FDA Head Wants New Regulations for Kratom and CBD — Pain News Network

[add to descartes]

I'm a little hesitant to go all "big pharma" on all of this. I know there are some things that are very true, but a lot of it strays into similar conspiracy theory territory believed by certain groups that also believe in more well known crazy stuff. I am just wary about falling into the "big pharma" conspiracy theory trope, conflating valid concerns about the industry with unfounded claims, and diminishing the overall credibility of the pro-kratom movement.

and for those who doubt that that's a thing, there's even a wikipedia page on it (which doesn't automatically mean it's legitimate, but it does highlight how widespread the thought is now, especially with people who are intelligent and don't believe in some of the wacked out crackpot theories of anti-vaxxers and Q-anon, or even the new age pseudoscientific chakra/crystals craze, for examples) that has sources and links to debunking-articles.

https://en.wikipedia.org/wiki/Big_Pharm ... y_theories

again, this is not to say that there aren't many very real and valid criticisms to be made of the pharmaceutical industry. but one needs to be careful not to fall into the big conspiracy theory rabbit hole.

I know there are probably some that will disagree with me on this, and who believe in some of "big pharma" cliches, I just wanted to make this suggestion.

[Kelleytoons]

LOL - one thing for sure, don't quote Wiki if you want to remain ANY sort of credible (it's about the worst source of info you could use).

Big Pharma is definitely a thing, though - as the old joke about Santa goes, it exists whether you believe in it or not.

[add to descartes]

LOL - one thing for sure, don't quote Wiki if you want to remain ANY sort of credible (it's about the worst source of info you could use).

Big Pharma is definitely a thing, though - as the old joke about Santa goes, it exists whether you believe in it or not.

I only used it because it has a collection of sources and articles at the bottom. I'm aware that the articles themselves can be written in a misleading way.

it's important to separate the legitimate criticisms from the unfounded, debunked claims that make their rounds on social media.

I have noticed that with a lot of kratom users who are otherwise scientifically and empirically minded buy into some of these tropes. it's one of those very touchy issues, that get people pretty heated sometimes. like you alluded to, they are completely convinced that they are right. it happens with every conspiracy theory. there's what James Randi termed "true believers" - absolutely nothing you can say, do, show them, will convince them it's not true. cognitive dissonance is very real.

I figured people would disagree with me, especially here, but it is a conspiracy theory, on the same level as some of the anti-vaxxer disinformation. there is some blatantly false claims on both, most of the times when people have an agenda. and there are people that buy into the entire "big pharma" conspiracy theory (some of it is extra kooky) that are completely willing to knowingly spread falsehoods to achieve their means. it's definitely not unique to either side.

[Kelleytoons]

The only thing I'll say to this is that the conspiracy theorists of today are the ones proven right tomorrow.

(But, again, you believe what you want - your beliefs don't make it so, only facts do. Facts clearly support my beliefs but that's not appropriate to get into on this forum). Let's just agree that the FDA can and is dangerous and that pharmaceutical companies, like ALL companies, are in it to make money. Once you understand that the rest just kind of comes together naturally.

[Daydreamsofmountains]

It is also illegal to sell kratom as "Not for Human Consumption" (NFHC) in the US. It can be sold as food without structure-function claims. I know we already discussed this lengthily, but it's important for vendors out there to see if they should stumble on this. This is why Top Tree Herbs is selling kratom tea bags. Alcohol is a drug, but the social context behind it makes it a food. It is REALLY IMPORTANT to regulate kratom as either a FOOD or a SUPPLEMENT as soon as possible. Here is why.

The FDA can absolutely ban kratom, and it may be planning to.

Wrong - Wrong - and Wrong... You have no idea what you're talking about. Sorry. Tea Bags ? are a scam.

ALL of the Small Batch vendors here on MM - and nearly ALL of 20 -40 vendors on this Vendor List, sell NFHC - Not For Human Consumption. Please read the "Terms" on each Website.

NFHC has been, and IS still, the safest way to sell Kratom. Vendors have been told that, directly, by local FDA Rep's doing inspections!!

