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FDA import refusals

FDA import refusals: bakery products from Japan

FDA category: Bakery Products, Doughs, Bakery Mixes, and Icings · October 2016 to May 21, 2025

FDA refused 65 bakery products shipment lines from Japan between October 2016 and May 21, 2025, 4 of them in 2025; the most refused products were cakes and chocolate filled/iced cookies, most often for NO ENGLISH (required label information not in English).

Data from FDA public records, last checked .

65
bakery products lines refused since October 2016
4
refused so far in 2025
10
firms with the most records, listed below

Bakery products 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 2025. The same numbers are in the table.0510152016 (from October 1): 2 refusal lines’162017: 11 refusal lines’172018: 6 refusal lines’182019: 13 refusal lines’192020: 2 refusal lines’202021: 1 refusal lines’212022: 7 refusal lines’222023: 14 refusal lines14’232024: 5 refusal lines’242025: 4 refusal lines4’25
FDA's refusal data starts on October 1, 2016, so 2016 covers three months.
Refusal lines by year
YearRefusal linesvs prior year
20254-20%
20245-64%
202314+100%
20227+600%
20211-50%
20202-85%
201913+117%
20186-45%
201711
2016 (from Oct)2

Cakes refusals from Japan

FDA refused 12 cakes lines from Japan between October 2016 and May 21, 2025, 18% of the bakery products lines.
Cakes product descriptions refused from Japan
FDA product descriptionLinesShare of bakery products
Cakes, filled (other than fruit or jelly)1218.5%

Recent cakes refusals

Recent Cakes refusals from Japan
DateFirmProductCharges
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource

Chocolate filled/iced cookies refusals from Japan

FDA refused 7 chocolate filled/iced cookies lines from Japan between October 2016 and May 21, 2025, 11% of the bakery products lines.
Chocolate filled/iced cookies product descriptions refused from Japan
FDA product descriptionLinesShare of bakery products
Chocolate filled/iced cookies,biscuits and wafers710.8%

Cookie refusals from Japan

FDA refused 6 cookie lines from Japan between October 2016 and May 21, 2025, 9% of the bakery products lines.
Cookie product descriptions refused from Japan
FDA product descriptionLinesShare of bakery products
Cookie,biscuit,wafer dough, n.e.c.69.2%

Other bakery products products refused from Japan

Products refused from Japan in bakery products
Product groupLinesShare
Flavored or party crackers69.2%
Biscuits57.7%
Plain cookies46.2%
Cake without custard or cream filling34.6%
Crackers n.e.c.34.6%
Mixed plain cookies34.6%
Other bakery products34.6%

Why FDA refused bakery products from Japan

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for bakery products from Japan
Charge codeMeaningLinesShare
NO ENGLISHRequired label information not in English4355%
NO PROCESSNo scheduled process filed1215%
COLOR LBLGArtificial coloring not declared68%
UNSAFE COLColor additive unsafe under section 72168%
LIST INGREIngredients not listed34%
FSVP VIOImporter not in compliance with FSVP23%
LABELINGFair Packaging and Labeling Act23%
NUTRIT LBLNutrition information missing from label23%
USUAL NAMECommon or usual name missing23%

Japan bakery products firms with the most FDA records

Counts are FDA records in SupplierRadar's data, not a ranking of quality.
Japan bakery products firms with the most FDA records
FirmCityFDA records
Marukyo Co., Ltd.Yonago12
Sato Foods Co.,Ltd.Niigata3
Morinaga Co LtdMinato3
Wakabato Seika Co.,LtdNagoya2
Ishiya Seika Co., Ltd.Sapporo2
Ezaki GlicoOsaka2
YaokinYashio2
Yaokin Co., Ltd.SUMIDA-KU2
MiZuki International Corp.Kobe2
Lotte Company, Ltd.Shinjuku1

Latest bakery products refusals from Japan

Latest FDA bakery products refusals from Japan
DateFirmProductCharges
Wakabato ConfectioneryNagoya, JapanRice crackersCOLOR LBLGSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Wakabato ConfectioneryNagoya, JapanFlavored or party crackersUNSAFE COLSource
Wakabato ConfectioneryNagoya, JapanFlavored or party crackersUNSAFE COLSource
Kado Co., Ltd.Joso, JapanFlavored or party crackersNO ENGLISHSource
Hiroshi YamamotoTokyo, JapanFlavored or party crackersNO ENGLISHSource
Yaokin Co., Ltd.SUMIDA-KU, JapanCrackers (non filled) n.e.cNO ENGLISHSource
Yaokin Co., Ltd.SUMIDA-KU, JapanFlavored or party crackersNO ENGLISHSource
Wakabato Seika Co.,LtdNagoya, JapanCrackers (non filled) n.e.cCOLOR LBLGSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Bourbon Co., Ltd. Haguro FactoryTsuruoka, JapanCreme filled/iced cookie,biscuit,waferNO ENGLISHSource
Marukin CorporationToyohashi, JapanCake without custard or cream fillingFSVP VIOSource
Marukin CorporationToyohashi, JapanCake without custard or cream fillingFSVP VIOSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource
Marukyo Co., Ltd.Yonago, JapanCakes, filled (other than fruit or jelly)NO PROCESSSource

Questions about bakery products refusals from Japan

How many bakery products shipments from Japan did FDA refuse in 2025?
FDA refused 4 shipment lines of bakery products from Japan in 2025 through May 21, 2025, compared with 5 in 2024.
Why does FDA refuse bakery products from Japan?
FDA records a charge code on every refused shipment line. For bakery products from Japan the most frequent are NO ENGLISH (required label information not in English, 43 lines), NO PROCESS (no scheduled process filed, 12 lines) and COLOR LBLG (artificial coloring not declared, 6 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover bakery products 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.