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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.
Bar chart: refusal lines by 2016 to 2024. The same numbers are in the table.00.511.522016 (from October 1): 2 refusal lines2’162024: 2 refusal lines2’24
FDA's refusal data starts on October 1, 2016, so 2016 covers three months.
Refusal lines by year
YearRefusal linesvs prior year
20242
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.
Herbals & botanicals product descriptions refused from Romania
FDA product descriptionLinesShare of dietary supplements
Herbals & botanicals (not teas), n.e.c.250.0%

Recent herbals & botanicals refusals

Recent Herbals & botanicals refusals from Romania
DateFirmProductCharges
Columbovet SRLOradea, RomaniaHerbals & botanicals (not teas), n.e.cNEW VET DRSource
Columbovet SRLOradea, RomaniaHerbals & botanicals (not teas), n.e.cNEW VET DRSource

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.
Omega-3 product descriptions refused from Romania
FDA product descriptionLinesShare of dietary supplements
Omega-3 (fats and lipid substances)250.0%

Recent omega-3 refusals

Recent Omega-3 refusals from Romania
DateFirmProductCharges
S.C. Canah International srlSalonta, RomaniaOmega-3 (fats and lipid substances)NO ENGLISHNCONTACTLABELING+2Source
S.C. Canah International srlSalonta, RomaniaOmega-3 (fats and lipid substances)NO ENGLISHNCONTACTLABELING+2Source

Why FDA refused dietary supplements from Romania

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for dietary supplements from Romania
Charge codeMeaningLinesShare
LABELINGFair Packaging and Labeling Act217%
NCONTACTNo U.S. adverse event contact on supplement label217%
NEW VET DRAppears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food,…217%
NO ENGLISHRequired label information not in English217%
NUTRIT LBLNutrition information missing from label217%
UNAPPROVEDUnapproved new drug217%

Latest dietary supplements refusals from Romania

Latest FDA dietary supplements refusals from Romania
DateFirmProductCharges
Columbovet SRLOradea, RomaniaHerbals & botanicals (not teas), n.e.cNEW VET DRSource
Columbovet SRLOradea, RomaniaHerbals & botanicals (not teas), n.e.cNEW VET DRSource
S.C. Canah International srlSalonta, RomaniaOmega-3 (fats and lipid substances)NO ENGLISHNCONTACTLABELING+2Source
S.C. Canah International srlSalonta, RomaniaOmega-3 (fats and lipid substances)NO ENGLISHNCONTACTLABELING+2Source

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.

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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.