Kava and K@: A Legal and Ethical Perspective

[Rick.Sanchez]

@KavaKhris, I'm sorry to hear you had a poor experience with the plant. I've used K@ daily, and Ive personally found the withdrawals to be less severe than caffeine withdrawals. Like any other medicine, I think those things should be decided on a case-by-case basis. If the benefits outweigh the negatives, line it does for many, then it's probably worth using. If not, then don't use it.

Cheese also contains mu-opioid agonists, so is it fair to apply that same logic to cheese and call it an opioid? Most research has shown that K@ does not recruit beta-arrestin in the same way our pharmaceutical opioids do. Without getting too detailed, beta-arrestin recruitment is responsible for addiction and many off-target toxicities. It can still happen with K@, but it happens to an extremely small degree and more slowly. That's partly why there are ZERO overdoses that can be directly implicated on K@. There are a handful that are associated with kratkm, but they're more likely due to other drugs such as tramadol which is an SNRI/opioid that is only schedule IV.

I guess this is the point where the discussion devolves into the opioid = evil demonization if K@.

@verticity, obviously if it's sold for human consumption, then they're breaking the law. Like I said, the 'not for human consumption' label is what people are able to hide behind. That's not to say many people disregard it all together anyways. I'm not trying to say that it gives people a free pass to sell it for human consumption. Simply stating the fact that it's been enough ambiguity to provide some plausible deniability if vendors are careful.

 

[KavaKhris]

@KavaKhris, I'm sorry to hear you had a poor experience with the plant. I've used K@ daily, and Ive personally found the withdrawals to be less severe than caffeine withdrawals. Like any other medicine, I think those things should be decided on a case-by-case basis. If the benefits outweigh the negatives, line it does for many, then it's probably worth using. If not, then don't use it.

Cheese also contains mu-opioid agonists, so is it fair to apply that same logic to cheese and call it an opioid? Most research has shown that K@ does not recruit beta-arrestin in the same way our pharmaceutical opioids do. Without getting too detailed, beta-arrestin recruitment is responsible for addiction and many off-target toxicities. It can still happen with K@, but it happens to an extremely small degree and more slowly. That's partly why there are ZERO overdoses that can be directly implicated on K@. There are a handful that are associated with kratkm, but they're more likely due to other drugs such as tramadol which is an SNRI/opioid that is only schedule IV.

I guess this is the point where the discussion devolves into the opioid = evil demonization if K@.

@verticity, obviously if it's sold for human consumption, then they're breaking the law. Like I said, the 'not for human consumption' label is what people are able to hide behind. That's not to say many people disregard it all together anyways. I'm not trying to say that it gives people a free pass to sell it for human consumption. Simply staying it's enough ambiguity to provide some plausible deniability if vendors are careful.

I mean, that is kind of fair but the mitragynine and 7-OH mitragynine have a BIG impact on mu-opioid receptors. This argument is more about semantics and less about what actually happens when you ingest an opioid containing plant on a daily basis (not everyone does this). 7-OH-M was even shown to have a higher efficacy and strength than morphine when used in isolation. You can view a lot of this information here (talk on K@ by an ACTUAL researcher begins at about 50 minutes);
The main problems with K@ are the extracts and adulteration (which does happen, check out the video,a couple of case studies of 2 people that popped for hydrocodone/hydro analogues and morphine in one from "leaf material"). Extracts throw mitra/7OH-mitra out of whack and tend to lean 7OH heavy. That being said, I think a big part of addiction and withdrawal can be explained by the kind of strains people are taking, their physical/mental health, etc. I don't mean to fear monger, K@ can be perfectly fine for those with self control. I just urge you to use caution and not buy into the "oh its as addictive as coffee", the pharmacology says otherwise, and with time more severe withdrawals will come, I don't think ANYONE will argue against that. That being said, it is an individual by individual experience and everyone should assess whether their relationship with substances is appropriate or not. Some can maintain a healthy relationship with K@, I just have a problem with the whole "oh its like coffee", that is total BS, and that kind of dishonesty is not what the K@ community needs.

K@ is dangerous for addictive personalities like mine, I understand it is OK and not the devil, but it SHOULD NOT be associated with kava in ANY WAY.

 

[Rick.Sanchez]

I mean, that is kind of fair but the mitragynine and 7-OH mitragynine have a BIG impact on mu-opioid receptors. This argument is more about semantics and less about what actually happens when you ingest an opioid containing plant on a daily basis (not everyone does this). 7-OH-M was even shown to have a higher efficacy and strength than morphine when used in isolation. You can view a lot of this information here (talk on K@ by an ACTUAL researcher begins at about 50 minutes);
The main problems with K@ are the extracts and adulteration (which does happen, check out the video,a couple of case studies of 2 people that popped for hydrocodone/hydro analogues and morphine in one from "leaf material"). Extracts throw mitra/7OH-mitra out of whack and tend to lean 7OH heavy. That being said, I think a big part of addiction and withdrawal can be explained by the kind of strains people are taking, their physical/mental health, etc. I don't mean to fear monger, K@ can be perfectly fine for those with self control. I just urge you to use caution and not buy into the "oh its as addictive as coffee", the pharmacology says otherwise, and with time more severe withdrawals will come, I don't think ANYONE will argue against that. That being said, it is an individual by individual experience and everyone should assess whether their relationship with substances is appropriate or not. Some can maintain a healthy relationship with K@, I just have a problem with the whole "oh its like coffee", that is total BS, and that kind of dishonesty is not what the K@ community needs.

