Import Alert 54-15
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(Note: This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 54-15
Published Date: 06/16/2014
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM
Reason for Alert:
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.
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.
Guidance:
Districts may detain, without physical examination, the specified products from the firms identified in the RED LIST of this alert. The specified dietary supplements and bulk dietary ingredients from the firms listed on the RED LIST of this Import Alert have been found to contain kratom.
When detained products appear to be dietary supplements or bulk dietary ingredients as discussed in this alert and are not currently listed on the RED LIST of this alert, Districts should forward appropriate evidence/documentation as a “Center Review Detention” case via CMS to CFSAN/OC/DE/LDSCT team. Based on the Center’s evaluation, a CMS case for addition to the RED LIST of this alert may be forwarded to DIO/IOMB team by the District’s Compliance Branch.
Districts should be on alert to the possibility that the labeling, marketing, and/or promotion of kratom and kratom-containing products may indicate that such products appear to be unapproved and/or misbranded drugs. For such products, Import Alert 66-41 may be applicable.
For questions or issues involving import operations, contact DIO’s Import Operations and Maintenance Branch at (301) 796-0356.
For questions or issues involving OASIS or PREDICT screening, contact DCS’s Import Compliance Systems Branch at ORAHQOEIODCSIMPCOMPLSYSBR@fda.hhs.gov
For questions or issues concerning preparation of samples for analysis or analytical methodology, contact ORA’s Office of Regulatory Science at 301-796-6600.
For questions on policy, sample collection recommendations, or other any addition questions, contact CFSAN/Division of Enforcement’s Labeling and Dietary Supplement Compliance Team (HFS-608) at CFSANEnforcement@fda.hhs.gov
Product Description:
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)
Charge:
“The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a dietary supplement or contains a dietary ingredient that is 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. [Adulteration, Section 402(f)(1)(B)].”
OASIS Charge Code: UNSFDIETSP
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CANADA
0904649 BC LTDDate Published : 02/28/2014
1-950 Old Victoria Rd , Nanaimo , British Columbia CANADA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Research Herbs
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Research Herbs
Kathina TDate Published : 02/28/2014
499 Granville St #28141 , Vancouver, British Columbia CANADA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Dry Incense
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Brown Incense Product Base
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Dry Incense
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Brown Incense Product Base
Malaspina GiftDate Published : 02/28/2014
950 Old Victoria# 1 , Nanaimonanaimo, BRITISH COLUMBIA CANADA
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Spiritual Herb Intense Euphoric
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Spiritual Herbs (All Natural Blend Capsules)
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Spiritual Herb Revved UP
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Spiritual Herb Green Goddess
Three Ocean ExportDate Published : 02/28/2014
1494 Sowden Street , North Vancouver, BC CANADA
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa Dried Leaf
INDONESIA
AguslieDate Published : 02/28/2014
Unknown Street , Medan, INDONESIA
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa; Powder
BikhukDate Published : 02/28/2014
Ptb Duren Sawit Bi No 10– , Jakartajakarta, INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna Speciosa
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna Speciosa
Bintang DuaDate Published : 02/28/2014
Jl. Purnama No. 141 , Pontianak, Kalimantan Barat INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna Javnica
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna Javnica
Borneo Khatulistiwa CvDate Published : 02/28/2014
Jl Karna Sosial Komp Asuransi 1 , Pontianak, INDONESIA
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Kratom – Mitragyna Speciosa