NOT 1 Single Online Vendor has ever been busted due to violations of selling NFHC - but MANY vendors have been busted, raided, and shut down for various violations of Retail = selling Caps as Dietary Supplements, et cetera. Did you MISS the large raid in Florida just a YEAR ago ?? Good Grief - Have you been living under a rock ?? Here's ONE example - FDA Seizes 37 Tons of Kratom in Florida - kratom powder and capsules labeled as “herbal supplements” https://www.painnewsnetwork.org/stories ... in-florida

The FDA - has NO power to enact ANY "Federal Ban" on Kratom... That would have to be done by Congress, and the D.E.A.

Please STOP the Fear Mongering... you're only hurting people by doing that! KISS the ass of AKA all you want, Support your AKA Retail head-shops, but please... Haven't we got ENOUGH mis-information about Kratom, already ?? Jesus Fuck! Kratom = The World of Bullshit. Getting impossible to plug the dike here the BS is leaking flooding out on EVERY Social Media.

Agreed re:NFHC. Some people say kratom is illegal in Denver which is incorrect. It can’t be sold for human consumption. We have stores in Denver who sell kratom and it is a non-issue here as long as the label is there.

[Daydreamsofmountains]

The only thing I'll say to this is that the conspiracy theorists of today are the ones proven right tomorrow.

(But, again, you believe what you want - your beliefs don't make it so, only facts do. Facts clearly support my beliefs but that's not appropriate to get into on this forum). Let's just agree that the FDA can and is dangerous and that pharmaceutical companies, like ALL companies, are in it to make money. Once you understand that the rest just kind of comes together naturally.

question everything. Not from a conspiracy theorist perspective but because nothing is usually as it seems.

[acct55]

Re: [one of] the ways the ways the FDA is trying to ban kratom--I posted another thread about this but it's not getting much attention at all there so I'm posting it again here:

The AKA held a webinar on 5/26 about the FDA's proposed changes to the FDUFA (prescription Drug User Fee Act). The proposed changes could result in a ban on kratom without needing to make it a controlled substance.

"The Prescription Drug User Fee Act or PDUFA is up for reauthorization, and proposed changes to it could give the FDA power to deny registration of all dietary supplements; granting them power to require kratom to be registered, and therefore the power to deny registration and effectively ban all kratom products"

I missed the webinar last night, did anyone else catch it?

Here's a link to the page with more info: https://aka.salsalabs.org/webinarmayupdate

You can click the links on that page to contact your congress person etc.

And here's a direct link to the bill: https://www.congress.gov/bill/117th-con ... 5d8894c2fc

[BallzDeep9]

I'm not fear-mongering, I'm just stating the realities of what absolutely could happen. I agree, it's crazy to think the FDA is not out to get kratom, I mean the FDA has been ACTIVELY trying to get kratom OFF THE MARKET SINCE 2011 .... Kelleytoons, thank you for your post. BallzDeep9, I'm sorry I questioned how much you care. It's clear that you care,

Well, My apology to Writer, for saying you're wrong on "everything", of course there IS a major problem with FDA, you are correct on that... The question is "How" big a threat, How much an issue really ? We also, now in 2022 - Have a history of AKA making outrageous fear mongering!! statements, over many years... And it's been at least Annual, and if memory serves Semi Annual... and it started happening exactly as Dave Herman left AKA - and Haddow & Salmon & their people in the Mormon Church took over.

At times, I've felt like the Lone Voice in the Wilderness, telling anyone who would listen "This is Fake!" there IS no (insert latest wild claim of "A Ban" pushed by AKA.), one time they claimed FDA was going to begin seizing all shipments... I revealed on Reddit the FACT - that FDA's Import Alert Red List has not been updated in FIVE years - and the very well known FACT, that FDA does not have the manpower OR the Legal authority, for any such "Ban". So a History of shameless money grubbing by AKA - driven by the Retail side of Kratom which is full of crappy over-priced products.

