 1): 33 refusal lines’162017: 212 refusal lines212’172018: 171 refusal lines’182019: 179 refusal lines’192020: 77 refusal lines’202021: 65 refusal lines’212022: 84 refusal lines’222023: 135 refusal lines’232024: 167 refusal lines’242025: 82 refusal lines’252026 (year to date): 61 refusal lines61’26*
* 2026 is year to date, through October 15, 2026. FDA's refusal data starts on October 1, 2016, so 2016 covers three months.
Refusal lines by year
YearRefusal linesvs prior year
2026 (to date)61
202582-51%
2024167+24%
2023135+61%
202284+29%
202165-16%
202077-57%
2019179+5%
2018171-19%
2017212
2016 (from Oct)33

Why FDA refused Japan shipment lines

FDA records a charge code on each refused line; one line can carry several. Each code opens FDA's official statement and the countries and products behind it.
Most frequent refusal charges for Japan
Charge codeMeaningLinesShare
NO ENGLISHRequired label information not in English50434%
UNSAFE COLColor additive unsafe under section 72125417%
NUTRIT LBLNutrition information missing from label1379%
COLOR LBLGArtificial coloring not declared1138%
LIST INGREIngredients not listed1117%
NO PROCESSNo scheduled process filed1037%
MFRHACCPSeafood HACCP requirements not met956%
NEEDS FCEProcessor not registered for canned or acidified foods664%
LACKS FIRMManufacturer name and address missing624%
LABELINGFair Packaging and Labeling Act503%

What FDA refused from Japan, by product category

FDA product categories, most refused first. Open a category for its product, charge and firm tables.
FDA import refusals from Japan by product category
CategoryMost refused productsLines
Candy and chewing gumCandy without Chocolate, Candy Specialties, and Chewing GumFlavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate); Jellied candy, soft (jelly beans, gum drops, etc.), without nuts and fruit (without chocolate); Gel cups, fruit flavored308
SeafoodFishery/Seafood ProductsYellowtail, amberjack; Scallops; Fish, n.e.c.218
Root vegetables and mushroomsVegetables and Vegetable Products (root and tuber vegetables, fungi)Radish (root & tuber vegetable); Ginger root (root & tuber vegetable); Radish, with sauce133
Dietary supplementsVitamins, Minerals, Proteins, and Unconventional Dietary SpecialtiesVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Herbals & botanicals (not teas), n.e.c.; Protein n.e.c.109
Bakery productsBakery Products, Doughs, Bakery Mixes, and IcingsCakes, filled (other than fruit or jelly); Chocolate filled/iced cookies,biscuits and wafers; Cookie,biscuit,wafer dough, n.e.c.65
Coffee and teaCoffee and TeaTea, n.e.c.; Tea, green; Coffee, n.e.c.65
Noodles and pastaMacaroni and Noodle ProductsOriental noodles (flavored with shrimp,chicken,beef,lobster,crab,plain,etc.); Noodles, instant; Noodles and noodle products, n.e.c.43
Vegetables (legumes and leafy)Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)Seaweed, dried or paste; Bamboo shoots (leaf & stem vegetable); Gourd, dried or paste31
Soft drinks and waterSoft Drinks and WatersNoncarbonated soft drink, n.e.c.; Carbonated soft drink, n.e.c.; Soft drinks and waters not mentioned elsewhere, n.e.c.31
Sauces and prepared mealsMultiple Food Dinners, Gravies, Sauces, and SpecialtiesSauces, n.e.c.; Soy sauce; Bean curd, fried (multilple food specialties, side dishes and desserts)29
Tropical and pit fruitFruit and Fruit Products (pit, subtropical and tropical fruits)Plum (pit fruit); Imitation fruit, jam, jelly, preserves, marmalade, butter or candied, n.e.c.; Plum, dried or paste28
Beverage basesBeverage BasesBeverage base, cola, liquid; Beverage base not mentioned elsewhere, n.e.c.; Beverage base of non-fruit origin, n.e.c.27
SoupsSoupsSoup, n.e.c.; Concentrated broth, n.e.c.; Broth, n.e.c. (meat and/or vegetable stock)27
Chocolate and cocoaChocolate and Cocoa ProductsChocolate candy bar, without nuts and fruit; Chocolate candy pieces, without nuts and fruit; Chocolate bars25
Snack foodsSnack Food ItemsPotato snacks (flavored or unflavored), vegetable snacks (other than pulses) baked; Snack foods not elsewhere mentioned, n.e.c.; Baked snack food, n.e.c.21
Grains and starchWhole Grains, Milled Grain Products, and StarchRice meal processed (packaged); Rice flour; Rice, processed (packaged) n.e.c.19
Meal replacementsDietary Conventional Foods and Meal ReplacementsFoods with supplemental nutrients added, with or without artifical sweetners; Dietary conventional foods, n.e.c.; Foods (including water) with excessive nutritional claims16
Cereals and breakfast foodsCereal Preparations, Breakfast FoodsCereal preparations not elsewhere mentioned, n.e.c.; Granola bars; Mixed cereal flakes,shredded and other forms ready to eat15
SpicesSpices, Flavors, and SaltsGinger, whole (spice); Mixed spices and seasoning with salt, n.e.c.; Meat tenderizer (with salt)10
Baby foodBaby (Infant and Junior) Food ProductsVegetable soups and soup mix (baby); Milk base infant formula product (0-12 months), powder formula; Mixed cereal, with fruit (baby)8
Dressings and condimentsDressings and CondimentsFlavored mustard , prepared; Horseradish, prepared; Non-standardized dressing, n.e.c.7
Berries and citrusFruit and Fruit Products (berries, citrus and core fruits)Citron, citrus fruit juices or concentrates; Berry juice, n.e.c. berry juice or concentrates; Lemon, jam, jelly, preserves, marmalade, butter and candied6
Gelatin and puddingsGelatin, Rennet, Pudding Mixes, and Pie FillingsGelatin, flavored; Pudding (pie filling) mix, n.e.c. (not custard)6
Nuts and seedsNuts and Edible SeedsSesame seed (edible seed paste); Millet seed (edible seed); Peanut, nut flour/meal5
Food additives (stabilizers)Food Additives for Human Use (stabilizers, thickeners, other)Food additives for human use, n.e.c.4
Milk and butterMilk, Butter, and Dried Milk ProductsDried milk, non fat; Low fat milk product, n.e.c.2
Pet foodPet and Laboratory Animal FoodsFish-seafood prod pet cat food; Pet treats, n.e.c.2
Imitation milkFilled Milk and Imitation Milk ProductsImitation milk, fluid cream type product1
Vegetable proteinVegetable Protein Products (Simulated Meats)Vegetable protein products not elsewhere mentioned, n.e.c.1
Vine and other fruitFruit and Fruit Products (vine and other fruits)Korean melon1
Vegetable oilsVegetable Oils (Includes Olive Oil)Mustard oil, refined, single ingredient, see 28o for mustard oil as a flavoring1
Food additives (flavors and colors)Food Additives for Human Use (flavors, colors, leavening and other agents)Antioxidants (food additives for human use)1
Color additivesColor Additives for Foods, Drugs, and CosmeticsColors for food use (not certified), n.e.c.1

