FDA import refusals
FDA import refusals: dietary supplements from Chile
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to September 24, 2025
FDA refused 15 dietary supplements shipment lines from Chile between October 2016 and September 24, 2025, 2 of them in 2025; the most refused products were vitamin and herbals & botanicals, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 15
- dietary supplements lines refused since October 2016
- 2
- refused so far in 2025
- 1
- firms with the most records, listed below
Dietary supplements refusals from Chile by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2025 | 2 | |
| 2023 | 4 | -20% |
| 2022 | 5 | |
| 2019 | 1 | |
| 2017 | 3 |
Vitamin refusals from Chile
FDA refused 8 vitamin lines from Chile between October 2016 and September 24, 2025, 53% 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. | 5 | 33.3% |
| Vitamin, n.e.c. | 3 | 20.0% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Chilean LaboratorySantiago, Chile | Vitamin, n.e.c | UNAPPROVED | Source | |
| SlimsnacPucon, Chile | Vitamin, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| SlimsnacPucon, Chile | Vitamin, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Fredson JeantySantiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELINGUNAPPROVED | Source | |
| Fredson JeantySantiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELINGUNAPPROVED | Source |
Herbals & botanicals refusals from Chile
FDA refused 3 herbals & botanicals lines from Chile between October 2016 and September 24, 2025, 20% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 3 | 20.0% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratorios Garden House Farmaceutica S.A.San Bernardo, Chile | Herbals & botanicals (not teas), n.e.c | FALSEPLANT PARTNCONTACT+1 | Source | |
| Laboratorios Garden House Farmaceutica S.A.San Bernardo, Chile | Herbals & botanicals (not teas), n.e.c | PLANT PARTNCONTACTNUTRIT LBL | Source | |
| Laboratorios Garden House Farmaceutica S.A.San Bernardo, Chile | Herbals & botanicals (not teas), n.e.c | FALSEPLANT PARTNCONTACT+1 | Source |
Vitamin c refusals from Chile
FDA refused 3 vitamin c lines from Chile between October 2016 and September 24, 2025, 20% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin c (ascorbic acid) | 3 | 20.0% |
Recent vitamin c refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Importado y DistribuidoSantiago, Chile | Vitamin c (ascorbic acid) | NOT LISTEDFRNMFGREGUNAPPROVED | Source | |
| Laboratorios Andromaco S.A.Penalolen, Chile | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Laboratorio AdromacoSantiago, Chile | Vitamin c (ascorbic acid) | UNAPPROVED | Source |
Other dietary supplements products refused from Chile
| Product group | Lines | Share |
|---|---|---|
| Folic acid | 1 | 6.7% |
Why FDA refused dietary supplements from Chile
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 10 | 26% |
| NO ENGLISH | Required label information not in English | 6 | 16% |
| NUTRIT LBL | Nutrition information missing from label | 6 | 16% |
| LABELING | Fair Packaging and Labeling Act | 4 | 11% |
| NCONTACT | No U.S. adverse event contact on supplement label | 4 | 11% |
| PLANT PART | Is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C… | 3 | 8% |
| FALSE | False or misleading labeling | 2 | 5% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 1 | 3% |
| HEALTH C | Unauthorized nutrient content or health claim | 1 | 3% |
| NOT LISTED | Product not listed with FDA | 1 | 3% |
Chile 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 |
|---|---|---|
| Laboratorios Garden House Farmaceutica S.A. | San Bernardo | 3 |
Latest dietary supplements refusals from Chile
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Chilean LaboratorySantiago, Chile | Vitamin, n.e.c | UNAPPROVED | Source | |
| Importado y DistribuidoSantiago, Chile | Vitamin c (ascorbic acid) | NOT LISTEDFRNMFGREGUNAPPROVED | Source | |
| SlimsnacPucon, Chile | Vitamin, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| SlimsnacPucon, Chile | Vitamin, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Laboratorios Garden House Farmaceutica S.A.San Bernardo, Chile | Herbals & botanicals (not teas), n.e.c | FALSEPLANT PARTNCONTACT+1 | Source | |
| Laboratorios Garden House Farmaceutica S.A.San Bernardo, Chile | Herbals & botanicals (not teas), n.e.c | PLANT PARTNCONTACTNUTRIT LBL | Source | |
| Laboratorios Garden House Farmaceutica S.A.San Bernardo, Chile | Herbals & botanicals (not teas), n.e.c | FALSEPLANT PARTNCONTACT+1 | Source | |
| Fredson JeantySantiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELINGUNAPPROVED | Source | |
| Fredson JeantySantiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELINGUNAPPROVED | Source | |
| Fredson JeantySantiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELINGUNAPPROVED | Source | |
| Fredson JeantySantiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELINGUNAPPROVED | Source | |
| Nutrartis S.A.Santiago, Chile | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NCONTACTNUTRIT LBLHEALTH C+1 | Source | |
| Instituto Samitas SASantiago, Chile | Folic acid (vitamin) | UNAPPROVED | Source | |
| Laboratorios Andromaco S.A.Penalolen, Chile | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Laboratorio AdromacoSantiago, Chile | Vitamin c (ascorbic acid) | UNAPPROVED | Source |
Questions about dietary supplements refusals from Chile
- How many dietary supplements shipments from Chile did FDA refuse in 2025?
- FDA refused 2 shipment lines of dietary supplements from Chile in 2025 through September 24, 2025.
- Why does FDA refuse dietary supplements from Chile?
- FDA records a charge code on every refused shipment line. For dietary supplements from Chile the most frequent are UNAPPROVED (unapproved new drug, 10 lines), NO ENGLISH (required label information not in English, 6 lines) and NUTRIT LBL (nutrition information missing from label, 6 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 Chile?
- As of October 26, 2026, no import alert numbered under this category lists a firm in Chile in SupplierRadar's records. General food alerts numbered 99-xx can still list Chile 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.