This Time ? I'm always willing to LISTEN to Mac, and go from there... The AHPA (American Herbal Products Assn.) Has come out against this PDUFA; I think we need to stand with AHPA - not necessarily AKA (a member of AHPA-) but there's an overview article at Whole Foods mag online. It's a fairly complex issue - Labeling and some aspects don't affect Online Kratom at all - but rather affect Retail head-shop kratom - which does not concern most of us here on MM!! -- https://wholefoodsmagazine.com/suppleme ... ustry-20m/

[kratomwriter]

All good, Ballz! Thanks for looking into the issue I was trying to explain. BTW, I also despise the AKA's fear-mongering, and I look at each new development closely itself. After reading the legislation, I determined that it actually was very worth sharing and acting against. In my opinion, the actual piece of legislation is more alarming than the way the AKA apparently addressed it in their email, which didn't divulge most of the details I presented here.

No, historically, the FDA has not had the manpower to enforce any bans. However, as mentioned above, this new draft could allow them to ban kratom (or at least make it incredibly difficult for most sellers to continue) from the market WITHOUT criminalizing it.

If this passes and they try this maneuver, will they necessarily succeed? We cannot say, but it would certainly pose a new challenge for all vendors. Furthermore, I'm not spouting any conspiracy theories here. I'm just looking at the FDA's recent actions, especially with NAC, and stating the very real possibility that they could do this with other supplements and use it to ban unapproved NDI's.

[kratomwriter]

I'm a little hesitant to go all "big pharma" on all of this. I know there are some things that are very true, but a lot of it strays into similar conspiracy theory territory believed by certain groups that also believe in more well known crazy stuff. I am just wary about falling into the "big pharma" conspiracy theory trope, conflating valid concerns about the industry with unfounded claims, and diminishing the overall credibility of the pro-kratom movement.

I totally agree that unfounded conspiracy-like talk looks bad for the kratom industry. And I'm not saying the FDA doing all of this to stuff money in Big Pharma's pockets.

Though if you look into it, there is plenty of evidence that the FDA is a partner in profit to Big Pharma. For example, the 2 principal FDA reviewers who originally approved Purdue’s oxycodone application both took positions at Purdue after leaving the agency and over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers.

Furthermore, a research survey found that FDA scientists said they felt pressure to alter findings to get pharmaceutical drugs approved.

It's not a conspiracy to doubt the FDA's intentions, and to look at what it has done recently with NAC and draw the logical conclusion that it can use that as a precedent. Now, saying "NAC was a sneaky move to set them up for banning more important things, like kratom or CBD" IS going into conspiracy-talk territory. Yes, I happen to tend towards thinking this could very well be the case, but it is unfounded and we should refrain from such statements when taking an activist role.

[mivanqua]

The FDA IS Pharma man. Look at the revolving door of heads of the FDA and the boards of pharma corps. Its undeniable. Its not a conspiracy st all. Its life.

[Daydreamsofmountains]

Senate voted it down

[acct55]

Senate voted it down

Which did they vote down? S.4090 Dietary Supplement Listing Act of 2022? Or something else?

[Jordan Borneohale]

this is very complicated.
when Kratom became more and more popular a lot of laws hit it.

Until now the shipping cost is higher than the product
looks like kratom will continue to be popular.
farmers become excited and also weak.

[Daydreamsofmountains]

Senate voted it down

Which did they vote down? S.4090 Dietary Supplement Listing Act of 2022? Or something else?

I was wrong. I had read an incorrect article. My apologies.

[add to descartes]

I was wrong. I had read an incorrect article. My apologies.

what was the source of the incorrect article? I'd like to know who is putting out misinformation. stuff like this should be corrected by the author/website.

[Daydreamsofmountains]

I was wrong. I had read an incorrect article. My apologies.

what was the source of the incorrect article? I'd like to know who is putting out misinformation. stuff like this should be corrected by the author/website.

It was on Kratom United, a Facebook group and the error was realized and addressed. Which is how I found out I was wrong before I saw your comment.

