"Not for Human Consumption" Disclaimers

[kratomwriter]

Hello everyone. Been lurking, but I'm back with a new question—specifically for kratom vendors or anyone with knowledge on the topic. This is in regards to the industry marketing guidelines for unapproved botanicals and FDA compliance.

I've seen companies run into legal trouble by stating "not for human consumption" in their Terms & Conditions or on product packaging (of course, often the company is guilty of other violations before they get called out for that).

Vendors, how do you get around this? I know it's more straightforward if you simply sell powdered kratom, as the FDA is harsher about extracts and even capsules . So if a kratom vendor sells extracts, is it better for them to

1. Avoid the "extracts are intended as a botanical specimen for research and not human consumption route" altogether and give a general disclaimer? Or—
2. Should a business maintain that their extracts are not for consumption? If the latter, what should be done regarding customer reviews/comments that indicate that they are, in fact, consuming extracts? If so, then which of these options should they take?:

• Moderate comments that indicate customers are consuming extracts (and indicate they have the right to moderate comments in the general Terms &
  Conditions, OR

• Give a disclaimer such as "we do not endorse any customer reviews...yadda yadda" and keep the customer reviews about consuming extracts up?

Summary: What is the best legal disclaimer for vendors who sell extracts?

Anticipated disclaimer: While I think that extracts pose more issues for the future safety & regulation of kratom (especially when companies use words like "silver" or "gold" without indicating the strength of an extract anywhere), I think that it would be too far to ban kratom extracts. Rather, I think that in the future they should be sold similar to highly-concentrated CBD/cannabinoid tinctures. Consumers should be given a serving size and/or warning that the product should not be taken in high amounts. After all, there are people who responsibly use high-quality extracts in proper amounts—they prefer the benefits of less mess and easier consumption. Irresponsible vendors and customers should not ruin something for the businesses that sell pure and high-quality extracts while making an effort to be transparent with consumers. But currently, kratom still faces greater challenges with the FDA than CBD and even Delta 9, so even adding a recommended serving on the labels is difficult.

Related question: Does anyone know how Kats Botanicals is able to provide a serving size on their packaging without running into issues? (On a side note, I like buying Kats to re-use the packaging when traveling. It looks legit, everyone assumes I'm just a health nut with another powdered supplement. Kudos to Kats, I think quality packaging does a lot for improving perspectives on kratom...but HOW do they manage to secure the serving size and even CALORIES??).

[Blergs]

Disclaimer is to help protect them ...
And generally there is no serving size because in many places it's not legal for human consumption, like to sell it as such. Like in Canada.. you can have it but to sell it it's "not for human consumption" .

[kratomwriter]

Disclaimer is to help protect them ...

True, but how much does it protect them if the FDA calls out vendors for this? Would it be more protective to say "kratom is not approved by the FDA, poses [insert risks] and it's up to the buyer's discretion how to use our products," or is that worse?

And generally there is no serving size because in many places it's not legal for human consumption, like to sell it as such. Like in Canada.. you can have it but to sell it it's "not for human consumption" .

But in the US you can't really sell something as "not for human consumption" if you know your buyers are consuming it. The FDA is dumb but they're not so dumb that they think people are buying kratom as potting mix or for "botanical research."

[BallzDeep9]

I've seen companies run into legal trouble... by stating "not for human consumption" in their Terms & Conditions or on product packaging (of course, often the company is guilty of other violations before they get called out for that).

The 1 case you referenced - (Forfeit $10.7 million linked to — Proven Peptides, Sarmsx, Coastline Kratom, Kratom Crazy, Best Kratom, Peak Nootropics.) WAS in business for many years selling SARM's... IMO he got busted for the SARM's not kratom - but also, his kratom companies were frauds. Coastline and Crazy were featured on "Worst Ripoff" lists for years. Search the big sub on Reddit. He was spamming advertisements and really, pushing the envelope on "Medical Claims" and, Crazy had a website with LOTS of user comments, and certainly Claims there...

OTOH, companies certainly HAVE been busted, big-time, for illegally selling kratom FOR human consumption. Just selling capped kratom, may be considered evidence. Less than 1 year ago. 37 Tons of Kratom in Florida LINK ... A couple years ago, the Earth Kratom seizure in South Caroline. Again TONS, they were selling & marketing capped Retail products.

The whole problem is Retail!! Head Shop sales of capped "Dietary Supplements" which does... Violate FDA Regs. . Kratom is NOT approved by FDA as a Dietary Supplement... So, what is AKA doing ? Well, AKA is a Legal / Political organization representing ALL of the large Retailer vendors. They are fighting the FDA, and they do advise their Members, to sell with a Supplement Facts Label, in direct violation of FDA - and basically act like that's approved when it's not...

NOT 1 single Online Vendor, has EVER been busted by FDA, on Federal charges for selling Plain Leaf powder NFSC - Not For Human Consumption.

However Extract - As you suggest - is more questionable. Most online sellers have avoided selling Extract, BUT it's getting to the point where consumers demand it - As Quality of plain powder has declined, thanks to the Drug Lab companies and large Wholesale importers.

[Blergs]

Disclaimer is to help protect them ...

True, but how much does it protect them if the FDA calls out vendors for this? Would it be more protective to say "kratom is not approved by the FDA, poses [insert risks] and it's up to the buyer's discretion how to use our products," or is that worse?

And generally there is no serving size because in many places it's not legal for human consumption, like to sell it as such. Like in Canada.. you can have it but to sell it it's "not for human consumption" .

But in the US you can't really sell something as "not for human consumption" if you know your buyers are consuming it. The FDA is dumb but they're not so dumb that they think people are buying kratom as potting mix or for "botanical research."

Most companies won't respond to emails talking about use for eg.
And yes you can sell it for "not for human consumption"
Could be for research, incense, scent , building stuff or something. The point is they are not saying take it. It does cover their ass... I worked for a research chemical company for over 11. Yrs, trust me I know.
Also it's not illegal in all countries or places.. but why would you limit your potential customer base and leave out places that it is legal, just as long as it's not sold for consumption.. and yes the FDA knows many do take it. Nothing they can do unless they change some law or a vendor messes up.
That's not to say some vendors won't put themselves in more risk be not caring. In Canada it's completely fine for not human consumption. Every site that does say that is still around. And it's in a contract/terms of service you agree to by buying.
What you do after is none of their business or concern, you broke their terms by taking it.
If they openly talk about using it or to use their product, then they are fuked too.

Some say not FDA approved . Or not FDA approved for human consumption.

Point is it does something, that's how it is and that's it. Even if you think it's stupid

[Blergs]

I've seen companies run into legal trouble... by stating "not for human consumption" in their Terms & Conditions or on product packaging (of course, often the company is guilty of other violations before they get called out for that).

The 1 case you referenced - (Forfeit $10.7 million linked to — Proven Peptides, Sarmsx, Coastline Kratom, Kratom Crazy, Best Kratom, Peak Nootropics.) WAS in business for many years selling SARM's... IMO he got busted for the SARM's not kratom - but also, his kratom companies were frauds. Coastline and Crazy were featured on "Worst Ripoff" lists for years. Search the big sub on Reddit. He was spamming advertisements and really, pushing the envelope on "Medical Claims" and, Crazy had a website with LOTS of user comments, and certainly Claims there...

