@Paul-Kemp With the news of the AKA getting into bed with the FDA is not good for the kratom world. I can't speak for anyone else but I want to know what does it mean for the legality of this leaf? This plant has saved millions and, while I've donated to the AKA in the past, I cannot see the good it would do to send them money if they are in bed with the enemy we have fought for years. What are your thoughts on this?
@Paul-Kemp With the news of th
as a former board member and cto I wouldn't send them a dime.
They ejected anyone that actually consumed kratom or switched them into contractors (Angie and robin I'm looking at you). They removed me for pursuing this app. Despite my tree farm and work with local universities to study this tree!
but when you look at what they have achieved as an orgization you can see the potential power for good. It's definitely a tough one for me.
@will thank you for your past and present work. I have no doubt the AKA was founded with the best of intentions.
The current incarnation has me very concerned. Regardless of whether they are still acting with the best of intentions, if they are successful their actions will lead to fewer choices and higher prices. And to be honest, I’m not convinced Kratom will be any safer, or even remain legal.
Rather than harassing small vendors with “snitch” programs, shipping dilemmas, and threatening legal action through the KCPA, I would prefer they spend their time and money funding research and educating consumers and vendors.
@Monnie-Fuq-LaVenus I signed a non-disparagement agreement when I left the AKA Board, so I will just say that I've found that if you obtain your kratom from groups in Indonesia who have been working for years to improve the quality and sanitation practices, or if you deal with quality-minded U.S. vendors who have integrity and work with farmers who are knowledgeable in harvesting practices, and you avoid buying shady products in smokeshops that practically scream words to the effect, "Stronger than Oxy!" you'll never run into any "laced" kratom. Nor are you likely to get salmonella!
That's my experience, from mostly toss & washing hundred of samples, many of them before there was any push to get GMP processing & labeling in place -- and I never got sick except 2 times when I accidentally took too much. I've had salmonella from restaurant food, so I know what it's like. Never had any spiked kratom, but I'm sure I could find it among some of the cartoon-logo garbage making medical claims in seedy smokeshops.
Again, buying from U.S. growers who are conscientious, I would have no qualms about consuming their products. Having said that, the U.S. is a very litigious country. On one side you're trying to appease the FDA, which may never give up on trying to ban kratom; on the other hand, you may get sued or be the subject of a complaint from a customer (or competitor) for selling "tainted product" and get reported to the FDA.
Selling rooted plants might be a good small business in the Southern states, while avoiding the expense of testing and sanitary handling, labeling, etc.
the aka and the fda have teamed up to ask consumers to "snitch" on vendors who do not follow GMP requirements. Truth in Labeling is what it's called and many are asking why is this happening when the fda has been against us from the start.
i don’t think the FDA has any involvement in this though. This is the AKAs attempt to help regulate the industry. Making health claims is not smart for vendors bc they could get jail time. When you sell a “new dietary ingredient” (which is what kratom is classified as) and market with health claims, the fda then considers it an unapproved new drug and you can get screwed. Any vendor who makes claims and is snitched on might just be getting saved from worse. Don’t get me wrong, I want anyone to be able to sell kratom and I think regulation starts to cut some ppl out. If the FDA really worked with the AKA that might not be great for the small vendors who don’t have any regulatory measures, but for the consumer it’s assurance that kratom is here for the long haul. But I think the fda still wants kratom to look dangerous and sketchy to the public so they can continue their fear mongering tactics.
I don't think any action on our part is going to change the FDA's opposition to this plant, short of paying up and submitting kratom as a New Dietary Ingredient and getting no opposition from the FDA. One large vendor told me he had submitted such an application and heard no complaint, but he never showed me proof, so I'll assume the NDI wasn't accepted. I won't say who it was.