[add to descartes]

an incorrect article on Facebook? no way!
(just kidding of course)

[Daydreamsofmountains]

an incorrect article on Facebook? no way!
(just kidding of course)

Haha! I get it. Fwiw, Kratom United is not your typical Facebook vendor or site. It is actually a nonprofit focused on educating others about kratom, supports those who are disabled and veterans (in getting and using kratom) and is pretty anti extracts (focused on the leaf itself). They do a lot to advocate for kratom at the state and federal level and promote aka and protectkratom

[kratomwriter]

Today is the last day to sign the Congressional contact form to protest the FDA's mandatory product listing.

Again, this bill is a really big deal, as it could give the FDA the power to ban many supplements that don't meet its definition, including CBD. And, of course, it could give the FDA the power to ban kratom without criminalizing it or proving that it is unsafe.

Regardless of how they end up using it, why give such a corrupt agency this kind of power?

Even if you're not concerned by the potential consequences of this draft, it is still a blatant attack on our rights. Kratom companies already have little to no means of getting an NDI approval without spending millions—why would we want to make it even harder for small businesses to sell their products?

[add to descartes]

Today is the last day to sign the Congressional contact form to protest the FDA's mandatory product listing.

Again, this bill is a really big deal, as it could give the FDA the power to ban many supplements that don't meet its definition, including CBD. And, of course, it could give the FDA the power to ban kratom without criminalizing it or proving that it is unsafe.

Regardless of how they end up using it, why give such a corrupt agency this kind of power?

Even if you're not concerned by the potential consequences of this draft, it is still a blatant attack on our rights. Kratom companies already have little to no means of getting an NDI approval without spending millions—why would we want to make it even harder for small businesses to sell their products?

the last day? it's only in committee now.

[kratomwriter]

Welp, the FDASLA passed. The US Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-9 to grant the power to the FDA to significantly restrict the marketing and sales of dietary supplements.

Here's the scoop.

The Antagonists: A handful of dietary supplements trade groups supported the legislation clearly because it would help eliminate market competition. They have a financial interest in fighting to keep the FDASLA the way it is.

The Protagonists (I use this term lightly):

• The majority of dietary supplements trade groups, including those who would normally support such legislation, are against it and are pushing for amendments, and they have a lot of support.
  
  • The AKA stated that it will continue to lobby House members "to strike or modify the Senate-passed language that gives these new powers to the FDA."
  • Although the Council for Responsible Nutrition (CRN) has generally advocated for the requirement for mandatory product listing (MPL), including the Dietary Supplement Listing Act of 2022, even CRN has called for changes in the FDASLA Act, including a request that the FDASLA be amended to clearly state that the FDA cannot reject a listing given properly to it. CRN maintains that MPL should not be a form of premarket approval; furthermore, CRN is prepared to oppose the bill if Senate does not grant its requested changes.
  • There are consumer groups fighting the legislation, including the American Medical Association (AMA), the Center for Science in the Public Interest (CSPI) and Pew Charitable Trusts.
  • Our former enemies (Natural Products Association (NPA) and Fabricant) cannot help but be aligned with kratom vendors on this because it hurts them too. Fabricant, who has very recently stopped going after kratom, is actively fighting for amendments; Fabricant requested specifying that the FDA doesn’t have authority to "remove or restrict any product from listing unless that product has been the subject of final agency action," stating that “Prohibiting the FDA from excluding or removing products from the listing unless there is final agency action is the only way the industry can preserve any due-process rights against the agency should a dispute arrive, like the current disputes over CBD and NAC." We all know Fabricant is a dick. But at least requesting final agency action would allow for vendors to have a defense against the agency, rather than giving it the authoritative power.
  The Main Antagonist: In response to NPA’s backlash, the FDA spokesperson stated: “The FDA does not comment on pending legislation. That said, the FDA has proposed – as part of the FY 2023 president’s budget – the authority to require products marketed as dietary supplements to be listed with the FDA.”
  
  “This would allow the FDA to know when new products are introduced, quickly identify illegal products, improve transparency and promote risk-based regulation.”
  
