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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
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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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-------
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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
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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
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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
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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
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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
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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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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
Loc: hades
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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 
I knew this the second I heard it. Same way they did salvia...they bring it up expecting to get shot down...and then move one step closer etc..eventually they just ban it and who can argue? Its complete sheep herding mentality... as soon as some faceless article pops up saying its banned everyone here will just accept it as fact... you cant question the shit, you'll never get a call back or an answer... it just "becomes" fact..
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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FreeTheSoul
The wonderer.
Registered: 01/04/14
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Last seen: 2 years, 2 months
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I think you guys aren't realizing if the government really wanted it gone it would be gone. I know for a fact at least one state tried making it illegal but they didn't go through with it because of all the support people gave to keep it legal. It is illegal in a few states currently though.
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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]
#21820848 - 06/17/15 08:58 PM (8 years, 7 months ago) |
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.....and then they threaten your livelyhood with it. I hope you love your government.
--------------------
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:
FreeTheSoul said: I think you guys aren't realizing if the government really wanted it gone it would be gone. I know for a fact at least one state tried making it illegal but they didn't go through with it because of all the support people gave to keep it legal. It is illegal in a few states currently though.
Dont for a second fall for that shit..thats the plan...you cant upset the herd you have to gradually manipulate it..
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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lowbrow
Paddy Time!!!!


Registered: 09/12/08
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Re: FDA import alert kratom [Re: Amanita86]
#21820856 - 06/17/15 09:00 PM (8 years, 7 months ago) |
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Salvia is still legal.
-------------------- Amanita86 said: Sui is trying to mod right now. Kinda like a newborn calf tryin ta stand fer the first time ain’t it..
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
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Re: FDA import alert kratom [Re: Amanita86]
#21820862 - 06/17/15 09:01 PM (8 years, 7 months ago) |
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You cant shock it, that would cause rebellion, you have to gradually make it accept and give up..
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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Adden

Registered: 06/04/03
Posts: 39,201
Loc:
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Yeah which is not a good sign. Remember what happened to poppy pods? That got shut down so fast. The big Texas vendor was the first to go and they even got a florist, I mean come on. I'd seriously say stock up now, I still have salvia since I was 18 and that was 14 years ago. Even some nice dried torch in a closet somewhere. 5 kilos of red vein borneo now is a lot cheaper than it will be this time next year, I've seen other vendors skyrocket.
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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: lowbrow]
#21820865 - 06/17/15 09:01 PM (8 years, 7 months ago) |
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Quote:
Amanita86 said: .....and then they threaten your livelyhood with it. I hope you love your government.
They arent threatening your livelyhood. An import alert does not make it illegal. It just gives customs the right to seize the package.Quote:
lowbrow said: Salvia is still legal.
Not in a lot of states.
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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: lowbrow]
#21820867 - 06/17/15 09:02 PM (8 years, 7 months ago) |
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Quote:
lowbrow said: Salvia is still legal.
Not here.. and not in a lot of places.. weed is "legal" but not here, and not in a lot of places.
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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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Quote:
FreeTheSoul said: They arent threatening your livelyhood. An import alert does not make it illegal. It just gives customs the right to seize the package.
Thats how it starts..
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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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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Re: FDA import alert kratom [Re: Amanita86]
#21821270 - 06/17/15 10:45 PM (8 years, 7 months ago) |
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I read somewhere that the problem is that some vendors are putting dosages on the packages and making it obvious it was for human use. If you are a vendor you need to say it is a soap cleaner or for aromatherapy or whatever and say not for human consumption.
I think it might fall under some dietary supplement thing in which they might not be able to regulate quite as much as a research chemical.
Again this could be completely wrong.
If this is only a ban on it slipping through American customs I doubt it would stop someone like me from Canada getting some shipped from Indonesia. Time will tell but if it ever becomes banned or impossible to import I will order a lifetime supply.
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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Konyap

Registered: 06/30/07
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fucking crazy so many people are giving themselves heart attacks in 30/40 years, lung cancer, ass cancer etc.
but kratom causes respiratory depression? hallucinations? these people should be fired or thrown into a collective ditch...
Edited by Konyap (06/18/15 11:04 AM)
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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
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Last seen: 8 years, 4 months
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Re: FDA import alert kratom [Re: Konyap]
#21823623 - 06/18/15 01:24 PM (8 years, 7 months ago) |
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I don't blame the FDA in a way. To them kratom is basically the same as bath salts and they see no difference.
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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Magicman69
All About the Benjamins



Registered: 05/29/13
Posts: 6,876
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Quote:
Almond Flour said: I still think its only a matter of time. If it happened to JHW-18 It will happen to Kratom
Not really the same thing since Kratom is a leaf and JWH a synthetic chemical created as an analogue to an already illegal substance. Your right though in the sense that it's only a matter of time.
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Konyap

Registered: 06/30/07
Posts: 33,945
Loc: Planet Piss
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Re: FDA import alert kratom [Re: Magicman69]
#21823719 - 06/18/15 01:50 PM (8 years, 7 months ago) |
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We should not take this lying down IMO They have no studies that say kratom is dangerous and yet it's specifically stated in the memo. The compound itself isn't addicting, and it doesn't cause respiratory depression, the chemistry tells you.
Quote:
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.
it's been used for thousands of years. this is what they did with coca and poppies before they became first world exit plans...
it's almost as bad as saying medical weed doesn't help people to them it's probably a easy way to monopolize molecules
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hex_enduction
satta massa gana



