FDA import refusals
FDA import refusals: food additives (stabilizers) from China
FDA category: Food Additives for Human Use (stabilizers, thickeners, other) · October 2016 to October 26, 2021
FDA refused 7 food additives (stabilizers) shipment lines from China between October 2016 and October 26, 2021, 4 of them in 2021; the most refused products were food additives for human use and stabilizers and thickeners, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 7
- food additives (stabilizers) lines refused since October 2016
- 4
- refused so far in 2021
- 2
- firms with the most records, listed below
Food additives (stabilizers) refusals from China by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2021 | 4 | +300% |
| 2020 | 1 | 0% |
| 2019 | 1 | |
| 2017 | 1 |
Food additives for human use refusals from China
FDA refused 6 food additives for human use lines from China between October 2016 and October 26, 2021, 86% of the food additives (stabilizers) lines.
| FDA product description | Lines | Share of food additives (stabilizers) |
|---|---|---|
| Food additives for human use, n.e.c. | 6 | 85.7% |
Recent food additives for human use refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | HEALTH CUNAPPROVED | Source | |
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | HEALTH CUNAPPROVED | Source | |
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | HEALTH CUNAPPROVED | Source | |
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | UNAPPROVED | Source | |
| Xi'an Yuensun Biological TechnologyXi`An, China | Food additives for human use, n.e.c | PESTICIDE | Source |
Stabilizers and thickeners refusals from China
FDA refused 1 stabilizers and thickeners line from China between October 2016 and October 26, 2021, 14% of the food additives (stabilizers) lines.
| FDA product description | Lines | Share of food additives (stabilizers) |
|---|---|---|
| Stabilizers and thickeners (food additives for human use) | 1 | 14.3% |
Recent stabilizers and thickeners refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Zhoushan Healthy Chef Food Products Co.Zhoushan, China | Stabilizers and thickeners (food additives for human use) | FALSE | Source |
Why FDA refused food additives (stabilizers) from China
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 4 | 40% |
| HEALTH C | Unauthorized nutrient content or health claim | 3 | 30% |
| FALSE | False or misleading labeling | 1 | 10% |
| PESTICIDE | Pesticide chemical residue | 1 | 10% |
| UNSAFE ADD | Food additive unsafe under section 409 | 1 | 10% |
China food additives (stabilizers) firms with the most FDA records
Counts are FDA records in SupplierRadar's data, not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Hangzhou Johncan Mushroom Bio-technology Co.,Ltd | Hangzhou | 4 |
| Xi'an Yuensun Biological Technology | Xi`An | 1 |
Latest food additives (stabilizers) refusals from China
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | HEALTH CUNAPPROVED | Source | |
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | HEALTH CUNAPPROVED | Source | |
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | HEALTH CUNAPPROVED | Source | |
| Hangzhou Johncan Mushroom Bio-technology Co.,LtdHangzhou, China | Food additives for human use, n.e.c | UNAPPROVED | Source | |
| Xi'an Yuensun Biological TechnologyXi`An, China | Food additives for human use, n.e.c | PESTICIDE | Source | |
| Zhoushan Healthy Chef Food Products Co.Zhoushan, China | Stabilizers and thickeners (food additives for human use) | FALSE | Source | |
| Pure Synmr Ingredients LimitedSHANGHAI, China | Food additives for human use, n.e.c | UNSAFE ADD | Source |
Questions about food additives (stabilizers) refusals from China
- How many food additives (stabilizers) shipments from China did FDA refuse in 2021?
- FDA refused 4 shipment lines of food additives (stabilizers) from China in 2021 through October 26, 2021, compared with 1 in 2020.
- Why does FDA refuse food additives (stabilizers) from China?
- FDA records a charge code on every refused shipment line. For food additives (stabilizers) from China the most frequent are UNAPPROVED (unapproved new drug, 4 lines), HEALTH C (unauthorized nutrient content or health claim, 3 lines) and FALSE (false or misleading labeling, 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 (stabilizers) from China?
- As of October 26, 2026, no import alert numbered under this category lists a firm in China in SupplierRadar's records. General food alerts numbered 99-xx can still list China 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.