OTOH, companies certainly HAVE been busted, big-time, for illegally selling kratom FOR human consumption. Just selling capped kratom, may be considered evidence. Less than 1 year ago. 37 Tons of Kratom in Florida LINK ... A couple years ago, the Earth Kratom seizure in South Caroline. Again TONS, they were selling & marketing capped Retail products.

The whole problem is Retail!! Head Shop sales of capped "Dietary Supplements" which does... Violate FDA Regs. . Kratom is NOT approved by FDA as a Dietary Supplement... So, what is AKA doing ? Well, AKA is a Legal / Political organization representing ALL of the large Retailer vendors. They are fighting the FDA, and they do advise their Members, to sell with a Supplement Facts Label, in direct violation of FDA - and basically act like that's approved when it's not...

NOT 1 single Online Vendor, has EVER been busted by FDA, on Federal charges for selling Plain Leaf powder NFSC - Not For Human Consumption.

However Extract - As you suggest - is more questionable. Most online sellers have avoided selling Extract, BUT it's getting to the point where consumers demand it - As Quality of plain powder has declined, thanks to the Drug Lab companies and large Wholesale importers.

Well put!

[kratomwriter]

Disclaimer is to help protect them ...

True, but how much does it protect them if the FDA calls out vendors for this? Would it be more protective to say "kratom is not approved by the FDA, poses [insert risks] and it's up to the buyer's discretion how to use our products," or is that worse?

And generally there is no serving size because in many places it's not legal for human consumption, like to sell it as such. Like in Canada.. you can have it but to sell it it's "not for human consumption" .

But in the US you can't really sell something as "not for human consumption" if you know your buyers are consuming it. The FDA is dumb but they're not so dumb that they think people are buying kratom as potting mix or for "botanical research."

Most companies won't respond to emails talking about use for eg.
And yes you can sell it for "not for human consumption"
Could be for research, incense, scent , building stuff or something. The point is they are not saying take it. It does cover their ass... I worked for a research chemical company for over 11. Yrs, trust me I know.
Also it's not illegal in all countries or places.. but why would you limit your potential customer base and leave out places that it is legal, just as long as it's not sold for consumption.. and yes the FDA knows many do take it. Nothing they can do unless they change some law or a vendor messes up.
That's not to say some vendors won't put themselves in more risk be not caring. In Canada it's completely fine for not human consumption. Every site that does say that is still around. And it's in a contract/terms of service you agree to by buying.
What you do after is none of their business or concern, you broke their terms by taking it.
If they openly talk about using it or to use their product, then they are fuked too.

Some say not FDA approved . Or not FDA approved for human consumption.

Point is it does something, that's how it is and that's it. Even if you think it's stupid

Gotcha! So what disclaimer is needed when customers leave reviews indicating that they consume the products?

[BallzDeep9]

Gotcha! So what disclaimer is needed when customers leave reviews indicating that they consume the products?

Reviews and discussion on 3rd Party websites, are outside of vendor's control ... Notice, very FEW vendors participate directly on MM, or other "Forum" sites?

Of Course, everyone knows kratom is consumed... But it's a Legal situation and vendors are told by their attorneys, stay OFF social media, and you'll be fine. Case in point - Smiley Time Herbals, started his business a few years ago. He was very active on Reddit. He began a Group on MeWe. He quickly became very popular and, sure enough... Customers posted various Medical Claims on his Mewe group Chat. I think he made, like 1 attempt to caution people and control the Chat - then suddenly poof . GONE from Mewe!

It's kind of a paradox. Vendors who are well established, have money invested in a REAL business, website, fancy packaging, a warehouse, etc - Do NOT encourage "Reviews" on any social media. At least not directly, (they do, using anonymous Shill accounts, yes!) - So that leaves, the micro vendors, Chat Room folks, backpack'ers who ARE popular because of "Reviews", BUT exposed legally - Those have very little invested anyway and would likely just... disappear IF they were contacted by FDA or any law enforcement.

The concern is a Musical Chairs scenario, for the small guys, where any large scale FDA enforcement, or even signs that AKA vendors were shifting to active measures under KCPA - Lawsuits in State courts, charging the small guys with crimes - I think we'd see a mass wave of Exit Scams, like domino's falling within weeks, and some paid customers hung out to dry - Left holding the bag (or NO bag in this case ?) and... nowhere safe to sit down.

[kratomwriter]

It's kind of a paradox. Vendors who are well established, have money invested in a REAL business, website, fancy packaging, a warehouse, etc - Do NOT encourage "Reviews" on any social media. At least not directly, (they do, using anonymous Shill accounts, yes!) - So that leaves, the micro vendors, Chat Room folks, backpack'ers who ARE popular because of "Reviews", BUT exposed legally - Those have very little invested anyway and would likely just... disappear IF they were contacted by FDA or any law enforcement.

I didn't know that that had happened to Smiley's! Thanks for the info. I've followed some long and winding trails on the internet to find out what happened to users/vendors who've disappeared. I'm trying to gather a mental compilation of everything that vendors get slapped on the wrist for so that I can help new vendors avoid similar pitfalls. I read through the FDA's warnings (like this one) against kratom companies regularly and try to reach out to vendors who have problems with their content (medical claims, things that might cause them to get flagged as "spam," etc.) to let them know what needs to be changed and offer my help. I'm really concerned by one lawsuit in particular because I can't find any FDA warnings for the company (Atofil) or any unsubstantiated medical claims that got them in this hot water with the Department of Justice.

The concern is a Musical Chairs scenario, for the small guys, where any large scale FDA enforcement, or even signs that AKA vendors were shifting to active measures under KCPA - Lawsuits in State courts, charging the small guys with crimes - I think we'd see a mass wave of Exit Scams, like domino's falling within weeks, and some paid customers hung out to dry - Left holding the bag (or NO bag in this case ?) and... nowhere safe to sit down.

I don't foresee the AKA vendors pushing for lawsuits against the little guys, nor the FDA or the DOJ. Many of the AKA-vendor owners I've spoken to hate lawsuits and feds, and have nothing against small vendors. They don't tend to see the AKA's mission as profitable for them; many are AKA-affirmed simply because they feel they're doing their part for keeping kratom legal (even vendors who aren't participating with the AKA's GMP push for the KCPA and GMP for this reason.) Quite a few of them came from nothing themselves, and they know next to nil about the "rivalry" against them from small vendors; they don't want to see them go out of business either. They have a solid customer base already, and they just want to keep doing their thing, AKA or not.

Similarly, the AKA isn't very involved with its own approved vendors, so accusing them of "favoritism" isn't exactly fitting. There's a disconnect between them and their participating vendors; they're not buddying up. Yes, the AKA makes money off of them, and they like money, but their goal isn't to monopolize. They are more involved with political negotiations than vendor matters.

