FDA import refusals
FDA import refusals: dietary supplements from Italy
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 8, 2026
FDA refused 253 dietary supplements shipment lines from Italy between October 2016 and October 8, 2026, 2 of them in 2026; the most refused products were vitamin and l-arginine, most often for SUPPL GMP (dietary supplement CGMP not met).
Data from FDA public records, last checked .
- 253
- dietary supplements lines refused since October 2016
- 2
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Italy 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) | 2 | |
| 2025 | 6 | -40% |
| 2024 | 10 | +67% |
| 2023 | 6 | +500% |
| 2022 | 1 | -50% |
| 2021 | 2 | -92% |
| 2020 | 24 | +243% |
| 2019 | 7 | -92% |
| 2018 | 84 | -24% |
| 2017 | 111 |
Vitamin refusals from Italy
FDA refused 218 vitamin lines from Italy between October 2016 and October 8, 2026, 86% 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. | 195 | 77.1% |
| Vitamin, n.e.c. | 23 | 9.1% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Erbozeta S.p.A.Chiesanuova, Italy | Vitamin, n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Fine Foods & Pharmaceuticals N.T.M. S.P.A.Verdellino, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Fine Foods & Pharmaceuticals N.T.M. S.P.A.Verdellino, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Biofarma SpaMereto Di Tomba, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
L-arginine refusals from Italy
FDA refused 14 l-arginine lines from Italy between October 2016 and October 8, 2026, 6% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| L-arginine (protein) | 14 | 5.5% |
Herbals & botanicals refusals from Italy
FDA refused 4 herbals & botanicals lines from Italy between October 2016 and October 8, 2026, 2% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 4 | 1.6% |
Other dietary supplements products refused from Italy
| Product group | Lines | Share |
|---|---|---|
| Omega-3 | 3 | 1.2% |
| Selenium | 2 | 0.8% |
| Vitamin a | 2 | 0.8% |
| Vitamin d2 | 2 | 0.8% |
| Bilberry | 1 | 0.4% |
| Biotin | 1 | 0.4% |
Why FDA refused dietary supplements from Italy
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| SUPPL GMP | Dietary supplement CGMP not met | 102 | 20% |
| NUTRIT LBL | Nutrition information missing from label | 89 | 17% |
| NCONTACT | No U.S. adverse event contact on supplement label | 78 | 15% |
| LIST INGRE | Ingredients not listed | 75 | 14% |
| NO ENGLISH | Required label information not in English | 49 | 9% |
| DIETARYLBL | Not identified as a dietary supplement | 46 | 9% |
| UNSAFE COL | Color additive unsafe under section 721 | 30 | 6% |
| UNAPPROVED | Unapproved new drug | 21 | 4% |
| STD NAME | Appears to be misbranded within the meaning of Section 403(g)(2) of the FD&C Act in that the article… | 18 | 3% |
| LABELING | Fair Packaging and Labeling Act | 12 | 2% |
Italy 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 |
|---|---|---|
| Forza Vitale Italia S.r.l. | Corato | 123 |
| Pharma Green S.R.L. | Falciano | 71 |
| E Pharma Trento Spa | Trento | 8 |
| Dulac Farmaceutici 1982 SRL | Turin | 6 |
| Citozeatec SRL | Peschiera Borromeo | 5 |
| E-Pharma Trento SPA | Trento | 3 |
| Farmacia Loreto Gallo | Napolinapoli | 3 |
| Evergreen Life Products | San Giovanni Al Natisone | 2 |
| Fisiopharma Srl | Palomonte | 2 |
| LABOMAR S.p.A. | Istrana | 2 |
Latest dietary supplements refusals from Italy
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Viatris Pharma SRLMilan, Italy | Vitamin d2 (calciferol) | UNAPPROVED | Source | |
| Doppel Farmaceutici SrlRozzano, Italy | Biotin (vitamin h, coenzyme r) | UNAPPROVED | Source | |
| Erbozeta S.p.A.Chiesanuova, Italy | Vitamin, n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Fine Foods & Pharmaceuticals N.T.M. S.P.A.Verdellino, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Fine Foods & Pharmaceuticals N.T.M. S.P.A.Verdellino, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Biofarma SpaMereto Di Tomba, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Sanofi S.P.A.Turin, Italy | Mineral n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Uga Nutraceutlcals SrlGubbio, Italy | Omega-3 (fats and lipid substances) | DIETARYLBLNCONTACTLABELING | Source | |
| Abiogen Pharma SpaOspedaletto, Italy | Vitamin d2 (calciferol) | UNAPPROVED | Source | |
| Dulac FarmaceuticiRivoli, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLNO ENGLISH+3 | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHSTD NAME+3 | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHSTD NAME+3 | Source | |
| Medixa SRLSan Sebastiano Al Vesuvio, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLNO ENGLISH+4 | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLNO ENGLISH+4 | Source | |
| Dulac Farmaceutici 1982 SRLTurin, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLNO ENGLISH+4 | Source | |
| E-Pharma Trento SPATrento, Italy | Vitamin, n.e.c | DIETARYLACKS N/CNO ENGLISH | Source | |
| Citozeatec SRLPeschiera Borromeo, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELING | Source | |
| Citozeatec SRLPeschiera Borromeo, Italy | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELING | Source |
Questions about dietary supplements refusals from Italy
- How many dietary supplements shipments from Italy did FDA refuse in 2026?
- FDA refused 2 shipment lines of dietary supplements from Italy in 2026 through October 8, 2026, compared with 6 in 2025.
- Why does FDA refuse dietary supplements from Italy?
- FDA records a charge code on every refused shipment line. For dietary supplements from Italy the most frequent are SUPPL GMP (dietary supplement CGMP not met, 102 lines), NUTRIT LBL (nutrition information missing from label, 89 lines) and NCONTACT (no U.S. adverse event contact on supplement label, 78 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 Italy?
- As of October 25, 2026, no import alert numbered under this category lists a firm in Italy in SupplierRadar's records. General food alerts numbered 99-xx can still list Italy firms; see the country page.
Built for the person who signs the FSVP file
Buying dietary supplements from Italy?
Check each Italy 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.