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FDA import refusals

FDA import refusals: food additives (flavors and colors) from Japan

FDA category: Food Additives for Human Use (flavors, colors, leavening and other agents) · October 2016 to September 7, 2017

FDA refused 1 food additives (flavors and colors) shipment line from Japan between October 2016 and September 7, 2017, 1 of them in 2017; the most refused product was antioxidants, most often for UNAPPROVED (unapproved new drug).

Data from FDA public records, last checked .

1
food additives (flavors and colors) lines refused since October 2016
1
refused so far in 2017
0
firms with the most records, listed below

Food additives (flavors and colors) 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 2017 to 2017. The same numbers are in the table.00.250.50.7512017: 1 refusal lines1’17
Refusal lines by year
YearRefusal linesvs prior year
20171

Antioxidants refusals from Japan

FDA refused 1 antioxidants line from Japan between October 2016 and September 7, 2017, 100% of the food additives (flavors and colors) lines.
Antioxidants product descriptions refused from Japan
FDA product descriptionLinesShare of food additives (flavors and colors)
Antioxidants (food additives for human use)1100.0%

Recent antioxidants refusals

Recent Antioxidants refusals from Japan
DateFirmProductCharges
Kohjin Life Sciences Co LtdTokyo, JapanAntioxidants (food additives for human use)UNAPPROVEDSource

Why FDA refused food additives (flavors and colors) from Japan

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for food additives (flavors and colors) from Japan
Charge codeMeaningLinesShare
UNAPPROVEDUnapproved new drug1100%

Import alerts for food additives (flavors and colors) that list Japan firms

Import alerts for food additives (flavors and colors) listing firms in Japan
AlertCoversRedGreen
45-02Foods with illegal or undeclared colors8211
45-06Stevia leaves, crude extracts and foods containing them10

Latest food additives (flavors and colors) refusals from Japan

Latest FDA food additives (flavors and colors) refusals from Japan
DateFirmProductCharges
Kohjin Life Sciences Co LtdTokyo, JapanAntioxidants (food additives for human use)UNAPPROVEDSource

Questions about food additives (flavors and colors) refusals from Japan

How many food additives (flavors and colors) shipments from Japan did FDA refuse in 2017?
FDA refused 1 shipment line of food additives (flavors and colors) from Japan in 2017 through September 7, 2017.
Why does FDA refuse food additives (flavors and colors) from Japan?
FDA records a charge code on every refused shipment line. For food additives (flavors and colors) from Japan the most frequent are UNAPPROVED (unapproved new drug, 1 line). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover food additives (flavors and colors) from Japan?
As of October 26, 2026, the FDA import alerts for this category that list Japan firms are Import Alert 45-02 (93 firms) and Import Alert 45-06 (10 firms). General food alerts numbered 99-xx can list Japan firms too; 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.