The American Kratom Association has been trying to meet with the FDA in hopes of educating them with science to back up Kratom in the fight to keep Kratom legal. They are trying to enact the KCPA on the federal and this truth labeling act is the start of this process imo. https://www.americankratom.org/mediak/news/kratom-truth-in-labeling-policy-brief.html
The AKA is not in bed with the FDA. They have refused to meet with the AKA for over 3 years.
What is true is that the FDA has expanded its attack on kratom by convincing state regulatory agencies like the Ohio Department of Agriculture that kratom should not be permitted for sale because kratom vendors are marketing kratom as a drug with specific drug claims. This is a transparent misapplication of the Bolger v. Youngs Drug Products case (463 U.S. 60, 66-67 (1983)) where the Court established a “totality of circumstances test” to determine whether the speech is an advertisement, whether it refers to a specific product, and whether the speaker has an economic motive. While none of these factors alone would allow the FDA to classify the speech as “commercial,” together they would.
What the FDA is trying to do is to define kratom by the therapeutic claims made by kratom vendors that would classify kratom as an unapproved drug. Under this theory, the FDA argues that when vendors induce consumers to purchase kratom using such therapeutic claims, they can legitimately characterize these advertisements as commercial speech that allows the FDA to exercise the authority Congress gave them in the Food, Drug, & Cosmetic (FD&C) Act to enforce regulatory control based on whether a vendor claim is false or misleading. If successful, the FDA can limit even truthful speech because the kratom product being advertised is not a drug approved by the FDA.
Our defense is to demonstrate to regulatory agencies that the kratom consumer population is not represented by commercial speech, and in fact is actively engaged in repudiating such impermissible health claims under the FD&C Act. That prevents the FDA from making the claim to any regulatory agency they should regulate kratom as a drug, but rather recognize and regulate it as a food or dietary ingredient based on its intended use by consumers -- who have the right under noncommercial speech rights recognized by the courts.
Some vendors are upset that they will have to make the investments in equipment to assure kratom products are properly manufactured and meet good manufacturing practice standards required of food vendors to assure consumers their products are not contaminated. In fact, if the FDA were properly regulating kratom today those standards would apply to all kratom manufacturers. Just look at a bottle of water or a soft drink and you will see the labeling requirements imposed by the FDA for such food products.
The new AKA Truth in Labeling Program will protect kratom from another regulatory overreach by the FDA and provide kratom consumers with a legitimate defense when we litigate these issues in OOhio. The FDA has REFUSED to even properly review new dietary ingredient applications by kratom vendors which demonstrates they are not willing to recognize the legitimate uses kratom consumers have the right to use kratom for in maintaining their health and well-being.
I have immense respect for those who have been involved in the fight like Paul and Will, and while we may occasionally have internal disagreements on strategies and tactics, I have no doubt kratom advocates like them are warriors who deserve respect. They have mine.
the idea is to make every vendor produce packaging like this to show exactly what is in the package and that it is pure product with no adulteration, correct?
This appears to be a label that does not make any impermissible health claims, and from what I can read of it I believe it is a very good example of how kratom products should be labeled.
I’m not sure it’s just about labels. Wouldn’t websites, emails, forums, and even chat discussions in places like Discord and MeWe be included?
This is spreading a false narrative. Why not delete it. Or explain yourself and this statement PLEASE. The statement ‘getting into bed with someone’ in politics means to be associated with an entity or someone in an undesirable way. The AKA is NOT associated with the FDA in any sort of undesirable way. This statement fuels the misdirected hostility within this community. Please explain yourself and delete it.
I am not trying to spread any false information but from the word we have gotten, there is a relationship between the AKA and the FDA. We've been trying to get the FDA to listen to us and the science for a very long time and suddenly we are buddies with them? I'm all for making sure vendors follow GMA guidelines and those who choose not to, those are the ones we turn in to the FDA? Am I understanding this correctly?