  This is not good news for the outlook on how the agency would treat kratom under this law. The FDA has continually tried to spew evidence of kratom's risks and maintains even its outdated evidence. "Risk-based regulation" means that without reforms, the agency could use its authoritative power to ban kratom from the market based on its risks alone, rather than its risk-to-benefit ratio or evidence of its relative safety, the two things which play a major role in protecting kratom vendors in court.

[kratomwriter]

Why the Hell Should the Kratom Community Bother Aligning with the NPA and Fabricant, When They Opposed Kratom in the Past?

I had to address this because I know I mentioned some groups and names that we all have issues with. Some of you guys got your cages rattled when I shared the NPA's form to speak out against this, but it seems as if they are leaders of the pack when it comes to getting this awful piece of legislation amended or stricken. In this case, we are on the same page with Fabricant. I am guessing that the reason Fabricant has stopped going after kratom might be because he sees how his own interests with the NPA are aligned with kratom vendors, and he can't have his cake and eat it too.

In other words, the NPA's cutthroat attempt to get kratom off the market is no longer worth it because the way things have lined up with the FDASLA, the NPA cannot successfully cut kratom off the market to avoid competition without keeping the doors open for other bigger, more powerful companies and trade groups to restrict the market at the cost of the Natural Products Association. Hell, this law takes dietary supplements one step closer to being exposed to direct competition with Big Pharma, who could literally crush the NPA.

If Fabricant flip-flops again and comes after kratom down the road, we'll fucking fight him. But right now, we don't have to like him or NPA to fight the same cause as them; I mean, nobody in their right mind could really "like" Fabricant. But he and the NPA are sort of forced to align with us on this.

[Kelleytoons]

Wait - are you just saying this passed out of committee? But that's all?

Bills come out of committee ALL the time. Doesn't mean shit. Until and unless they are voted on by both Houses AND signed by the Prez they are not law. And around 99% of all bills do not get signed into law (tells you how many they actually propose).

So - worth keeping an eye on, and perhaps telling your legislator, but I wouldn't get my panties in a bunch just yet.

[kratomwriter]

Certainly, there's no need for any panties to be in a bunch, but the severity of this law makes it worth fighting at every stage. Thank you for your input; I do not want to sound like a fear-monger in any way! Just trying to get people in the know and caring about it so that they're ready to act.

[Kelleytoons]

It's a bad bill, to be sure. But - all the more reason it's probably going to be easy to defeat IF folks just write their representatives. IOW, I can't imagine any senator or congressperson giving a shit about this passing (aside from Big Pharma - which some naive folks around here think doesn't exist - lining their pockets) but they will be very aware of their constituents are against it. So, an easy bill for them to vote down.

But hopefully there is an organized effort to let them know.

[BallzDeep9]

... the agency could use its authoritative power to ban kratom from the market based on its risks alone, rather than its risk-to-benefit ratio or evidence of its relative safety, the two things which play a major role in protecting kratom vendors in court.

That's just NOT true - You still don't understand, The FDA does not, and cannot, have Legal power to "Ban" a SUBSTANCE - That would have to be, The DEA and Congress.

Kratom is NOT "approved by the FDA" as a Dietary Supplement. This Law.... applies to "Dietary Supplements"... of which Kratom is NOT included!! - So, we would continue selling Kratom as a grey market, NFHC product... which is perfectly LEGAL - This Law would ONLY affect those vendors, who now Label their Kratom as a Supplement... who are pretending that Kratom IS a Supplement, (based on politics from AKA.) - mostly Retail Store vendors.

The great majority of ONLINE kratom vendors, are selling NFHC - Not as a Supplement! YES, this could "possibly" affect ONLY, Retail, Gas station, Head-shop, products... But let's not Fear Monger this as being another "Ban" and so far, I'm not seeing the usual Fear Mongering from AKA here.

