FDA import refusals
FDA import refusals: meal replacements from Japan
FDA refused 16 meal replacements shipment lines from Japan between October 2016 and September 3, 2026, 2 of them in 2026; the most refused products were foods with supplemental nutrients added and dietary conventional foods, most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 16
- meal replacements lines refused since October 2016
- 2
- refused so far in 2026
- 1
- firms with the most records, listed below
Meal replacements refusals from Japan by year
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 2 | |
| 2024 | 2 | -67% |
| 2023 | 6 | +100% |
| 2022 | 3 | 0% |
| 2021 | 3 |
Foods with supplemental nutrients added refusals from Japan
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Foods with supplemental nutrients added, with or without artifical sweetners | 8 | 50.0% |
Recent foods with supplemental nutrients added refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Expandy Co LtdNishinomiya, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | LIST INGREINCONSPICULACKS FIRM+1 | Source | |
| FCC Horiuchi Co., Ltd.Kurume, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | SUPPL GMP | Source | |
| Around the World KkEdogawa, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | NO ENGLISH | Source | |
| Hirata Nouen Co.,LtdTakasaki, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | NUTRIT LBL | Source | |
| Hirata Nouen Co.,LtdTakasaki, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | INCONSPICUNO ENGLISHNUTRIT LBL | Source |
Dietary conventional foods refusals from Japan
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Dietary conventional foods, n.e.c. | 6 | 37.5% |
Recent dietary conventional foods refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Nagatanien CoTokyo, Japan | Dietary conventional foods, n.e.c | NO ENGLISHLABELING | Source | |
| Okawari JapanOta, Japan | Dietary conventional foods, n.e.c | NO ENGLISH | Source | |
| B&S Corporation Co., Ltd.Fujinomiya, Japan | Dietary conventional foods, n.e.c | DIETARYLBLNO ENGLISH | Source | |
| The Osone Co., Ltd.Chichibu, Japan | Dietary conventional foods, n.e.c | INCONSPICULACKS N/CLABELING+1 | Source | |
| Okinawa AgentItoman, Japan | Dietary conventional foods, n.e.c | LIST INGREDIETARYLBLLACKS FIRM+4 | Source |
Foods with excessive nutritional claims refusals from Japan
| FDA product description | Lines | Share of meal replacements |
|---|---|---|
| Foods (including water) with excessive nutritional claims | 1 | 6.3% |
Recent foods with excessive nutritional claims refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Sunsho Pharmaceutical Co. (Fujine Factory)Fujinomiya, Japan | Foods (including water) with excessive nutritional claims | UNAPPROVED | Source |
Other meal replacements products refused from Japan
| Product group | Lines | Share |
|---|---|---|
| Medical foods | 1 | 6.3% |
Why FDA refused meal replacements from Japan
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NO ENGLISH | Required label information not in English | 8 | 26% |
| NUTRIT LBL | Nutrition information missing from label | 5 | 16% |
| DIETARYLBL | Not identified as a dietary supplement | 4 | 13% |
| INCONSPICU | Required information not conspicuous | 3 | 10% |
| LIST INGRE | Ingredients not listed | 3 | 10% |
| LABELING | Fair Packaging and Labeling Act | 2 | 6% |
| LACKS FIRM | Manufacturer name and address missing | 2 | 6% |
| LACKS N/C | Net quantity statement missing | 2 | 6% |
| ALLERGEN | Major food allergen not declared | 1 | 3% |
| FALSE | False or misleading labeling | 1 | 3% |
Japan meal replacements firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| FCC Horiuchi Co., Ltd. | Kurume | 1 |
Latest meal replacements refusals from Japan
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Expandy Co LtdNishinomiya, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | LIST INGREINCONSPICULACKS FIRM+1 | Source | |
| Sunsho Pharmaceutical Co. (Fujine Factory)Fujinomiya, Japan | Foods (including water) with excessive nutritional claims | UNAPPROVED | Source | |
| FCC Horiuchi Co., Ltd.Kurume, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | SUPPL GMP | Source | |
| Nagatanien CoTokyo, Japan | Dietary conventional foods, n.e.c | NO ENGLISHLABELING | Source | |
| Around the World KkEdogawa, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | NO ENGLISH | Source | |
| Hirata Nouen Co.,LtdTakasaki, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | NUTRIT LBL | Source | |
| Hirata Nouen Co.,LtdTakasaki, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | INCONSPICUNO ENGLISHNUTRIT LBL | Source | |
| Okawari JapanOta, Japan | Dietary conventional foods, n.e.c | NO ENGLISH | Source | |
| B&S Corporation Co., Ltd.Fujinomiya, Japan | Medical foods, n.e.c | DIETARYLBLNO ENGLISH | Source | |
| B&S Corporation Co., Ltd.Fujinomiya, Japan | Dietary conventional foods, n.e.c | DIETARYLBLNO ENGLISH | Source | |
| The Osone Co., Ltd.Chichibu, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | DIETARYLBL | Source | |
| The Osone Co., Ltd.Chichibu, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | LIST INGREALLERGEN | Source | |
| The Osone Co., Ltd.Chichibu, Japan | Dietary conventional foods, n.e.c | INCONSPICULACKS N/CLABELING+1 | Source | |
| AFC-HD AMS Life Science Co., Ltd.Shizuoka, Japan | Foods with supplemental nutrients added, with or without artifical sweetners | FALSE | Source | |
| Okinawa AgentItoman, Japan | Dietary conventional foods, n.e.c | LIST INGREDIETARYLBLLACKS FIRM+4 | Source | |
| Okinawa AgentItoman, Japan | Dietary conventional foods, n.e.c | NO ENGLISH | Source |
Questions about meal replacements refusals from Japan
- How many meal replacements shipments from Japan did FDA refuse in 2026?
- FDA refused 2 shipment lines of meal replacements from Japan in 2026 through September 3, 2026.
- Why does FDA refuse meal replacements from Japan?
- FDA records a charge code on every refused shipment line. For meal replacements from Japan the most frequent are NO ENGLISH (required label information not in English, 8 lines), NUTRIT LBL (nutrition information missing from label, 5 lines) and DIETARYLBL (not identified as a dietary supplement, 4 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 Japan?
- As of October 26, 2026, no import alert numbered under this category lists a firm in Japan in SupplierRadar's records. General food alerts numbered 99-xx can still list Japan firms; see the country page.
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