Import Alert 54-14: Detention without physical examination of dietary supplement products from firms that have not met dietary supplement GMP
FDA last published FDA alert page
As of October 25, 2026, FDA Import Alert 54-14 (Supplements from firms not meeting supplement GMP) lists 53 firms on its red list in 16 countries, covering dietary supplements, bulk or finished; 2 firms were added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 53
- firms on the red list
- 16
- countries
- 2
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.
Removed from Import Alert 54-14
SupplierRadar has recorded no removals from Import Alert 54-14 in the last 90 days, as of October 25, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.
Added to Import Alert 54-14
| Firm | Country | List | Date published |
|---|---|---|---|
| Nikken Medical CorporationFujinomiya, Japan | Japan | Red | |
| Powerful Health Food Co., Ltd.Kamiminochi-Gun, Japan | Japan | Red |
Firms on Import Alert 54-14, by country
53 listings in 16 countries. Each name links to the firm's FDA record history; the date is the one FDA published on the alert.
Listings by country
| Country | Red list | Total |
|---|---|---|
| Mexico | 12 | 12 |
| India | 8 | 8 |
| Canada | 7 | 7 |
| China | 5 | 5 |
| Japan | 5 | 5 |
| Fiji | 4 | 4 |
| Germany | 3 | 3 |
| Australia | 1 | 1 |
| Belgium | 1 | 1 |
| Brazil | 1 | 1 |
| Czech Republic | 1 | 1 |
| Dominican Republic | 1 | 1 |
Show the other 4 countries
| Country | Red list | Total |
|---|---|---|
| Jamaica | 1 | 1 |
| Malaysia | 1 | 1 |
| Spain | 1 | 1 |
| United Kingdom | 1 | 1 |
Mexico (12)
FDA refusals from Mexico| Firm | List | Products | Date published |
|---|---|---|---|
| Apicola de Allende, S.A. de C.V.Allende | Red | Royal Jelly; Royal Jelly Capsules; Propolis Liquid Extract Drops; Propolis Capsules; Bee Pollen; EspectiBron | |
| Armonia En Envasado y Nutricion SA de CVTlaquepaque | Red | Apple Fiber; Green Juice (Jugo Verde); Forte Concentrated Fiber; Canary Seed Milk; Colageno | |
| Dibar Nutricional S. de R.L. de C.V.Morelia | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Healthy People Labs S de RL de CVIrapuato | Red | Healthy Flex; Rena Extreme | |
| Herbal Solution's Health S.A. de C.V.Irapuato | Red | Active CL Dietary Supplement; Prosmen Dietary Supplement; HP Liv Dietary Supplement | |
| Herbal Solutions Health, S.A. de C.VIrapuato | Red | Active CL Dietary Supplement; Prosmen Dietary Supplement; HP Liv Dietary Supplement | |
| Herbolaris InternacionalZapopan | Red | XYN-S Syrup; Nutry Light Shake; Mi Desayuno Diario (My Daily Breakfast) | |
| Laboratorio Mas Natural S. de R.L. de C.V.Irapuato | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Mas Natural Salud Y BienestarIrapuato | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Mas Natural Salud y Bienestar, S. de R.L. de C.V.Irapuato | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Olnatura, S. A. de C. V.Jiutepec | Red | All Vit/Min/Prot/Unconv Diet (Human/Animal) | |
| Tonic Life S de RLIrapuato | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar |
India (8)
FDA refusals from India| Firm | List | Products | Date published |
|---|---|---|---|
| Chakrapani Ayurveda Clinic & Research CenterJaipur | Red | Sanshamani; Gokshuradi Guggul; Yograj Guggul Powder; Triphala Guggul Powder; Kaishore Guggul Powder; Shwas (Asthma help) | |
| Falcon System of Ayurvedic ProductsBelgaum | Red | All Dietary Supplement Products | |
| Goodcare Pharma Pvt. Ltd.West Bengal | Red | Arthplus (Leaf Care Brand); Kaishore Guggulu (Goodcare Brand); Bhumi Amla (Leaf Care Brand); Safed Musali (Leaf Care Bra | |
| Khandige Organic Health Products Pvt LtdBengaluru | Red | All Dietary Supplement Products | |
| M/S Svatv Herbs India Pvt. Ltd.New Delhi | Red | Svatv %u2013 Beet Root Powder; Svatv %u2013 Bhumi Amla Powder; Svatv %u2013 Giloy Powder; Svatv %u2013 Shatavari Powder | |
| Patanjali Ayurved LimitedHaridwar | Red | Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | |
| Planet Ayurveda Private LimitedSas Nagar (Mohali) | Red | Brahni powder (capsules); Arjuna powder and tea; Nature-Amino powder blend; Livo Plan syrup; Motion Stop tablets; Arjuna | |