Most refused products from Japan

FDA's product descriptions on the refused lines, grouped case-insensitively.
Most refused products from Japan
ProductLinesShare
Flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate)624.9%
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.624.9%
Radish (root & tuber vegetable)524.1%
Jellied candy, soft (jelly beans, gum drops, etc.), without nuts and fruit (without chocolate)463.6%
Yellowtail, amberjack443.5%
Gel cups, fruit flavored352.8%
Tea, n.e.c.292.3%
Ginger root (root & tuber vegetable)282.2%
Candy specialties, n.e.c. (without chocolate)272.1%
Scallops272.1%

FDA import alerts that list Japan firms

29 alerts list at least one firm in Japan: 229 firms on a red list, 260 firms on any list.
Import alerts listing firms in Japan
AlertCoversRedGreen
45-02Foods with illegal or undeclared colors8211
16-39Ready-to-eat seafood: Listeria monocytogenes22
16-74Uneviscerated salt-cured, dried, smoked or fermented fish202
99-37Low-acid canned/acidified foods without scheduled process19
16-125Refrigerated raw fish in reduced oxygen packaging215
99-39Imported foods that appear to be misbranded17
16-120Seafood from processors not in compliance with HACCP15
99-21Foods with undeclared added sulfiting agents13
16-119Fish products from importer and processor combinations12
45-06Stevia leaves, crude extracts and foods containing them10
99-08Processed human and animal foods: pesticides9
99-22Undeclared or mislabeled major food allergens9

The 12 alerts with the most listings. All alerts are on the import alerts page.

Japan firms with the most FDA records

Counts are FDA records in SupplierRadar's data (refusals, import alert listings and other events), not a ranking of quality.
Japan firms with the most FDA records
FirmCityFDA records
Ribon Company, Ltd.Komaki35
Nara Co.,Ltd.Ibusuki33
Fukusui Shoji Ltd.Fukuoka33
ACE BAKERY.Co., LtdKomaki24
UHA Mikakuto Co.,Ltd.Yamatokoriyama23
Inoue Shokuhin Co., Ltd. (Reizoko)Kobe18
Okazaki bussanKoshigaya16
UmeyoshiHidaka-Gun15
Maruka ShokuhinOnomichi-shi14
Marukyo Co., Ltd.Yonago12

