FDA import refusals
FDA import refusals: dietary supplements from Japan
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to September 29, 2026
FDA refused 109 dietary supplements shipment lines from Japan between October 2016 and September 29, 2026, 7 of them in 2026; the most refused products were vitamin and herbals & botanicals, most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 109
- dietary supplements lines refused since October 2016
- 7
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Japan 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) | 7 | |
| 2025 | 11 | +10% |
| 2024 | 10 | -9% |
| 2023 | 11 | 0% |
| 2022 | 11 | +120% |
| 2021 | 5 | 0% |
| 2020 | 5 | -55% |
| 2019 | 11 | +83% |
| 2018 | 6 | -73% |
| 2017 | 22 | |
| 2016 (from Oct) | 10 |
Vitamin refusals from Japan
FDA refused 66 vitamin lines from Japan between October 2016 and September 29, 2026, 61% 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. | 62 | 56.9% |
| Vitamin, n.e.c. | 4 | 3.7% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| P.A.I. Japan Co., LtdKobe, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLACKS FIRMALLERGEN+2 | Source | |
| Seishin Seiyaku Co.Tosu, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREUSUAL NAMEALLERGEN+2 | Source | |
| Kobayashi PharmaceuticalOsaka, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from Japan
FDA refused 18 herbals & botanicals lines from Japan between October 2016 and September 29, 2026, 17% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 18 | 16.5% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Herbals & botanicals (not teas), n.e.c | SUPPL GMP | Source | |
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Herbals & botanicals (not teas), n.e.c | SUPPL GMP | Source | |
| Kanehide Bio Co., Ltd.Itoman, Japan | Herbals & botanicals (not teas), n.e.c | LIST INGREDIETARYLBLLACKS FIRM+2 | Source | |
| Chlorella Industry Co, LtdChikugo, Japan | Herbals & botanicals (not teas), n.e.c | NO ENGLISH | Source | |
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Herbals & botanicals (not teas), n.e.c | SUPPL GMP | Source |
Protein n.e.c. refusals from Japan
FDA refused 9 protein n.e.c. lines from Japan between October 2016 and September 29, 2026, 8% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Protein n.e.c. | 9 | 8.3% |
Other dietary supplements products refused from Japan
| Product group | Lines | Share |
|---|---|---|
| Vitamin c | 3 | 2.8% |
| Mint | 2 | 1.8% |
| Vitamin e | 2 | 1.8% |
| Animal by-products and extracts | 1 | 0.9% |
| Bovine | 1 | 0.9% |
| Coenzyme q10 | 1 | 0.9% |
Why FDA refused dietary supplements from Japan
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 | 49 | 30% |
| NUTRIT LBL | Nutrition information missing from label | 32 | 19% |
| UNAPPROVED | Unapproved new drug | 26 | 16% |
| DIETARYLBL | Not identified as a dietary supplement | 13 | 8% |
| NCONTACT | No U.S. adverse event contact on supplement label | 10 | 6% |
| LACKS FIRM | Manufacturer name and address missing | 8 | 5% |
| SUPPL GMP | Dietary supplement CGMP not met | 8 | 5% |
| LABELING | Fair Packaging and Labeling Act | 7 | 4% |
| LIST INGRE | Ingredients not listed | 7 | 4% |
| DIRECTIONS | Is a device whose label appears to not bear adequate directions for use. | 6 | 4% |
Import alerts for dietary supplements that list Japan firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-14 | Supplements from firms not meeting supplement GMP | 5 |
Japan 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 |
|---|---|---|
| Kanehide Bio Co., Ltd. | Itoman | 8 |
| Nizona Corporation | Kobe | 7 |
| Japan Yamato Trading Co.,Ltd. | Chuo | 6 |
| Nichiyaku, Co., Ltd. | Fujinomiya | 5 |
| Ryukakusan Co. Ltd. | Katori-Gun | 4 |
| Sunsho Pharmaceutical Co., Ltd. | Fuji | 4 |
| Otsuka Pharmaceutical Co., Ltd. | Chiyoda | 4 |
| Nikko Yakuhin Kogyo Co.,Ltd. | Nagoya | 3 |
| Japan Bio Science Laboratory Co Ltd | Osaka | 2 |
| MEIJI Co., Ltd. - OSAKA FACTORY | Takatsuki | 1 |
Latest dietary supplements refusals from Japan
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Herbals & botanicals (not teas), n.e.c | SUPPL GMP | Source | |
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Herbals & botanicals (not teas), n.e.c | SUPPL GMP | Source | |
| P.A.I. Japan Co., LtdKobe, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLACKS FIRMALLERGEN+2 | Source | |
| Kanehide Bio Co., Ltd.Itoman, Japan | Herbals & botanicals (not teas), n.e.c | LIST INGREDIETARYLBLLACKS FIRM+2 | Source | |
| Chlorella Industry Co, LtdChikugo, Japan | Herbals & botanicals (not teas), n.e.c | NO ENGLISH | Source | |
| Showa Pharmaceutical Co.,Ltd.Toyohashi, Japan | Senna (herbal & botanical teas) | HEALTH C | Source | |
| Seishin Seiyaku Co.Tosu, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREUSUAL NAMEALLERGEN+2 | Source | |
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Mint (herbal & botanicals, not teas - if tea form see 31p) | SUPPL GMP | Source | |
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Mint (herbal & botanicals, not teas - if tea form see 31p) | SUPPL GMP | Source | |
| Sunsho Pharmaceutical Co., Ltd.Fuji, Japan | Herbals & botanicals (not teas), n.e.c | SUPPL GMP | Source | |
| Kobayashi PharmaceuticalOsaka, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Nichiyaku, Co., Ltd.Fujinomiya, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Ajinomoto Co., Inc.Chuo-ku, Japan | Vitamin, n.e.c | DIETARYLBLINCONSPICUDIETARYING | Source | |
| Kanehide Bio Co., Ltd.Itoman, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHNCONTACT | Source | |
| Nichizen MedicoOsaka, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Kanehide Bio Co., Ltd.Itoman, Japan | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHLABELING | Source |
Questions about dietary supplements refusals from Japan
- How many dietary supplements shipments from Japan did FDA refuse in 2026?
- FDA refused 7 shipment lines of dietary supplements from Japan in 2026 through September 29, 2026, compared with 11 in 2025.
- Why does FDA refuse dietary supplements from Japan?
- FDA records a charge code on every refused shipment line. For dietary supplements from Japan the most frequent are NO ENGLISH (required label information not in English, 49 lines), NUTRIT LBL (nutrition information missing from label, 32 lines) and UNAPPROVED (unapproved new drug, 26 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 Japan?
- As of October 26, 2026, the FDA import alerts for this category that list Japan firms are Import Alert 54-14 (5 firms). General food alerts numbered 99-xx can list Japan firms too; see the country page.
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