If you look at the Utah version of the KCPA (which as you've shown is more expensive and harmful to small businesses than the Florida/Georgia versions), the processor fees for vendors to register "are based on the size of the facility and processing methodology." The heftier fee is for the product registration ($260.00 fee Per formulation! So the fewer kratom products you want to sell, the lower the fine). This money goes to the Utah Department of Agriculture and Food Product Registration, not the AKA. These fees strengthen the AKA's negotiations with state officials—lawmakers may be incentivized to approve this version because it's profitable for the state's Department of Agriculture, which the politicians who pass the KCPA feel they can take credit for.

The idea behind the fees in the Utah bill is to cover the administrative costs of issuing licenses to kratom vendors and weed out anybody who's not dedicated to selling kratom (and yes, also to make the state money). The goal is to get Utah filled with serious vendors following protocols, weeding out the rest. This appeals to Utah legislators more than the kratom community, but they are the ones who have the power.

The FL/GA version is possibly the best thing we can currently strive for. However, seeing how many KCPA bills die in committee (including a promising-looking Texas version), it may be more persuasive for lawmakers to pass the Utah version, thus speeding up the AKA's "progress." Regulation almost always comes with fees. Even supplements companies have to pay large fees. We should push lawmakers to take the FL/Georgia route, but if worse comes to worst, the little guys can take out a small business loan; some of the "Big Kratom" companies got started by taking out such loans, and some are still repaying them. It sucks, but the system favors the wealthy, so we play the game and strive to get there.

[Blergs]

True, but how much does it protect them if the FDA calls out vendors for this? Would it be more protective to say "kratom is not approved by the FDA, poses [insert risks] and it's up to the buyer's discretion how to use our products," or is that worse?



But in the US you can't really sell something as "not for human consumption" if you know your buyers are consuming it. The FDA is dumb but they're not so dumb that they think people are buying kratom as potting mix or for "botanical research."

Most companies won't respond to emails talking about use for eg.
And yes you can sell it for "not for human consumption"
Could be for research, incense, scent , building stuff or something. The point is they are not saying take it. It does cover their ass... I worked for a research chemical company for over 11. Yrs, trust me I know.
Also it's not illegal in all countries or places.. but why would you limit your potential customer base and leave out places that it is legal, just as long as it's not sold for consumption.. and yes the FDA knows many do take it. Nothing they can do unless they change some law or a vendor messes up.
That's not to say some vendors won't put themselves in more risk be not caring. In Canada it's completely fine for not human consumption. Every site that does say that is still around. And it's in a contract/terms of service you agree to by buying.
What you do after is none of their business or concern, you broke their terms by taking it.
If they openly talk about using it or to use their product, then they are fuked too.

Some say not FDA approved . Or not FDA approved for human consumption.

Point is it does something, that's how it is and that's it. Even if you think it's stupid

Gotcha! So what disclaimer is needed when customers leave reviews indicating that they consume the products?

Most don't allow reviews on their site, or that it's indirectly, like " that super green was great with long legs" etc. As for groups, websites etc, not their concern . Bigger risk if they made the group , but not their concern.

Like what if I made a group about drinking Windex, and many started also posting how they love it to wake up and they can clean their throats and windows at the same time. For eg....
Why would Windex window cleaner get in trouble?

[kratomwriter]

Most don't allow reviews on their site, or that it's indirectly, like " that super green was great with long legs" etc. As for groups, websites etc, not their concern . Bigger risk if they made the group , but not their concern.

Like what if I made a group about drinking Windex, and many started also posting how they love it to wake up and they can clean their throats and windows at the same time. For eg.... Why would Windex window cleaner get in trouble?

Yeah, I wanted to know why vendors take down reviews on their websites or do them indirectly. Why not just provide a disclaimer that they don't endorse them? I know of some vendors who moderate every review and only approve those that don't mention things like "stimulating" or "pain relief." Isn't it only a problem if the vendor says those things themselves? I think the FDA scared a lot of vendors into unnecessary precautions after cracking down in 2018.

[Blergs]

Most don't allow reviews on their site, or that it's indirectly, like " that super green was great with long legs" etc. As for groups, websites etc, not their concern . Bigger risk if they made the group , but not their concern.

Like what if I made a group about drinking Windex, and many started also posting how they love it to wake up and they can clean their throats and windows at the same time. For eg.... Why would Windex window cleaner get in trouble?

Yeah, I wanted to know why vendors take down reviews on their websites or do them indirectly. Why not just provide a disclaimer that they don't endorse them? I know of some vendors who moderate every review and only approve those that don't mention things like "stimulating" or "pain relief." Isn't it only a problem if the vendor says those things themselves? I think the FDA scared a lot of vendors into unnecessary precautions after cracking down in 2018.

Acknowledgments to human use, even saying "we don't condone reviews of human use" is a bad idea period.

[kratomwriter]

I was thinking more along the lines of "we do not endorse or promote any reviews or comments with medical claims?" After all, that's only acknowledging what the FDA really goes after vendors for saying themselves. Plenty of kratom websites acknowledge human consumption of kratom (i.e. "kratom tea" "Best Kratom Tea Recipies" or "capsules are free from kratom's bitter taste") and I don't see any warning issued against them.

What I have seen is the Kratom Crazy guy getting called out for saying "not for human consumption" when he knew customers were using it for human consumption (although he got in trouble for many other things more so than this).

Medical claims are the FDA's #1 issued warning against kratom companies. Currently, they don't even seem to be going after vendors too much for selling a bulk or encapsulated "new dietary ingredient" despite not registering to sell an NDI (because the FDA would reject them anyway). They're hitting hard on the medical claims.

I'm interested in everyone's thoughts on this article: "Is Kratom Really Not for Human Consumption?"

[StringThing]

I don't think the FDA regulates dietary supplements. You can put almost anything in a pill and sell it. There are vendors that sell kratom pills and extract shots and brownies and all kinds of things with kratom and other herbs in it. The FDA does not approve herbs one by one.

I see some people talking about a court case in here, but does anyone have a link to the ruling? You can get in BIG trouble for making medical claims about supplements. You cannot even vaguely allude to things like kratom being used for pain. There are some 'safe' terms like 'mood lift' or 'chill' but stuff like anti-anxiety/cure diabetes/stabs cancer in the groin, nope. None of that.

IF you sell it for human consumption you open yourself up to all kinds of inspection from the FDA. You need a clean facility and can't just be bagging up kratom at home with a registered business (which many of these vendors are not!) Probably some state laws to worry about there too.

[Blergs]

I was thinking more along the lines of "we do not endorse or promote any reviews or comments with medical claims?" After all, that's only acknowledging what the FDA really goes after vendors for saying themselves. Plenty of kratom websites acknowledge human consumption of kratom (i.e. "kratom tea" "Best Kratom Tea Recipies" or "capsules are free from kratom's bitter taste") and I don't see any warning issued against them.

What I have seen is the Kratom Crazy guy getting called out for saying "not for human consumption" when he knew customers were using it for human consumption (although he got in trouble for many other things more so than this).


Medical claims are the FDA's #1 issued warning against kratom companies. Currently, they don't even seem to be going after vendors too much for selling a bulk or encapsulated "new dietary ingredient" despite not registering to sell an NDI (because the FDA would reject them anyway). They're hitting hard on the medical claims.