| Vanity VisionFaridabad | Red | All Dietary Supplement Products |
Canada (7)
FDA refusals from Canada| Firm | List | Products | Date published |
|---|---|---|---|
| Celex Laboratories Inc.Richmond | Red | VORST IRON; VORST Advanced Join Formula; Vorst Alpha Lipoic Acid | |
| Herbaland Naturals IncRichmond | Red | All dietary supplement products | |
| NNS Organics LimitedLawrencetown | Red | Women's Mena and Meno Balance Formula | |
| NuEra Nutraceutical IncRichmond | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Nutralab Canada Corp.Scarborough | Red | Active Green Pro Fiber Boost Prebiotic Probiotic Powder (Unflavored); Noor Vitamins Hair & Skin Softgels; Noor Vitamins | |
| Pharmalab 1982 Inc.Levis | Red | Multi-Vita K2 Multi-Vitamin and Mineral Supplement; Multi-Vita Multi-Vitamin and Mineral Supplement; Raspberry Hydrolyze | |
| Prime Health ProductsEtobicoke | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar |
China (5)
FDA refusals from China| Firm | List | Products | Date published |
|---|---|---|---|
| Hubei Minkang Pharmaceutical Co., Ltd.Yichang | Red | Huang Lian Su Herbal Supplement Tablets; Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets | |
| Lanzhou Foci Pharmaceutical Co., Ltd.Lanzhou | Red | Bao He Teapills (Bao He Wan); Xiang Sha Yang Wei Wan (Digestive Aid); Xiao Chai Hu Tang Wan (Liver Smooth); Bao He Wan ( | |
| Life Rising (Tianjin) Natural Product R&D Center LTDWuqing | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Shantou Olive Branch Biotechnology Co. Ltd.Shantou | Red | Zhen Wu Tang Herbal Dietary Supplement; Di Gu Pi San Herbal Dietary Supplement | |
| Tianjin Medicines & Health Products Import & Export Corp.Tianjin | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar |
Japan (5)
FDA refusals from Japan| Firm | List | Products | Date published |
|---|---|---|---|
| FCC Horiuchi Co., Ltd.Kurume | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Nikken Medical CorporationFujinomiya | Red | LAC Taut Premium Collagen Replenishment Formula with Grape Seed Extract; LAC Taut Premium Collagen Replenishment Formula | |
| Nikko Yakuhin Kogyo Co.,Ltd.Nagoya | Red | Pure Gold Collagen | |
| Powerful Health Food Co., Ltd.Kamiminochi-Gun | Red | All liquid and jelly dietary supplement products | |
| Sunsho Pharmaceutical Co., Ltd.Fuji | Red | All Dietary Supplement Products |
Fiji (4)
FDA refusals from Fiji| Firm | List | Products | Date published |
|---|---|---|---|
| Ace Kava ExportersNadi | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar | |
| Dateline KavaSuva | Red | All Dietary Supplement Products | |
| Frezco BeveragesNadi | Red | Noni juice | |
| Vinod Maharaj Kava Exports PTE LTDNausori | Red | All Dietary Supplement Products |
Germany (3)
FDA refusals from Germany| Firm | List | Products | Date published |
|---|---|---|---|
| Bio-Gen Milchserum Marketing GmbHMontabaur | Red | Hair Plus; Q10 Plus | |
| Plantafood Medical GmbhLaudert | Red | Sleep Food; Skin Food; Repair Food; Sugarit; Cinamit | |
| Plantafood Medical GmbHLeiningen | Red | Sleep Food; Skin Food; Repair Food; Sugarit; Cinamit |
Australia (1)
FDA refusals from Australia| Firm | List | Products | Date published |
|---|---|---|---|
| Steric Trading Pty LtdFairfield East | Red | Collagen Inner Beauty Boost; Glow Ageless Inner Beauty Essential; Clear Skin Inner Beauty Support; Antioxidant Inner Bea |
Belgium (1)
FDA refusals from Belgium| Firm | List | Products | Date published |
|---|---|---|---|
| LAMBO LaboratoriaWijnegem | Red | All Dietary Supplement Products |
Brazil (1)
FDA refusals from Brazil| Firm | List | Products | Date published |
|---|---|---|---|
| Riclan S.A.Rio Claro | Red | Vitamin C drops |
Czech Republic (1)
FDA refusals from Czech Republic| Firm | List | Products | Date published |
|---|---|---|---|
| UNIREGEN spol s.r.o.Nachod | Red | Imuregen (liquid) products; Imuregen Glucan (Capsules) products; Imuregen (Capsules) products |
Dominican Republic (1)
FDA refusals from Dominican Republic| Firm | List | Products | Date published |
|---|---|---|---|
| Alopecil Corporation, S.R.L.Santo Domingo | Red | Balsamic Honey Syrup; Watercress and Onion Radish Honey Syrup (Herro y Cebolla); Punch Natural |
Jamaica (1)
