FDA import refusals
FDA import refusals: dietary supplements from South Korea
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to August 13, 2026
FDA refused 143 dietary supplements shipment lines from South Korea between October 2016 and August 13, 2026, 19 of them in 2026; the most refused products were vitamin and ginseng, most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 143
- dietary supplements lines refused since October 2016
- 19
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from South Korea 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) | 19 | |
| 2025 | 7 | -36% |
| 2024 | 11 | -15% |
| 2023 | 13 | +63% |
| 2022 | 8 | -43% |
| 2021 | 14 | +100% |
| 2020 | 7 | 0% |
| 2019 | 7 | -56% |
| 2018 | 16 | -59% |
| 2017 | 39 | |
| 2016 (from Oct) | 2 |
Vitamin refusals from South Korea
FDA refused 64 vitamin lines from South Korea between October 2016 and August 13, 2026, 45% 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. | 64 | 44.8% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Duksan Pure Chemicals Co., Ltd.Ansan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Handok PharmSeoul, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Pio Pharm Co., Ltd.Hwaseong, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Cosmax Bio, Inc.Jecheon, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Hanmi Nutrition Inc.Paju, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLLACKS FIRM+5 | Source |
Ginseng refusals from South Korea
FDA refused 24 ginseng lines from South Korea between October 2016 and August 13, 2026, 17% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Ginseng (herbal & botanical teas) | 12 | 8.4% |
| Ginseng (herbal & botanicals, not teas) | 12 | 8.4% |
Recent ginseng refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| DroindChungcheongnam-do, South Korea | Ginseng (herbal & botanical teas) | NCONTACT | Source | |
| Geunsan Dukwon Co LtdChungcheongnam-Do, South Korea | Ginseng (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Geumsan Black Ginseng Co. Ltd.Geumsan, South Korea | Ginseng (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Suheung Healthcare Co., Ltd.Cheongju, South Korea | Ginseng (herbal & botanicals, not teas) | PESTICIDE | Source |
Herbals & botanicals refusals from South Korea
FDA refused 15 herbals & botanicals lines from South Korea between October 2016 and August 13, 2026, 10% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 15 | 10.5% |
Other dietary supplements products refused from South Korea
| Product group | Lines | Share |
|---|---|---|
| Herbals & botanical teas | 7 | 4.9% |
| Milk thistle | 7 | 4.9% |
| Angelica | 5 | 3.5% |
| Ginkgo biloba | 5 | 3.5% |
| Ginseng unconventional dietary speciality for humans or animals | 4 | 2.8% |
| Animal by-products and extracts | 2 | 1.4% |
Why FDA refused dietary supplements from South Korea
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NO ENGLISH | Required label information not in English | 74 | 30% |
| NUTRIT LBL | Nutrition information missing from label | 39 | 16% |
| UNAPPROVED | Unapproved new drug | 34 | 14% |
| DIETARYLBL | Not identified as a dietary supplement | 25 | 10% |
| NCONTACT | No U.S. adverse event contact on supplement label | 19 | 8% |
| LIST INGRE | Ingredients not listed | 15 | 6% |
| LACKS FIRM | Manufacturer name and address missing | 12 | 5% |
| INCONSPICU | Required information not conspicuous | 11 | 4% |
| LABELING | Fair Packaging and Labeling Act | 11 | 4% |
| NO PROCESS | No scheduled process filed | 9 | 4% |
Import alerts for dietary supplements that list South Korea firms
South Korea 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 |
|---|---|---|
| KOLMAR BNH CO., LTD Eumseong Factory | Eumseong | 17 |
| Jw Pharmaceutical Corporation | Seoul | 13 |
| Kolmar Bnh Co.,Ltd.(Sbt) | Sejong | 6 |
| Cosfarm Co., Ltd. | Cheonan | 6 |
| Hanpoong Pharm Co.,Ltd. | Jeonju | 5 |
| Genko Korea Ltd | Seoul | 4 |
| Daedong Korea Ginseng Co., Ltd. | Geumsan-gun | 3 |
| Suheung Healthcare Co., Ltd. | Cheongju | 3 |
| Wooshin Labottach Co.,Ltd. | Seoul | 3 |
| Hanmi Nutrition Inc. | Paju | 2 |
Latest dietary supplements refusals from South Korea
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| DroindChungcheongnam-do, South Korea | Ginseng (herbal & botanical teas) | NCONTACT | Source | |
| Duksan Pure Chemicals Co., Ltd.Ansan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Elanco Animal Health Korea Co.,LtdGyeonggi-Do 15427, South Korea | Vitamin b12 (cyanocobalamin) | NO ENGLISHNEW VET DR | Source | |
| Handok PharmSeoul, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Pio Pharm Co., Ltd.Hwaseong, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| William XylitolUlsan, South Korea | Mineral n.e.c | LIST INGRENUTRIT LBLHEALTH C+1 | Source | |
| Cosmax Bio, Inc.Jecheon, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Hanmi Nutrition Inc.Paju, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLLACKS FIRM+5 | Source | |
| Hanmi Nutrition Inc.Paju, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Caregen Co., Ltd.Gunpo, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LABELINGNUTRIT LBLHEALTH C | Source | |
| Geunsan Dukwon Co LtdChungcheongnam-Do, South Korea | Ginseng (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Geumsan Black Ginseng Co. Ltd.Geumsan, South Korea | Ginseng (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Suheung Healthcare Co., Ltd.Cheongju, South Korea | Ginseng (herbal & botanicals, not teas) | PESTICIDE | Source | |
| Cosfarm Co., Ltd.Cheonan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Cosfarm Co., Ltd.Cheonan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Cosfarm Co., Ltd.Cheonan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Cosfarm Co., Ltd.Cheonan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Cosfarm Co., Ltd.Cheonan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Cosfarm Co., Ltd.Cheonan, South Korea | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNUTRIT LBL | Source | |
| Pharmtech KoreaWonju-City, South Korea | Animal by-products and extracts, n.e.c | UNSAFE ADD | Source |
Questions about dietary supplements refusals from South Korea
- How many dietary supplements shipments from South Korea did FDA refuse in 2026?
- FDA refused 19 shipment lines of dietary supplements from South Korea in 2026 through August 13, 2026, compared with 7 in 2025.
- Why does FDA refuse dietary supplements from South Korea?
- FDA records a charge code on every refused shipment line. For dietary supplements from South Korea the most frequent are NO ENGLISH (required label information not in English, 74 lines), NUTRIT LBL (nutrition information missing from label, 39 lines) and UNAPPROVED (unapproved new drug, 34 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 South Korea?
- As of October 26, 2026, the FDA import alerts for this category that list South Korea firms are Import Alert 54-07 (1 firm) and Import Alert 54-16 (1 firm). General food alerts numbered 99-xx can list South Korea firms too; see the country page.
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