K@ is dangerous for addictive personalities like mine, I understand it is OK and not the devil, but it SHOULD NOT be associated with kava in ANY WAY.

I've read at least half the pharmacological research done on K@ and it's alkaloids. I preferred peer reviewed sources of information. Many scientists think that K@ could (emphasis on could. We won't know unless we're allowed to research it which won't happen if its scheduled) be the key to developing better opioid pain medications. Our current pharmacopeia for treating moderate-severe pain is utter garbage that's not dissimilar to what's been used for millennia. It's kind of sad that we schedule almost every psychoactive substance. Research has been stymied.

And yes, I totally advocate against the use of using addictive substances recreationally except in rare occasions. And yes, people with addictive personalities should stay away from addictive drugs like alcohol, tobacco, benzodiazepines, barbiturates, opioids, etc. This is why I think kava is a truly amazing plant. However, I also think K@ tends to get a totally unfair rap here.

Also, the information about 7-oh mitragynine being more potent than morphine is looking at the two drugs purely in terms of binding affinity. In reality, mitragynine and 7-oh-mitragynine have poor blood-brain-barrier permability, low bioavailability, and they're not full-agonists. Those potency comparisons are pretty bogus in reality.

Also, there's reason to believe that alot of the "K@ extracts" are really just ultra-potent tramadol analogues. Because tramadol is scheduled IV, people can legally sell analogues. And I'll agree with you there. They're very bad. Tramadol is extremely addictive. The FDA has completely failed the public when it comes to supplements and CNS-active drugs

 

[SelfBiasResistor]

I don't think anyone is going to be messing with K@, as scheduling is in the works. Why chase after something you can't catch when you can just wait for it to get tired? I feel bad for those that do need K@ to function, it can be a great help to some, but the scheduling (in the US at least) seems totally inevitable and quite imminent.

I wouldn't say the scheduling is inevitable but there is still a good chance of it. The DEA proved to be incompetent last fall when they were requested to provide evidence or back off. Now to wait on the FDA to give their recommendation, which we all know how they feel about it but with media attention and pressure from the AKA, they will need to come up with a good excuse. None of this banning it as a synthetic BS that a few states have done.

 

[KavaKhris]

I've read at least half the pharmacological research done on K@ and it's alkaloids. I preferred peer reviewed sources of information. Many scientists think that K@ could (emphasis on could. We won't know unless we're allowed to research it which won't happen if its scheduled) be the key to developing better opioid pain medications. Our current pharmacopeia for treating moderate-severe pain is utter garbage that's not dissimilar to what's been used for millennia. It's kind of sad that we schedule almost every psychoactive substance. Research has been stymied.

And yes, I totally advocate against the use of using addictive substances recreationally except in rare occasions. And yes, people with addictive personalities should stay away from addictive drugs like alcohol, tobacco, benzodiazepines, barbiturates, opioids, etc. This is why I think kava is a truly amazing plant. However, I also think K@ tends to get a totally unfair rap here.

Also, the information about 7-oh mitragynine being more potent than morphine is looking at the two drugs purely in terms of binding affinity. In reality, mitragynine and 7-oh-mitragynine have poor blood-brain-barrier permability, low bioavailability, and they're not full-agonists. Those potency comparisons are pretty bogus in reality.

Also, there's reason to believe that alot of the "K@ extracts" are really just ultra-potent tramadol analogues. Because tramadol is scheduled IV, people can legally sell analogues. And I'll agree with you there. They're very bad. Tramadol is extremely addictive. The FDA has completely failed the public when it comes to supplements and CNS-active drugs

Good point on the BB barrier, was not aware of that. I just feel like the K@ world is full of so much bias and misinformation, and I totally get why people want to make comparisons to coffee instead of opioids, many eyes are on the K@ community. Believe me I loved K@ and think its a great tool for those that need it, I simply did not need it which led to abuse, which becomes easy for me and many others. Please forgive me, I have a bitter taste left in my mouth (pun intended?) from withdrawals, which were very recent and fresh in my mind. I appreciate your thoughts, you seem to have a very well-educated and balanced view.

 

[KavaKhris]

I wouldn't say the scheduling is inevitable but there is still a good chance of it. The DEA proved to be incompetent last fall when they were requested to provide evidence or back off. Now to wait on the FDA to give their recommendation, which we all know how they feel about it but with media attention and pressure from the AKA, they will need to come up with a good excuse. None of this banning it as a synthetic BS that a few states have done.

