Johns Hopkins Medicine, Kratom Survey

[BallzDeep9]

This came out several months ago. Important! LINK:

Natural Herb Kratom May Have Therapeutic Effects And Relatively Low Potential For Abuse Or Harm

Researchers say findings underscore need for research and regulation, but NOT an outright ban on sales

“Although our findings show kratom to be relatively safe according to these self-reports, unregulated medicinal supplements raise concerns with respect to contamination or higher doses of the active chemicals, which could increase negative side effects and harmful responses,” says Garcia-Romeu. “This is why we advocate for the FDA to regulate kratom, which would require testing for impurities and maintaining safe levels of the active chemicals. Otherwise, unregulated products run the risk of unsafe additives and dosing problems, which could be like getting a shot of grain alcohol when you were trying to order a beer.”

MY TAKE: The prestigious Johns Hopkins University Medical Center, is known & recognized by ALL doctors ~ IF Johns Hopkins says: "Kratom is relatively safe", then you can take that... to the bank!! lol. Print this article. Share it with your doctor, family, whoever! The color graphic, prints very nice on Page 2 from your browser.... Most "Regulation" language applies to the kratom shots, retail drug products, Viva Zen, etc - NOT to pure powder leaf!

There won't be any "Ban" on Kratom! ~ So Please Ignore any SCAMS, groups fear-mongering for money!!

https://www.hopkinsmedicine.org/news/ne ... ser-survey

[Loveandpeace]

Lovely news, indeed. Good looking out ballzdeep9.

[humbles2390]

Interesting. Definitely going to read this. I heard from LuckyHerbals NIDA was doing a study currently and I'll be interested in that when it comes out as well.

Ballz, do you think it'll be better or worse for consumers, or vendors for that matter, if the FDA regulates kratom? I'd be interested in hearing some of your opinions on the pros and cons. I'd like to hear what everyone on doubleM thinks about it actually.

[Jestrice2002]

That's GREAT news!

... But I still can't stop collecting...

[LuckyHerbals]

Interesting. Definitely going to read this. I heard from FF NIDA was doing a study currently and I'll be interested in that when it comes out as well.

Ballz, do you think it'll be better or worse for consumers, or vendors for that matter, if the FDA regulates kratom? I'd be interested in hearing some of your opinions on the pros and cons. I'd like to hear what everyone on doubleM thinks about it actually.

Hey Humbles, we were just talking about this yesterday. The FDA needs to stop doing THIS BS https://www.accessdata.fda.gov/cms_ia/i ... _1137.html, same crap that they used to take 100kg of our last shipment. Exact quote from the top of the import alert:

"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."

The district in Louisville, KY took our shipment on 7/22 and placed an FDA hold on it... on 7/29 they sent it back to my supplier. It's been sitting in China (stuck) for a couple weeks now, AFTER they sent us a letter asking us how we intended to use the product, and specifically, wanted to know if we would be selling it. What kind of effery is that!? I don't think anyone is getting that shipment, and my supplier has been battling the shipping company to get his money back. Lesson learned, and also a warning to any vendors using any sort of air cargo companies right now...make sure they have their crap together! If it's going to be delivered by UPS once it gets stateside, you have a 50/50 chance you'll lose the shipment. We already knew about this, but the shipping company decided to keep that information from us.

[humbles2390]

Iheard from FF

My mistake. I definitely talked to you about this Lucky. My bad to both you and FF...

Editing...

[humbles2390]

But yes obviously they have inserted a loophole for them to seize whatever and whenever they want.

This may be naive, but what if a small sample was shipped from the supplier for sampling purposes, so that the bulk shipment could then be sealed (so to speak) with the test amounts from the sample?

I know this would take double the time in receiving shipments, and would obviously hurt small vendors. With how this is written it looks like there just needs to be more research conducted by prominent facilities so this broad article of theirs can be revised or phased out....

Big brother always looking out

[TheStanman]

Ballz, do you think it'll be better or worse for consumers, or vendors for that matter, if the FDA regulates kratom? I'd be interested in hearing some of your opinions on the pros and cons. I'd like to hear what everyone on doubleM thinks about it actually.

While many of us prefer the unregulated current state (myself included), my fear is it's not sustainable given how popular and growing kratom is. The US track record suggests there are two long-term scenarios - regulated or illegal. I think we all know what we'd prefer of those two.

Regulation does not have to be too onerous. In Georgia, we've passed the Kratom Consumer Protection Act which has reasonable regulations - must be 18+, labeling, etc.

Ultimately, my preference is common-sense regulations that do not disadvantage small-batch vendors.

