FDA import refusals
FDA import refusals: dietary supplements from Hong Kong
FDA refused 125 dietary supplements shipment lines from Hong Kong between October 2016 and June 11, 2026, 10 of them in 2026; the most refused products were herbals & botanical teas and vitamin, most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 125
- dietary supplements lines refused since October 2016
- 10
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Hong Kong by year
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 10 | |
| 2025 | 26 | +271% |
| 2024 | 7 | +17% |
| 2023 | 6 | -25% |
| 2022 | 8 | -60% |
| 2021 | 20 | +100% |
| 2020 | 10 | -63% |
| 2019 | 27 | +200% |
| 2018 | 9 | |
| 2016 (from Oct) | 2 |
Herbals & botanical teas refusals from Hong Kong
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanical teas, n.e.c. | 51 | 40.8% |
Recent herbals & botanical teas refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Hong Kong Jingongfu Biotechnology Co., Ltd.Tsim SHa Tsui, Hong Kong | Herbals & botanical teas, n.e.c | UNAPPROVED | Source |
Vitamin refusals from Hong Kong
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 34 | 27.2% |
| Vitamin, n.e.c. | 5 | 4.0% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | INCONSPICULACKS FIRMPLANT PART+3 | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLACKS FIRMNO ENGLISH+4 | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLACKS FIRMNO ENGLISH+4 | Source | |
| Venogen BiochemicalsHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LACKS FIRMNO ENGLISHDIETARYING+2 | Source |
Herbals & botanicals refusals from Hong Kong
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 14 | 11.2% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Gui Nan Hong Company LimitedSheung Wan, Hong Kong | Herbals & botanicals (not teas), n.e.c | NUTRIT LBL | Source | |
| Gui Nan Hong Company LimitedSheung Wan, Hong Kong | Herbals & botanicals (not teas), n.e.c | SULFITELBL | Source | |
| Gui Nan Hong Company LimitedSheung Wan, Hong Kong | Herbals & botanicals (not teas), n.e.c | SULFITELBL | Source |
Other dietary supplements products refused from Hong Kong
| Product group | Lines | Share |
|---|---|---|
| Ginseng | 10 | 8.0% |
| Kratom | 7 | 5.6% |
| Protein n.e.c. | 2 | 1.6% |
| Chrysanthemum | 1 | 0.8% |
| Ephedra | 1 | 0.8% |
Why FDA refused dietary supplements from Hong Kong
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NO ENGLISH | Required label information not in English | 45 | 17% |
| LACKS FIRM | Manufacturer name and address missing | 36 | 13% |
| NCONTACT | No U.S. adverse event contact on supplement label | 34 | 13% |
| DIETARYLBL | Not identified as a dietary supplement | 29 | 11% |
| NUTRIT LBL | Nutrition information missing from label | 28 | 10% |
| UNAPPROVED | Unapproved new drug | 23 | 9% |
| DIETARYING | Dietary ingredients not listed | 21 | 8% |
| LIST INGRE | Ingredients not listed | 20 | 7% |
| PESTICIDE | Pesticide chemical residue | 19 | 7% |
| USUAL NAME | Common or usual name missing | 14 | 5% |
Import alerts for dietary supplements that list Hong Kong firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-16 | Foods/supplements with active pharmaceutical ingredient | 4 |
Hong Kong dietary supplements firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Hongkong Fu Wah Medicine Co., Ltd | Kowloon | 25 |
| Sun Wah (Kei Kee) Medicine Co | Sheung Wan | 13 |
| Tsang Fook Kee Medicine Company | Sai Ying Pun | 12 |
| Wing Hing Tong Ginseng Hong | HONG KONG | 9 |
| Smart Sense Group Limited | Hong Kong | 9 |
| Yulai(Guangzhou) Health Technology Co. | Guangdong | 8 |
| Ocean East | Yuen Long | 6 |
| Gui Nan Hong Company Limited | Sheung Wan | 6 |
| Hong Hung Asia Co., LTD | Sai Ying Pun | 4 |
| Wing Cheong Marine Product | Hong Kong | 1 |
Latest dietary supplements refusals from Hong Kong
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | INCONSPICULACKS FIRMPLANT PART+3 | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLACKS FIRMNO ENGLISH+4 | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLLACKS FIRMNO ENGLISH+4 | Source | |
| Venogen BiochemicalsHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LACKS FIRMNO ENGLISHDIETARYING+2 | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LACKS FIRMNO ENGLISHDIETARYING+2 | Source | |
| Smart Sense Group LimitedHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LACKS FIRMNO ENGLISHDIETARYING+2 | Source | |
| Egood Technology Co.,LimitedKowloon Bay, Hong Kong | Vitamin, n.e.c | UNAPPROVED | Source | |
| Hk Dan Hong Hao Tian e-CommercecoTsuen Wan, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Gui Nan Hong Company LimitedSheung Wan, Hong Kong | Herbals & botanicals (not teas), n.e.c | NUTRIT LBL | Source | |
| Venogen BiochemicalsHong Kong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Venogen BiochemicalsHong Kong, Hong Kong | Kratom (herbal and botanicals, not teas ii) | UNAPPROVED | Source | |
| Gui Nan Hong Company LimitedSheung Wan, Hong Kong | Herbals & botanicals (not teas), n.e.c | SULFITELBL | Source | |
| Biozein Technology Corp LtdKwai Chung, Hong Kong | Protein n.e.c | POISONOUSMELAMINEUNFIT4FOOD | Source | |
| Hk Hongtailong LimitedWan Chai, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LACKS FIRMNCONTACT | Source | |
| Hong Kong Jingongfu Biotechnology Co., Ltd.Tsim SHa Tsui, Hong Kong | Herbals & botanical teas, n.e.c | UNAPPROVED | Source | |
| Gui Nan Hong Company LimitedSheung Wan, Hong Kong | Herbals & botanicals (not teas), n.e.c | SULFITELBL | Source | |
| Haique LimitedKwun Tong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGRENCONTACT | Source | |
| Haique LimitedKwun Tong, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LIST INGRENCONTACT | Source | |
| Roselle Group LimitedKowloon, Hong Kong | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Questions about dietary supplements refusals from Hong Kong
- How many dietary supplements shipments from Hong Kong did FDA refuse in 2026?
- FDA refused 10 shipment lines of dietary supplements from Hong Kong in 2026 through June 11, 2026, compared with 26 in 2025.
- Why does FDA refuse dietary supplements from Hong Kong?
- FDA records a charge code on every refused shipment line. For dietary supplements from Hong Kong the most frequent are NO ENGLISH (required label information not in English, 45 lines), LACKS FIRM (manufacturer name and address missing, 36 lines) and NCONTACT (no U.S. adverse event contact on supplement label, 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 Hong Kong?
- As of October 26, 2026, the FDA import alerts for this category that list Hong Kong firms are Import Alert 54-16 (4 firms). General food alerts numbered 99-xx can list Hong Kong firms too; see the country page.
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