FDA refusals from Jamaica| Firm | List | Products | Date published |
|---|---|---|---|
| Delightful Gardens Enterprise LimitedJunction | Red | All Dietary Supplement Products; Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) |
Malaysia (1)
FDA refusals from Malaysia| Firm | List | Products | Date published |
|---|---|---|---|
| Phyto ScienceBandar Baru Bangi | Red | Apple Stem Cell And Grape Stem Cell Supplement Powder |
Spain (1)
FDA refusals from Spain| Firm | List | Products | Date published |
|---|---|---|---|
| laboratorios tegorZamudio | Red | Omega Aging; LaviGor brand Colagen Supra Plus; LaviGor brand Laviprobiotic Forte; LaviGor brand Lavimeno |
United Kingdom (1)
FDA refusals from United Kingdom| Firm | List | Products | Date published |
|---|---|---|---|
| Parkacre LimitedGainsborough | Red | Whole Grains/Milled Grain Products/Starches; Bakery Products/Dough/Mixes/Icings; Macaroni/Noodle Products; Cereal Prepar |
Refusal charges named on this alert
FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| SUPPL GMP | Dietary supplement CGMP not met | 352 |
What the alert covers and why FDA issued it
FDA's wording, with FDA's change markers removed.
- Official title
- DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP
- Product scope
- Dietary Supplements, Bulk or Finished
- Last published
Section 402(g)(2) of the Federal Food, Drug, and Cosmetic Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices (GMP) for dietary supplements. On June 25, 2007, FDA published a final rule setting out the GMP requirements for dietary supplements in the Federal Register [72 FR 34752].
The final rule created Title 21, part 111 (21 CFR Part 111), which established the minimum current GMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Per the regulation, quality means that the dietary supplement consistently meets the established specifications for the identity, purity, strength, and composition, and for limits on those types of contaminations that may adulterate or that may lead to adulteration of the finished batch of the product. Any dietary supplement imported or offered for import into the United States is subject to the aforementioned regulation.
Read the rest of the reason
FDA performs foreign inspections of dietary supplement manufacturers to determine compliance with the regulation. FDA may detain without physical examination (DWPE) and refuse admission of affected dietary supplements if inspection has revealed that a firm is not operating in conformity with current GMPs.
When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement product(s) may be removed from detention without physical examination.
Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.
Questions about Import Alert 54-14
- What is Import Alert 54-14?
- Import Alert 54-14, “Detention without physical examination of dietary supplement products from firms that have not met dietary supplement GMP”, is an FDA import alert. FDA may detain dietary supplements, bulk or finished from the firms on its red list without physical examination; FDA last published the alert on September 21, 2026.
- Which firms are on Import Alert 54-14?
- As of October 25, 2026, 53 firms are listed on Import Alert 54-14 in 16 countries; the most listings are in Mexico (12), India (8) and Canada (7). The full table, grouped by country, is below on this page and every firm links to its record.
- How do firms get off Import Alert 54-14?
- A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 54-14; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 54-14?
- The charge section of Import Alert 54-14 names SUPPL GMP (dietary supplement CGMP not met). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
- Which firms were added to Import Alert 54-14 recently?
- As of October 25, 2026, 2 firms were added to Import Alert 54-14 in the last 90 days, including Nikken Medical Corporation and Powerful Health Food Co., Ltd.. The list with dates is below.
- Which firms were removed from Import Alert 54-14 recently?
- SupplierRadar has recorded no removals from Import Alert 54-14 in the last 90 days, as of October 25, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.
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