FDA import alert
Import Alert 54-16
DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT
99
Red-list entries
0
Green-list entries
19
Countries
2026-07-09
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
Red-list entries by country
Firms on this red list
Showing 30 of 99 entries — search a specific firm on the free checker.
MOLECULAR DYNAMICS SAS
03/12/2024
Argentina · Vitamin, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Michelle Gleneuine
05/11/2015
Brazil · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
Nugale Pharmaceutical Inc.
04/14/2015
Canada · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
PNP Pharmaceuticals Inc.
05/26/2020
Canada · Vitamin, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
BEIJING JIANYANG HEALTH PRODUCT CO., LTD
05/07/2015
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
Beijing Kowloon Pharmaceutical Factory
06/29/2015
China · L-Arginine (Protein); Yohimbe (Herbal & Botanicals, not Teas); Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Casco Blu Qingdao
09/28/2016
China · Tea, Green; Willowbark (Herbal & Botanicals, not Teas); Herbals & Botanicals (not Teas), N.E.C.
ELT Technology
04/17/2015
China · Coffee/Tea; Sibutramine HCL Monohydrate (Anorexic)
Eagene Biotechnology Co., Ltd.
05/12/2015
China · Animal By-Products and Extracts, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Tadalafil
Guangzhou Garden City (Biological) Health Food Factory
04/23/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
Guangzhou Meilai Biotechnology Co., Ltd.
04/23/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
Guangzhou Yan Xiang Co, LTD
05/19/2015
China · Bee Pollen (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.); Sibutramine HCL Monohydrate (Anorexic); Miscellaneous Patent Medicines, Etc.
HENGS JEWELLRY LTD
02/15/2018
China · Coffee; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)
Jiangsu Shenhua Pharmaceutical Co., Ltd
09/22/2023
China · Herbals & Botanicals (not Teas), N.E.C.; Tadalafil
Jiangsu Shenli Enterprise Co Ltd
09/22/2023
China · Herbals & Botanicals (not Teas), N.E.C.; Tadalafil
Kunming DaLi Industry & Trade Co., Ltd
04/01/2015
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
La Sha City Limited Company
05/15/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator); Miscellaneous Patent Medicines, Etc.
Much New Limited
07/07/2015
China · Hawthorn (Herbal & Botanicals, not Teas); Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
NET D ACTIVE NUTRA TRADING CO.
06/22/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.
No. 8 IIAlley
05/04/2015
China · Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); Pharm Necess & Ctnr For Drug/Bio; Human and Animal Therapeutic Biologic and Biosimilar Drugs
Qinghai Baojiantang Pharmaceutical Co., Ltd
09/25/2015
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Miscellaneous Patent Medicines, Etc.; Exhibits - Other Drug Related Items N.E.C.
Rizhao Rande Trading
08/01/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sildenafil Citrate (Regulator)
Sha Double Nutra Biotech Coltd
05/23/2016
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Shenzhen Baoyitong
10/26/2016
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Suppressant N.E.C.; Miscellaneous Patent Medicines, Etc.
Suzhou MyLand Pharm&Nutrition Inc.
11/09/2015
China · Herbals & Botanicals (not Teas), N.E.C.; Anti-Depressant N.E.C.
TopLife International
10/04/2016
China · Herbals & Botanical Teas, N.E.C.; Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
TopLife International (HK)
03/02/2017
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
TopLife International (HK)
09/12/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
TopLife International Co., Ltd.
09/12/2016
China · Herbals & Botanicals (not Teas), N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
Zheng Xu Bin
11/10/2016
China · Herbals & Botanical Teas, N.E.C.; Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.; Sibutramine HCL Monohydrate (Anorexic)
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