Latest refusals from Japan

The 20 most recent refused lines, each with its FDA source.
Latest FDA import refusals from Japan
DateFirmProductCharges
Expandy Co LtdNishinomiya, JapanWhey base infant formula product (0-12 months), powder formulaINCONSPICULACKS N/CSource
NAGASAKI TAKARA SYOKUHIN Co., Ltd. KYOUDOMARI FACTORYNagasaki, JapanSquid, breaded, other aquatic speciesMFRHACCPSource
Morinaga Co LtdMinato, JapanCandy specialties, n.e.c. (without chocolate)NO ENGLISHSource
Eye Factory Co., LtdGifushigifuc, JapanCandy specialties, n.e.c. (without chocolate)NO ENGLISHSource
Akita Shokusan, Co., LtdSemboku-Gun Misato-Ch, JapanGinger root (root & tuber vegetable)UNSAFE COLSource
Akita Shokusan, Co., LtdSemboku-Gun Misato-Ch, JapanGinger root (root & tuber vegetable)UNSAFE COLSource
Oak K.K., CorporationSakaiminato, JapanMackerel (all except scomberomorus sp, eg spanish or king see '22')MFRHACCPSource
Oak K.K., CorporationSakaiminato, JapanMackerel (all except scomberomorus sp, eg spanish or king see '22')MFRHACCPSource
Sunsho Pharmaceutical Co., Ltd.Fuji, JapanHerbals & botanicals (not teas), n.e.cSUPPL GMPSource
Kirishima Nousan Co.,Ltd.Kobayashi, JapanRadish (root & tuber vegetable)UNSAFE COLSource
Expandy Co LtdNishinomiya, JapanFoods with supplemental nutrients added, with or without artifical sweetnersLIST INGREINCONSPICULACKS FIRM+1Source
Oak K.K., CorporationSakaiminato, JapanMackerel (all except scomberomorus sp, eg spanish or king see '22')MFRHACCPSource
Oak K.K., CorporationSakaiminato, JapanMackerel (all except scomberomorus sp, eg spanish or king see '22')MFRHACCPSource
Eye Factory Co., LtdGifushigifuc, JapanCandy specialties, n.e.c. (without chocolate)NO ENGLISHSource
Muraoka Foods Co., Ltd.Maebashi, JapanPlum (pit fruit)UNSAFE COLNO ENGLISHSource
Yamaki Co., Ltd.Iyo, JapanBroth, n.e.c. (meat and/or vegetable stock)NO ENGLISHSource
Asahi Group Foods LtdAzumaba, JapanCandy specialties, n.e.c. (without chocolate)NO ENGLISHSource
Akai Bohshi Co LtdShibuya, JapanCandy specialties, n.e.c. (without chocolate)NO ENGLISHSource
Akita Shokusan, Co., LtdSemboku-Gun Misato-Ch, JapanGinger root (root & tuber vegetable)UNSAFE COLSource
Akita Shokusan, Co., LtdSemboku-Gun Misato-Ch, JapanGinger root (root & tuber vegetable)UNSAFE COLSource

Questions about FDA refusals from Japan

How many Japan shipments did FDA refuse in 2026?
FDA refused 61 shipment lines from Japan in 2026 through October 15, 2026, compared with 82 in 2025 (a full year).
Why does FDA refuse food from Japan?
FDA records a charge code on every refused shipment line. For Japan the most frequent are NO ENGLISH (required label information not in English, 504 lines), UNSAFE COL (color additive unsafe under section 721, 254 lines) and NUTRIT LBL (nutrition information missing from label, 137 lines). A charge describes what FDA's reference table says about one shipment line; it is not a finding about every firm in the country.
Which Japan firms have the most FDA refusals?
In SupplierRadar's records the Japan firms with the most FDA records (refusals, import alert listings and other events) are Ribon Company, Ltd. (Komaki) with 35 records, NARA CO.,LTD. (Ibusuki) with 33 records and Fukusui Shoji Ltd. (Fukuoka) with 33 records. Each firm's page lists every record with its FDA source.
Which FDA import alerts list Japan firms?
As of October 25, 2026, 29 FDA import alerts list at least one firm in Japan. The alerts with the most Japan listings are Import Alert 45-02 (93 firms), Import Alert 16-39 (22 firms) and Import Alert 16-74 (22 firms).
How many Japan firms are on an FDA import alert red list?
As of October 25, 2026, 229 Japan firms are on the red list of at least one FDA import alert in SupplierRadar's records, and 260 firms are on any list.

All Japan suppliers with FDA records (531)

Every Japan firm in SupplierRadar's data with an active import alert, a warning letter or at least five FDA records, most recently active first. Each name opens the firm's FDA record history.

Built for the person who signs the FSVP file

Buying from Japan?

Check each Japan supplier against every FDA record in one paste, free for five suppliers. Watch the ones you buy from and get the source the day a record changes.

Check five suppliers freeWatch a supplier free

SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.