FDA import refusals
FDA import refusals: dietary supplements from Ireland
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to June 5, 2019
FDA refused 5 dietary supplements shipment lines from Ireland between October 2016 and June 5, 2019, 4 of them in 2019; the most refused products were calcium and angelica, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 5
- dietary supplements lines refused since October 2016
- 4
- refused so far in 2019
- 1
- firms with the most records, listed below
Dietary supplements refusals from Ireland by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2019 | 4 | +300% |
| 2018 | 1 |
Calcium refusals from Ireland
FDA refused 4 calcium lines from Ireland between October 2016 and June 5, 2019, 80% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Calcium (mineral) | 4 | 80.0% |
Recent calcium refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | UNAPPROVED | Source | |
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | UNAPPROVED | Source | |
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | UNAPPROVED | Source | |
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | NEW VET DR | Source |
Angelica refusals from Ireland
FDA refused 1 angelica line from Ireland between October 2016 and June 5, 2019, 20% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Angelica (herbal & botanicals, not teas) | 1 | 20.0% |
Recent angelica refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Copperfield Equine TherapyKilfrush, Ireland | Angelica (herbal & botanicals, not teas) | NOT LISTEDFRNMFGREG | Source |
Why FDA refused dietary supplements from Ireland
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 3 | 50% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 1 | 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,… | 1 | 17% |
| NOT LISTED | Product not listed with FDA | 1 | 17% |
Ireland 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 |
|---|---|---|
| Celtic Sea Minerals | Cork | 4 |
Latest dietary supplements refusals from Ireland
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | UNAPPROVED | Source | |
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | UNAPPROVED | Source | |
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | UNAPPROVED | Source | |
| Celtic Sea MineralsCork, Ireland | Calcium (mineral) | NEW VET DR | Source | |
| Copperfield Equine TherapyKilfrush, Ireland | Angelica (herbal & botanicals, not teas) | NOT LISTEDFRNMFGREG | Source |
Questions about dietary supplements refusals from Ireland
- How many dietary supplements shipments from Ireland did FDA refuse in 2019?
- FDA refused 4 shipment lines of dietary supplements from Ireland in 2019 through June 5, 2019, compared with 1 in 2018.
- Why does FDA refuse dietary supplements from Ireland?
- FDA records a charge code on every refused shipment line. For dietary supplements from Ireland the most frequent are UNAPPROVED (unapproved new drug, 3 lines), FRNMFGREG (FRNMFGREG, 1 line) and NEW VET DR (NEW VET DR, 1 line). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover dietary supplements from Ireland?
- As of October 26, 2026, no import alert numbered under this category lists a firm in Ireland in SupplierRadar's records. General food alerts numbered 99-xx can still list Ireland firms; see the country page.
Built for the person who signs the FSVP file
Buying dietary supplements from Ireland?
Check each Ireland 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.