Broerry SoetarnoDate Published : 02/28/2014
Ponkianak , Kal Bar, INDONESIA
54 A – – 99 Vitamin, N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa (kratom)
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa (kratom)
C.V. BALI HERBALDate Published : 02/28/2014
JALAN GUNUNG TALANG VIII No.1 , PADANG SAMBIAN , Denpasar, Bali INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna Speciosa
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna Speciosa
CV. PRASADA BALI UTAMADate Published : 06/16/2014
Jln Tukad Balian , Denpasar, Bali INDONESIA
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 06/16/2014
Desc:Dried Mitragyna Speciosa
Citra Nuansa BuanaDate Published : 02/28/2014
Jl Soekarno Hatta 761 Lt 1 R05 , Jawa Barat, INDONESIA
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Kratom
Cv Putra Bali AgungDate Published : 02/28/2014
18 Jln Ngurah Rai , Denpasar, Bali INDONESIA
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Herbal Kratom Leaf (Dried)
Deni IDate Published : 02/28/2014
Perumahan BDB III Blok KL No 35 , Cibinong, West Java, INDONESIA
53 E – – 99 Other Hair Preparations, Non-coloring), N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Acacia Mangium and Green Riau
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Acacia Mangium and Green Riau
Dr. Mahdiri BersamaDate Published : 02/28/2014
Pontianak , Kalbar, INDONESIA
54 Y – – 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa Extract
Erlan SetiawanDate Published : 02/28/2014
Pang Semanggi No. 28 , Pontianak, INDONESIA
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Kratom (Mitragyna Speciosa)
Faisal Putra PerdanaDate Published : 02/28/2014
Jl Karra Sosial Konack Asuransi No 1 , Pontiak, INDONESIA
24 T – – 99 Leaf & Stem Vegetables, N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa
54 F – – 95 Banaba (Herbal & Botanicals, not Teas)Date Published: 02/28/2014
Desc:Mitragyna Speciosa
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa
Mulyadi PasaribuDate Published : 02/28/2014
Jl Kenanga Raya Gg , Medan, INDONESIA
66 V – – 99 Miscellaneous Patent Medicines, Etc.Date Published: 02/28/2014
Desc:Mitragyna Speciosa
Mumung MulharyanaDate Published : 02/28/2014
JL Berkat Usaha Rt 001 009 , Pontianak, INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna Speciosa Extract
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna Speciosa Extract
PT Ambat TradingDate Published : 02/28/2014
JL Kramat Raya 5A , Jakarta, Pusat, INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna
PT. PANCA LAKSINDO EXPRESSDate Published : 02/28/2014
Jalan Kalibata Utara II no.26 , Jakarta Selatan , Jakarta Selatan, ID-JK INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna Speciosa (Kratom)
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna Speciosa (Kratom)
PriyantiDate Published : 02/28/2014
Jl. Tunjung Biru 12 , Bogor , West Java, INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Dried Kedemba Leaves
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Dried Kedemba Leaves
Pt MkeDate Published : 02/28/2014
Vila Melati Mas M-12/15serpong Tangerang , Serpong, Jabotabek INDONESIA
41 Y – – 99 Dietary Conventional Foods, N.E.C.Date Published: 02/28/2014
Desc:Naulcea Speciosa Powder
Teguh ApDate Published : 02/28/2014
Jl Kom Yas Sudarso 99 Sambas No 1 , Pontianak, INDONESIA
54 F – – 99 Herbals & Botanicals (not Teas), N.E.C.Date Published: 02/28/2014
Desc:Mitragyna Speciosa
ZulfikarDate Published : 02/28/2014
JL J Rading Arahman No 4 , Pontianak, INDONESIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Mitragyna Speciosa Extract
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Mitragyna Speciosa Extract
MALAYSIA
Jaymen Mack EnterpriseDate Published : 02/28/2014
1009 Lorong Kantan 2,Tmn Jaya , Bukit Mertajam, MY-07 MALAYSIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Uncaria Gembier
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Uncaria Gembier
WISDOM HERBS ENTERPRISEDate Published : 02/28/2014
72, Taman Gottlieb , Georgetown, MY-07 MALAYSIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Uncaria Gembier
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Uncaria Gembier
Wisdom Herbs EnterpriseDate Published : 02/28/2014
Jalan Siput Remis 69l , Pulau Pinang, Pulau Pinang MALAYSIA
53 – – – — CosmeticsDate Published: 02/28/2014
Desc:Uncaria Gembier
54 – – – — Vit/Min/Prot/Unconv Diet(Human/Animal)Date Published: 02/28/2014
Desc:Uncaria Gembier