I'm interested in everyone's thoughts on this article: "Is Kratom Really Not for Human Consumption?"

Don't you get that ANY acknowledgement of any sort of human consumption is bad?
Even warning or not endorsing of usage talk, is acknowledgement?
"Not for human consumption" is all that needs to be said on the topic period.. done..

I don't know why this thread is still going tbh. . But I have nothing left to say on this.

Cheers

[Blergs]

I don't think the FDA regulates dietary supplements. You can put almost anything in a pill and sell it. There are vendors that sell kratom pills and extract shots and brownies and all kinds of things with kratom and other herbs in it. The FDA does not approve herbs one by one.

I see some people talking about a court case in here, but does anyone have a link to the ruling? You can get in BIG trouble for making medical claims about supplements. You cannot even vaguely allude to things like kratom being used for pain. There are some 'safe' terms like 'mood lift' or 'chill' but stuff like anti-anxiety/cure diabetes/stabs cancer in the groin, nope. None of that.

IF you sell it for human consumption you open yourself up to all kinds of inspection from the FDA. You need a clean facility and can't just be bagging up kratom at home with a registered business (which many of these vendors are not!) Probably some state laws to worry about there too.

This is of big risk too, and it's not legal/approved to sell as a supplement either. It's for non human consumption period..
For places that have those laws, like USA and Canada etc.
Then there are places it's not illegal, but not around here or most places.
And they do regulate supplements, in a differing way. Like if you say any sup , herb etc, treats or cures any disease, they will come after you. There are indirect ways of mentioning it though (for things approved for human consumption) . Like:
Calcium supplement- "helps to support the health bodies bone health"
Or valerian root pills: "may help promote/support the bodies natural sleep functions.

Etc etc.
But kratom is not legal for human consumption here, thus this does not apply..

Be nice if that changes though

[brave777]

Reading this makes me want to support not for consumption only vendors. Why would FDA not consider plain leaf a supplement? I see it as a supplement since it never been messed with by labs. Why would even FDA care? I dont think they should care and leave natural stuff to people. But if they hitting vendors with a bat on head for putting it can be consumed then only option left is to put not for consumption and let people gain respect for small vendor trust. This whole kratom thing seems is build on trust, once people start cherry picking vendors more will follow, thats just way of life. So i rather buy from vendors that get their own back and consumers back by putting not for human consumption and its up to us to consume it or not or make candles at least vendors will be happy and we as customers will gain trust, few bad batches and they are out. Trust has to be earned. Rumors spread fast. Kind of like clean your life example or mystical island who got big batch of junk and decided to sell to people. Like if some vendors here decided to go not for human consumption and i trust them, it wont bother me much to buy from them. The rest is up to me what i do with it, be it consume or make tons of soaps.

[StringThing]

But kratom is not legal for human consumption here, thus this does not apply..

This is untrue. Kratom doesn't have to be approved for human consumption according to FDA guidelines. I'm not sure why you're making the assumption it needs to be approved or 'legalized' for consumption.

The only regulation on supplements (besides the medical claims thing) is that they are made in a clean facility and are free of adulterants. This is why the FDA instates a recall when they find batches with heavy metals or salmonella. The FDA does have a list of products which you cannot sell as supplements, as well as various guidelines for substances not listed. Other than that you can basically sell any non-prohibited plant as a supplement.

https://www.fda.gov/safety/recalls-mark ... salmonella

https://www.fda.gov/food/dietary-supple ... ngredients


Like I said in my previous post, vendors DO NOT have to claim it's 'not for human consumption' unless they are selling it as a supplement. You can sell it as soap materials, or incense, and the FDA cannot prove otherwise and does not care as this is not in their purview.

I did quite a lot of research into this when I was looking at starting a dry goods/herbal supplement/kratom/cbd company. Didn't end up doing it but, i got my CFPM anyway. I am pretty sure that all these vendors who have been selling kratom pills and such for years, are not doing it illegally, and they were not given illegal advice by their lawyers. You can get kratom intended for human consumption at almost every smoke shop in America. I don't know how you can believe its illegal to sell for human consumption. Would be interested in seeing your source for that.

[kratomwriter]

I don't think the FDA regulates dietary supplements. You can put almost anything in a pill and sell it. There are vendors that sell kratom pills and extract shots and brownies and all kinds of things with kratom and other herbs in it. The FDA does not approve herbs one by one.

This is somewhat untrue, but I see what you mean. Both dietary ingredients and dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was proposed by Senator Orrin Hatch. Although imperfect (it needs to be modernized), DSHEA is actually an important bill for small businesses and the American public. On the negative side, with DSHEA, the FDA doesn't have a tight control over supplements and dietary ingredients. But on the positive side, it made it much easier for new businesses to get started selling supplements without having to go through a rigorous approval process (in which the FDA could reject many supplements from even being sold).

This is the whole reason why the AKA chose Mac Haddow, and he was the best way to get kratom approved by Senator Hatch (Mac was a major proponent for DSHEA, which he talks about here and here). If it weren't for the DSHEA, we would have limited access to not only kratom, but many of the other supplements we are able to access. More kratom business owners need to understand the exact regulations that govern them.

I see some people talking about a court case in here, but does anyone have a link to the ruling?

Here's a link to the release from the DOJ in Pennsylvania: "To evade regulation by the Food and Drug Administratio[/b]n, which regulates the sale of drugs in interstate commerce, Fulton and his co-conspirators included disclaimers on their websites and the parcels shipped to consumers, falsely indicating that the products were not for human consumption." You can find more legal links online if you look. LMK if you want more kratom court cases.

You can get in BIG trouble for making medical claims about supplements. You cannot even vaguely allude to things like kratom being used for pain. There are some 'safe' terms like 'mood lift' or 'chill' but stuff like anti-anxiety/cure diabetes/stabs cancer in the groin, nope. None of that.

Yes, you can get in big trouble for medical claims. So it's important to include disclaimers about content "not being medical advice" and "not proven safe." You can even list the FDA's cited risks regarding kratom in your Terms & Conditions. But you don't have to say "not for human consumption" if you're careful to follow the legal restrictions and don't make medical claims.

IF you sell it for human consumption you open yourself up to all kinds of inspection from the FDA. You need a clean facility and can't just be bagging up kratom at home with a registered business (which many of these vendors are not!) Probably some state laws to worry about there too.

Whether you sell it for human consumption or not, the FDA can and will keep an eye on you. The risk is greater for the big kratom vendors who make a lot of sales and have a lot of funds the DOJ can seize. The "not for human consumption" thing is not as protective as knowing the regulation requirements & restrictions on marketing claims and abiding by them.

This is of big risk too, and it's not legal/approved to sell as a supplement either. It's for non human consumption period.

It's classified as a "New Dietary Ingredient" (NDI). No, it cannot be sold as a supplement or a safe dietary ingredient. It can be sold as "not proven safe for human consumption" with other disclaimers. Look at the FDA's long legal past with kratom companies. They've tried to get vendors in trouble for selling it "as a supplement," not "for human consumption." Don't make any medical claims, don't say it's safe, don't tout it as a treatment, and reference the FDA's warnings and you should be covered better.