[Daydreamsofmountains]

It's a bad bill, to be sure. But - all the more reason it's probably going to be easy to defeat IF folks just write their representatives. IOW, I can't imagine any senator or congressperson giving a shit about this passing (aside from Big Pharma - which some naive folks around here think doesn't exist - lining their pockets) but they will be very aware of their constituents are against it. So, an easy bill for them to vote down.

But hopefully there is an organized effort to let them know.

Ironically, Hickenlooper - senator here in CO - who is a home beer brewer nonetheless - is on the committee who passed it and he sent me a stupid form letter last week in response to my letter advocating he oppose it that essentially said “we have to put in some regulations as supplements are so unregulated.” Not being political and as Ballz pointed out the NFHC - which has been the deal here in Denver for a bit - probably means it won’t be an issue for kratom, the whole power grab sucks and I will be looking for someone else to represent our state come elections.

[mivanqua]

... the agency could use its authoritative power to ban kratom from the market based on its risks alone, rather than its risk-to-benefit ratio or evidence of its relative safety, the two things which play a major role in protecting kratom vendors in court.

That's just NOT true - You still don't understand, The FDA does not, and cannot, have Legal power to "Ban" a SUBSTANCE - That would have to be, The DEA and Congress.

Kratom is NOT "approved by the FDA" as a Dietary Supplement. This Law.... applies to "Dietary Supplements"... of which Kratom is NOT included!! - So, we would continue selling Kratom as a grey market, NFHC product... which is perfectly LEGAL - This Law would ONLY affect those vendors, who now Label their Kratom as a Supplement... who are pretending that Kratom IS a Supplement, (based on politics from AKA.) - mostly Retail Store vendors.

The great majority of ONLINE kratom vendors, are selling NFHC - Not as a Supplement! YES, this could "possibly" affect ONLY, Retail, Gas station, Head-shop, products... But let's not Fear Monger this as being another "Ban" and so far, I'm not seeing the usual Fear Mongering from AKA here.

THIS RIGHT HERE IS WHY WE LOVE YOU Ballz. I was TERRIFIED when I saw that this passed and my little spooky cat brain went haywire. Thanks for putting it into perspective.

They have just tried so hard to get it.banned and it must be horrible for them (flat out fucking HILARIOUS to us) they they get their huevos handed to them at every (slithery) turn. I know I know FUCK THEM, I'm just saying, they have tried every method and like it's been said, we really can't let our guard down with these scumbags. It's ok though, some things are worth fighting for.

If you have even a shred of trust in anything ANY bureaucratic monkey is trying to peddle these days, STOP IT! (Should that be my signature? )

EDIT : I tried but it's too long.


That's what she said.

[Kelleytoons]

Ironically, Hickenlooper - senator here in CO - who is a home beer brewer nonetheless - is on the committee who passed it and he sent me a stupid form letter last week in response to my letter advocating he oppose it that essentially said “we have to put in some regulations as supplements are so unregulated.” Not being political and as Ballz pointed out the NFHC - which has been the deal here in Denver for a bit - probably means it won’t be an issue for kratom, the whole power grab sucks and I will be looking for someone else to represent our state come elections.

That's exactly the right thing to do. While this old man is quickly losing faith in our democracy, at the very least you young people need to keep voting and voting for the people that DO represent you. And if you are REALLY serious, make an effort to get others to do the same (your own vote can be magnified many times by this).

[Daydreamsofmountains]

THIS RIGHT HERE IS WHY WE LOVE YOU Ballz. I was TERRIFIED when I saw that this passed and my little spooky cat brain went haywire. Thanks for putting it into perspective.

They have just tried so hard to get it.banned and it must be horrible for them (flat out fucking HILARIOUS to us) they they get their huevos handed to them at every (slithery) turn. I know I know FUCK THEM, I'm just saying, they have tried every method and like it's been said, we really can't let our guard down with these scumbags. It's ok though, some things are worth fighting for.

If you have even a shred of trust in anything ANY bureaucratic monkey is trying to peddle these days, STOP IT! (Should that be my signature? )

EDIT : I tried but it's too long.


