FDA import refusals
FDA import refusals: dietary supplements from Sri Lanka
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 8, 2026
FDA refused 40 dietary supplements shipment lines from Sri Lanka between October 2016 and October 8, 2026, 17 of them in 2026; the most refused products were vitamin and herbals & botanicals, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 40
- dietary supplements lines refused since October 2016
- 17
- refused so far in 2026
- 4
- firms with the most records, listed below
Dietary supplements refusals from Sri Lanka 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) | 17 | |
| 2025 | 1 | |
| 2022 | 1 | 0% |
| 2021 | 1 | -75% |
| 2020 | 4 | +33% |
| 2019 | 3 | -73% |
| 2018 | 11 | +450% |
| 2017 | 2 |
Vitamin refusals from Sri Lanka
FDA refused 25 vitamin lines from Sri Lanka between October 2016 and October 8, 2026, 63% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 21 | 52.5% |
| Vitamin, n.e.c. | 4 | 10.0% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | ADDDRUGBIO | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from Sri Lanka
FDA refused 7 herbals & botanicals lines from Sri Lanka between October 2016 and October 8, 2026, 18% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 7 | 17.5% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source |
Herbals & botanical teas refusals from Sri Lanka
FDA refused 5 herbals & botanical teas lines from Sri Lanka between October 2016 and October 8, 2026, 13% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanical teas, n.e.c. | 5 | 12.5% |
Other dietary supplements products refused from Sri Lanka
| Product group | Lines | Share |
|---|---|---|
| Senna | 2 | 5.0% |
| Vegetable protein powder | 1 | 2.5% |
Why FDA refused dietary supplements from Sri Lanka
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 34 | 63% |
| NUTRIT LBL | Nutrition information missing from label | 6 | 11% |
| LIST INGRE | Ingredients not listed | 4 | 7% |
| DIRECTIONS | Is a device whose label appears to not bear adequate directions for use. | 2 | 4% |
| HEALTH C | Unauthorized nutrient content or health claim | 2 | 4% |
| NCONTACT | No U.S. adverse event contact on supplement label | 2 | 4% |
| ADDDRUGBIO | Appears to be a food to which has been added either a drug approved under section 505, a biological product… | 1 | 2% |
| DIETARYLBL | Not identified as a dietary supplement | 1 | 2% |
| FALSE | False or misleading labeling | 1 | 2% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 1 | 2% |
Sri Lanka 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 |
|---|---|---|
| Dru Era (Pvt) Ltd | Dehiwala | 29 |
| Link Natural Products Private Ltd | Colombo | 5 |
| Regency Teas (PVT) | Gampaha District | 2 |
| Ceylon Royal Tea And Supplies | Homagama | 1 |
Latest dietary supplements refusals from Sri Lanka
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | ADDDRUGBIO | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Astron LimitedRatmalanaratmalana, Sri Lanka | Vegetable protein powder (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | LIST INGRENUTRIT LBL | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dru Era (Pvt) LtdDehiwala, Sri Lanka | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Questions about dietary supplements refusals from Sri Lanka
- How many dietary supplements shipments from Sri Lanka did FDA refuse in 2026?
- FDA refused 17 shipment lines of dietary supplements from Sri Lanka in 2026 through October 8, 2026, compared with 1 in 2025.
- Why does FDA refuse dietary supplements from Sri Lanka?
- FDA records a charge code on every refused shipment line. For dietary supplements from Sri Lanka the most frequent are UNAPPROVED (unapproved new drug, 34 lines), NUTRIT LBL (nutrition information missing from label, 6 lines) and LIST INGRE (ingredients not listed, 4 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 Sri Lanka?
- As of October 25, 2026, no import alert numbered under this category lists a firm in Sri Lanka in SupplierRadar's records. General food alerts numbered 99-xx can still list Sri Lanka 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.