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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
Loc: Alberta, Canada
Last seen: 8 years, 4 months
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FDA import alert kratom
#21820345 - 06/17/15 07:13 PM (8 years, 7 months ago) |
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Import Alert 54-15 Print Share E-mail FDA Home Import Program Import Alerts Imports Alerts by Number Import Alert -
(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: 06/09/2015 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)]."
I think this deserves it's own thread. What do you guys think?
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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pslyke
fantasmagoric



Registered: 06/12/10
Posts: 4,107
Loc:
Last seen: 1 minute, 22 seconds
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-------------------- "What appears impenetrable to us does exist, manifesting itself in the deepest wisdom and the most radiant beauty" Einstein "The conservatives of 70 years ago would be outraged at what has come to pass. It embodies everything they took up arms for to defeat"Asante
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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Re: FDA import alert kratom [Re: pslyke]
#21820682 - 06/17/15 08:25 PM (8 years, 7 months ago) |
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The devil speaks..
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Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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Re: FDA import alert kratom [Re: Amanita86]
#21820714 - 06/17/15 08:32 PM (8 years, 7 months ago) |
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I always find it funny how people get so anti christian and seperation of church and state. They always talk shit about churches asking for money....but default fall into government agendas who "take" your money...freedoms..etc.. spin information.. believe what they see in movies...
Better study history, this is old news.. but who's going to do anything? "Come and play come and play, forget about the movement.."
Same old story..
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Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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Re: FDA import alert kratom [Re: Amanita86]
#21820734 - 06/17/15 08:35 PM (8 years, 7 months ago) |
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FreeTheSoul
The wonderer.
Registered: 01/04/14
Posts: 2,297
Last seen: 2 years, 2 months
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Re: FDA import alert kratom [Re: Amanita86]
#21820741 - 06/17/15 08:37 PM (8 years, 7 months ago) |
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Isn't this old news, I remember something like this happening awhile back.
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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Yea..
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Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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Almond Flour
...get off my lawn!



Registered: 12/26/08
Posts: 11,340
Last seen: 8 years, 4 months
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I still think its only a matter of time. If it happened to JHW-18 It will happen to Kratom
-------------------- Hippies and Liberals love Pope Francis, so why dont I quote him for you guys. "There is NO SALVATION outside the Catholic Church"
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Rebelutionsssss
Mdmazing



Registered: 07/23/14
Posts: 13,137
Loc: San Francisco
Last seen: 2 years, 2 months
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Just bought a key
-------------------- : To define is to confine.
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Detached
You know where...


Registered: 02/27/15
Posts: 2,942
Last seen: 10 months, 15 days
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Re: FDA import alert kratom [Re: Amanita86]
#21820765 - 06/17/15 08:41 PM (8 years, 7 months ago) |
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Biak-biak, cratom, gratom, ithang, kakuam, katawn, kedemba, ketum, krathom, krton, mambog, madat, Maeng da leaf, nauclea, Nauclea speciosa, or thang.
All in alphabetical order.
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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It'll happen to anything that shows up..salvia, you name it. This new UK law proves it.. get used to cuffs..learn how veal lives.. get used to it..
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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Quote:
Rebelutionsssss said: Just bought a key 
It wont last long, where will you be when its gone?
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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Lophosaurus
suruasohpol


Registered: 08/09/07
Posts: 8,744
Loc: CA
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The stuff I get isn't sold as food or drugs. I hope they don't make it illegal.
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Imperfect Iam
^means imperfect,not I'm perfect


Registered: 03/05/13
Posts: 7,237
Loc: center of the universe
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Re: FDA import alert kratom [Re: Detached]
#21820786 - 06/17/15 08:46 PM (8 years, 7 months ago) |
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So WTF, is it now illegal or something, or you are going to be under investigation or something for buying it, WTF.
-------------------- All you touch, and all you see, is all your life will ever be- Pink Floyd Life is what happens while you're busy making other plans- John Lennon
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Rebelutionsssss
Mdmazing



Registered: 07/23/14
Posts: 13,137
Loc: San Francisco
Last seen: 2 years, 2 months
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Re: FDA import alert kratom [Re: Amanita86]
#21820789 - 06/17/15 08:47 PM (8 years, 7 months ago) |
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Quote:
Amanita86 said:
Quote:
Rebelutionsssss said: Just bought a key 
It wont last long, where will you be when its gone?
I see what you're getting at
-------------------- : To define is to confine.
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mysticalmagickal
believe in foolish miracles


Registered: 05/11/15
Posts: 541
Last seen: 6 months, 8 days
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Re: FDA import alert kratom [Re: Detached] 1
#21820792 - 06/17/15 08:47 PM (8 years, 7 months ago) |
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Yep it's bound to be done for any second now, oh no a plant that helps people let's ban it
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Mental Taco



Registered: 07/02/14
Posts: 2,290
Loc: Hell
Last seen: 6 years, 8 months
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Wtf this shits like coffee.
Edited by Mental Taco (06/17/15 08:51 PM)
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FreeTheSoul
The wonderer.
Registered: 01/04/14
Posts: 2,297
Last seen: 2 years, 2 months
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It basically means when a vendor sends it through customs they can seize it.
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Adden

Registered: 06/04/03
Posts: 39,201
Loc:
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Re: FDA import alert kratom [Re: FreeTheSoul] 1
#21820814 - 06/17/15 08:53 PM (8 years, 7 months ago) |
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Ordered 5 kilos in case, I mean you never know today. It's such a beneficial plant for so many reasons if used correctly (and has different effects on different types). Down to a kilo or less anyway. I'd rather have a lot for 10 or more years than none for nothing.
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FreeTheSoul
The wonderer.
Registered: 01/04/14
Posts: 2,297
Last seen: 2 years, 2 months
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Quote:
mysticalmagickal said: Yep it's bound to be done for any second now, oh no a plant that helps people let's ban it 
They had another import alert along time ago. The DEA has had kratom on its watch list since I believe 2004.
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