FDA import refusals
FDA import refusals: sweeteners from Malaysia
FDA category: Food Sweeteners (Nutritive) · October 2016 to June 11, 2025
FDA refused 37 sweeteners shipment lines from Malaysia between October 2016 and June 11, 2025, 1 of them in 2025; the most refused product was honey, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 37
- sweeteners lines refused since October 2016
- 1
- refused so far in 2025
- 9
- firms with the most records, listed below
Sweeteners refusals from Malaysia by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2025 | 1 | 0% |
| 2024 | 1 | 0% |
| 2023 | 1 | -50% |
| 2022 | 2 | -78% |
| 2021 | 9 | +800% |
| 2020 | 1 | -89% |
| 2019 | 9 | +200% |
| 2018 | 3 | -70% |
| 2017 | 10 |
Honey refusals from Malaysia
FDA refused 37 honey lines from Malaysia between October 2016 and June 11, 2025, 100% of the sweeteners lines.
| FDA product description | Lines | Share of sweeteners |
|---|---|---|
| Honey | 24 | 64.9% |
| Honey, n.e.c. | 13 | 35.1% |
Recent honey refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Sk Mart TradingKuala Kelawang, Malaysia | Honey, n.e.c | ADDDRUGBIO | Source | |
| Drs Secret Worldwide Manufacturing Sdn BhdButterworth, Malaysia | Honey | LACKS FIRMNUTRIT LBLUNAPPROVED | Source | |
| Dose Vital Manufacturing SDN BHDKuala Lumpur, Malaysia | Honey, n.e.c | DIRECTIONSUNSAFE ADDPOISONOUS+1 | Source | |
| Medcare Smart SDN BHDKuala, Malaysia | Honey | UNAPPROVED | Source | |
| Kingdom Honey Sdn BhdKuala Lumpur, Malaysia | Honey | UNAPPROVED | Source |
Why FDA refused sweeteners from Malaysia
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 25 | 37% |
| FALSE | False or misleading labeling | 8 | 12% |
| DIRSEXMPT | Appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. | 6 | 9% |
| UNSAFE ADD | Food additive unsafe under section 409 | 6 | 9% |
| NUTRIT LBL | Nutrition information missing from label | 5 | 7% |
| DIRECTIONS | Is a device whose label appears to not bear adequate directions for use. | 4 | 6% |
| LABELING | Fair Packaging and Labeling Act | 4 | 6% |
| POISONOUS | Poisonous or deleterious substance | 4 | 6% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 3 | 4% |
| LACKS N/C | Net quantity statement missing | 2 | 3% |
Import alerts for sweeteners that list Malaysia firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 36-04 | Honey and blended syrup: drug residues | 5 |
Malaysia sweeteners firms with the most FDA records
Counts are FDA records in SupplierRadar's data, not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Kingdom Honey Sdn Bhd | Kuala Lumpur | 9 |
| Biotivity SDN BHD | Bota | 6 |
| Kingdom Honey SDN. BHD. | Kuala Lumpur | 5 |
| Dose Vital Manufacturing SDN BHD | Kuala Lumpur | 3 |
| Etumax | Petaling | 2 |
| Achlim Trading Sdn Bhd | Kuala Lumpur | 2 |
| Drs Secret Worldwide Manufacturing Sdn Bhd | Butterworth | 1 |
| Medcare Smart SDN BHD | Kuala | 1 |
| KHAN aLASSAL | Selangor | 1 |
Latest sweeteners refusals from Malaysia
Questions about sweeteners refusals from Malaysia
- How many sweeteners shipments from Malaysia did FDA refuse in 2025?
- FDA refused 1 shipment line of sweeteners from Malaysia in 2025 through June 11, 2025, compared with 1 in 2024.
- Why does FDA refuse sweeteners from Malaysia?
- FDA records a charge code on every refused shipment line. For sweeteners from Malaysia the most frequent are UNAPPROVED (unapproved new drug, 25 lines), FALSE (false or misleading labeling, 8 lines) and DIRSEXMPT (DIRSEXMPT, 6 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover sweeteners from Malaysia?
- As of October 26, 2026, the FDA import alerts for this category that list Malaysia firms are Import Alert 36-04 (5 firms). General food alerts numbered 99-xx can list Malaysia 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.