That's what she said.
[/quote]
A healthy dose of skepticism is always good to have though. There are online vendors who won’t to ship to Denver because they believe kratom is illegal here. It is not, it is only illegal to sell it for human consumption (I may be a broken record but it is frustrating - we have dedicated kratom stores in the city for the love). As long as you are not selling it for that, it is all good but the passage of the ordinance was enough to scare some vendors away. I offer this in that it will be interesting to see what vendors do with the regulations depending on where this all eventually lands.

[Daydreamsofmountains]

THIS RIGHT HERE IS WHY WE LOVE YOU Ballz. I was TERRIFIED when I saw that this passed and my little spooky cat brain went haywire. Thanks for putting it into perspective.

They have just tried so hard to get it.banned and it must be horrible for them (flat out fucking HILARIOUS to us) they they get their huevos handed to them at every (slithery) turn. I know I know FUCK THEM, I'm just saying, they have tried every method and like it's been said, we really can't let our guard down with these scumbags. It's ok though, some things are worth fighting for.

If you have even a shred of trust in anything ANY bureaucratic monkey is trying to peddle these days, STOP IT! (Should that be my signature? )

EDIT : I tried but it's too long.


That's what she said.
[/quote]

A healthy dose of skepticism is always good to have though. There are online vendors who won’t to ship to Denver because they believe kratom is illegal here. It is not, it is only illegal to sell it for human consumption (I may be a broken record but it is frustrating - we have dedicated kratom stores in the city for the love). As long as you are not selling it for that, it is all good but the passage of the ordinance was enough to scare some vendors away. I offer this in that it will be interesting to see what vendors do with the regulations depending on where this all eventually lands.
[/quote]

[kratomwriter]

That's just NOT true - You still don't understand, The FDA does not, and cannot, have Legal power to "Ban" a SUBSTANCE - That would have to be, The DEA and Congress.

No, they cannot ban a substance. But they can effectively ban it from being legally sold on the market. That's what this is about. I keep laying this out as the context, but I will try to be more specific each time.

Kratom is NOT "approved by the FDA" as a Dietary Supplement. This Law.... applies to "Dietary Supplements"... of which Kratom is NOT included!! - So, we would continue selling Kratom as a grey market, NFHC product... which is perfectly LEGAL - This Law would ONLY affect those vendors, who now Label their Kratom as a Supplement... who are pretending that Kratom IS a Supplement, (based on politics from AKA.) - mostly Retail Store vendors.

You're missing the point. The scariest thing if this were to pass is that the FDA could REQUIRE kratom to be registered as a supplement because the FDA makes and sets the definition of what a dietary supplement is. The FDA could easily request that kratom itself be listed and registered by ANYONE who sells it, whether or not they want to sell it as a supplement. And then it could reject that listing, effectively making any kratom products an illegal supplement. This is how they could ban it from the market without criminalizing it.

If you consider the fact that it is illegal to sell RX pink eye drops if you don't have a medical license, you could say that the FDA has effectively banned RX pink eye drops from the market outside of the realm of prescription drugs. This is what I'm talking about when I say "ban."


Not saying it would happen, but this is how MPL changes things from the way there are now. The big fear is that the FDA will research kratom as a drug and use the drug exclusionary principle to make it illegal to sell as anything BUT a drug.

[kratomwriter]

I agree with your points on skepticism, Daydreamsofmountains. And it's interesting to point out that while inside Denver, it is illegal to sell kratom anything other than NFHC—outside of Denver, it is technically illegal to sell kratom as "not for human consumption." Outside of Denver, you have to list the ingredients as the KCPA regulates kratom as a dietary ingredient, which is, by definition, not NFHC.

So, although many AKA-certified vendors sell kratom NFHC, they would be fine if they took off NFHC warning as long as they sell in states/ordinances where kratom is legal because in those locations, it's not NFHC that's protecting them; they are protected enough if they don't make structure-function claims and can provide adequate evidence that their products aren't contaminated or linked to adverse effects. NFHC can provide more protection only if the vendor otherwise violates marketing restrictions, is linked to adverse effects, or sells kratom in states/countries where kratom is illegal. For example, vendors who sell kratom to Canada must use NFHC.