[Jfish030]

Interesting. Definitely going to read this. I heard from FF NIDA was doing a study currently and I'll be interested in that when it comes out as well.

Ballz, do you think it'll be better or worse for consumers, or vendors for that matter, if the FDA regulates kratom? I'd be interested in hearing some of your opinions on the pros and cons. I'd like to hear what everyone on doubleM thinks about it actually.

Hey Humbles, we were just talking about this yesterday. The FDA needs to stop doing THIS BS https://www.accessdata.fda.gov/cms_ia/i ... _1137.html, same crap that they used to take 100kg of our last shipment. Exact quote from the top of the import alert:

"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."

The district in Louisville, KY took our shipment on 7/22 and placed an FDA hold on it... on 7/29 they sent it back to my supplier. It's been sitting in China (stuck) for a couple weeks now, AFTER they sent us a letter asking us how we intended to use the product, and specifically, wanted to know if we would be selling it. What kind of effery is that!? I don't think anyone is getting that shipment, and my supplier has been battling the shipping company to get his money back. Lesson learned, and also a warning to any vendors using any sort of air cargo companies right now...make sure they have their crap together! If it's going to be delivered by UPS once it gets stateside, you have a 50/50 chance you'll lose the shipment. We already knew about this, but the shipping company decided to keep that information from us.

If this is your first seizure, your either new or have been extremely "lucky", lol. Just to let you know, your name and address are now flagged so your more likely to get another one seized next time. It sounds like you were using air cargo with a consolidated shipment, basically your supplier threw your small order in with other peoples orders and sent 1 shipment with a few others. The problem with those is if someone is flagged like you are now, well your shipment gets flagged too. If it never made it to America there is a better chance to get it back to your supplier. The problem is that air cargo cost so much that the powder would be more efficiently destroyed then to pay additional shipping to move it back. There are no refunds from the shipping company for shipping cost due to a seizure. Unless you have a really good/big supplier. The guarantee they always told you about probably wont occur so you are out whatever money you paid. The downside to a little supplier overseas is they cant afford to reship and that guarantee they give you is just talk.

[psychonaut]

"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"

Don't know about y'all but I'll be calling it thang from now on.

[DennisHopper]

"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"

Don't know about y'all but I'll be calling it thang from now on.

[BallzDeep9]

If this is your first seizure, your either new or have been extremely "lucky", lol. Just to let you know, your name and address are now flagged so your more likely to get another one seized next time. It sounds like you were using air cargo with a consolidated shipment, basically your supplier threw your small order in with other peoples orders and sent 1 shipment with a few others. The problem with those is if someone is flagged like you are now, well your shipment gets flagged too. If it never made it to America there is a better chance to get it back to your supplier. The problem is that air cargo cost so much that the powder would be more efficiently destroyed then to pay additional shipping to move it back. There are no refunds from the shipping company for shipping cost due to a seizure. Unless you have a really good/big supplier. The guarantee they always told you about probably wont occur so you are out whatever money you paid. The downside to a little supplier overseas is they cant afford to reship and that guarantee they give you is just talk.

JFish the process of FDA flagging a name address, known as The FDA Red List - is published HERE (same FDA website as Lucky posted ^). aka the FDA 54-15 Import Alert ~ which I know you're familiar with, but for purpose of discussion ~ Question IS: Why or How, could FDA be flagging anything which isn't part of their official FDA record here? This is the FDA Red List!

Are you saying, FDA now has another, different, List of names besides their official List? Note: this Red List has NOT had a name added in four years!! All of these are from 2016. The page has a Published Date: 06-11-2019, so updated a year ago... I guess I don't understand this idea (coming from AKA!) that FDA is doing or saying, things about kratom - when nothing IS part of the official record? Fact is, FDA has made NO public statement regarding kratom, in over two years!!

It sounds like... UPS and DHL, have their own directive to grab shipments, based on 54-15, and they are re-routing suspected shipments, back through a U.S. Customs office for Inspection, and possible seizure depending on the labeling. IF shipment is labeled Green Tea, and they inspect & decide it's kratom ~ then shipment will be seized due to mis-labeling. Not because it's kratom... However IF shipment is correctly labeled Mitragyna, they'll ask Receiver what is the purpose. IF there is any hint of human consumption (Vendor's website, capsules being sold, for example!) then... shipment is seized!

Bottom Line: Kratom MUST be shipped and sold "Not For Human Consumption".

[LuckyHerbals]

Ballz is correct, JFish. The import alert red lists the shipper, not the importer. I'm definitely not on a list LOL. And we've been around for 2 years, so not too new? And yes, several suppliers went together on one shipment, very common these days now that air cargo is being used quite a bit with all the shipping issues in Indo. I'm also starting to believe Ballz that it's not getting banned...there hasn't been talk in 2 years just like you said. It's all a money grab IMO... Nevertheless, cGMP is our goal, and I think we can definitely reach that level in another year. It's going to cost around $30k to get started.

