Unless you have no idea what Kratom is you have likely seen disclaimers on websites selling it and packaging that say things like “Not For Human Consumption”, “For research purposes and comes with no directions on use”, “For Soap Making/Incense/etc.” and the list goes on. How can a substance that works like Kratom does actually achieve anything if its not being consumed? Well the reality is both the government and the industry selling Kratom products know that its being consumed by the vast majority of customers no matter what anyone wants to claim.

When Kratom was under the radar several years ago you would see many using these disclaimers to reduce their perceived liability and requirement to follow the regulations that apply in theory. The reality is it fooled absolutely no one and the FDA, who is in charge of oversight on dietary ingredients, likely just doesn’t have the manpower or capability to enforce the regulations heavily that apply under the Dietary Supplement Health and Education Act. But wait, how is Kratom a “supplement” exactly if the industry isn’t providing instructions for use? Several years ago the FDA released the 54–15 and at that time solidified the status of Kratom going forward, as a dietary ingredient and when sold directly to consumers it becomes a health supplement.

https://www.accessdata.fda.gov/cms_ia/importalert_1137.html

Now here is where the million-dollar question comes up, “How can it be a dietary ingredient/supplement if the seller isn’t marketing it as such?” No matter what a vendor or consumer may claim, once the FDA released the 54–15, due to the entire market and its open use, it became that of a dietary ingredient/supplement if sold in bulk or raw unfinished form. Now if a marketer actually made the powder in to soap, then obvious and distinct other regulations dealing with cosmetics and such would likely apply but lets be real that kratom soap is not used by many but good that it stays available for those that like it. Due to how most Kratom is marketed and sold outside of following 21cfr111 and DSHEA though many, maybe most, are already in direct violation of those regulations and selling an obvious illegal product. This also isn’t something that will surprise the government and shouldn’t surprise anyone buying/selling Kratom. Included you will see one of many cases that have already addressed what happens when one violates the regulations by using a “loophole” that doesn’t actually exist. These regulations apply no matter what the substance is. Linked below is just one of those cases where a seller of a consumable decided to try his luck with “Not For Human Consumption”.

Just one exerpt from this that talks to the issue “Mr. Keightly owned and operated businesses that marketed and sold peptides (a type of amino acid), along with other non-controlled bodybuilding chemicals, to individuals seeking to enhance their physiques. He marketed these products on his website while providing a disclaimer that the substances were not for human consumption and use (“for research purposes only”). Customers who visited the website seeking these products for bodybuilding purposes would falsely attest that they were buying the chemicals for research purposes. Mr. Keightly knew that the buyers were lying about what they would do with the chemicals. By marketing the products to the online bodybuilding community, Mr. Keightly knew that purchasers would use the products for personal consumption rather than research. The “research only” disclaimer was a device to circumvent the regulatory authority of the Food and Drug Administration (FDA). “ This doesnt work for bodybuilding substances, this didnt work for the headshop highs and this will no longer work for Kratom.

https://www.pacermonitor.com/public/case/19783421/USA_v_Keightly (link requires membership to read what’s included)

So what can you do as a seller or consumer of Kratom? Well for starters it’s long past time to work towards compliance with the law. The words Current Good Manufacturing Practices or cGMP should be ingrained in your vocabulary, not only because it provides far more safety to the customer but also lets others know you have established professional Standard Operating Procedures to address every step of importation, manufacturing and marketing. If you are buying Kratom products and supporting anyone not following the regulations long ago established, you are directly affecting the long-term legality of Kratom. It’s fairly simple, if you are selling Kratom and using loopholes or buying from a vendor that isn’t at least making a solid effort toward compliance with the laws then soon enough it will be banned.

This is why for some time many have pushed for that compliance, starting with a small group of vendors and the Botanical Education Alliance and now moving forward with the vendor compliance program that the American Kratom Association is establishing with insight from several knowledgeable third parties.

The DEA, FDA, NIDA and many other government entities are making it clear, via their #LeaferMadness push on social media that they are gearing up for what may be the final fight in this video game. In the past few days the DEA has their field offices tweeting and now NIDA is tweeting much of the same propaganda, likely in the hope that the media will pick it up and repeat it.

https://twitter.com/NIDAnews/status/1021092790485254144

Is it too late to act? Absolutely not. Now is the perfect time to openly support the AKA, other organizations and the vendors who are making the effort to follow the current regulations as solidly as possible. The one draw back here is Kratom products so far have not gotten the nod as a New Dietary Ingredient but if the industry largely cleans up their actions its fairly obvious that those next steps could be far more achievable at some point. If the industry does not clean up their actions and consumers don’t largely support that work then the days are numbered for Kratom legality. Without doing this clean up the Kratom community will for sure lose what support they have in Congress as well as the media, who are all watching to see if we all know what real organizing and professionalism is about. Do you want to see Kratom to be available a year from now? Stop supporting the idea that Kratom is “Not For Human Consumption” and just follow the laws to the best of your ability. We all want Kratom to be around for years to come so lets show the public thats the truth.

Included are links to the Dietary Supplement Health and Education Act of 1994 as well as US Regulation 21 CFR 111, educate yourself please.

https://ods.od.nih.gov/About/DSHEA_Wording.aspx

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111

If you are a vendor of Kratom products it would be worth looking in to both the American Kratom Associations GMP program as well as the American Herbal Products Assocations educational offers for members.

https://www.americankratom.org/aka-gmp-standards

http://www.ahpa.org

I want to see Kratom stay legal forever, I want to see far more research in to the benefits (and risks) with Kratom use and I want to have my quality of life protected. I suspect if you are reading this you probably want that also. Lets work hard to see that stay the path we are all on.

Just remember to keep fighting because This Isn’t Over.