FDA import refusals
FDA import refusals: dietary supplements from Spain
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to September 22, 2026
FDA refused 144 dietary supplements shipment lines from Spain between October 2016 and September 22, 2026, 13 of them in 2026; the most refused products were vitamin and herbals & botanicals, most often for NUTRIT LBL (nutrition information missing from label).
Data from FDA public records, last checked .
- 144
- dietary supplements lines refused since October 2016
- 13
- refused so far in 2026
- 7
- firms with the most records, listed below
Dietary supplements refusals from Spain 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) | 13 | |
| 2025 | 11 | -27% |
| 2024 | 15 | +67% |
| 2023 | 9 | +200% |
| 2022 | 3 | +200% |
| 2021 | 1 | -89% |
| 2020 | 9 | -44% |
| 2019 | 16 | +33% |
| 2018 | 12 | +9% |
| 2017 | 11 | |
| 2016 (from Oct) | 44 |
Vitamin refusals from Spain
FDA refused 53 vitamin lines from Spain between October 2016 and September 22, 2026, 37% 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. | 46 | 31.9% |
| Vitamin, n.e.c. | 7 | 4.9% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratoires Quinton InternationAlicante, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NCONTACTNUTRIT LBL | Source | |
| Grupo Cantabria LabsMadrid, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHLABELING+1 | Source | |
| Masi Anti Aging ScienceBarcelona, Spain | Vitamin, n.e.c | UNAPPROVED | Source | |
| Dr Healthcare, S.L.U.Barcelona, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dr Healthcare, S.L.U.Barcelona, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from Spain
FDA refused 19 herbals & botanicals lines from Spain between October 2016 and September 22, 2026, 13% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 19 | 13.2% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Grupo Cantabria LabsMadrid, Spain | Herbals & botanicals (not teas), n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Equisalud SluHuarte, Spain | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source |
Soy lecithin refusals from Spain
FDA refused 6 soy lecithin lines from Spain between October 2016 and September 22, 2026, 4% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Soy lecithin (fats and lipid substances) | 6 | 4.2% |
Recent soy lecithin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | Source | ||
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source |
Other dietary supplements products refused from Spain
| Product group | Lines | Share |
|---|---|---|
| Angelica | 5 | 3.5% |
| St. john's wort | 5 | 3.5% |
| Manganese | 4 | 2.8% |
| Valerian | 4 | 2.8% |
| Aloe) | 3 | 2.1% |
| Ginkgo biloba | 3 | 2.1% |
Why FDA refused dietary supplements from Spain
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NUTRIT LBL | Nutrition information missing from label | 83 | 19% |
| NCONTACT | No U.S. adverse event contact on supplement label | 76 | 17% |
| NO ENGLISH | Required label information not in English | 76 | 17% |
| DIETARYLBL | Not identified as a dietary supplement | 52 | 12% |
| LACKS FIRM | Manufacturer name and address missing | 40 | 9% |
| DIRECTIONS | Is a device whose label appears to not bear adequate directions for use. | 38 | 9% |
| UNAPPROVED | Unapproved new drug | 35 | 8% |
| LIST INGRE | Ingredients not listed | 23 | 5% |
| ALLERGEN | Major food allergen not declared | 6 | 1% |
| FILTHY | Filthy, putrid or decomposed substance | 6 | 1% |
Import alerts for dietary supplements that list Spain firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-14 | Supplements from firms not meeting supplement GMP | 1 |
Spain 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 |
|---|---|---|
| Equisalud S.L.U. | Huarte | 49 |
| Sincrofarm, S.L. | Cornella De Llobregat | 10 |
| Equisalud Slu | Huarte | 7 |
| Rioja Nature Pharma, S.L. | Arnedo | 6 |
| Famar Health Care Services Madrid S.A. | Alcorcon | 6 |
| Dachser Spain | Paterna | 6 |
| Fai Natur SL | Barcelona | 1 |
Latest dietary supplements refusals from Spain
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratoires Quinton InternationAlicante, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NCONTACTNUTRIT LBL | Source | |
| Ecoagricola El TalMadrid, Spain | Aloe (herbal and botanical (not teas) ii (continued)) | NO ENGLISH | Source | |
| unknownunknown, Spain | Ginkgo biloba (herbal & botanicals, not teas) | NO ENGLISH | Source | |
| BarbariaCheste, Spain | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | Source | ||
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Grupo Cantabria LabsMadrid, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHLABELING+1 | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Vitabiotics Ltd.London, Spain | Vitamin b12 (cyanocobalamin) | LABELINGHEALTH C | Source | |
| Masi Anti Aging ScienceBarcelona, Spain | Vitamin, n.e.c | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Fats and lipid substances, n.e.c | UNAPPROVED | Source | |
| Famar Health Care Services Madrid S.A.Alcorcon, Spain | Soy lecithin (fats and lipid substances) | UNAPPROVED | Source | |
| BTSA, Biotecnologias AplicadasAlcala de Henares, Spain | Vitamin e (tocopherol) | UNSAFE ADD | Source | |
| VersalyaAlcobendas, Spain | Folic acid (vitamin) | UNAPPROVED | Source | |
| Dr Healthcare, S.L.U.Barcelona, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Dr Healthcare, S.L.U.Barcelona, Spain | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Grupo Cantabria LabsMadrid, Spain | Herbals & botanicals (not teas), n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Equisalud SluHuarte, Spain | Valerian (herbal & botanicals, not teas ii) | UNAPPROVED | Source | |
| Equisalud SluHuarte, Spain | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source |
Questions about dietary supplements refusals from Spain
- How many dietary supplements shipments from Spain did FDA refuse in 2026?
- FDA refused 13 shipment lines of dietary supplements from Spain in 2026 through September 22, 2026, compared with 11 in 2025.
- Why does FDA refuse dietary supplements from Spain?
- FDA records a charge code on every refused shipment line. For dietary supplements from Spain the most frequent are NUTRIT LBL (nutrition information missing from label, 83 lines), NCONTACT (no U.S. adverse event contact on supplement label, 76 lines) and NO ENGLISH (required label information not in English, 76 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 Spain?
- As of October 26, 2026, the FDA import alerts for this category that list Spain firms are Import Alert 54-14 (1 firm). General food alerts numbered 99-xx can list Spain firms too; see the country page.
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