Registered: 01/26/14
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Quote:
Bitter Cactus said: I don't blame the FDA in a way. To them kratom is basically the same as bath salts and they see no difference.
As a drug regulation administration, their job is to see the difference between safe and unsafe drugs. I think it's safe to say that they're responsible for some of the blame here.
--------------------
Connoisseur said: oh ive cried on drugs sunshine said: Tragic. I told the cop not to do it but he didn't listen.
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Konyap

Registered: 06/30/07
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I've dealt with this in college basically the people that are supposed to advise and warn become the heads of the science department overnight because they have a degree in communication which is really just behavior based bullshit and shoe stringing the members of the community changing the rules, changing who they want permision from on a day to day basis depending on who you talk to
they're daft thinking about them makes me want to punch them in the face and I've done fairly well dealing with them... but to make me walk back and forth like that because you can't hold on to your line of bullshit for more then a week/semester
and it's like that everywhere, you get double billed for something? Fuck you, the people that deal with humans here deal with another set of humans over there and they... FML
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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
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Re: FDA import alert kratom [Re: Konyap]
#21824221 - 06/18/15 03:50 PM (8 years, 7 months ago) |
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The problem is headshops selling this stuff in extracts and capsules and fancy packages.
No way in hell the DEA and FDA is gonna let this go unnoticed.
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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Konyap

Registered: 06/30/07
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Extracts can't be sold to people..
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Amanita86
OTD Keymaster


Registered: 09/26/12
Posts: 89,464
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Re: FDA import alert kratom [Re: Konyap]
#21824305 - 06/18/15 04:09 PM (8 years, 7 months ago) |
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you sure?
--------------------
Orange clock, pencil "They threw me off the hay truck about noon..."
*Mark 15:34  Gam zeh ya’avor...
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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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Re: FDA import alert kratom [Re: Konyap]
#21824367 - 06/18/15 04:21 PM (8 years, 7 months ago) |
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Quote:
Illyabo said: Extracts can't be sold to people..
They can only be sold to crab people.
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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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: Konyap]
#21824498 - 06/18/15 04:51 PM (8 years, 7 months ago) |
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What, my vendor sells all kinds of extracts , 10x's-25x's extract, but TBH, I get off better on the leaf, does not make since,since it is suppose to be 25x's stronger then the leaf, but its not, marketing ploy, plus it cost way more.
I have tried extracts from many vendors, and none owned up to the hype, I like straight maeng da
-------------------- 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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LogicaL Chaos
Ascension Energy & Alien UFOs




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Wait, can Kratom really cause hallucinations?
No wayz....
-------------------- "What you must understand is that your physical dimension affects everyone in the higher dimensions as well. All things are interconnected. All things are One. Therefore, if one dimension is broken or out of balance, then all other dimensions will experience repercussions." - Pleiadian Prophecy 2020 The New Golden Age by James Carwin PROJECT BLUE BOOK ANALYSIS! (312 pages!) | Psychedelics & UFOs | Ready to Contact UFOs? | The Source on Mushrooms | Trippy Gematrix | Dj TeknoLogical | Fentanyl Test Kits R.I.P. Big Worm || The Start of the Ascension Process was 2020. Welcome to the Next Great Era of Earth 🌎🌍🌏
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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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I sure the fuck have never happened to me, and when I eat kratom, I eat a half ounce of maeng da at a time, cause of my very high opiate tolerance, from using oxycodone ir, prescribed by my doc
-------------------- 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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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
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Kratom causes hallucinations. Confirmed by the FDA lol
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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Konyap

Registered: 06/30/07
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We must work for years to get other people high for ten to two hours.
Getting high from plants is wrong.
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LiquidVisions
Consumes Psychoactive Material



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Re: FDA import alert kratom [Re: Konyap]
#21826055 - 06/18/15 11:05 PM (8 years, 7 months ago) |
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I just got some in yesterday. We can't let this happen..the only reason the FDA is doing this is because of the amount of money that is being lost from pills. They're in cahoots with the pharmaceutical companies. This is an outrage!
-------------------- Step 1: Stare at this for 30 seconds
Step 2: Look at this after following step one
Step 3: Enjoy the mini trip
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FreeTheSoul
The wonderer.
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They did this last year I believe. They do it with alot of products, like cosmetics etc. Also all the people who are saying DEA is making kratom illegal should realize kratom has been on their watch list since I believe 2004. I know that when the DEA wants something banned it usually happens pretty damn fast.
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Konyap

Registered: 06/30/07
Posts: 33,945
Loc: Planet Piss
Last seen: 4 years, 2 months
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Not really they promote themselves based on how many people they call a 'faggot'
so say you're an employee there and you find a bunch of faggots then you can rat on the faggots and get promoted now what we have here is a global faggot alert which means they do anything in the power banning extract would be good but to make an impression like you're the big mean bitch, you have to ban regular kratom as well so your job is already finished and you don't have to come back later
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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: Konyap]
#23633134 - 09/10/16 05:02 PM (7 years, 4 months ago) |
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If the government wanted it to be gone it would be gone? N people calling me stupid on here.. good thang I signed the petition fer not listing it as a schedule 1 this month...
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