FDA import refusals
FDA import refusals: meal replacements from South Korea
FDA refused 49 meal replacements shipment lines from South Korea between October 2016 and September 25, 2026, 9 of them in 2026; the most refused products were meal replacements and dietary conventional foods, most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 49
- meal replacements lines refused since October 2016
- 9
- refused so far in 2026
- 2
- firms with the most records, listed below
Meal replacements refusals from South Korea by year
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 9 | |
| 2025 | 6 | +500% |
| 2024 | 1 | -89% |
| 2023 | 9 | +350% |
| 2022 | 2 | 0% |
| 2021 | 2 | +100% |
| 2020 | 1 | |
| 2017 | 1 | |
| 2016 (from Oct) | 18 |
Meal replacements refusals from South Korea
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Meal replacements (not labeled for treatment of disease) | 19 | 38.8% |
Recent meal replacements refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Silicon II Pa TeamBundang District, South Korea | Meal replacements (not labeled for treatment of disease) | NO ENGLISH | Source |
Dietary conventional foods refusals from South Korea
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Dietary conventional foods, n.e.c. | 15 | 30.6% |
Recent dietary conventional foods refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| O2Bio Co., Ltd.Cheonan-Si, South Korea | Dietary conventional foods, n.e.c | INCONSPICUNO ENGLISH | Source | |
| Minu Story Co LtdPyeongtaek, South Korea | Dietary conventional foods, n.e.c | INCONSPICUNO ENGLISH | Source | |
| Minu Story Co LtdPyeongtaek, South Korea | Dietary conventional foods, n.e.c | INCONSPICUNO ENGLISH | Source | |
| Wooltari KoreaSeoul, South Korea | Dietary conventional foods, n.e.c | DIETARYLBLLACKS FIRMLACKS N/C+2 | Source | |
| Pio Pharm Co., Ltd.Hwaseong, South Korea | Dietary conventional foods, n.e.c | HEALTH C | Source |
Foods with supplemental nutrients added refusals from South Korea
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Foods with supplemental nutrients added, with or without artifical sweetners | 15 | 30.6% |
Recent foods with supplemental nutrients added refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| AmazonherbYesan, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | LIST INGREDIETARYLBLINCONSPICU+4 | Source |
Why FDA refused meal replacements from South Korea
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NO ENGLISH | Required label information not in English | 39 | 30% |
| UNSAFE ADD | Food additive unsafe under section 409 | 18 | 14% |
| LACKS N/C | Net quantity statement missing | 16 | 13% |
| NUTRIT LBL | Nutrition information missing from label | 15 | 12% |
| LABELING | Fair Packaging and Labeling Act | 11 | 9% |
| LIST INGRE | Ingredients not listed | 11 | 9% |
| INCONSPICU | Required information not conspicuous | 5 | 4% |
| NO PROCESS | No scheduled process filed | 5 | 4% |
| DIETARYLBL | Not identified as a dietary supplement | 4 | 3% |
| NCONTACT | No U.S. adverse event contact on supplement label | 4 | 3% |
South Korea meal replacements firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Nutribiotech Co Ltd | Seoul | 18 |
| Hanmi Nutrition Inc. | Paju | 4 |
Latest meal replacements refusals from South Korea
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Silicon II Pa TeamBundang District, South Korea | Meal replacements (not labeled for treatment of disease) | NO ENGLISH | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| Natural N Co., Ltd.Yeongcheon, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO PROCESS | Source | |
| AmazonherbYesan, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | LIST INGREDIETARYLBLINCONSPICU+4 | Source | |
| O2Bio Co., Ltd.Cheonan-Si, South Korea | Dietary conventional foods, n.e.c | INCONSPICUNO ENGLISH | Source | |
| Minu Story Co LtdPyeongtaek, South Korea | Dietary conventional foods, n.e.c | INCONSPICUNO ENGLISH | Source | |
| Minu Story Co LtdPyeongtaek, South Korea | Dietary conventional foods, n.e.c | INCONSPICUNO ENGLISH | Source | |
| Esther Formula IncYongin Si, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | NO ENGLISHUNAPPROVED | Source | |
| Wooltari KoreaSeoul, South Korea | Dietary conventional foods, n.e.c | DIETARYLBLLACKS FIRMLACKS N/C+2 | Source | |
| Wooltari KoreaSeoul, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | LIST INGREDIETARYLBLLACKS FIRM+4 | Source | |
| Pio Pharm Co., Ltd.Hwaseong, South Korea | Dietary conventional foods, n.e.c | HEALTH C | Source | |
| Kitoketo Tasty & Healthy LifestySeoul, South Korea | Dietary conventional foods, n.e.c | NO ENGLISHNCONTACTNUTRIT LBL | Source | |
| Ckd Healthcare CorpDANGJIN-SI, South Korea | Dietary conventional foods, n.e.c | NO ENGLISHUSUAL NAME | Source | |
| e-roumSeongnam, South Korea | Dietary conventional foods, n.e.c | NO PROCESS | Source | |
| Suheung Co., LtdCheongju, South Korea | Dietary conventional foods, n.e.c | NO ENGLISH | Source | |
| Livinglife Co.,LtdGwangju-si, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | LACKS N/CNO ENGLISH | Source | |
| Livinglife Co.,LtdGwangju-si, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | LACKS N/CNO ENGLISH | Source | |
| Livinglife Co.,LtdGwangju-si, South Korea | Foods with supplemental nutrients added, with or without artifical sweetners | LACKS N/CNO ENGLISH | Source |
Questions about meal replacements refusals from South Korea
- How many meal replacements shipments from South Korea did FDA refuse in 2026?
- FDA refused 9 shipment lines of meal replacements from South Korea in 2026 through September 25, 2026, compared with 6 in 2025.
- Why does FDA refuse meal replacements from South Korea?
- FDA records a charge code on every refused shipment line. For meal replacements from South Korea the most frequent are NO ENGLISH (required label information not in English, 39 lines), UNSAFE ADD (food additive unsafe under section 409, 18 lines) and LACKS N/C (net quantity statement missing, 16 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover meal replacements from South Korea?
- As of October 26, 2026, no import alert numbered under this category lists a firm in South Korea in SupplierRadar's records. General food alerts numbered 99-xx can still list South Korea firms; see the country page.
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