Straight Dope Message Board

[Jonathan Chance]

OK, so some people are pitching this stuff at me. Sounds dodgy.

They're looking for financial representation and come highly referred by a CPA I trust.

But I want to get my head around this stuff. It sure looks like the FDA isn't happy with this stuff and shipments coming into the states have been intercepted and held from time to time. I don't really understand the legalities of the whole thing.

So what's the story? In a way of sounding sort of 'food supplement' dodgy, they tell me it's a natural way to ease symptoms from opiate withdrawls - which sounds like it functions as an opiate itself - and has other beneficial unspecified health advantages.

What's the scoop? Should I deal with these hippy-types or what? 1

[Cleophus]

Originally Posted by Jonathan Chance

What's the scoop? Should I deal with these hippy-types or what?

Probably not. The FDA seizes shipments because it's being sold to people for consumption, but the raw product and sellers aren't approved for that. Think printing "for research purposes" or "not for human consumption" on packages with a wink-wink-nudge-nudge.

It contains a chemical, mitragynine, that is an opiate receptor agonist (but not an opioid itself). It's definitely used like an "opiate-lite". The DEA proposed scheduling it as Schedule I in 2017, but dropped it. 2

[MrDibble]

I'd be leery as it might get regulated before too long even if it's legal now. 3

[Section Maker:Jupe]

I would study up on it, before you make any decision. There is quite alot of info available from both the medical community and the proponents and sellers of kratom. I would find out the FDA's plans for future action. They seem to be in a holding pattern regarding legality, and are accepting public input.

Anything that can help people get off/slow down their opioid problems should be given a good hard look. 4

[Czarcasm]

It is being sold as a "legal high" in various marijuana dispensaries and some convenience stores here in Oregon. 5

[Jackmannii]

Let's see...a supplement with inflated claims that is on the road to being banned in some places.

Sounds like a great business opportunity! 6

[steatopygia]

Sure, you can deal with them. Just get paid up front.
Kratom is another in a line of not yet regulated pharmaceuticals that is pitched as being "all natural" without harmful side effects. BS on several fronts. Anything that has effects has side effects.
Kratom is also sold as a supplement, meaning no regulation on what is actually in the bag.

Info on how it works. 7

[Tim@T-Bonham.net]

I remember reading about a new drug that was developed as a morphine substitute for cough suppressants that did not have morphine's addictive side-effects. It was widely market by its maker, Bayer company, under its trademarked name, Heroin™.

But Bayer did make a good deal of money on this, before it was banned. Seems like these people (and your CPA!) are giving you an opportunity to get in at the start with this. 8

[Littleman]

Its already on the downturn. The craze was 2-4 years ago. 9

[Wesley Clark]

Some people have good luck with it and it helps curb their cravings for stronger opiates or alcohol.

Other people get addicted to it and it just creates new problems.

On the whole, it seems to be a fairly benign substance. It is near impossible to OD on, it is cheap and the effects aren't overpowering. 10

[Jonathan Chance]

Originally Posted by Jackmannii

Let's see...a supplement with inflated claims that is on the road to being banned in some places.

Sounds like a great business opportunity!

Sure. I get that.

But even with import problems they're moving multiple millions worth of the stuff per year. It's astonishing. 11

[steatopygia]

Originally Posted by Jonathan Chance

Sure. I get that.

But even with import problems they're moving multiple millions worth of the stuff per year. It's astonishing.

I think many a cautionary tale has started with those exact same thoughts.
Despite what I said earlier, I would stay far away unless you have experience with similar things, specifically marijuana. You are likely to have the same issues, local acceptance or at least non-interest, and a possible later intense interest from the Feds.
I wouldn't Chance it. 12

[KidCharlemagne]

Any kratom business comes with huge regulatory risk. Scott Gottlieb was going after it pretty hard (ever since he got a seat on the board of a drug company that was attempting to make a drug based on mitragynine) but has recently stepped down. The Kratom lobby, the AKA has been remarkably effective in keeping Kratom legal thus far. I'm a daily Kratom user for chronic pain and the stuff is a lifesaver. While users do develop some tolerance, Kratom seems to remain effective for the majority of users. It also helps many heroin users make the transition off drugs completely. It certainly could be addictive though I've stopped completely a couple of times with moderate tapering and suffered almost no side effects. Other people have had a more difficult time. I think that overall it's a net benefit to society. Anyone who wants to get rid of Kratom should be stricken with chronic pain for a while. I think banning it would drive a not significant number of people to opiates. I'd like to see mandatory third party testing but that's about it. 13

[KidCharlemagne]

Originally Posted by Jackmannii

Let's see...a supplement with inflated claims that is on the road to being banned in some places.

