SupplierRadar

FDA import refusals

FDA import refusals: meal replacements from Japan

FDA category: Dietary Conventional Foods and Meal Replacements · October 2016 to September 3, 2026

FDA refused 16 meal replacements shipment lines from Japan between October 2016 and September 3, 2026, 2 of them in 2026; the most refused products were foods with supplemental nutrients added and dietary conventional foods, most often for NO ENGLISH (required label information not in English).

Data from FDA public records, last checked .

16
meal replacements lines refused since October 2016
2
refused so far in 2026
1
firms with the most records, listed below

Meal replacements 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 2021 to 2026. The same numbers are in the table.02462021: 3 refusal lines’212022: 3 refusal lines’222023: 6 refusal lines6’232024: 2 refusal lines’242026 (year to date): 2 refusal lines2’26*
* 2026 is year to date, through September 3, 2026.
Refusal lines by year
YearRefusal linesvs prior year
2026 (to date)2
20242-67%
20236+100%
202230%
20213

Foods with supplemental nutrients added refusals from Japan

FDA refused 8 foods with supplemental nutrients added lines from Japan between October 2016 and September 3, 2026, 50% of the meal replacements lines.
Foods with supplemental nutrients added product descriptions refused from Japan
FDA product descriptionLinesShare of meal replacements
Foods with supplemental nutrients added, with or without artifical sweetners850.0%

Recent foods with supplemental nutrients added refusals

Recent Foods with supplemental nutrients added refusals from Japan
DateFirmProductCharges
Expandy Co LtdNishinomiya, JapanFoods with supplemental nutrients added, with or without artifical sweetnersLIST INGREINCONSPICULACKS FIRM+1Source
FCC Horiuchi Co., Ltd.Kurume, JapanFoods with supplemental nutrients added, with or without artifical sweetnersSUPPL GMPSource
Around the World KkEdogawa, JapanFoods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHSource
Hirata Nouen Co.,LtdTakasaki, JapanFoods with supplemental nutrients added, with or without artifical sweetnersNUTRIT LBLSource
Hirata Nouen Co.,LtdTakasaki, JapanFoods with supplemental nutrients added, with or without artifical sweetnersINCONSPICUNO ENGLISHNUTRIT LBLSource

Dietary conventional foods refusals from Japan

FDA refused 6 dietary conventional foods lines from Japan between October 2016 and September 3, 2026, 38% of the meal replacements lines.
Dietary conventional foods product descriptions refused from Japan
FDA product descriptionLinesShare of meal replacements
Dietary conventional foods, n.e.c.637.5%

Recent dietary conventional foods refusals

Recent Dietary conventional foods refusals from Japan
DateFirmProductCharges
Nagatanien CoTokyo, JapanDietary conventional foods, n.e.cNO ENGLISHLABELINGSource
Okawari JapanOta, JapanDietary conventional foods, n.e.cNO ENGLISHSource
B&S Corporation Co., Ltd.Fujinomiya, JapanDietary conventional foods, n.e.cDIETARYLBLNO ENGLISHSource
The Osone Co., Ltd.Chichibu, JapanDietary conventional foods, n.e.cINCONSPICULACKS N/CLABELING+1Source
Okinawa AgentItoman, JapanDietary conventional foods, n.e.cLIST INGREDIETARYLBLLACKS FIRM+4Source

Foods with excessive nutritional claims refusals from Japan

FDA refused 1 foods with excessive nutritional claims line from Japan between October 2016 and September 3, 2026, 6% of the meal replacements lines.
Foods with excessive nutritional claims product descriptions refused from Japan
FDA product descriptionLinesShare of meal replacements
Foods (including water) with excessive nutritional claims16.3%

Recent foods with excessive nutritional claims refusals

Recent Foods with excessive nutritional claims refusals from Japan
DateFirmProductCharges
Sunsho Pharmaceutical Co. (Fujine Factory)Fujinomiya, JapanFoods (including water) with excessive nutritional claimsUNAPPROVEDSource

