FDA import refusals
FDA import refusals: dietary supplements from China
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 7, 2026
FDA refused 564 dietary supplements shipment lines from China between October 2016 and October 7, 2026, 31 of them in 2026; the most refused products were vitamin and herbals & botanicals, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 564
- dietary supplements lines refused since October 2016
- 31
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from China 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) | 31 | |
| 2025 | 58 | +49% |
| 2024 | 39 | -28% |
| 2023 | 54 | +108% |
| 2022 | 26 | -28% |
| 2021 | 36 | -18% |
| 2020 | 44 | -14% |
| 2019 | 51 | -50% |
| 2018 | 103 | -1% |
| 2017 | 104 | |
| 2016 (from Oct) | 18 |
Vitamin refusals from China
FDA refused 239 vitamin lines from China between October 2016 and October 7, 2026, 42% 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. | 213 | 37.8% |
| Vitamin, n.e.c. | 26 | 4.6% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from China
FDA refused 153 herbals & botanicals lines from China between October 2016 and October 7, 2026, 27% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 153 | 27.1% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Hangzhou Lukang Biotech Co.,Ltd.Hangzhou, China | Herbals & botanicals (not teas), n.e.c | NOT LISTEDNO ENGLISHUNAPPROVED | Source | |
| Jiangsu Shenhua Pharmaceutical Co., LtdHuaian, China | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Xian Ebos Biotech Co LtdXian, China | Herbals & botanicals (not teas), n.e.c | LIST INGREINCONSPICULACKS FIRM | Source |
Protein n.e.c. refusals from China
FDA refused 20 protein n.e.c. lines from China between October 2016 and October 7, 2026, 4% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Protein n.e.c. | 20 | 3.5% |
Recent protein n.e.c. refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| GL Biochem (Shanghai) LtdShanghai, China | Protein n.e.c | UNAPPROVED | Source | |
| Richtek LtdDalian, China | Protein n.e.c | UNSAFE ADD | Source |
Other dietary supplements products refused from China
| Product group | Lines | Share |
|---|---|---|
| Ginseng | 16 | 2.8% |
| Herbals & botanical teas | 13 | 2.3% |
| L-alanine | 10 | 1.8% |
| Mecobalamin | 8 | 1.4% |
| Multiple vitamins | 8 | 1.4% |
| Coenzyme q10 | 6 | 1.1% |
Why FDA refused dietary supplements from China
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 133 | 22% |
| LACKS FIRM | Manufacturer name and address missing | 80 | 13% |
| NUTRIT LBL | Nutrition information missing from label | 71 | 12% |
| LIST INGRE | Ingredients not listed | 67 | 11% |
| VETDRUGRES | Animal drug residue | 57 | 10% |
| FALSE | False or misleading labeling | 43 | 7% |
| PESTICIDE | Pesticide chemical residue | 40 | 7% |
| DIETARYLBL | Not identified as a dietary supplement | 39 | 7% |
| NOT LISTED | Product not listed with FDA | 35 | 6% |
| UNSAFE COL | Color additive unsafe under section 721 | 31 | 5% |
Import alerts for dietary supplements that list China firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-16 | Foods/supplements with active pharmaceutical ingredient | 27 | |
| 54-14 | Supplements from firms not meeting supplement GMP | 5 | |
| 54-18 | Supplements and ingredients with new dietary ingredients | 3 | |
| 54-12 | Foods that do not properly declare ginseng | 2 |
China 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 |
|---|---|---|
| Shantou Olive Pharmaceutical Co.,Ltd | Shantou | 57 |
| Yuxing Biotechnology (Group) Co., Ltd. | Xingtai | 16 |
| Weihai Baihe Biology Technological Co., Ltd. | Weihai | 12 |
| Kunming Aoqun Bio-Tech Co,. Ltd | Kunming | 12 |
| Yulai (Guangzhou) Health Technology Co., Ltd | Guangzhou | 12 |
| Zhongjing Wanxi Pharmaceutical Co | Nanyang | 11 |
| Shijiazhuang Yiling Pharmaceutical Co., Ltd. | Shijiazhuang | 9 |
| Pharmatech Asia Group Ltd. | Shenzhen | 9 |
| Guangdong Yichao Biological Co Ltd | Shantou | 9 |
| Yunnan Panlong Yunhai Pharmaceutical Co., Ltd. | Chuxiongyizu Autonomous Prefecture | 9 |
Latest dietary supplements refusals from China
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Lanzhou Taibao Pharmaceutical Company, LLCLanzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Ningbo Excare Pharm IncNingbo, China | Ginseng (herbal & botanicals, not teas) | SBGINSENG | Source | |
| Effepharm (Shanghai) Co., LtdShanghai, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREDIETARYLBLLACKS FIRM+2 | Source | |
| Hangzhou Lukang Biotech Co.,Ltd.Hangzhou, China | Herbals & botanicals (not teas), n.e.c | NOT LISTEDNO ENGLISHUNAPPROVED | Source | |
| Zhejiang Sanhe Bio-Tech Co., Ltd.Quzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Guangzhou Lively Superfoods Biotech Co..Ltd.Panyu, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGREINCONSPICULACKS FIRM+1 | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Hydroxocobalamin (vitamin) | DRUG GMPS | Source | |
| Jiangsu Shenhua Pharmaceutical Co., LtdHuaian, China | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Guangzhou Wei Xin Biological Technology Co., Ltd.Guangzhou, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LACKS FIRMNCONTACTNUTRIT LBL | Source | |
| Xian Ebos Biotech Co LtdXian, China | Herbals & botanicals (not teas), n.e.c | LIST INGREINCONSPICULACKS FIRM | Source | |
| GL Biochem (Shanghai) LtdShanghai, China | Protein n.e.c | UNAPPROVED | Source | |
| Shandong Runxin Biotechnology Co., Ltd.Qufu, China | Ginseng unconventional dietary speciality for humans or animals | DIETARYLBLSBGINSENGDIETARYING+1 | Source | |
| Guangdong Come Health Biotechnology Co., Ltd.Dongguan, China | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNSAFE COLCOLOR LBLG | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Mecobalamin (vitamin) | SUPPL GMP | Source | |
| Aogubio Co LtdXian, China | Nicotinamide (niacinamide) (vitamin) | UNAPPROVED | Source | |
| Richtek LtdDalian, China | Protein n.e.c | UNSAFE ADD | Source |
Questions about dietary supplements refusals from China
- How many dietary supplements shipments from China did FDA refuse in 2026?
- FDA refused 31 shipment lines of dietary supplements from China in 2026 through October 7, 2026, compared with 58 in 2025.
- Why does FDA refuse dietary supplements from China?
- FDA records a charge code on every refused shipment line. For dietary supplements from China the most frequent are UNAPPROVED (unapproved new drug, 133 lines), LACKS FIRM (manufacturer name and address missing, 80 lines) and NUTRIT LBL (nutrition information missing from label, 71 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 China?
- As of October 26, 2026, the FDA import alerts for this category that list China firms are Import Alert 54-16 (27 firms), Import Alert 54-14 (5 firms), Import Alert 54-18 (3 firms) and Import Alert 54-12 (2 firms). General food alerts numbered 99-xx can list China firms too; see the country page.
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