Sounds like a great business opportunity!

What is inflated about the claims? 14

[Jackmannii]

Originally Posted by KidCharlemagne

What is inflated about the claims?

"The FDA sent warning letters to Chillin Mix Kratom and Mitra Distributing over claims that the herbal product would "relieve opium withdrawals" and treats medical conditions, including diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, and alcoholism.

To date there have been no "adequate and well-controlled scientific studies" involving the use of kratom as a treatment for medical conditions or diseases in humans, the warning stated."

https://www.philly.com/philly/health...-20180911.html

Nice Pharma Shill gambit there re Dr. Gottlieb. 15

[yellow sausage bandit]

Well, it's actually a (mild) opioid, so it has (dis)advantages similar to other opioids. It makes you feel good, it relieves pain, it kills your dick and any sexual desire, it makes you lose appetite, it gives you dry mouth, it makes you constipated (high quality kratom always made my lips and asshole bleed) and it's pretty addictive. Apart from that, people are also reporting elevated liver enzymes and seizures due to kratom. I wouldn't invest in it, there are too many negative effects from this drug. 16

[Jonathan Chance]

No no no. You guys aren't quite there.

They're not asking me to invest in their enterprise. They're asking me to handle the money they make from it. Much different thing. 17

[Czarcasm]

Originally Posted by Jonathan Chance

No no no. You guys aren't quite there.

They're not asking me to invest in their enterprise. They're asking me to handle the money they make from it. Much different thing.

So if something goes wrong, you wouldn't be a victim-You would be an accomplice? 18

[Wrenching Spanners]

Originally Posted by Jonathan Chance

No no no. You guys aren't quite there.

They're not asking me to invest in their enterprise. They're asking me to handle the money they make from it. Much different thing.

In what sense? Are you being asked to divest their earnings, or to manage their liquidity? Or are you being asked to take on some financial operational role such as acting as an external controller or setting up and managing their legal entity structure?

If it’s standard money-management, I don’t see any issues. I’d make sure you’ve got some anti-money laundering boiler-plate language in your contract, along with a break clause. But beyond that, it’s really a matter of how you pick your clients and what your personal red lines are. However, anything hands-on and the risk that comes to mind is being implicated in racketeering. What happens to someone involved in a business if a legal, unregulated product becomes illegal? Way too far outside my knowledge base to discuss meaningfully, but definitely tread carefully. 19

[KidCharlemagne]

Originally Posted by Jackmannii

"The FDA sent warning letters to Chillin Mix Kratom and Mitra Distributing over claims that the herbal product would "relieve opium withdrawals" and treats medical conditions, including diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, and alcoholism.

To date there have been no "adequate and well-controlled scientific studies" involving the use of kratom as a treatment for medical conditions or diseases in humans, the warning stated."

https://www.philly.com/philly/health...-20180911.html

Nice Pharma Shill gambit there re Dr. Gottlieb.

If exaggerated claims by a few companies made something illegitimate then nothing would be legitimate. Considering Gottlieb is on the product advisory board of Glaxo, the company who happens to have a patent on the crystallized form of mitragynine, and their patent says it is more effective than codeine, but with fewer side effects, I'd say that's a conflict if interest. 20

[Jackmannii]

I've seen no evidence that Scott Gottlieb was personally involved in the FDA investigation of companies making false claims about kratom (he had specifically announced on taking the leadership job that he would recuse himself from any decisions involving companies he had been affiliated with).
Gottlieb has been widely regarded as one of the Administration's most competent and respected officials (by the Washington Post and others), who's not been afraid to take on big corporations over such issues as drug pricing and vaping hazards, so I'm afraid your Industry Shill accusations are weak to say the least.

You'd have to add in multiple other government agencies to your conspiracy musings, including those looking at classifying kratom as a Schedule 1 drug, and the CDC (investigating a multiple-state Salmonella outbreak which may have been caused by kratom use). Oh, and those medical organizations warning about kratom - must be Big Pharma stooges too!

https://www.mayoclinic.org/healthy-l...m/art-20402171

It's not just a couple of bad apples in the kratom barrel either.

https://www.forbes.com/sites/davidkr.../#d231eb42d5af

At least this thread may have quashed one of my favorite gripes about "natural" plant-based supplements - where devotees note that many modern drugs are derived from plants, yet practically in the same breath complain that plant-based drugs aren't properly investigated because they can't be patented. 21

[Jonathan Chance]

Originally Posted by Wrenching Spanners

If it’s standard money-management, I don’t see any issues. I’d make sure you’ve got some anti-money laundering boiler-plate language in your contract, along with a break clause. But beyond that, it’s really a matter of how you pick your clients and what your personal red lines are. However, anything hands-on and the risk that comes to mind is being implicated in racketeering. What happens to someone involved in a business if a legal, unregulated product becomes illegal? Way too far outside my knowledge base to discuss meaningfully, but definitely tread carefully.