Be nice if that changes though

Yep, that's why the AKA is trying to get it regulated as a dietary ingredient or a supplement. We can't regulate it as a drug—it's extremely highly unlikely to do without Big Pharma taking over and making it a prescription. Goodbye small businesses altogether if that happens.

KCPA is our best bet. But for now, consult your legal professionals and make your Terms & Conditions as good as possible. Hope this info is helpful!

[kratomwriter]

But kratom is not legal for human consumption here, thus this does not apply..

Kratom doesn't have to be approved for human consumption according to FDA guidelines. I'm not sure why you're making the assumption it needs to be approved or 'legalized' for consumption.

This exactly!

The only regulation on supplements (besides the medical claims thing) is that they are made in a clean facility and are free of adulterants. This is why the FDA instates a recall when they find batches with heavy metals or salmonella. The FDA does have a list of products which you cannot sell as supplements, as well as various guidelines for substances not listed. Other than that you can basically sell any non-prohibited plant as a supplement.

Yes, DSHEA. Kratom is of course one of the ingredients that are forbidden to sell as a supplement (no record of safety), as are other New Dietary Ingredients (NDI's), which must be approved by the FDA before selling as a supplement (of course any application to the FDA for a kratom business fails).

Like I said in my previous post, vendors DO NOT have to claim it's 'not for human consumption' unless they are selling it as a supplement. You can sell it as soap materials, or incense, and the FDA cannot prove otherwise and does not care as this is not in their purview.

And to avoid selling it as "a supplement," just avoid any and all health claims. Put in your Terms & Services that kratom is not a supplement, nor is it FDA-approved to sell as a supplement.

I did quite a lot of research into this when I was looking at starting a dry goods/herbal supplement/kratom/cbd company. Didn't end up doing it but, i got my CFPM anyway. I am pretty sure that all these vendors who have been selling kratom pills and such for years, are not doing it illegally, and they were not given illegal advice by their lawyers. You can get kratom intended for human consumption at almost every smoke shop in America. I don't know how you can believe its illegal to sell for human consumption. Would be interested in seeing your source for that.

This is my understanding as well. I've talked to attorneys about this too, but it is complicated for NDI's, so best consult an FDA-compliance attorney.

I don't know why this thread is still going tbh. . But I have nothing left to say on this.
Cheers

I'm still open to the counterargument, so if you (or anyone) has good legal example that provides why "not for human consumption" is necessary, respond! Because right now, itt seems like it's better for the kratom community to be honest and take the time to learn all of the legal regulations.

[kratomwriter]

Last but not least, know of a kratom vendor who has changed his web domain, company name, and business "type" over 3 times because he kept getting warnings from the FDA.

His current website says "So that you and us are [safe from the FDA], we distribute our KRATOM as memorabilia...we are not providing it for consumption." He adds some conspiracy-theory stuff about the FDA "causing" the epidemic and kratom saving lives from it. I know he's been through a lot, but the he's making things more difficult for himself.

All of his websites contained unabashed health claims. No matter how many warnings the FDA sent him, he's still selling kratom with health claims. Selling it as "memorabilia" and "not for consumption" may protect him somewhat from his health claims for now, but it will not hold up in court, as he's tried to add that kind of disclaimer before (I think by selling kratom apparel). He'll probably have to disappear and pop up again elsewhere with a new site, making the same violations.

But all he had to do was remove the health claims. Even if the FDA warns you about the health claims, you just have to take them all down. I want to re-write this guy's Terms & Conditions to better protect him, but I haven't reached out yet. I hope he's okay.

Long story short, vendors should know about the regulatory laws and abide by them, not try to pursue a loophole that doesn't really exist. We need to in order to get kratom legitimized as a business.

[BallzDeep9]

I'm still open to the counterargument, so if you (or anyone) has good legal example that provides why "Not For Human Consumption" is necessary, respond! Because right now, itt seems like it's better for the kratom community to be honest and take the time to learn all of the legal regulations.

I think the NFHC Label is being mis-understood here, or you're confusing the issue(s) here... Start with the Facts: Kratom is NOT approved by the FDA as a Dietary Supplement. Right? SO - vendors who SELL kratom, do so using a Legal Disclaimer, on advice of their Attorney - that Disclaimer IS Part of a Sales Contract (Website, Terms Of Service, Agreement) under which the product is sold. It serves to protect vendor from liability.

Why ? Ask an Attorney... Last I checked a year ago, nearly ALL of the small, independent, online vendors who promote around here, # 40 or more, use some Version of the NFHC Disclaimer... Only a couple, use the FDA's Supplement Facts label, even though it's unapproved - Lucky Herbals (for example) has a very nice, Retail type package that appears to suggest it's for consumption? OK. I'm sure Lucky and their attorneys have reviewed this.

Example 2: Okie Kratom, a well established, popular, Online Vendor - also has Supplement Facts label. However the following text appears on every Product page, as well as Terms page: Okie - The FDA has not approved this product for human internal consumption and is sold as a botanical only. You must be 18 years old to purchase. See terms of service.

Example 3: One of THE largest and longest established kratom websites, IS - Legal Herb Shop. Not too popular here, but they DO sell all the head-shop Retail products, shots, extracts, caps, etc. All of the "Brand Name" kratom products as well as plain powder, Delta 8, CBD, huge selection - LHS is very clear: Purchaser agrees to this Disclaimer: Kratom has not been evaluated by the FDA. // Buyer understands that all information on this site is for educational purposes only. We do not suggest, or imply, or want you to ingest the kratom we sell. Kratom is not FDA-approved for human consumption so it cannot and is not sold as a food item.

The buyer understands and accepts that www.legalherbalshop.com products are sold “NOT FOR HUMAN CONSUMPTION” and are sold as herbarium specimen, collection, legitimate research, plant propagation, incense, educational and/or ornamental purposes only. Capsules are used solely for the purpose of weighing and speed of packaging and novelty items, not consumption. - https://legalherbalshop.com/product/opm ... -capsules/

"BY PLACING AN ORDER YOU ARE AGREEING TO THIS DISCLAIMER."

LHS proudly displays the AKA Logo, is a supporter of AKA and a seller of all AKA Member retail "Brand" products.

[BallzDeep9]

That's why the AKA is trying to get it regulated as a dietary ingredient or a supplement. We can't regulate it as a drug—it's extremely highly unlikely to do without Big Pharma taking over and making it a prescription. Goodbye small businesses altogether if that happens.

Do you think AKA really wants FDA Approval as a Dietary Supplement ?? - Say Goodbye to all 200 sketchy kratom vendors!

Think about it... As soon as FDA approves Kratom, the AKA "Party is Over". . meaning... their Cash Cow. Immediately the Big Supplement companies move in, and we'd see kratom in Walmart, sold on Amazon, and marketed by - Gaia Herbs, Rainbow Light, New Chapter, NOW foods, and many others.

At very reasonable prices, too. Just like Kava Kava and many other "FDA Approved" herbs... NO, plain powder kratom won't be regulated as a drug, because it's NOT a drug, it's an herb - plants can't be patented! However - various Kratom Extract products made in labs, could certainly be patented, and refined - With standardized Mitragynine content just like ALL other legit herbal supplements!