@Monnie-Fuq-LaVenus I don’t think the AKA is buddies with the FDA. Because they want vendors to produce GMP compliant product why would that mean they are ‘buddies’. Because we want safe product the same as the FDA?? We don’t want to go against them if their rules make sense. Why would we disagree with the FDA if they simply want Krstom to be safe and GMP compliant ~ Right? @Mac-Haddow
@Monnie-Fuq-LaVenus Any representation that AKA has any relationship with the FDA is false. Despite our best efforts to engage the FDA on a discussion of why pure, unadulterated, and non-contaminated kratom should be properly classified and regulated as a food, the FDA REFUSES to even respond.
What the AKA is dedicated to is protecting and preserving the freedom of kratom consumers to make informed choices on products they use to manage their health and well-being. Consumer have the absolute right -- under the standards established by the courts for noncommercial speech -- to make such decisions.
The FDA has clearly adopted a very aggressive posture to claim the vast majority of kratom manufacturers refuse to follow GMPS and label their products with illegal therapeutic claims, and that is the argument they are promoting today to state regulatory agencies. Some vendors want NO REGUATIONS of any kind. That is not the real world, and it will never be possible even when we convince the Congress to do the same thing they did in 1994 with the Dietary Supplement Health & Education Act (DSHEA) where they limited FDA's regulatory authority over vitamins and dietary supplements. Kratom vendors will be subject to the regulations on food and dietary ingredients, and if they choose to market kratom as a dietary supplement, all of the regulations covered in DSHEA for those kinds of products.
Those who argue for no regulation paint a target on kratom and that will empower the FDA to argue all kratom must be banned.
If you really are not interested in promoting false information about the AKA, then now would be the time to stand up and repudiate these absurd attacks and question the motives of those making them.
I am glad to talk personally on this subject if needed. My email is mhaddow@americankratom.org.
So, all their asking us to do is if we run across a vendor who chooses not to follow GMP guidelines then we refer it to the AKA first, then they will kick it off to the FDA if necessary? Do I understand this right?
@pete2000 Yes, the courts have permitted the FDA to look at all forms of a vendor's "speech" that included blogs, websites, social medial platforms and marketing materials disseminated in any way in which an economic benefit can be imputed. This commercial speech prohibits any vendor from making therapeutic claims for any product for which there has not been an approval granted by the FDA.
@machaddow your very correct. It's why vendors need to watch what they say and how they act online.
@Monnie-Fuq-LaVenus The process will be for any report submitted on a possible illegal therapeutic claim to (1) be evaluated based on the evidence submitted; (2) an independent verification that the claims are actually being made; (3) a contact with the vendor to see if they will voluntarily correct any impermissible therapeutic claims -- and if they do the issue will be considered resolved; and (4) for vendors who cannot be reached because they do not provide required contact information or if they refuse to correct verified suspect claims, then the report will be forwarded to the FDA under current adverse event and therapeutic claim reporting systems for investigation.
It is likely that many vendors are unaware of the limitations on marketing, and AKA wants to protect the kratom consumers from the FDA using such marketing practices to be more aggressive in enforcement than they already are.
No vendor needs to make any health claims on their products or on their site. I get that there are vendors (i havent shopped recently so I can't say I know of any offhand) who claim their product "cures what ails you" or will fix any pain you have. We've been fighting that since forever and just to get this point across, One particular person I came across about a year ago claimed his kratom was the "best opiate on the market" and i messaged him and, although I may have stated it a bit harsh, i told him he needed to change his sales pitch and he came back with "that's what makes it sell so good". Things like that are what we are fighting. IF that's what we are concentrating on, then I'm on board. My issue with all of this is that we've fought the FDA tooth and nail for years and with every fiber of our being put all we had into every time we've had a success. I can't speak for anyone else but i think many people feel like we're getting too close to the entity that has been wanting to shut us down since day one. It's a terrifying thing. Many of us wouldn't be alive without this leaf and the thought of losing it scares us literally to death. @machaddow I'm not personally attacking you, i want to make that clear. I'll keep fighting the good fight. I just want to make sure my efforts are going the right direction.