Other meal replacements products refused from Japan

Products refused from Japan in meal replacements
Product groupLinesShare
Medical foods16.3%

Why FDA refused meal replacements from Japan

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for meal replacements from Japan
Charge codeMeaningLinesShare
NO ENGLISHRequired label information not in English826%
NUTRIT LBLNutrition information missing from label516%
DIETARYLBLNot identified as a dietary supplement413%
INCONSPICURequired information not conspicuous310%
LIST INGREIngredients not listed310%
LABELINGFair Packaging and Labeling Act26%
LACKS FIRMManufacturer name and address missing26%
LACKS N/CNet quantity statement missing26%
ALLERGENMajor food allergen not declared13%
FALSEFalse or misleading labeling13%

Japan meal replacements firms with the most FDA records

Counts are FDA records in SupplierRadar's data, not a ranking of quality.
Japan meal replacements firms with the most FDA records
FirmCityFDA records
FCC Horiuchi Co., Ltd.Kurume1

Latest meal replacements refusals from Japan

Latest FDA meal replacements refusals from Japan
DateFirmProductCharges
Expandy Co LtdNishinomiya, JapanFoods with supplemental nutrients added, with or without artifical sweetnersLIST INGREINCONSPICULACKS FIRM+1Source
Sunsho Pharmaceutical Co. (Fujine Factory)Fujinomiya, JapanFoods (including water) with excessive nutritional claimsUNAPPROVEDSource
FCC Horiuchi Co., Ltd.Kurume, JapanFoods with supplemental nutrients added, with or without artifical sweetnersSUPPL GMPSource
Nagatanien CoTokyo, JapanDietary conventional foods, n.e.cNO ENGLISHLABELINGSource
Around the World KkEdogawa, JapanFoods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHSource
Hirata Nouen Co.,LtdTakasaki, JapanFoods with supplemental nutrients added, with or without artifical sweetnersNUTRIT LBLSource
Hirata Nouen Co.,LtdTakasaki, JapanFoods with supplemental nutrients added, with or without artifical sweetnersINCONSPICUNO ENGLISHNUTRIT LBLSource
Okawari JapanOta, JapanDietary conventional foods, n.e.cNO ENGLISHSource
B&S Corporation Co., Ltd.Fujinomiya, JapanMedical foods, n.e.cDIETARYLBLNO ENGLISHSource
B&S Corporation Co., Ltd.Fujinomiya, JapanDietary conventional foods, n.e.cDIETARYLBLNO ENGLISHSource
The Osone Co., Ltd.Chichibu, JapanFoods with supplemental nutrients added, with or without artifical sweetnersDIETARYLBLSource
The Osone Co., Ltd.Chichibu, JapanFoods with supplemental nutrients added, with or without artifical sweetnersLIST INGREALLERGENSource
The Osone Co., Ltd.Chichibu, JapanDietary conventional foods, n.e.cINCONSPICULACKS N/CLABELING+1Source
AFC-HD AMS Life Science Co., Ltd.Shizuoka, JapanFoods with supplemental nutrients added, with or without artifical sweetnersFALSESource
Okinawa AgentItoman, JapanDietary conventional foods, n.e.cLIST INGREDIETARYLBLLACKS FIRM+4Source
Okinawa AgentItoman, JapanDietary conventional foods, n.e.cNO ENGLISHSource

Questions about meal replacements refusals from Japan

How many meal replacements shipments from Japan did FDA refuse in 2026?
FDA refused 2 shipment lines of meal replacements from Japan in 2026 through September 3, 2026.
Why does FDA refuse meal replacements from Japan?
FDA records a charge code on every refused shipment line. For meal replacements from Japan the most frequent are NO ENGLISH (required label information not in English, 8 lines), NUTRIT LBL (nutrition information missing from label, 5 lines) and DIETARYLBL (not identified as a dietary supplement, 4 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover meal replacements from Japan?
As of October 26, 2026, no import alert numbered under this category lists a firm in Japan in SupplierRadar's records. General food alerts numbered 99-xx can still list Japan firms; see the country page.

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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.