Yeah, I can't help but think, especially with our AG, that things will only get more challenging for K@. Our government is seeking to battle the opioid epidemic, and with the wrong information they may be lead to believe that K@ is in fact a component OF the opioid epidemic rather than a potential solution.

Relating back to kava, this is why the association of K@ and kava is concerning. Luckily I think kava is well enough established that it shouldn't be dragged down into the mess.

 

[F3TU5]

Down at the Colorado Springs Kava bar it's turned into a botanical bar within the last year. Have even seen them promoting K@ with articles or in store. No where near the same vibe as before.

 

[kavayo]

@Kapmcrunk

To recap, K@ is a drug that was nearly added as a DEA Schedule 1 Drug and has absolutely no precedence as a food or dietary supplement. Kava, in contrast, is a recognized FDA Dietary Supplement, has a 3000+ year precedence as a food, will soon be added to the International Codex Alimentarius and USA GRAS, and is under current consideration as the National Beverage of Hawaii.

Are you basing the GRAS status to change because it is going to be (?) added to CODEX? Or is there an analysis being done by an organization which will present its findings to the FDA to support the petitioning of changing its status to GRAS?

 

[kavayo]

I am basing the GRAS status on Codex inclusion. A petition will still be necessary, but imo inclusion in the the international list (of which the US is a member) should ensure USA GRAS approval.

Does CODEX require it to be safe for consumption by pregnant women and children? If not, a scientific study to prove its safety will be required for GRAS status to change. This will likely need to be done using pigs as you cannot cut pregnant women and children open to see the effects of kava after the fact. Contact me after CODEX is complete as I would possibly be willing to help fund such a study.

 

[kavayo]

The easiest route towards GRAS would be to present evidence of interstate trade in kava prior to 1958. I ve recently posted articles about companies selling kava out of San Francisco in 1908 I think

This was looked into and I was told by a lawyer and FDA consultant that it would likely require some sort of import logs from a shipping dock or similar.

 

[kavayo]

In fact it appears that kava has been sold (and produced!) in the United States for longer than many popular spices or yerba mate

I do not doubt this at all, but they'll still require some importation logs/certificates for proof.

 

[kavayo]

Well, what about ads, newspaper articles etc from that period? I mean, can you even get "importation logs" for goods moved within America? Wouldn't the fact that kava has been "made in the USA" suffice?

I can't say that it wouldn't be possible with those, am just passing along the information I received from my lawyer and consultant. Both of whom had consistent information on the subject.

 

[kavayo]

any chance you could talk to these guys again?

Do you have the ads or relevant material?

 

[kavayo]

I could find them.. I have newspaper articles describing this trade.

I'll pass them on to my lawyer, he'll be the first to know the probability of this route. If they're are multiple verifiable materials(?) for proof I don't see why it wouldn't be worth a shot. The FDA is known to be tyrants of sorts though, so no matter what, Kava might be an uphill battle the whole way. I was told by four extremely versed and reputable FDA professionals (two whom work for the FDA) that proving it is safe for pregnant women and also children will be an absolute necessity to getting it GRAS. Which will require a lot of investment into studies and also possibly replicating them.

 

[kavayo]

Do you know if anyone had to prove that Yerba Mate, Green Tea and Coconut Water are safe for pregnant women? I am just not sure I understand how the system works.

I think it all depends on whether Hawaii can be seen as part of the US prior to it becoming a state. If yes then the use of kava there prior to 1958 constitutes "common use as food". The sale of Hawaiian awa to mainland customers prior to 1958 constitutes (in my view) evidence of interstate commerce..

Not sure about those. I'm absolutely sure that TODAY it is a requirement, may not have been a while back. That was told to me by 2017 FDA Lawyer of the year, two dietary supplement department workers within the FDA, and also the owner of the biggest GRAS Consulting company in the US. This is an issue I have spent 100s (and more $ than I'd like to admit) of hours working on and towards.

 

[verticity]

I do not doubt this at all, but they'll still require some importation logs/certificates for proof.

Those exist. This is a record of kava being imported from Samoa to San Francisco in 1918. This kind of thing is easy to find on Google.

Source

 

[verticity]

But if you have to prove it is safe in children that would be hard to do. Can you use piglets for that?

 

[verticity]

It does seem that getting on the GRAS list will be an uphill struggle. The only other psychoactive substance on that list that I see is caffeine.
https://www.accessdata.fda.gov/scri...nce&order=ASC&showAll=true&type=basic&search=

 

[verticity]

@Deleted User or someone, correct me if I'm wrong, but the Codex Alimentarius is an international standard for foods and food additives. However, in the US, kava is not a "food", but a supplement, so is subject to a completely different kind of regulation than, say, New Zealand, where it is regulated as a food. So it would seem that kava being added to the international Codex wouldn't necessarily have any effect at all on how the FDA views it. I doubt the FDA will just suddenly start viewing kava as a food.