Ballz disagrees with me on my NFHC argument, but after speaking to an FDA-compliance attorney, I can tell you that my summary here is sound. Still, I think our back-and-forth is kind of funny, and it really shows how much of a grey-market industry kratom is. The FDA has not approved any New Dietary Ingredients applications for kratom because there are next to no kratom vendors who could afford to do the process completely.

Funny enough, if a vendor did hypothetically get an NDI approved, it would mean that all other kratom vendors could not legally sell kratom without applying for and getting their product approved as an NDI. The NDI-approved kratom vendor would theoretically have a monopoly on all kratom products sold on the market, but this would be extremely unlikely because the FDA hardly enforces NDI exclusions on the market. The only reason it would legally require all other companies to file an NDI thereafter is a blatant money grab; the NDI process can cost millions to do properly. The FDA doesn't have the resources to enforce it, though, and deep down, they know it's about money and not public safety.

But, to bring it back to the FDASLA, if the FDA were to mandate kratom be registered as a dietary supplement and were then to reject it, it could try to enforce that kratom not be sold anywhere on the market. The FDA would almost certainly fail to keep it off the market, but it could buy it time to research kratom as a drug and then enforce the drug exclusionary principle to actually ban kratom from all other markets.

Back to the Colorado thing—Daydreams, do you know how the KPCA will affect kratom's legality in Denver?

[Daydreamsofmountains]

I agree with your points on skepticism, Daydreamsofmountains. And it's interesting to point out that while inside Denver, it is illegal to sell kratom anything other than NFHC—outside of Denver, it is technically illegal to sell kratom as "not for human consumption." Outside of Denver, you have to list the ingredients as the KCPA regulates kratom as a dietary ingredient, which is, by definition, not NFHC.

So, although many AKA-certified vendors sell kratom NFHC, they would be fine if they took off NFHC warning as long as they sell in states/ordinances where kratom is legal because in those locations, it's not NFHC that's protecting them; they are protected enough if they don't make structure-function claims and can provide adequate evidence that their products aren't contaminated or linked to adverse effects. NFHC can provide more protection only if the vendor otherwise violates marketing restrictions, is linked to adverse effects, or sells kratom in states/countries where kratom is illegal. For example, vendors who sell kratom to Canada must use NFHC.

Ballz disagrees with me on my NFHC argument, but after speaking to an FDA-compliance attorney, I can tell you that my summary here is sound. Still, I think our back-and-forth is kind of funny, and it really shows how much of a grey-market industry kratom is. The FDA has not approved any New Dietary Ingredients applications for kratom because there are next to no kratom vendors who could afford to do the process completely.

Funny enough, if a vendor did hypothetically get an NDI approved, it would mean that all other kratom vendors could not legally sell kratom without applying for and getting their product approved as an NDI. The NDI-approved kratom vendor would theoretically have a monopoly on all kratom products sold on the market, but this would be extremely unlikely because the FDA hardly enforces NDI exclusions on the market. The only reason it would legally require all other companies to file an NDI thereafter is a blatant money grab; the NDI process can cost millions to do properly. The FDA doesn't have the resources to enforce it, though, and deep down, they know it's about money and not public safety.

But, to bring it back to the FDASLA, if the FDA were to mandate kratom be registered as a dietary supplement and were then to reject it, it could try to enforce that kratom not be sold anywhere on the market. The FDA would almost certainly fail to keep it off the market, but it could buy it time to research kratom as a drug and then enforce the drug exclusionary principle to actually ban kratom from all other markets.

Back to the Colorado thing—Daydreams, do you know how the KPCA will affect kratom's legality in Denver?

I appreciate this perspective; totally resonates with me.

No idea - I assume they are waiting to see what the KCPA looks like. I mean, weed is legal and mushrooms are decriminalized here. People don’t get too wound up about these kind of things. We have way worse things to worry about like high school kids OD’ing by doing drugs laced with fent. It’s a brave new world these days