Standard money management. Retirement, savings and so forth. I don't fear prosecution for doing so as I'm not involved - and can't be, by regulation - involved in the business. I'm just trying to get my head around the business in the first place to see if it has legs and is worth taking on the client. 22

[KidCharlemagne]

Originally Posted by Jackmannii

I've seen no evidence that Scott Gottlieb was personally involved in the FDA investigation of companies making false claims about kratom (he had specifically announced on taking the leadership job that he would recuse himself from any decisions involving companies he had been affiliated with).
Gottlieb has been widely regarded as one of the Administration's most competent and respected officials (by the Washington Post and others), who's not been afraid to take on big corporations over such issues as drug pricing and vaping hazards, so I'm afraid your Industry Shill accusations are weak to say the least.

You'd have to add in multiple other government agencies to your conspiracy musings, including those looking at classifying kratom as a Schedule 1 drug, and the CDC (investigating a multiple-state Salmonella outbreak which may have been caused by kratom use). Oh, and those medical organizations warning about kratom - must be Big Pharma stooges too!

https://www.mayoclinic.org/healthy-l...m/art-20402171

It's not just a couple of bad apples in the kratom barrel either.

https://www.forbes.com/sites/davidkr.../#d231eb42d5af

At least this thread may have quashed one of my favorite gripes about "natural" plant-based supplements - where devotees note that many modern drugs are derived from plants, yet practically in the same breath complain that plant-based drugs aren't properly investigated because they can't be patented.

I never said Gottlieb was personally involved in those investigations. Do I really need to link to the articles from NYT, Wash Post, etc that voiced serious concerns about his ties to the pharmaceutical industry? Should we make Romaine lettuce illegal because it's caused Salmonella poisoning in some cases or maybe just regulate it? Kratom has been a life saver for me and many others. Yes it should be regulated but schedule 1 is insane. You do know there is an area somewhere between toadie and conspiracist? 23

[Jackmannii]

Originally Posted by KidCharlemagne

I never said Gottlieb was personally involved in those investigations.

C'mon, you've said he was "going after" kratom owing to a "conflict of interest"; your implication is that the FDA's concerns about false marketing and abuse are just because their former chief was a "toadie" for Big Pharma (not borne out by his performance at the agency).
Such allegations require evidence, not conspiratorial hand-waving. And you'd still have to explain why other health agencies and physicians have serious concerns about lack of efficacy and harm (including reported deaths, and kratom users showing up in ERs with withdrawal symptoms).

My take on kratom is pretty much the same as with all supplements (which are basically unregulated, thus prone to mislabeling/adulteration/contamination/bogus claims). Health claims should be backed by solid evidence, without which the stuff shouldn't be on the market.

There seem to be plenty of "hippy-types" (to use the OP's phrase) looking to score big money off users. Personally I'd feel uneasy about facilitating their ride to riches, even if I thought it probably wouldn't come back to bite me in a legal sense. 24

[KidCharlemagne]

Originally Posted by Jackmannii

C'mon, you've said he was "going after" kratom owing to a "conflict of interest"; your implication is that the FDA's concerns about false marketing and abuse are just because their former chief was a "toadie" for Big Pharma (not borne out by his performance at the agency).
Such allegations require evidence, not conspiratorial hand-waving. And you'd still have to explain why other health agencies and physicians have serious concerns about lack of efficacy and harm (including reported deaths, and kratom users showing up in ERs with withdrawal symptoms).

My take on kratom is pretty much the same as with all supplements (which are basically unregulated, thus prone to mislabeling/adulteration/contamination/bogus claims). Health claims should be backed by solid evidence, without which the stuff shouldn't be on the market.

There seem to be plenty of "hippy-types" (to use the OP's phrase) looking to score big money off users. Personally I'd feel uneasy about facilitating their ride to riches, even if I thought it probably wouldn't come back to bite me in a legal sense.

Now you're going after kratom's efficacy?

Read:
https://www.urmc.rochester.edu/news/...s-bad-rap.aspx 25

[Jackmannii]

From your link: “There is a clear need for more rigorous, well-controlled, prospective studies to support a sophisticated, nuanced understanding of the plant,” said Swogger."

Nowhere in that story do I see anyone arguing that kratom should be legal for sale everywhere by any supplement dealer without a guarantee of content or purity, and that sellers should be able to make any claims they want.

If you lined up all the drugs that were felt at some point to have potential but never panned out or had serious limitations that precluded their use, you'd have a hell of a long line of drugs. 26