FDA import refusals
FDA import refusals: dietary supplements from Romania
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to September 17, 2024
FDA refused 4 dietary supplements shipment lines from Romania between October 2016 and September 17, 2024, 2 of them in 2024; the most refused products were herbals & botanicals and omega-3, most often for LABELING (Fair Packaging and Labeling Act).
Data from FDA public records, last checked .
- 4
- dietary supplements lines refused since October 2016
- 2
- refused so far in 2024
- 0
- firms with the most records, listed below
Dietary supplements refusals from Romania by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2024 | 2 | |
| 2016 (from Oct) | 2 |
Herbals & botanicals refusals from Romania
FDA refused 2 herbals & botanicals lines from Romania between October 2016 and September 17, 2024, 50% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 2 | 50.0% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Columbovet SRLOradea, Romania | Herbals & botanicals (not teas), n.e.c | NEW VET DR | Source | |
| Columbovet SRLOradea, Romania | Herbals & botanicals (not teas), n.e.c | NEW VET DR | Source |
Omega-3 refusals from Romania
FDA refused 2 omega-3 lines from Romania between October 2016 and September 17, 2024, 50% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Omega-3 (fats and lipid substances) | 2 | 50.0% |
Recent omega-3 refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| S.C. Canah International srlSalonta, Romania | Omega-3 (fats and lipid substances) | NO ENGLISHNCONTACTLABELING+2 | Source | |
| S.C. Canah International srlSalonta, Romania | Omega-3 (fats and lipid substances) | NO ENGLISHNCONTACTLABELING+2 | Source |
Why FDA refused dietary supplements from Romania
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| LABELING | Fair Packaging and Labeling Act | 2 | 17% |
| NCONTACT | No U.S. adverse event contact on supplement label | 2 | 17% |
| NEW VET DR | Appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food,… | 2 | 17% |
| NO ENGLISH | Required label information not in English | 2 | 17% |
| NUTRIT LBL | Nutrition information missing from label | 2 | 17% |
| UNAPPROVED | Unapproved new drug | 2 | 17% |
Latest dietary supplements refusals from Romania
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Columbovet SRLOradea, Romania | Herbals & botanicals (not teas), n.e.c | NEW VET DR | Source | |
| Columbovet SRLOradea, Romania | Herbals & botanicals (not teas), n.e.c | NEW VET DR | Source | |
| S.C. Canah International srlSalonta, Romania | Omega-3 (fats and lipid substances) | NO ENGLISHNCONTACTLABELING+2 | Source | |
| S.C. Canah International srlSalonta, Romania | Omega-3 (fats and lipid substances) | NO ENGLISHNCONTACTLABELING+2 | Source |
Questions about dietary supplements refusals from Romania
- How many dietary supplements shipments from Romania did FDA refuse in 2024?
- FDA refused 2 shipment lines of dietary supplements from Romania in 2024 through September 17, 2024.
- Why does FDA refuse dietary supplements from Romania?
- FDA records a charge code on every refused shipment line. For dietary supplements from Romania the most frequent are LABELING (Fair Packaging and Labeling Act, 2 lines), NCONTACT (no U.S. adverse event contact on supplement label, 2 lines) and NEW VET DR (NEW VET DR, 2 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 Romania?
- As of October 26, 2026, no import alert numbered under this category lists a firm in Romania in SupplierRadar's records. General food alerts numbered 99-xx can still list Romania firms; see the country page.
Built for the person who signs the FSVP file
Buying dietary supplements from Romania?
Check each Romania supplier against every FDA record in one paste, free for five suppliers. Watch the ones you buy from and get the source the day a record changes.
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.