[Fhietra899]

That's why the AKA is trying to get it regulated as a dietary ingredient or a supplement. We can't regulate it as a drug—it's extremely highly unlikely to do without Big Pharma taking over and making it a prescription. Goodbye small businesses altogether if that happens.

Do you think AKA really wants FDA Approval as a Dietary Supplement ?? - Say Goodbye to all 200 sketchy kratom vendors!

Think about it... As soon as FDA approves Kratom, the AKA "Party is Over". . meaning... their Cash Cow. Immediately the Big Supplement companies move in, and we'd see kratom in Walmart, sold on Amazon, and marketed by - Gaia Herbs, Rainbow Light, New Chapter, NOW foods, and many others.

At very reasonable prices, too. Just like Kava Kava and many other "FDA Approved" herbs... NO, plain powder kratom won't be regulated as a drug, because it's NOT a drug, it's an herb - plants can't be patented! However - various Kratom Extract products made in labs, could certainly be patented, and refined - With standardized Mitragynine content just like ALL other legit herbal supplements!

I think its really complicated situations. One side if its regulated Big companies will joined in and will be hard to vendors that sell kratom for years and fight for this plant, in other side if its regulated consumers will get the advantages.

[Blergs]

But kratom is not legal for human consumption here, thus this does not apply..

This is untrue. Kratom doesn't have to be approved for human consumption according to FDA guidelines. I'm not sure why you're making the assumption it needs to be approved or 'legalized' for consumption.

The only regulation on supplements (besides the medical claims thing) is that they are made in a clean facility and are free of adulterants. This is why the FDA instates a recall when they find batches with heavy metals or salmonella. The FDA does have a list of products which you cannot sell as supplements, as well as various guidelines for substances not listed. Other than that you can basically sell any non-prohibited plant as a supplement.

https://www.fda.gov/safety/recalls-mark ... salmonella

https://www.fda.gov/food/dietary-supple ... ngredients


Like I said in my previous post, vendors DO NOT have to claim it's 'not for human consumption' unless they are selling it as a supplement. You can sell it as soap materials, or incense, and the FDA cannot prove otherwise and does not care as this is not in their purview.

I did quite a lot of research into this when I was looking at starting a dry goods/herbal supplement/kratom/cbd company. Didn't end up doing it but, i got my CFPM anyway. I am pretty sure that all these vendors who have been selling kratom pills and such for years, are not doing it illegally, and they were not given illegal advice by their lawyers. You can get kratom intended for human consumption at almost every smoke shop in America. I don't know how you can believe its illegal to sell for human consumption. Would be interested in seeing your source for that.

Omg.. it's not legal for human consumption! .
It is illegal to sell as such.
It is not approved for human consumption in Canada, not under a supplements act or any other... It is regulated for only non human use in Canada.
Thus the extra caution of putting " not for human consumption" etc on packages and sites.

maybe the laws differ from yours..

It's legal to sell for other uses.
It's not in the same class at a random herbal supp , not here. Other places are the same, or legal, or illegal..
It's just generally safer for vendor to put that and avoid hassles when they ship to places with differing laws.
For example it's illegal to have a kava bar, though I see some change on the way hopefully. But in the USA it's common it seems

[Blergs]

But kratom is not legal for human consumption here, thus this does not apply..

Kratom doesn't have to be approved for human consumption according to FDA guidelines. I'm not sure why you're making the assumption it needs to be approved or 'legalized' for consumption.

This exactly!

The only regulation on supplements (besides the medical claims thing) is that they are made in a clean facility and are free of adulterants. This is why the FDA instates a recall when they find batches with heavy metals or salmonella. The FDA does have a list of products which you cannot sell as supplements, as well as various guidelines for substances not listed. Other than that you can basically sell any non-prohibited plant as a supplement.

Yes, DSHEA. Kratom is of course one of the ingredients that are forbidden to sell as a supplement (no record of safety), as are other New Dietary Ingredients (NDI's), which must be approved by the FDA before selling as a supplement (of course any application to the FDA for a kratom business fails).

Like I said in my previous post, vendors DO NOT have to claim it's 'not for human consumption' unless they are selling it as a supplement. You can sell it as soap materials, or incense, and the FDA cannot prove otherwise and does not care as this is not in their purview.

And to avoid selling it as "a supplement," just avoid any and all health claims. Put in your Terms & Services that kratom is not a supplement, nor is it FDA-approved to sell as a supplement.

I did quite a lot of research into this when I was looking at starting a dry goods/herbal supplement/kratom/cbd company. Didn't end up doing it but, i got my CFPM anyway. I am pretty sure that all these vendors who have been selling kratom pills and such for years, are not doing it illegally, and they were not given illegal advice by their lawyers. You can get kratom intended for human consumption at almost every smoke shop in America. I don't know how you can believe its illegal to sell for human consumption. Would be interested in seeing your source for that.

This is my understanding as well. I've talked to attorneys about this too, but it is complicated for NDI's, so best consult an FDA-compliance attorney.

I don't know why this thread is still going tbh. . But I have nothing left to say on this.
Cheers

I'm still open to the counterargument, so if you (or anyone) has good legal example that provides why "not for human consumption" is necessary, respond! Because right now, itt seems like it's better for the kratom community to be honest and take the time to learn all of the legal regulations.

I can't anymore geeze..
Good luck

[mivanqua]

Wait, you're supposed to ingest this stuff? I've been boofing candles that I made out of it this whole time!! It's lit, but only sometimes.

[kratomwriter]

It is not approved for human consumption in Canada, not under a supplements act or any other... It is regulated for only non human use in Canada.
Thus the extra caution of putting " not for human consumption" etc on packages and sites.

maybe the laws differ from yours..

It's legal to sell for other uses.
It's not in the same class at a random herbal supp , not here. Other places are the same, or legal, or illegal..
It's just generally safer for vendor to put that and avoid hassles when they ship to places with differing laws.
For example it's illegal to have a kava bar, though I see some change on the way hopefully. But in the USA it's common it seems

Hey pal, no worries! I missed that you were just discussing Canada. You're correct about Canada. In the USA, the laws are different. Cheers!

[kratomwriter]

I'm still open to the counterargument, so if you (or anyone) has good legal example that provides why "Not For Human Consumption" is necessary, respond! Because right now, itt seems like it's better for the kratom community to be honest and take the time to learn all of the legal regulations.

I think the NFHC Label is being mis-understood here, or you're confusing the issue(s) here... Start with the Facts: Kratom is NOT approved by the FDA as a Dietary Supplement. Right? SO - vendors who SELL kratom, do so using a Legal Disclaimer, on advice of their Attorney - that Disclaimer IS Part of a Sales Contract (Website, Terms Of Service, Agreement) under which the product is sold. It serves to protect vendor from liability.

Thanks for the run-down! However, I understand the purpose of the NFHC label, and I understand its purpose/function. My primary questions are not being addressed.

