Import Alert 54-15: Detention without physical examination of dietary supplements and bulk dietary ingredients that are or contain Mitragyna speciosa or kratom
As of October 26, 2026, FDA Import Alert 54-15 (Supplements and ingredients containing kratom) lists 58 firms on its red list in 5 countries, covering kratom; 1 firm was added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 58
- firms on the red list
- 5
- countries
- 1
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 54-15
SupplierRadar has recorded no removals from Import Alert 54-15 in the last 90 days, as of October 26, 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 54-15
| Firm | Country | List | Date published |
|---|---|---|---|
| 1001387362 Ontario IncMississauga, Canada | Canada | Red |
Firms on Import Alert 54-15, by country
Listings by country
| Country | Red list | Total |
|---|---|---|
| Indonesia | 47 | 47 |
| Canada | 6 | 6 |
| Malaysia | 3 | 3 |
| Philippines | 1 | 1 |
| Thailand | 1 | 1 |
Indonesia (47)
FDA refusals from Indonesia| Firm | List | Products | Date published |
|---|---|---|---|
| Aguslie ShMedan | Red | Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II); Mitragyna Speciosa; Powde | |
| AswinPontianak | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Batuah Maan CvPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| BikhukJakartajakarta | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Bintang DuaPontianak | Red | Mitragyna Javnica; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Borneo Khatulistiwa CvPontianak | Red | Kratom - Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Broerry SoetarnoKal Bar | Red | Mitragyna Speciosa (kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| C.V. Bali HerbalDenpasar | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Cv Fabulift Borneo MitraPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Cv LeafsyncKalmantan Barat | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| CV. Prasada Bali UtamaDenpasar | Red | Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II); Dried Mitragyna Speciosa | |
| Cv. Putra Bali AgungDenpasar-Bali | Red | Herbal Kratom Leaf (Dried); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II | |
| Davine BotanicalPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Deni ICibinong, West Java | Red | Mitragyna Speciosa; Acacia Mangium and Green Riau; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and | |
| Dr. Mahdiri BersamaKalbar | Red | Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II); Mitragyna Speciosa Extrac | |
| Enggang BorneoPontianak | Red | Mitragyna Speciosa Tea (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Te | |
| Erlan SetiawanPontianak | Red | Kratom (Mitragyna Speciosa); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Faisal Putra PerdanaPontiak | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Hendra RPontianak | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| M. Ridho Rizki Maulufi AlkPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Mahmudi SEPontianak | Red | Mitragyna Speciosa declared as Mitragyna Javinica; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and | |
| MardiantoPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Marjan PutraPontianak | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Mhd Syamsu BahriPontianak | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| MkeSerpong | Red | Naulcea Speciosa Powder; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) |
Show 22 more firms in Indonesia
| Firm | List | Products | Date published |
|---|---|---|---|
| Mulyadi PasaribuMedan | Red | Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II); Mitragyna Speciosa | |
| Mumung MulharyanaPontianak | Red | Mitragyna Speciosa Extract; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II | |
| MusmuriadiPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Nusi WandriPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| PerwantoPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| PriyantiWest Java | Red | Dried Kedemba Leaves; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| PT Ambat TradingJakarta | Red | Mitragyna; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Pt Badar Jaya SaktiTangerang | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Pt Buana Adhu GemilangPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| PT Indigo PrimaJakarta | Red | Raw Incense Material (Javanica Speciosa Dried leaves powder); Kratom (Herbal and Botanical Teas II, continued); Kratom ( | |
| Pt Rifa AgungPontianak Kalbar | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Pt Rifa AgungPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| PT Transindo Antariksa BorneoPontianak | Red | Mitragyna Speciosa (Kratom tea) | |
| PT. Angkutan Jasa AviasiPontianak | Red | Mitragyna Speciosa (Kratom) | |
