FDA import refusals
FDA import refusals: dietary supplements from Indonesia
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 1, 2026
FDA refused 940 dietary supplements shipment lines from Indonesia between October 2016 and October 1, 2026, 3 of them in 2026; the most refused products were kratom and herbals & botanicals, most often for UNSFDIETSP (dietary ingredient without safety assurance).
Data from FDA public records, last checked .
- 940
- dietary supplements lines refused since October 2016
- 3
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Indonesia by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 3 | |
| 2025 | 5 | -67% |
| 2024 | 15 | -46% |
| 2023 | 28 | +27% |
| 2022 | 22 | -82% |
| 2021 | 124 | -21% |
| 2020 | 156 | -41% |
| 2019 | 263 | +22% |
| 2018 | 216 | +248% |
| 2017 | 62 | |
| 2016 (from Oct) | 46 |
Kratom refusals from Indonesia
FDA refused 760 kratom lines from Indonesia between October 2016 and October 1, 2026, 81% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Kratom (herbal and botanicals, not teas II) | 402 | 42.8% |
| Kratom (herbal and botanical teas II, continued) | 358 | 38.1% |
Recent kratom refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| PT. Raw Botanical NusantaraKota Semarang, Indonesia | Kratom (herbal and botanical teas ii, continued) | UNSFDIETSP | Source | |
| PT Bumindo Inti MakmurSidoarjo, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| CV Razqa AnugerahKalimanta Barat, Indonesia | Kratom (herbal and botanical teas ii, continued) | NDIDIETSP | Source | |
| PT. Aditama Sentosa IndonesiaMalang, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source |
Herbals & botanicals refusals from Indonesia
FDA refused 60 herbals & botanicals lines from Indonesia between October 2016 and October 1, 2026, 6% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 60 | 6.4% |
Moringa oleifera contd refusals from Indonesia
FDA refused 60 moringa oleifera contd lines from Indonesia between October 2016 and October 1, 2026, 6% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Moringa oleifera (herbal and botanical (not teas II) contd | 60 | 6.4% |
Other dietary supplements products refused from Indonesia
| Product group | Lines | Share |
|---|---|---|
| Vitamin | 35 | 3.7% |
| Herbals & botanical teas | 12 | 1.3% |
| Moringa oleifera | 4 | 0.4% |
| Animal by-products and extracts | 2 | 0.2% |
| Betel leaf II) | 1 | 0.1% |
Why FDA refused dietary supplements from Indonesia
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNSFDIETSP | Dietary ingredient without safety assurance | 826 | 75% |
| FALSE | False or misleading labeling | 47 | 4% |
| LABELING | Fair Packaging and Labeling Act | 43 | 4% |
| LIST INGRE | Ingredients not listed | 42 | 4% |
| UNAPPROVED | Unapproved new drug | 40 | 4% |
| LACKS FIRM | Manufacturer name and address missing | 33 | 3% |
| SALMONELLA | Salmonella | 25 | 2% |
| DIRECTIONS | Is a device whose label appears to not bear adequate directions for use. | 24 | 2% |
| INCONSPICU | Required information not conspicuous | 17 | 2% |
| UNSAFE ADD | Food additive unsafe under section 409 | 10 | 1% |
Import alerts for dietary supplements that list Indonesia firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-15 | Supplements and ingredients containing kratom | 47 |
Indonesia dietary supplements firms with the most FDA records
Counts are FDA records in SupplierRadar's data, not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Amc Line Express | Bekasi | 151 |
| Amc | Bekasi | 98 |
| CV Raf | Pontianak | 30 |
| adi dharma putra | Pontianak | 28 |
| Pt Hny Ekspres Indonesia | Bekasi | 24 |
| Ryan Onara Rosnadi | Cirebon | 19 |
| Albert | Tangerang | 16 |
| Egi Astria | Jakarta Selatan | 15 |
| Phils Herbals | Bekasi | 11 |
| CV Aqsa | Kalimantan Barat | 11 |
Latest dietary supplements refusals from Indonesia
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| CV Anugerah UtamaSurabaya, Indonesia | Animal by-products and extracts, n.e.c | NO ENGLISHLABELINGSALMONELLA | Source | |
| PT. Raw Botanical NusantaraKota Semarang, Indonesia | Kratom (herbal and botanical teas ii, continued) | UNSFDIETSP | Source | |
| PT Bumindo Inti MakmurSidoarjo, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Dipa Pharmalab IntersainsJakarta, Indonesia | Vitamin d2 (calciferol) | UNAPPROVED | Source | |
| Titan CenterTangerang, Indonesia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| CV. Ihsan Jaya LogistikBarat, Indonesia | Herbals & botanical teas, n.e.c | UNSFDIETSPSTD IDENTLACKS FIRM | Source | |
| CV. Ihsan Jaya LogistikBarat, Indonesia | Herbals & botanical teas, n.e.c | UNSFDIETSPSTD IDENTLACKS FIRM | Source | |
| CV. Ihsan Jaya LogistikBarat, Indonesia | Herbals & botanical teas, n.e.c | UNSFDIETSPLACKS FIRM | Source | |
| CV Razqa AnugerahKalimanta Barat, Indonesia | Kratom (herbal and botanical teas ii, continued) | NDIDIETSP | Source | |
| PT. Aditama Sentosa IndonesiaMalang, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| Dr Cissie NugrahaJakarta Utara, Indonesia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dr Cissie NugrahaJakarta Utara, Indonesia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| CV King Premier FamilyJakarta Timur, Indonesia | Moringa oleifera (herbal and botanical teas ii, (continued) | NDIDIETSPLABELING | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| PT Sahabat Sukses Kalimantan BaratKuburaya, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSFDIETSP | Source | |
| CV Tritop Borneo KencanaWest Kalimantan, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSAFE ADD | Source | |
| CV Tritop Borneo KencanaWest Kalimantan, Indonesia | Kratom (herbal and botanicals, not teas ii) | NOT LISTEDFRNMFGREGUNAPPROVED | Source | |
| CV Tritop Borneo KencanaWest Kalimantan, Indonesia | Kratom (herbal and botanicals, not teas ii) | UNSAFE ADD | Source | |
| CV Tritop Borneo KencanaWest Kalimantan, Indonesia | Kratom (herbal and botanicals, not teas ii) | NOT LISTEDFRNMFGREGUNAPPROVED | Source |
Questions about dietary supplements refusals from Indonesia
- How many dietary supplements shipments from Indonesia did FDA refuse in 2026?
- FDA refused 3 shipment lines of dietary supplements from Indonesia in 2026 through October 1, 2026, compared with 5 in 2025.
- Why does FDA refuse dietary supplements from Indonesia?
- FDA records a charge code on every refused shipment line. For dietary supplements from Indonesia the most frequent are UNSFDIETSP (dietary ingredient without safety assurance, 826 lines), FALSE (false or misleading labeling, 47 lines) and LABELING (Fair Packaging and Labeling Act, 43 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover dietary supplements from Indonesia?
- As of October 25, 2026, the FDA import alerts for this category that list Indonesia firms are Import Alert 54-15 (47 firms). General food alerts numbered 99-xx can list Indonesia 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.