Why ? Ask an Attorney... Last I checked a year ago, nearly ALL of the small, independent, online vendors who promote around here, # 40 or more, use some Version of the NFHC Disclaimer... Only a couple, use the FDA's Supplement Facts label, even though it's unapproved - Lucky Herbals (for example) has a very nice, Retail type package that appears to suggest it's for consumption? OK. I'm sure Lucky and their attorneys have reviewed this.

Not sure if I put it in this thread, but I did ask some attorneys. So far all I've found is that you can't endorse safe human consumption, and you can't use marketing claims for your products. Yes, you need a disclaimer to protect ya neck, but I am not finding evidence that it must be "not for human consumption." Doesn't a warning that acknowledges that it's not safe and not FDA-approved for any use cover those grounds, as long as you're not marketing the product as safe or beneficial?

Example 2: Okie Kratom, a well established, popular, Online Vendor - also has Supplement Facts label. However the following text appears on every Product page, as well as Terms page: Okie - The FDA has not approved this product for human internal consumption and is sold as a botanical only. You must be 18 years old to purchase. See terms of service.


Example 3: One of THE largest and longest established kratom websites, IS - Legal Herb Shop. Not too popular here, but they DO sell all the head-shop Retail products, shots, extracts, caps, etc. All of the "Brand Name" kratom products as well as plain powder, Delta 8, CBD, huge selection - LHS is very clear: Purchaser agrees to this Disclaimer: Kratom has not been evaluated by the FDA. // Buyer understands that all information on this site is for educational purposes only. We do not suggest, or imply, or want you to ingest the kratom we sell. Kratom is not FDA-approved for human consumption so it cannot and is not sold as a food item.

The buyer understands and accepts that www.legalherbalshop.com products are sold “NOT FOR HUMAN CONSUMPTION” and are sold as herbarium specimen, collection, legitimate research, plant propagation, incense, educational and/or ornamental purposes only. Capsules are used solely for the purpose of weighing and speed of packaging and novelty items, not consumption. - https://legalherbalshop.com/product/opm ... -capsules/

"BY PLACING AN ORDER YOU ARE AGREEING TO THIS DISCLAIMER."

LHS proudly displays the AKA Logo, is a supporter of AKA and a seller of all AKA Member retail "Brand" products.

I love Okie's, I buy from him and I've read his T&C. I'm familiar with many examples out there who have the NFHC disclaimer on their websites. I am aware that the majority of them have it. I have also asked vendors why they have it in there: they all do it to avoid liability, but many of them borrowed it from other kratom vendors T&C. I am asking for examples of legal cases in which the NFHC disclaimer would protect a vendor whereas a "not FDA-approved, Warning: may lead to addiction and health consequences, is not for medical use or treatment, etc" disclaimer would not.

Please see my post below this one (this is getting crowded).

[kratomwriter]

Please read this article if you haven't about why "not for human consumption" doesn't help as much as you think.

And look at this other example of a court case in which a vendor got in trouble for "misbranding" kratom with the NFHC disclaimer:

"Dailey knowingly and fraudulently portrayed his kratom products to the FDA as “incense,” “paint pigment,” and other substances not intended for human consumption. By deceiving the FDA in this manner, Dailey was able to import several tons of kratom into the United States."

And if you're still wondering what I'm looking for as evidence, look at this list of instances in which vendors got in trouble with the FDA. It's all in the marketing. Don't market kratom for beneficial uses. Be open about the risks, and don't endorse it for medical use. But saying "not for human consumption" does not take away all liability from the vendor.

The "Not for human consumption" disclaimer does not work like it used to. Vendors need to try to follow the laws to the best of their ability.

[Blergs]

Lol

[BallzDeep9]

Please read this article ... if you haven't about why "not for human consumption" doesn't help as much as you think.

Check the Date - I'm familiar with Andrew, we debated the issue 5 years ago on Reddit - He was wrong then - his dire warnings & predictions have not panned out - He was involved with a Retail Brand "Urban ICE" owner was waging a little war against online vendors - Because they cut his Prices in half. - Both are in the documentary A Leaf Of Faith. . Andrew aka Nerds, is a good guy & I hope he's doing well.

And look at this other example of a court case[/b] in which a vendor got in trouble for "misbranding" kratom with the NFHC disclaimer:

WRONG -- The Michigan case of Matthew Dailey, Nomad Botanicals, was convicted because of Medical Claims - had ZERO to-do with selling NFHC as a Disclaimer... re-read that Article and others about the case. His "misbranding" was on his import Shipment Label, importing huge packages, like a TON, with false labels... The case totally revolved around his website, pushing all kinds of Medical Claims: Kratom as "treatment" for various things. The Nomad case was also prosecuted by Michigan.. Sure the FDA chimed in, but it was a State case.

The "Not for human consumption" disclaimer does not work like it used to. Vendors need to try to follow the laws to the best of their ability.

That's exactly what they ARE doing -- NFHC IS really "The Law" according to FDA - Vendors have been TOLD this - BY FDA's own Inspectors !! - What AKA is doing, is playing both sides, WHY ?? Because all their Retail folks are clearly selling Caps, shots, and products packaged FOR consumption / "Drugs" at least the packaging - Maybe not illegal ? but totally UN-approved by FDA. So those Retail vendors, do have MORE Risk of prosecution... compared to Online Vendors who sell plain powder NFHC.

[onespeedstop]

I'm just concerned that they could all but kill "small vendor" kratom overnight like they did with vape juice - just make it illegal to ship. That's a muucccchhhh easier way to screw up an industry, no proof of medical anything required. Local vape shops still exist, but I'd bet the prices doubled (doubled from the already insane local prices, quadrupled+ from online prices) and the selection plummeted. Let the AKA flounder, they seem to be useless middlemen just skimming $ with promises they can't keep, ie - kratom politicians if you will.

But enough doom and gloom, meanwhile, in the 4+ years I've been into kratom now I've pretty much only seen more online vendors, good/better quality, and good/lower prices. Plus this forum, which seems far and away more useful than some of the biggest social media sites on the planet. So hopefully kratom stays underground/under the radar for years to come, just the way it's mostly been.

[kratomwriter]

Disclaimer is to help protect them ...
And generally there is no serving size because in many places it's not legal for human consumption, like to sell it as such. Like in Canada.. you can have it but to sell it it's "not for human consumption" .

Just a fun fact, a 2021 study showed that in Canada, only 47% percent (24 out of 51) of websites reviewed stated that their kratom products were solely for research purposes, not for human consumption, even though kratom is only legal in Canada (and some countries in Europe) if sold as NFHC. Even many of those that have NFHC still implied that kratom is for consumption. I don't think their disclaimer would help if they're acknowledging it, but even the study recognizes that it's purchased for consumption.

[kratomwriter]

Check the Date - I'm familiar with Andrew, we debated the issue 5 years ago on Reddit - He was wrong then - his dire warnings & predictions have not panned out - He was involved with a Retail Brand "Urban ICE" owner was waging a little war against online vendors - Because they cut his Prices in half. - Both are in the documentary A Leaf Of Faith. . Andrew aka Nerds, is a good guy & I hope he's doing well.