| PT. Citra Nuansa BuanaBandung | Red | Kratom; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| PT.Panca Laksindo ExpressJakarta | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Rere Adrea NovattraPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Rudi HartonaPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Tan Alaindo MantinaPontianak | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Teguh ApPontianak | Red | Mitragyna Speciosa; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Transindo Antariksa LogistikKalimantan Barat | Red | Mitragyna Speciosa (Kratom tea) | |
| ZulfikarPontianak | Red | Mitragyna Speciosa Extract; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II |
Canada (6)
FDA refusals from Canada| Firm | List | Products | Date published |
|---|---|---|---|
| 0904649 Bc LtdNanaimo | Red | Research Herbs; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| 1001387362 Ontario IncMississauga | Red | Blue Razz 20mg 7-OH tablets | |
| Andreas MandaiBurnaby | Red | Mitragyna Speciosa (Kratom); Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas I | |
| Kathina TVancouver | Red | Brown Incense Product Base; Dry Incense; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals | |
| Malaspina GiftNanaimonanaimo | Red | Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II); Spiritual Herb Green Godd | |
| Three Ocean ExportNorth Vancouver | Red | Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II); Mitragyna Speciosa Dried |
Malaysia (3)
FDA refusals from Malaysia| Firm | List | Products | Date published |
|---|---|---|---|
| Jaymen Mack EnterpriseBukit Mertajam | Red | Uncaria Gembier; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Wisdom Herbs EnterpriseGeorgetown | Red | Uncaria Gembier; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) | |
| Wisdom Herbs EnterprisePulau Pinang | Red | Uncaria Gembier; Kratom (Herbal and Botanical Teas II, continued); Kratom (Herbal and Botanicals, not Teas II) |
Philippines (1)
FDA refusals from Philippines| Firm | List | Products | Date published |
|---|---|---|---|
| Akita Herbal ProductsPampanga | Red | SERENOA 330-350mg capsules (Food Supplements) |
Thailand (1)
FDA refusals from Thailand| Firm | List | Products | Date published |
|---|---|---|---|
| CheevalomeChatuchak | Red | Mitragyna Speciosa (Kratom Capsules) |
Refusal charges named on this alert
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| UNSFDIETSP | Dietary ingredient without safety assurance | 1,109 |
What the alert covers and why FDA issued it
- Official title
- DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM
- Product scope
- Kratom (aka Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang)
- Last published
FDA has seen an increase in the number of shipments of dietary supplements and bulk dietary ingredients that are, or contain kratom, also known as Mitragyna speciosa, mitragynine extract, biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang. These shipments of kratom have come in a variety of forms, including capsules, whole leaves, processed leaves, leaf resins, leaf extracts, powdered leaves, and bulk liquids made of leaf extracts. Importers' websites have sometimes contained information about how their products are used.
Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(ff)(1)]. When marketed as a dietary ingredient, FDA also considers kratom to be a new dietary ingredient under section 413(d) of the Act [21 U.S.C. 350b(d)] because, to the best of the agency's knowledge, there is no information demonstrating that this substance was marketed as a dietary ingredient in the United States before October 15, 1994.
Read the rest of the reason
Furthermore, based on FDA's review of the publicly available information regarding kratom, there does not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient. In fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms. In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B)], because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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 54-15
- What is Import Alert 54-15?
- Import Alert 54-15, “Detention without physical examination of dietary supplements and bulk dietary ingredients that are or contain Mitragyna speciosa or kratom”, is an FDA import alert. FDA may detain kratom from the firms on its red list without physical examination; FDA last published the alert on August 17, 2026.
- Which firms are on Import Alert 54-15?
- As of October 26, 2026, 58 firms are listed on Import Alert 54-15 in 5 countries; the most listings are in Indonesia (47), Canada (6) and Malaysia (3). 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 54-15?
- 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 54-15; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 54-15?
- The charge section of Import Alert 54-15 names UNSFDIETSP (dietary ingredient without safety assurance). 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 54-15 recently?
- As of October 26, 2026, 1 firm was added to Import Alert 54-15 in the last 90 days, including 1001387362 Ontario Inc. The list with dates is below.
- Which firms were removed from Import Alert 54-15 recently?
- SupplierRadar has recorded no removals from Import Alert 54-15 in the last 90 days, as of October 26, 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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