[onespeedstop]

"Using results of a survey of more than 2,700 self-reported users"

^ Not to rain on any parades, but that's not a scientific study by any stretch of the imagination, and for them to comment on a survey is a joke. When has anything -self reported- ever been remotely accurate, ever, in the history of the world ?

A better "study" would have just to gather medical/dr. reports of people having issues with kratom, but I doubt there ever have been any that were because of kratom alone.

The fact that it's not sold on the street, and that it never would be because it's too mild for anyone to pay much for or go chasing illegally, kind of tells ya everything ya need to know about it. Then again, logic has no place in politics, so they could ban it tomorrow, much like they are essentially doing with vaping in a couple of weeks here.

Added : Also in that same article - "Otherwise, unregulated products run the risk of unsafe additives and dosing problems, which could be like getting a shot of grain alcohol when you were trying to order a beer.”

^ So it would be exactly the same then ? A normal bottle/can of beer contains the same amount of actual alcohol as a shot does. This whole article might as well be a Fox "news" article, or a post on some influencers blog.

[BallzDeep9]

^ Not to rain on any parades, but that's not a scientific study by any stretch of the imagination, and for them to comment on a survey is a joke.

Wow, you're missing the whole point... 1- this IS Johns Hopkins, 2- this study was funded by NIDA, if you read at the bottom.

However, says Albert Garcia-Romeu, Ph.D., instructor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, the new survey findings “suggest that kratom doesn’t belong in the category of a Schedule I drug, because there seems to be relatively low rate of abuse potential, and there may be medical applications to explore, including as a possible treatment for pain and opioid use disorder.”

“There has been a bit of fearmongering,” he adds, “because kratom is opioidlike,...

So, We have one of the top Scientists at Johns Hopkins, coming out publicly and saying ~ Kratom should NOT be scheduled, and basically kratom is NOT a drug and not an "opioid", he calls it opiodlike. Then, he calls out the fear-mongering BS (see AKA,) and says, basically that kratom is SAFE ~ ( "seemingly safe therapeutic potential", and "our findings show kratom to be relatively safe" ) and again, it's a whole team Report signed off, with funding from NIDA. Their conclusion, IS that more studies, more research... is needed. Because millions of people ARE using kratom!

This Report / statement from Johns Hopkins and NIDA... is HUGE. Of course it's not a full scientific study. They SAY that in the Report!! Jeezus man, you're tearing down a published Article that's the most positive OFFICIAL thing for Kratom in... 5 years? Maybe the biggest news ever ??

Just a few months ago, AKA claimed that FDA "Federal Ban" was imminent, and... all these fools wrote a check to AKA.

[Jscoggs81]

This is great news. I just printed this .will definitely. E sharing with all the neigh sayers in my circle

[mivanqua]

^ Not to rain on any parades, but that's not a scientific study by any stretch of the imagination, and for them to comment on a survey is a joke.

Wow, you're missing the whole point... 1- this IS Johns Hopkins, 2- this study was funded by NIDA, if you read at the bottom.

However, says Albert Garcia-Romeu, Ph.D., instructor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, the new survey findings “suggest that kratom doesn’t belong in the category of a Schedule I drug, because there seems to be relatively low rate of abuse potential, and there may be medical applications to explore, including as a possible treatment for pain and opioid use disorder.”

“There has been a bit of fearmongering,” he adds, “because kratom is opioidlike,...

So, We have one of the top Scientists at Johns Hopkins, coming out publicly and saying ~ Kratom should NOT be scheduled, and basically kratom is NOT a drug and not an "opioid", he calls it opiodlike. Then, he calls out the fear-mongering BS (see AKA,) and says, basically that kratom is SAFE ~ ( "seemingly safe therapeutic potential", and "our findings show kratom to be relatively safe" ) and again, it's a whole team Report signed off, with funding from NIDA. Their conclusion, IS that more studies, more research... is needed. Because millions of people ARE using kratom!

This Report / statement from Johns Hopkins and NIDA... is HUGE. Of course it's not a full scientific study. They SAY that in the Report!! Jeezus man, you're tearing down a published Article that's the most positive OFFICIAL thing for Kratom in... 5 years? Maybe the biggest news ever ??

Just a few months ago, AKA claimed that FDA "Federal Ban" was imminent, and... all these fools wrote a check to AKA.

Ballz, love you, bro. Thanks for this breath of fresh air. I needed it. Seriously.