Oh wow!!! I knew you were well-informed (I remember seeing your comments on Reddit back in the day) but you're really well-connected. I didn't know this; I was shocked to find such an article on Medium anyway. That's funny that you've already debated this with him and now you're having to do it again with me

WRONG -- The Michigan case of Matthew Dailey, Nomad Botanicals, was convicted because of Medical Claims - had ZERO to-do with selling NFHC as a Disclaimer... re-read that Article and others about the case. His "misbranding" was on his import Shipment Label, importing huge packages, like a TON, with false labels... The case totally revolved around his website, pushing all kinds of Medical Claims: Kratom as "treatment" for various things. The Nomad case was also prosecuted by Michigan.. Sure the FDA chimed in, but it was a State case.

I wasn't implying that the NFHC was what got him in trouble. I read the entire article. As I said before, it's almost always marketing claims that get a vendor in trouble—either that, salmonella contamination, illegal imports, or other issues that draw attention to a vendor. I'm just saying that the NFHC disclaimer isn't a 100% free pass. Even if it says "not for human consumption," the FDA can and will still go after it if you have medical claims. How does it protect the vendor then? I mean, the FDA has tried to argue that if it's in capsule form, it's a supplement. If a vendor did something that really made the State, FDA, DOJ, or feds persecute them, the NFHC disclaimer would not stand against them in court. The best way to protect yourself could still be to cite the risks and dangers of kratom, to lab-test your products and store samples of them in case anything should arise, and to not endorse your products.

If you look at the number of vendors who have gone to court and compare those who have the NFHC disclaimer and those who don't, the difference is often (as far as I know—please correct me if I'm wrong) negligible. What it comes down to is 1. Marketing, 2. Contamination, 3. Labeling, 4. Documentation of adverse effects associated with a vendor, and 5. legality of importation.

What I'm asking is this: If you don't make medical claims and you list all of the health and regulatory warnings about kratom (and you don't explicitly endorse or intend it for human consumption), how much greater is the risk for the vendor? If you don't market it for consumption and you're open about the risks, it's pretty similar. Now, in cities like Denver where kratom is banned for human consumption, the only way to sell it would be to go the Canada route with the NFHC disclaimer.

There's a reason why Denver decided to make it illegal to sell kratom for anything other than "not human consumption"—because vendors can sell it without this disclaimer in the US. It's all about marketing. Don't market it as safe or a cure for anything. Saying "not for human consumption" makes kratom seem really sketchy. At least in states that have passed the KCPA, kratom can be sold as a food.

That's exactly what they ARE doing -- NFHC IS really "The Law" according to FDA - Vendors have been TOLD this - BY FDA's own Inspectors !! - What AKA is doing, is playing both sides, WHY ?? Because all their Retail folks are clearly selling Caps, shots, and products packaged FOR consumption / "Drugs" at least the packaging - Maybe not illegal ? but totally UN-approved by FDA. So those Retail vendors, do have MORE Risk of prosecution... compared to Online Vendors who sell plain powder NFHC.

Just because it's the FDA's unofficial law does not mean that states will endorse it. Kratom is legal—there is no federal law stating that it must be sold "not for human consumption," and the FDA cannot enforce their unofficial law in states that passed the KCPA. The KCPA does protect vendors, even though it holds them to certain regulatory standards. That's one of the reasons why so many kratom vendors operate out of Nevada. The risk of Retail vendors who do not otherwise infringe on the FDA's laws (i.e. not making medical claims, not touting it as safe or as beneficial, not selling salmonella-contaminated products) can be equal to the vendors who use NFHC if they have other thorough disclaimers based on the discretion of a knowledgable FDA-compliance attorney.

[kratomwriter]

From Natural Products Insider :

According to the “charge” in the import alert, kratom “appears to be a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

Mac Haddow, senior fellow on public policy for the American Kratom Association (AKA), said his organization believes the import alert is appropriate for processors importing kratom into the U.S. for the purpose of marketing it as a dietary ingredient.

But he argued FDA has no authority to stop kratom raw materials from coming into the country by wholesalers. And he asserted FDA has no authority to take action against non-adulterated, uncontaminated kratom sold as food with no health or dietary ingredient claims.

[Blergs]

Please read this article ... if you haven't about why "not for human consumption" doesn't help as much as you think.

Check the Date - I'm familiar with Andrew, we debated the issue 5 years ago on Reddit - He was wrong then - his dire warnings & predictions have not panned out - He was involved with a Retail Brand "Urban ICE" owner was waging a little war against online vendors - Because they cut his Prices in half. - Both are in the documentary A Leaf Of Faith. . Andrew aka Nerds, is a good guy & I hope he's doing well.

And look at this other example of a court case[/b] in which a vendor got in trouble for "misbranding" kratom with the NFHC disclaimer:

WRONG -- The Michigan case of Matthew Dailey, Nomad Botanicals, was convicted because of Medical Claims - had ZERO to-do with selling NFHC as a Disclaimer... re-read that Article and others about the case. His "misbranding" was on his import Shipment Label, importing huge packages, like a TON, with false labels... The case totally revolved around his website, pushing all kinds of Medical Claims: Kratom as "treatment" for various things. The Nomad case was also prosecuted by Michigan.. Sure the FDA chimed in, but it was a State case.

The "Not for human consumption" disclaimer does not work like it used to. Vendors need to try to follow the laws to the best of their ability.

That's exactly what they ARE doing -- NFHC IS really "The Law" according to FDA - Vendors have been TOLD this - BY FDA's own Inspectors !! - What AKA is doing, is playing both sides, WHY ?? Because all their Retail folks are clearly selling Caps, shots, and products packaged FOR consumption / "Drugs" at least the packaging - Maybe not illegal ? but totally UN-approved by FDA. So those Retail vendors, do have MORE Risk of prosecution... compared to Online Vendors who sell plain powder NFHC.

Don't bother man.. he's just going to go on and on , and I'm not sure why...
Everything has been told and laid out over and over. If he's dead sit on his view, let it be . No point in pointless conversation..

[kratomwriter]

Don't bother man.. he's just going to go on and on , and I'm not sure why...
Everything has been told and laid out over and over. If he's dead sit on his view, let it be . No point in pointless conversation..

I appreciate your input, but also I know he has a lot of valuable knowledge. I'm not trying to persuade him of anything; I just wanted to hear him entirely out and find out why he's adamant about this, as it seems like there's confusion with the US laws, and getting to the bottom of it might be able to help others out.

I mean, his early argument already has had an influence—one person even said "Reading this makes me want to support not for consumption only vendors," which is kind of harmful for vendors who take the time to read and comprehend all of the regulatory and marketing guidelines for kratom (or consults with FDA-compliance attorneys) and perhaps don't have NFHC on their label/website. I mean in general, the public sees that NFHC is sketchy—it was the same disclaimer used on dangerous synthetic drugs like "K2" and "spice." Some states have even incorrectly banned kratom as a synthetic substance...I highly doubt the NFHC labels helped distinguish kratom from those synthetic drugs.

I want to promote what's best for the kratom community (not just vendors, but consumers) and I am ready to change my mind if someone is able to provide me with a concrete legal example to go by. But if there is no evidence (be it from litigation or an expert's testimony), stating that "Not for Human Consumption" is the best and only way to protect yourself and your business is misinformation.